SWOG
FALL 2014 GROUP MEETING
OCTOBER 22-25, 2014
CHICAGO, ILLINOIS
2 Fall 2014
Welcome to SWOG’s Fall 2014 Meeting!
At each meeting we try to review our progress, offer new opportunities, and, of course, to
revise and improve meeting sessions. But two events merit highlighting: our Hope Donor
Lounge, and our Kilimanjaro Climb for Cancer Clinical Trials.
The Donor Lounge offers comfort, meeting space, snacks, and even free Wi-Fi, targeted to
those who have donated to The Hope Foundation. If you haven’t yet, visit the Hope desk,
make your donation, and get your admission ribbon.
The recent decline in public funding for cancer (and other biomedical) research threatens
our progress. In February I’ll be climbing Mount Kilimanjaro, one of the Seven Summits,
to help raise awareness of how critical clinical trials are to cancer patients, and equally
importantly, to raise funds for cancer research (primarily for The Hope Foundation). Our
sister groups in the NCTN have pledged their support in this campaign, and we are working
on a partnership with ASCO’s Conquer Cancer Foundation so we can reach a wider public.
Stay tuned for much more!
While you’re here in Chicago, don’t let the wealth of professional opportunities keep you
from sampling what the city itself has to offer. I look forward to an exciting few days!
Sincerely,
Charles D. Blanke, M.D.
SWOG Chair
KILIMANJARO
Climb for Cancer Clinical Trials
SWOG & HOPE NCTN
Alliance ECOG-ACRIN
ASCO & the CCF
NRG Oncology
In February of 2015, SWOG Cancer Research Chair Dr. Charles D. Blanke will climb Mount Kilimanjaro to raise awareness of the importance of cancer clinical trials and to bring attention to the perils
of dwindling federal funding for the National Cancer Institute and its National Clinical Trials Network.
You can participate by donating to the Climb at swog.org/kilimanjaro!
Almost 100% of donations will go directly to fund cancer clinical research.
And like us on FaceBook! facebook.com/ClimbforCancerClinicalTrials
The Climb for Cancer Clinical Trials campaign is being conducted by the SWOG Cancer Research cooperative group
and The Hope Foundation, in support of the NCI National Clinical Trials Network, or NCTN. Participating cooperative groups within the NCTN include The Alliance for Clinical Trials in Oncology, ECOG-ACRIN Cancer Research
Group, and NRG Oncology. SWOG thanks the American Society for Clinical Oncology and its Conquer Cancer Foundation for their generous support in this effort.
SWOG • Leading Cancer Research. Together.
The Hope Foundation-2015 SWOG Agenda Booklet Donor Lounge Ad_03.pdf
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4:44 PM
SWOG Group Meeting Agenda 3
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SWOG • Leading Cancer Research. Together.
4 Fall 2014
GROUP MEETING INDEX
.PAGE(S)
The Hope Foundation............................................................................................................................................................ 3 & 13
Plenary Sessions.................................................................................................................................................................5, 15-16
Office Hours and Round Table Sessions.....................................................................................................................6, 7 & 16-17
Collaborative Opportunities at CSHL & JAX Labs for SWOG Investigators..................................................................... 7 & 17
Translational Medicine Retreat........................................................................................................................................... 8 & 19
Hyatt Regency Chicago Travel and Hotel Information and Hotel Maps..............................................................................10-11
Group Meeting Supporters................................................................................................................................................. 13 & 60
Schedule of Events.................................................................................................................................................................14-19
Roster of Committee Speakers..............................................................................................................................................20-21
Administrative Committees......................................................................................................................................................... 22
Committee Information
Adolescent and Young Adult (AYA) Committee....................................................................................................................15
Barlogie-Salmon Myeloma Committee.............................................................................................................15, 17 & 25-26
Breast Committee..........................................................................................................................................15, 17, & 27-30
Board of Governors............................................................................................................................................................. 18
Bone Marrow & Stem Cell Transplantation Committee........................................................................................................17
Cancer Control and Prevention Committees......................................................................................................15-16 & 31-39
Cancer Care Delivery Committee...................................................................................................................... 15 & 33 Cancer Survivorship Committee....................................................................................................................... 15 & 34
Prevention Committee................................................................................................................................. 15 & 35-37
Symptom Control and Quality of Life Committee.........................................................................................15 & 38-39
Committee Chairs............................................................................................................................................................... 18
Early Therapeutics and Rare Cancers Committee........................................................................................................ 15 & 40
Gastrointestinal Committee...................................................................................................................................18 & 41-43
Genitourinary Committee................................................................................................................................17, 18 & 44-46
Imaging Committee............................................................................................................................................................. 18
Leukemia Committee.......................................................................................................................................15, 16 & 47-49
Lung Committee....................................................................................................................................................18 & 50-52
Lymphoma Committee...........................................................................................................................................18 & 53-54
Melanoma Committee.....................................................................................................................................15, 17 & 55-56
Pharmaceutical Sciences Committee................................................................................................................................... 18
Radiation Oncology Committee................................................................................................................................... 16 & 24
Surgery Committee.................................................................................................................................................... 17 & 24
Training & Workshops
Jeri and Noboru Oishi Symposium/Continuing Education Workshop............................................................................. 14 & 23
Oncology Research Professionals (ORP) Open Forum.................................................................................................. 15 & 23
Special Symposia...........................................................................................................................................................23-24
Future Group Meeting Dates....................................................................................................................................................... 58
SWOG • Leading Cancer Research. Together.
SWOG Group Meeting Agenda 5
Plenary Part I (TM)
The fall meeting’s Translational Medicine Plenary will take place
Thursday, Oct 23, 2:30 - 4:30 pm, in Regency A-C.
Speakers and topics will include the following:
Introductory comments
Lee M. Ellis, MD, SWOG Vice-Chair for Translational Medicine
Targeting Cancer Stem Cells
Max Wicha, MD, University of Michigan
Emw/Wikipedia
Funding Opportunities Offered by SWOG and The Hope Foundation
Anne Schott, MD, SWOG Deputy Chair
Best of The Hope Foundation Grants
Mikala Egeblad, PhD, Cold Spring Harbor Laboratory
Accessing SWOG Biorepository for Translational Medicine and Biomarker Studies
James Rae, PhD, SWOG Executive Officer
MEK Targeting
Alex Adjei, MD, PhD, Roswell Park Cancer Center
Plenary Part II (General) ««« NOTE NEW MORNING TIME
The fall meeting's General Plenary will take place
Friday, Oct 24, 8 - 10 am, in Regency A-C.
Speakers and topics will include the following:
Chair’s welcoming and update
Charles D. Blanke, MD, SWOG Chair
Best of SWOG Update: Genitourinary
Ian M. Thompson, MD, Chair, Genitourinary Committee
Best of SWOG Update: Gastrointestinal
Howard Hochster, MD, Chair, Gastrointestinal Committee
Best of SWOG Update: Prevention
Powel Brown, MD, Co-Chair, Prevention Committee
SWOG Membership Opportunities and Benefits
Anne Schott, MD, SWOG Deputy Chair
Zephyris/Wikipedia
Ethical Aspects of Genetic Testing in Clinical-Translational Research
Angela R. Bradbury, MD, University of Pennsylvania
SWOG • Leading Cancer Research. Together.
6 Fall 2014
ONE-ON-ONE & SMALL GROUP
Round Table Discussions (advance registration needed)
Several SWOG and NCI leaders will be available to discuss challenges and opportunities in specific
subject areas and answer your questions, as detailed below. Space at these sessions is limited, so
visit the SWOG Registration Desk to register.
International Clinical Trial Participation
Laurence H. Baker, DO, SWOG Chair Emeritus & Manuel Valdivieso, MD, SWOG Senior Executive Officer
Fri, Oct 24, 2-3 pm, Picasso
Navigating SWOG for Young Investigators
Catherine Eng, MD, SWOG PI, MD Anderson
Fri, Oct 24, 10:30-11:30 am, Picasso
Fri, Oct 24, 3-4 pm, Jackson
Career Development Opportunities in the Experimental Therapeutics and Rare Cancers Committee
Razelle Kurzrock, MD, Chair, Experimental Therapeutics & Rare Cancers Committee
Fri, Oct 24, 10:30-11:30 am, Wright
Toxicity Reduction and Symptom Management in Clinical Trials
Lori Minasian, MD, NCI Division of Cancer Prevention
Fri, Oct 24, 2-3 pm, Jackson
Open Office Hours (no advance registration needed — drop-ins welcome)
Lung Observational Research Initiative
Antoinette Wozniak, MD, Karmanos Cancer Center
Fri, Oct 24, 1-3 pm, Gold Coast
Analysis and Design of Genomic Studies
Michael Wu, PhD, SWOG Statistical Center
Fri, Oct 24, 10-11:30 am, Gold Coast
Translational Medicine Office Hours (advance registration needed)
Several SWOG leaders and partners will hold pre-scheduled office hours. Visit the SWOG Registration Desk to sign up for a 20-minute appointment slot.
Nathan Eriksen, SWOG Group Chair’s Office — Fri, Oct 24, 10-11:40 am, Gold Coast
Topic: Biospecimen Banking and the SWOG Biorepository
Kevin Mills, MD, The Jackson Laboratory — Fri, Oct 24, 1:30-3:30 pm, New Orleans
Nilsa Ramirez, MD, Nationwide Children’s Hospital — Fri, Oct 24, 10-11:40 am, Gold Coast
David Tuveson, MD, Cold Spring Harbor Laboratory — Fri, Oct 24, 1:30-3:30 pm, New Orleans
Industry Office Hours (advance registration needed)
A chance to meet with industry partners. Sign up for an appointment at the SWOG Registration Desk.
Genentech/Roche
Fri, Oct 24, 10:30 am-12:10 pm, Stetson BC
Novartis
Fri, Oct 24, 10:30 am-12:10 pm, Stetson D
Foundation Medicine
Fri, Oct 24, 10:30 am-12:10 pm, New Orleans
Representatives from Genentech/Roche and Novartis will ALSO hold drop-in Open Office Hour
sessions on Friday afternoon, 1-2:30 pm, Genentech/Roche in Stetson BC, Novartis in Stetson D.
SWOG • Leading Cancer Research. Together.
SWOG Group Meeting Agenda 7
Collaborative Opportunities at CSHL and JAX
Labs for SWOG Investigators
Friday, October 24, 12-1:30 pm, Regency C
To help spark productive collaborations between laboratory and clinical researchers,
especially collaborations that might be appropriate for ITSC pilot grant program
funding, three scientists from each of SWOG's partner laboratories will give brief
introductions to their work, after which they will take questions from the audience.
Presenters include the following researchers:
Alea Mills, PhD, Professor, Cold Spring Harbor Laboratory
Dr. Mills will speak on the role of CHD5 in cancer.
JAX
Kevin Mills, PhD, Associate Professor and Associate Director for Translational Partnerships, Jackson Laboratory Cancer Center
Dr. Mills is working on development of therapeutics aimed at exploiting genomic instability in
cancer.
Karolina Palucka, MD, PhD, Professor & Associate Director of Cancer Immunology, Jackson Laboratory
Dr. Palucka is working in the development of dendritic-cell based cancer vaccines. She is especially interested in harnessing the JAX capacity for genomics and humanized mouse models to
design and validate future cancer immunotherapy.
Lloyd Trotman, PhD, Associate Professor, Cold Spring Harbor Laboratory
Dr. Trotman will talk about his mouse model for prostate cancer
Kyuson Yun, PhD, Assistant Professor, Jackson Laboratory
Dr. Yun has developed an ex vivo tumor slice system for detecting response to therapeutic challenge at the tissue level. This is a complement to the PDX models and the conditionally reprogrammed clones derived from them, giving us the capability to interrogate mechanisms of resistance at multiple levels of biological organization.
Yet To Be Named Draft Pick, Assistant Professor, Cold Spring Harbor Laboratory
Lorem ipsum
Post-Symposium Round Table
Friday, October 24, 1:30-2:30 pm, San Francisco
After the symposium ends, most of the speakers will
reconvene for an open round table to continue the discussion informally in a smaller group setting.
CSHL
SWOG • Leading Cancer Research. Together.
8 Fall 2014
SWOG Translational Medicine Retreat
October 25-26, 2014, Hyatt Regency Chicago
AGENDA
Saturday, October 25, 2014
1:00 – 2:00 PM
REGENCY D
Omics Platforms (genomic and proteomics): Led by James Rae, PhD
James Rae, PhD – Introduction
David Solit, MD – “Lessons from the study of extraordinary responders”
Neil Hayes, MD, MPH – “Discovering versus identifying driver mutations: Birds of a Different
Feather”
2:00 – 3:00 PM
REGENCY D
Histology Agnostic Studies: Led by Razelle Kurzrock, MD
Razelle Kurzrock, MD – “Histology-agnostic studies: A new paradigm”
Teresa Helsten, MD – “The FGF/FGFR Landscape in Cancer: Clinical Implications”
Panel Discussion
3:00 – 3:30 PM
REGENCY D
Break
3:30 – 4:30 PM
REGENCY D
TM: Administrative, Regulatory, and Financial: Led by Nathan Eriksen
Nathan Eriksen – Tissue Banking in SWOG
Nathan Eriksen – Navigator
Dana Sparks – SWOG TM
Panel Discussion
4:30 – 5:30 PM
REGENCY D
Master Protocols: Innovative Statistical Designs and Lessons Learned from Lung-MAP:
Led by David Gandara, MD
David Gandara, MD – Introduction
Vassiliki Papadimitrakopoulou, MD – “Addressing unmet needs through Master Protocols”
Philip Mack, PhD – “Incorporating Translational Science into the Master Protocols”
Mary Redman, PhD – “Statistical Designs for Master Protocols”
Panel Discussion – Speakers above plus Fred Hirsch, MD, PhD; Roy Herbst, MD, PhD;
and Michael LeBlanc, PhD
5:30 – 6:30 PM
REGENCY C
Reception
8:00 – 9:30 AM
GRAND A
Immune Therapy: Led by Kim Margolin, MD, and Mario Sznol, MD
Kim Margolin, MD – “Basis of cancer immunotherapy”
Mario Sznol, MD – “Checkpoint blockade therapy for cancer”
9:30 – 10:30 AM
GRAND A
Liquid Biopsies: Led by Scott Kopetz, MD, PhD, and Robert Kinders, PhD
E. Scott Kopetz, MD, PhD – “Circulating cell-free DNA from plasma to assess response
and resistance”
Robert Kinders, PhD – “Replacing research biopsies with pharmacodynamic assessment
of circulating tumor cells”
10:30 – 11:30 AM
Interactive Session: Moving TM Forward in SWOG
Participants will split into 2 breakout rooms to discuss and brainstorm
1. Administrative and financial barriers to TM studies
– Nathan Eriksen and Anne Schott, MD
2. How to explore/address common themes/problems within SWOG
and across NCTN Groups – David Gandara, MD, and Ian Thompson, MD
COLUMBUS AB
COLUMBUS CD
Sunday, October 26, 2014
11:30 – 12:00 PM
GRAND A
Break and group report prep
12:00 - 12:30 PM
GRAND A
Group Reports & Closing – Charles Blanke, MD
SWOG • Leading Cancer Research. Together.
SWOG Group Meeting Agenda 9
Go Mobile at the Meeting!
To manage your Group Meeting experience from your
smartphone, download our mobile guidebook.
You’ll be able to plan your day with a personalized
schedule and browse exhibitors, maps and general show
info, all in the palm of your hand.
The guidebook app is compatible with iPhones, iPads,
Android, and Blackberry devices.
To get the app, use your phone’s QR-code reader to scan
the code at right. Or choose one of these methods:
1. Download 'Guidebook' from the Apple App Store or the Android Marketplace OR
2. Go to m.guidebookapp.com from your Blackberry OR
3. Visit guidebookapp.com/getit from your phone's browser.
Once you’ve installed the Guidebook app, search for the SWOG Spring 2014
Group Meeting Guide in the "download guides" section of the app.
Tweeting the Meeting?
Tag your Group Meeting tweets
with
#swogonc
We’ll post the live stream of tagged Group Meeting
updates to the SWOG website, for ease of following by
those who couldn’t make it.
Follow SWOG at twitter.com/SWOG. Our username is @SWOG.
SWOG • Leading Cancer Research. Together.
10 Fall 2014
HYATT REGENCY CHICAGO
Meeting
Rooms / Hotel Services
Meeting Rooms/Hotel Services
West Tower, Gold Level
31 Acapulco,
31 Acapulco, West Tower, Gold Level
7
1
2 3
4 5
6 7
9
8
Stetson A-F Meeting Rooms located on
the Purple Level of the West Tower (one
level below the Gold Level). Business
Center and Package Pick-Up located on
the Purple Level of the East Tower.
Addams, West Tower, Silver Level
7
Addams, West Tower, Silver Level
36
Atlanta, West Tower, Gold Level
2
Burnham, West Tower, Silver Level
36 Atlanta, West Tower, Gold Level
20 Buckingham, West Tower, Bronze Level
20 Buckingham, West Tower, Bronze Level
2 Burnham, West Tower, Silver Level
24 Columbian, West Tower, Bronze Level
24 Columbian, West Tower, Bronze Level
37 Columbus A-F, East Tower, Gold Level
37 Columbus
A-F,Tower,
East Tower,
G-L, East
Gold Gold
LevelLevel
38 Columbus
38 Columbus
G-L, East
Tower,Level
Gold Level
West Tower,
Bronze
27 Comiskey,
SILVER LEVEL
27 Comiskey,
West Tower,
East Tower,
GreenBronze
Level Level
16 Concierge,
16 Concierge,
BallroomsEast
A-C,Tower,
WestGreen
Tower,Level
Green Level
15 Crystal
10
11
14
8
DuSable,
WestBallrooms
Tower, Silver
15 Crystal
A-C,Level
West Tower, Green Level
6
Field,
Tower,
Silver
Level
8 West
DuSable,
West
Tower,
Silver Level
Center,
Tower,
10 Fitness
6 Field,
WestWest
Tower,
Silver Blue
LevelLevel
Desk,
East
Tower,
Blue
Level
13 Front
29 Lakeshore Meeting Rooms**, East Tower, Bronze Level
13
Coast, West Tower, Bronze Level
21 Gold
13 Front Desk, East Tower, Blue Level
39 Grand Ballrooms A-F, East Tower, Gold Level
BLUE LEVEL
21
Gold Coast, West Tower, Bronze Level
22
Haymarket, West Tower, Bronze Level
32
Hong Kong, West Tower, Gold Level
22 Haymarket, West Tower, Bronze Level
32 Hong Kong, West Tower, Gold Level
1
1 Horner, West Tower, Silver Level
East Tower, Bronze Level
29 Jackson,
16
15
4
18
17
3 Orleans,
Ogden, West
WestTower,
Tower,Silver
GoldLevel
Level
35 New
39
3
GREEN LEVEL
23 Picasso,
Ogden,
West Tower,
West Silver
Tower, Level
Bronze Level
West
Tower, Bronze
Level Green Level
39 Plaza
23 Picasso,
Ballrooms,
East Tower,
East Tower,
Level Gold Level
39 Plaza
30 Ballrooms,
Regency Ballrooms
A-D,Green
West Tower,
21 25
26
4 McCormick,
West Tower,
McCormick,
West Tower,
SilverSilver
LevelLevel
35 NewEast
Orleans,
West
Tower,Level
Gold Level
Tower,
Bronze
29 Michigan,
19
20
22
23
24
Horner, West Tower, Silver Level
Tower,West
Bronze
Level
29 Randolph,
34 San East
Francisco,
Tower,
Gold Level
Ballrooms A-D, West Tower, Gold Level
30 Regency
9 Sandburg, West Tower, Silver Level
29
27
East Tower, Bronze Level
29 Roosevelt,
26 Soldier Field, West Tower, Bronze Level
28
34 San Francisco, West Tower, Gold Level
9
33
Toronto, West Tower, Gold Level
10
Fitness Center, West Tower, Blue Level
25
Water Tower, West Tower, Bronze Level
5
Wright, West Tower, Silver Level
Sandburg, West Tower, Silver Level
26 Soldier Field, West Tower, Bronze Level
BRONZE LEVEL
33 Toronto, West Tower, Gold Level
25 Water Tower, West Tower, Bronze Level
28 Wrigley, West Tower, Bronze Level
5 Wright, West Tower, Silver Level
31
30
32
33
35
39
West Tower, Bronze Level
28 Wrigley,
Restaurants/Bars
37
34 36
14
38
BIG Bar, East Tower, Blue Level
19 American Craft Kitchen & Bar, East Tower, Green Level
11 DaddyO’s Pub and Game Rm, West Tower, Blue Level
Bar, East Tower, Blue Level
14 BIG
18 Market
Tower,
Green
Level
PubChicago,
& GameEast
Room,
West
Tower,
Blue Level
11 DaddyO’s
GOLD LEVEL
WEST TOWER
19 American Craft Kitchen&Bar, East Tower, Green Level
Restaurants
/ Bars
Bar, East
17 Stetson’s
Chicago,Chop
East House
Tower,&Green
LevelTower, Green Level
18 Market
EAST TOWER
SWOG • Leading Cancer Research. Together.
17 Stetson’s Chop House & Bar, East Tower, Green Level
SWOG Group Meeting Agenda
Chicago Travel & Hotel Information
Hyatt Regency Chicago
151 East Wacker Drive
Chicago, Illinois 60601
Phone: 312-565-1234
Fax: 312-239-4414
Arrival/Departure:
Check-in time is 3:00 p.m. Check-out time is 12:00 noon.
Room amenities include a full bath, hair dryer, ironing
board and iron. The concierge staff serves as a liaison between guests and the hotel and outside services.
Hotel Safety Deposit Boxes:
For your convenience, safety deposit boxes are available
at the front desk for your valuables. Please do not leave
valuables in your room.
Recreational Facilities:
The fitness center offers a variety of exercise equipment,
free weights, treadmills, and more, exclusively for hotel
guests. It is open 24 hours a day.
Hotel Restaurants and Lounges:
• Stetsons Modern Steak & Sushi: Non-traditional
steakhouse experience in a comfortable urban setting,
specializing in steaks and seafood. Restaurant is open
daily from 5:00 p.m. - 11:00 p.m.
• American Craft Kitchen & Bar: Regionally inspired by
all corners of the country, they offer an approachable
dining experience with handcrafted food and drink.
This atrium restaurant is the perfect stop for breakfast
or lunch. Open daily from 6:00 a.m. - 3:00 p.m.
• Market Chicago: Offers breakfast, lunch or dinner for
a quick meal or coffee to go. Open 24 hours a day.
• DaddyO’s Pub & Game Room: Corner pub featuring
juicy burgers, local bres and wall-to-wall entertainment. Open 5:00 p.m. - 1:00 a.m.
• The BIG Bar features the longest free-standing bar
in North America and specializes in a wide variety
of cocktails, wines, champagnes and cognacs and
snacks. Open daily at 5:00 p.m.
• In-room dining is available from 6:00 a.m. - 12:00 a.m.
daily.
Business Center:
The Business Center is located on the Purple level in the
East Tower of the hotel. It is open 24 hours a day, 7 days
a week. The Business Center offers fax machines, computer services, color copies, mail drop, Internet access
and photocopying.
Ground Transportation:
• A taxi ride from O’Hare airport to the hotel is approximately $35.00 one-way.
• A taxi ride from Midway airport to the hotel is approximately $30.00 one-way.
• Valet parking at the hotel is $59.00 per day for hotel
guests.
Temperature:
The average high for October is 64 degrees and the average low is 46 degrees.
Area Attractions:
• Adler Planetarium and Astronomy Museum
• Architectural Boat Tours
• Art Institute of Chicago
• Brookfield Zoo
• Chicago ArchiCenter
• Chicago Architecture Foundation
• Chicago Botanic Garden
• Field Museum of National History
• John G. Shedd Aquarium
• John Hancock Center Observatory
• Millennium Park
• Museum of Contemporary Art
• Museum of Science and Industry
• Rockefeller Memorial Chapel
• Sears Tower Skydeck
Local Restaurants:
(The hotel concierge can assist with reservations and suggestions)
• Alinea - Eclectic
• Atwood Cafe - American
• Bistro 110 - Continental
• Cape Cod Room - Seafood
• Charlie Trotters - Eclectic
• Mia Francesca - Italian
• Mon Ami Gabi - French
• Shaw’s Crab House and Blue Crab Lounge - Seafood
• Silver Cloud - American
• Spiaggia - Italian
SWOG • Leading Cancer Research. Together.
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CME Credit Information
Procedures for CME Credit
CME credit forms for the Group Meeting are available in the
back of the Group Meeting agenda booklet. Only one form per
person is required to list the CME credits for the entire meeting.
Credits for each committee session are listed on the form.
Forms should be turned in to the Registration Desk before the
desk closes at 11:00 a.m. on October 25, 2014. If the forms
are not turned in to the desk, they can be mailed to the Operations
Office the week following the Group Meeting. The Operations Office will submit all CME forms to the accrediting institution at one
time. Forms will be submitted 30 days following the meeting.
You will then receive a certificate of completion in the mail
following submission and processing of the CME forms by the
accrediting institution.
Group Meeting Target Audience and Educational Objectives
SWOG meets semi-annually to keep its members abreast of Group
science. The target audience for these meetings are Physicians, Nurse
Oncologists and Clinical Research Associates.
The educational objectives of these meetings are: to educate attendees
about active and proposed studies so that they may implement the studies
at their local institutions; to educate attendees about new treatments
and prevention strategies that are available; to identify areas that can
be improved in cancer research and study implementation and educate
attendees on the best ways to implement the solutions at the local level.
These objectives apply to the following areas: Cancer Control and
Prevention, including Cancer Care Delivery Committee, Symptom
Control and Quality of Life Committee, Prevention Committee, Cancer
Survivorship Committee and Harry Hynes Symposium; Genitourinary
Committee; Early Therapeutics & Rare Cancers Committee; Myeloma
Committee; Melanoma Committee; Surgery Committee; Radiation
Oncology Committee; Plenary Sessions Part I and II; Leukemia Committee;
Breast Committee; Gastrointestinal Committee; Lung Committee, and
Lymphoma Committee.
Continuing Medical Education Credit
The Hope Foundation is accredited by the Accreditation Council for
Continuing Medical Education to provide continuing medical education
for physicians.
The Hope Foundation designates this live activity for a maximum of
26.25 AMA PRA Category 1 Credits™. Physicians should only claim
credit commensurate with the extent of their participation in the
activity.
SWOG • Leading Cancer Research. Together.
SWOG gratefully acknowledges the
support of our CME Commercial Supporters*
Platinum Supporters
Celgene
Eli Lilly & Co.
Novartis
Gold Supporters
Amgen
Silver Supporters
AbbVie
AstraZeneca
Bristol-Myers Squibb
Bronze Supporters
Otsuka
Sigma-Tau Pharmaceuticals
*Supporters as of September 17, 2014
Speaker and Planner CME Disclosure Information
Each speaker and planner for The Hope Foundation - CME courses has
been requested to complete a Faculty Disclosure Form prior to the activity
in accordance with ACCME standards. THF strives to provide accurate
and up-to-date information regarding affiliations or interests that might
be perceived as a potential conflict of interest for those who control
CME content. Please see the disclosure handout available at the SWOG
self-service and onsite registration desks. Best attempts will also be
made to provide up to date information on introductory slides at each
CME session.
SWOG Group Meeting Agenda
The Hope Foundation-2014 SWOG Agenda Booklet Ad_02.pdf
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14 Fall 2014
SCHEDULE OF EVENTS
WEDNESDAY, OCTOBER 22, 2014
THURSDAY, OCTOBER 23, 2014
Group Meeting Registration & Information Desk
1:00 p.m. - 5:00 p.m. - Regency Foyer (Gold Level, West Tower)
Group Meeting Registration & Information Desk
7:00 a.m. - 5:00 p.m. - Regency Foyer (Gold Level, West Tower)
1:00 p.m. – 3:00 p.m.
Nursing Research Subcommittee
Bronze Level, West Tower Room: Haymarket
Hope Foundation Information Desk
7:00 a.m. - 5:00 p.m. - Regency Foyer
2:00 p.m. – 3:00 p.m.
ORP Liaison Subcommittee Bronze Level, West Tower (Formerly Disease & Discipline Room: Gold Coast
and Research)
3:00 p.m. – 4:00 p.m.
SWOG Tissue Banking Meeting Bronze Level, West Tower (Invitation Only) Room: Soldier Field
3:00 p.m. – 5:30 p.m.
ORP Executive Committee Bronze Level, West Tower (Committee Members Only) Room: Haymarket
Innovation Working Group 4:00 p.m. – 6:00 p.m.
Bronze Level, West Tower (Working Group Members and Room: Water Tower
Invited Committee Members Only)
5:30 p.m. – 7:30 p.m.
Gold Level, West Tower
Room: Toronto
Site Operations (Formerly Head CRA) - Open to Member, Affiliate and CCOP Head CRAs Only
5:30 p.m. – 8:00 p.m.
Gold Level, West Tower
Room: Acapulco
Cancer Control and Prevention Executive Meeting (Committee Members Only)
Exhibits & Complimentary Coffee Service
7:00 a.m. - 4:00 p.m. - Regency Foyer
7:00 a.m. – 5:00 p.m.
Gold Level, West Tower
Room: Hong Kong
Hope Foundation Donor Lounge
(Donors Only) 7:30 a.m. – 8:00 a.m.
Gold Level, West Tower
Room: Regency C Foyer
8:00 a.m. – 8:15 a.m.
Room: Regency CD
Jeri and Noboru Oishi
Symposium & Continuing Education Workshop Check-In New Nurse/CRA Committee Orientation / Business Meeting (Open Session)
8:15 a.m. – 12:00 p.m.
Jeri and Noboru Oishi Room: Regency CD
Symposium & Continuing Education Workshop (Open Session)
Note: The Hope Foundation is accredited by the Accreditation
Council for Continuing Medical Education to provide continuing
medical education for physicians.
The Hope Foundation designates this live activity for a
maximum of 26.25 AMA PRA Category 1 Credits™.
Physicians should only claim credit commensurate with the
extent of their participation in the activity.
NOTE: Gray Areas Indicate Workshops
and Oncology Research Professional
(ORP) Sessions.
SWOG • Leading Cancer Research. Together.
SWOG Group Meeting Agenda
15
SCHEDULE OF EVENTS
THURSDAY, OCTOBER 23, 2014
Group Meeting Registration & Information Desk
7:00 a.m. - 5:00 p.m. - Regency Foyer (Gold Level, West Tower)
Hope Foundation Information Desk
7:00 a.m. - 5:00 p.m. - Regency Foyer
Exhibits & Complimentary Coffee Service
7:00 a.m. - 4:00 p.m. - Regency Foyer
8:00 a.m. – 10:00 a.m.
Bronze Level, East Tower
Room: Michigan
8:00 a.m. – 11:00 a.m.
Bronze Level, East Tower
Room: Roosevelt
ORP Open Forum 12:30 p.m. – 2:00 p.m.
Green Level, East Tower
Room: Plaza Ballroom
CANCER CARE DELIVERY
12:30 p.m. – 2:30 p.m.
Bronze Level, East Tower COMMITTEE
Room: Michigan
1:45 p.m. – 2:30 p.m.
Gold Level, West Tower
Room: Regency Foyer
Plenary Reception (Desserts & Coffee)
CANCER SURVIVORSHIP COMMITTEE
2:00 p.m. – 3:00 p.m.
ORP Education Subcommittee Bronze Level, East Tower (Formerly Education & Program)
Room: Randolph
Advocates Committee Meeting (Committee Members Only) 2:30 p.m. – 4:30 p.m.
Gold Level, West Tower
Room: Regency A-C
PLENARY I (Translational
Medicine)
Quality Initiative Meeting 10:00 a.m. – 12:00 p.m.
Bronze Level, West Tower (Committee Members Only)
Room: Haymarket
4:30 p.m. – 7:30 p.m.
Green Level, East Tower
Room: Plaza A
Myeloma Working Group (Working Group Members Only)
Social Media Working Group 10:00 a.m. – 12:00 p.m.
Bronze Level, West Tower (Working Group Members Only) Room: Wrigley
5:00 p.m. – 7:00 p.m.
Bronze Level, East Tower
Room: Michigan
5:00 p.m. – 7:00 p.m.
Bronze Level, East Tower
Room: Randolph
SYMPTOM CONTROL &
QUALITY OF LIFE
COMMITTEE
10:15 a.m. – 12:15 p.m.
PREVENTION COMMITTEE
Bronze Level, East Tower Room: Michigan
5:00 p.m. – 7:00 p.m.
Green Level, East Tower
Room: Plaza B
Breast Working Group (Working Group Members Only) 12:00 p.m. – 2:00 p.m.
Bronze Level, East Tower
Room: Randolph
12:15 p.m. – 2:15 p.m.
Bronze Level, East Tower
Room: Roosevelt
5:00 p.m. – 7:00 p.m.
Conflict Management Committee Bronze Level, East Tower (Committee Members Only) Room: Jackson
10:00 a.m. – 12:15 p.m.
Gold Level, West Tower
Room: Regency A
EARLY THERAPEUTICS &
RARE CANCERS COMMITTEE
Adolescent and Young Adult (AYA) Committee Leukemia Working Group (Working Group Members Only) Melanoma Working Group (Working Group Members Only) 7:30 p.m. – 9:30 p.m.
Hope Foundation Board Meeting Bronze Level, East Tower (Committee Members Only)
Room: Jackson
SWOG • Leading Cancer Research. Together.
16 Fall 2014
SCHEDULE OF EVENTS
FRIDAY, OCTOBER 24, 2014
Group Meeting Registration & Information Desk
7:00 a.m. - 5:00 p.m. - Regency Foyer (Gold Level, West Tower)
Hope Foundation Information Desk
7:00 a.m. - 5:00 p.m. - Regency Foyer
Exhibits & Complimentary Coffee Service
7:00 a.m. - 4:00 p.m. - Regency Foyer
7:00 a.m. – 5:00 p.m.
Gold Level, West Tower
Room: Hong Kong
Hope Foundation Donor Lounge (Donors Only) 7:00 a.m. – 8:00 a.m.
Drug Information Subcommittee Bronze Level, East Tower and Working Group (Working Room: Roosevelt
Group Members Only)
7:15 a.m. – 8:00 a.m.
Gold Level, West Tower
Room: Regency Foyer
Plenary Session Continental Breakfast 8:00 a.m. – 10:00 a.m.
Gold Level, West Tower
Room: Regency A-C
PLENARY II (General)
10:00 a.m. - 11:30 a.m.
Open Office Hours: Analysis and Bronze Level, West Tower Design of Genomic Studies
Room: Gold Coast
(Open for Drop-Ins)
10:00 a.m. – 11:40 a.m.
Office Hours: Biospecimen Bronze Level, West Tower Banking and the SWOG Room: Gold Coast
Biorepository (By Appt. Only)
10:00 a.m. – 11:40 a.m.
Office Hours: Project Bronze Level, West Tower Development using SWOG Room: Gold Coast
Biospecimens (By Appt. Only)
NOTE: Gray Areas Indicate Workshops and
Oncology Research Professional (ORP) Sessions.
Bolded Meetings Receive CME Credits
SWOG • Leading Cancer Research. Together.
10:15 a.m. – 12:15 p.m.
LEUKEMIA COMMITTEE
Gold Level, West Tower
Room: Regency D
SWOG Data & Safety Monitoring 10:15 a.m. – 12:15 p.m.
Bronze Level, East Tower Committee (Committee Members Room: Jackson
Only)
10:30 a.m. - 11:30 a.m.
“Navigating SWOG for Young
Bronze Level, West Tower Investigators” Round Table
Room: Picasso
(Registration Required)
10:30 a.m. - 11:30 a.m.
Silver Level, West Tower
Room: Wright
10:30 a.m. – 12:00 p.m.
Bronze Level, West Tower
Room: Wrigley
Career Development Opportunities in the Experimental Therapeutics and Rare Cancers Committee: A Round Table with Dr. Razelle Kurzrock (Registration Required)
RADIATION ONCOLOGY
COMMITTEE
10:30 a.m. – 12:00 p.m.
Quality Assurance Committee Silver Level, West Tower Meeting (Committee Members Room: Field
Only)
10:30 a.m. - 12:10 p.m.
Gold Level, West Tower
Room: New Orleans
Industry Office Hours: Foundation Medicine (By Appointment Only)
10:30 a.m. - 12:10 p.m.
Industry Office Hours: Purple Level, West Tower Genentech (By Appointment
Room: Stetson BC
Only)
10:30 a.m. - 12:10 p.m.
Industry Office Hours: Purple Level, West Tower Novartis (By Appointment
Room: Stetson D
Only)
10:30 a.m. – 12:30 p.m.
CANCER CONTROL AND Bronze Level, East Tower PREVENTION OUTREACH Room: Michigan
(HARRY HYNES SYMPOSIUM)
SWOG Group Meeting Agenda
17
SCHEDULE OF EVENTS
FRIDAY, OCTOBER 24, 2014
Group Meeting Registration & Information Desk
7:00 a.m. - 5:00 p.m. - Regency Foyer (Gold Level, West Tower)
Hope Foundation Information Desk
7:00 a.m. - 5:00 p.m. - Regency Foyer
Exhibits & Complimentary Coffee Service
7:00 a.m. - 4:00 p.m. - Regency Foyer
11:30 a.m. – 1:30 p.m.
MELANOMA COMMITTEE
Gold Level, West Tower
Room: Regency A
12:00 p.m. – 1:30 p.m.
Gold Level, West Tower
Room: Regency C
Collaborative Opportunities at
CSHL and JAX Labs for SWOG Investigators
12:30 p.m. – 2:00 p.m.
Bone Marrow & Stem Cell Bronze Level, East Tower Transplantation Committee
Room: Randolph
SURGERY COMMITTEE
12:30 p.m. – 2:30 p.m.
Bronze Level, West Tower
Room: Comiskey
12:30 p.m. – 3:30 p.m.
Gold Level, West Tower
Room: Toronto
GU Organ Site Meeting
(Working Group Members Only)
1:00 p.m. - 2:30 p.m.
Industry Office Hours: Purple Level, West Tower Genentech (Open for Drop-Ins)
Room: Stetson BC
1:00 p.m. - 2:30 p.m.
Industry Office Hours: Purple Level, West Tower Novartis (Open for Drop-Ins)
Room: Stetson D
1:00 p.m. - 3:00 p.m.
Lung Observational Research Bronze Level, West Tower Initiative Round Table (Open for
Room: Gold Coast
Drop-Ins)
1:30 p.m. - 2:30 p.m.
Gold Level, West Tower
Room: San Francisco
1:30 p.m. - 3:30 p.m.
Gold Level, West Tower
Room: New Orleans
Post-Symposium Round Table: with Speakers from the CSHL and JAX Labs Symposium (Open for drop-ins) 1:30 p.m. - 3:30 p.m.
Gold Level, West Tower
Room: New Orleans
Office Hours: Jackson Laboratory (By Appointment Only)
Office Hours: Cold Spring Harbor Laboratory (By Appointment Only)
2:00 p.m. - 3:00 p.m.
International Trial Participation: Bronze Level, West Tower Round Table (Registration Room: Picasso
Required)
2:00 p.m. – 3:00 p.m.
Bronze Level, East Tower
Room: Jackson
2:00 p.m. – 4:00 p.m.
Bronze Level, East Tower
Room: Michigan
Toxicity Reduction and Symptom Management in Clinical Trials: Round Table Discussion with Lori Minasian, M.D.
2:00 p.m. – 5:00 p.m.
Gold Level, West Tower
Room: Regency B
BREAST COMMITTEE
2:45 p.m. – 7:00 p.m.
Bronze Level, East Tower
Room: Roosevelt
S1316 Protocol Training
BARLOGIE-SALMON MYELOMA COMMITTEE
3:00 p.m. - 4:00 p.m.
“Navigating SWOG for Young
Bronze Level, East Tower Investigators” Round Table
Room: Jackson
(Registration Required)
3:00 p.m. – 5:00 p.m.
ORP Planning Meeting Silver Level, West Tower (Committee Members Only)
Room: Field
SWOG • Leading Cancer Research. Together.
18 Fall 2014
SCHEDULE OF EVENTS
FRIDAY, OCTOBER 24, 2014
SATURDAY, OCTOBER 25, 2014
Group Meeting Registration & Information Desk
7:00 a.m. - 5:00 p.m. - Regency Foyer (Gold Level, West Tower)
Group Meeting Registration & Information Desk
7:00 - 11:00 a.m. - Regency Foyer (Gold Level, West Tower)
Hope Foundation Information Desk
7:00 a.m. - 5:00 p.m. - Regency Foyer
Hope Foundation Information Desk
7:00 - 11:00 a.m. - Regency Foyer
Exhibits & Complimentary Coffee Service
7:00 a.m. - 4:00 p.m. - Regency Foyer
4:00 p.m. – 6:00 p.m.
Gold Level, West Tower
Room: San Francisco
Pharmaceutical Sciences Committee
4:00 p.m. – 6:00 p.m.
Lung Working Group (Working Bronze Level, West Tower Group Members Only)
Room: Comiskey
4:00 p.m. – 6:00 p.m.
Lymphoma Working Group
Bronze Level, West Tower Working Group Members Only)
Room: Gold Coast
4:00 p.m. – 6:00 p.m.
Gold Level, West Tower
Room: Toronto
GI Working Group (Working Group Members Only)
4:00 p.m. – 7:00 p.m.
Gold Level, West Tower
Room: Regency D
GU COMMITTEE
6:00 p.m. – 7:00 p.m.
Lung-MAP S1400 Master Lung Bronze Level, East Tower Protocol Update Meeting
Room: Michigan
6:45 p.m. – 8:00 p.m.
Gold Level, West Tower
Room: Regency AB
Reception
NOTE: Gray Areas Indicate Workshops and
Oncology Research Professional (ORP) Sessions.
Bolded Meetings Receive CME Credits
SWOG • Leading Cancer Research. Together.
7:00 a.m. – 11:00 a.m.
Gold Level, West Tower
Room: Hong Kong
Hope Foundation Donor Lounge (Donors Only)
7:00 a.m. – 8:00 a.m.
Gold Level, West Tower
Room: Regency C
Board of Governors (Board Members Only)
8:15 a.m. – 9:15 a.m.
Gold Level, West Tower
Room: Regency C
Committee Chairs (Committee
Members Only)
9:15 a.m. – 11:15 a.m.
Imaging Committee (Committee Bronze Level, West Tower Members Only)
Room: Gold Coast
9:30 a.m. – 10:30 a.m.
NCORP PI Meeting Bronze Level, West Tower
Room: Water Tower
9:30 a.m. – 12:30 p.m.
GI COMMITTEE Green Level, West Tower Room: Crystal C
9:30 a.m. – 12:30 p.m.
Gold Level, West Tower
Room: Regency B
LYMPHOMA COMMITTEE
9:30 a.m. – 12:30 p.m.
Gold Level, West Tower
Room: Regency A
LUNG COMMITTEE
SWOG Group Meeting Agenda
SATURDAY, OCTOBER 25, 2014
Group Meeting Registration & Information Desk
7:00 - 11:00 a.m. - Regency Foyer (Gold Level, West Tower)
Hope Foundation Information Desk
7:00 - 11:00 a.m. - Regency Foyer
10:00 a.m. – 11:00 a.m.
VA Working Group Meeting Silver Level, West Tower (Invitation Only) Room: Field
1:00 p.m. – 5:30 p.m.
Gold Level, West Tower
Room: Regency D
Translational Medicine Retreat (Registration Required) 19
SUNDAY, OCTOBER 26, 2014
8:00 a.m. – 12:30 p.m.
Gold Level, East Tower
Room: Grand A
Translational Medicine Retreat (Registration Required) 10:30 a.m. – 11:30 a.m.
Gold Level, East Tower
Room: Columbus AB
Translational Medicine Retreat Breakout #1 10:30 a.m. – 11:30 a.m.
Gold Level, East Tower
Room: Columbus CD
Translational Medicine Retreat Breakout #2 5:30 p.m. – 6:30 p.m.
Translational Medicine Retreat Gold Level, West TowerReception
Room: Regency C
SWOG • Leading Cancer Research. Together.
20 Fall 2014
Roster of Committee Speakers
Thursday, October 23, 2014
Cancer Survivorship Committee, 8:00 a.m. - 10:00 a.m. - Michigan
Sarcoma Survivorship: Opportunities for Research – Laurence H. Baker, D.O., University of Michigan
Early Therapeutics Committee, 10:00 a.m. - 12:15 p.m. - Regency A
Immunotherapy of Solid Tumors – Sandip Patel, M.D., University of California, San Diego
New Targeted Molecules Update – Monica Mita, M.D., Cedars-Sinai Medical Center
Prevention Committee, 10:15 a.m. - 12:15 p.m. - Michigan
Cancer Prevention Opportunities within SWOG – Marian Neuhouser, Ph.D., R.D., Fred Hutchinson Cancer
Research Center
Vaccines to Prevent the Development of Common Solid Tumors – Mary “Nora” Disis, M.D., University of
Washington
Cancer Care Delivery Committee, 12:30 p.m. - 2:30 p.m. - Michigan
Project ECHO (Extension for Community Healthcare Outcomes): Telementoring in Cancer Research
Michael J. Fisch, M.D., M.P.H., MD Anderson Cancer Center
Cancer Associated Thrombosis: From Clinical Trials to Real World Data – Gary Lyman, M.D., University of
Washington
Improve Cancer Outcomes: Can Researchers be Change Agents – Cary Gross, M.D., Yale University
SWOG • Leading Cancer Research. Together.
SWOG Group Meeting Agenda
Roster of Committee Speakers
Friday, October 24, 2014
Harry E. Hynes Symposium, 10:30 a.m. - 12:30 p.m. - Michigan
Energy Balance and Cancer Prevention: Mechanistic Insights from Transdisciplinary Studies
Stephen D. Hursting, M.D., University of North Carolina
Melanoma Committee, 11:30 a.m. - 1:30 p.m. - Regency A
MicroRNAs in Melanoma Diagnosis and Treatment – William E. Carson III, M.D., Ohio State University
Surgery Committee, 12:30 p.m. - 2:30 p.m. - Comiskey
Colorectal Cancer Imaging: Evidence, Belief and Controversy – Marc J. Gollub, M.D., F.A.C.R., Memorial
Sloan-Kettering Cancer Center
Hepatobiliary Imaging – Jinha Park, M.D., City of Hope
Imaging in GI Malignancy: The Surgeon’s Take – Thomas A. Aloia, M.D., MD Anderson Cancer Center
Breast Committee, 2:00 p.m. - 5:00 p.m. - Regency B
Update on Immunological Approaches for Breast Cancer: From Vaccines to Checkpoint Blockade
Mary “Nora” Disis, M.D., University of Washington
Adjuvant HER2 Peptide Vaccine for High Risk HER2+ Breast Cancer – Elizabeth Mittendorf, M.D., MD
Anderson Cancer Center
Adjuvant PDL-1 Antibody for High Risk Triple Negative Breast Cancer – Lajos Pusztai, M.D., Ph.D., Yale
University Cancer Center
SWOG • Leading Cancer Research. Together.
21
22 Fall 2014
SWOG ADMINISTRATIVE COMMITTEES
Adolescent & Young Adults
Chair: Brandon M. Hayes-Lattin, M.D.
Board of Governors
Chair: Charles D. Blanke, M.D.
Bone Marrow and Stem Cell Transplantation Committee
Chair: Patrick Stiff, M.D.
Conflict Management Committee
Chair: Vernon K. Sondak, M.D.
Data & Safety Monitoring Committee
Chair: Lawrence E. Flaherty, M.D.
Imaging Committee
Chair: Lawrence H. Schwartz, M.D.
Membership Committee
Chair: James K. Weick, M.D.
Oncology Research Professionals Committee
Chair: Keisha C. Humphries, R.N., B.S.N.
Patient Advocates Committee
Chair: Rick Bangs
Pharmaceutical Sciences Committee
Co-Chair: Siu-Fun Wong, Pharm.D.
Co-Chair: Susan Kadlubar, Ph.D.
Professional Review Committee
Chair: Primo N. Lara, Jr., M.D.
Quality Assurance Committee
Chair: Manuel Valdivieso, M.D.
Radiation Oncology Committee
Chair: Paul Okunieff, M.D.
Surgery Committee
Chair: George H. Yoo, M.D.
SWOG • Leading Cancer Research. Together.
SWOG Group Meeting Agenda
23
Special Symposia
Jeri and Noboru Oishi Symposium / Continuing Education Workshop
Thursday, October 23, 2014 - 8:00 a.m. - 12:00 p.m.
Location: Regency CD (Gold Level, West Tower)
Topic: “Biospecimens and Clinical Trials”
Featured Speakers:
• Basics of Biomarkers - Carol Bult, Ph.D.
• The Lung-MAP Trial - Vassiliki A. Papadimitrakopoulou, M.D.
• Specimen Submissions - General Guidelines - Annette Betley, B.S. and Filiz Muharrem, B.S.
• NCI CIRB - Linda Parreco, R.N., M.S.
• Changes at CTSU Related to NCTN Transition - Lucille Patrichuk
This activity has been submitted to the Oncology Nursing Society for approval to award contact hours. ONS is accredited as an approver
of continuing nursing education by the American Nurses Credentialing Center’s COA.
Certificates for continuing education credits (CEUs) will be distributed to attendees upon completion and return of their evaluation
sheets. Certificates of attendance will be given for Society of Clinical Research Associates.
Oncology Research Professionals Open Forum
Thursday, October 23, 2014 - 12:30 p.m. - 2:00 p.m.
Location: Plaza Ballroom (Green Level, East Tower)
Topic: This forum offers an opportunity to get answers to your clinical trial questions and address the science and technical
research issues that challenge us today.
Featured Topics:
• Quality Assurance Audits
• Regulatory Affairs
• Data Management Tips & Tools for CRAs
• CTCAEs v4.0 and SAE Q&A
• Cancer Treatment Modalities Q&A
• Specimen Preparation and Shipment
• SWOG Federal Reimbursements
• SWOG CTI Non-Federal Reimbursements
• Hot Topics in Site Administration
• Recruitment Efforts Maximized
SWOG • Leading Cancer Research. Together.
24 Fall 2014
Special Symposia
Radiation Oncology Committee
Friday, October 24, 2014 - 10:30 a.m. - 12:00 p.m.
Location: Wrigley (Bronze Level, West Tower)
Agenda:
1. Brainstorm Session: Progress in recent years and future vision
2. In Silico Project Report - Dr. David Fuller
3. Committee Business:
a. Chair Update - Drs. Okunieff & Kachnic
b. Protocol Concepts
c. Subcommittee Updates
d. Strategic Subcommittee - Dr. Steven Finkelstein
e. GU - Drs. Raben & Swanson
f.
GI - Dr. Lisa Kachnic
g. Lung - Dr. Laurie Gaspar
h. Lymphoma - Dr. Louis Constine
i.
Myeloma/Melanoma - Dr. Michael Tomblyn
j.
Breast - Dr. Reshma Jagsi
4. IROC/QARC Update
5. IROC/RPC Update - Dr. Stephen Kry
6. Other Business
Surgery Committee
Friday, October 24, 2014 - 12:30 p.m. - 2:30 p.m.
Location: Comiskey (Bronze Level, West Tower)
Topic: Imaging Affecting Gastrointestinal Surgical Oncology Decision Making
Featured Speakers and Topics:
• Colorectal Cancer Imaging: Evidence, Belief and Controversy - Marc J. Gollub, M.D., F.A.C.R., Department of Radiology,
Memorial Sloan-Kettering Cancer Center, Professor of Radiology, Weill-Cornell Medical College
• Hepatobilliary Imaging - Jinha Park, M.D., Assistant Professor, Department of Diagnostic Radiology, City of Hope
• Imaging in GI Malignancy: The Surgeon’s Take - Thomas A. Aloia, M.D., MD Anderson Cancer Center
SWOG • Leading Cancer Research. Together.
SWOG Group Meeting Agenda
25
BARLOGIE-SALMON MYELOMA COMMITTEE
Committee Leadership
Chair: Robert Z. Orlowski, M.D., Ph.D.
Vice-Chair: Brian G.M. Durie, M.D.
Executive Officer
Susan M. O’Brien, M.D.
Statisticians: Antje Hoering, Ph.D.
Rachael Sexton, M.S.
Scientific Leadership
Translational Medicine: Joshua Epstein, D.Sc.
Radiation:
Michael Tomblyn, M.D.
Surgery:
J. Sybil Biermann, M.D.
Imaging:
Saad Z. Usmani, M.D.
Eric M. Rohren, M.D., Ph.D.
Pathology:
Robert B. Lorsbach, M.D., Ph.D.
Early Therapeutics:
Fritz van Rhee, M.D., Ph.D.
Designates
CCOP Representative:
James D. Bearden, III, M.D.
Data Coordinators:
Jeri Jardine
Laura Kingsbury, M.R.T.
Oncology Research Professionals:
CRAs: Ellen Chase, B.S.
Nurses: Steven M. Burt, NP-C
Deborah A. Halk, R.N.
Patient Advocate:
Jack Aiello
Pharmaceutical Science:
Lara M. Au, Pharm.D.
Craig Elg, Pharm.D.
Protocol Coordinator:
Sandi Fredette
Time/Location
Friday, October 24, 2014
Room: Michigan (Bronze Level, East Tower)
2:00 p.m. - 4:00 p.m.
Agenda
Presentations
Active Studies
■■ S1211, “A Phase II Study of Optimal Induction Therapy for
Newly Diagnosed High Risk Multiple Myeloma (HRMM).” Dr.
Usmani. Activated: 10/12/12.
■■ S1304, “A Phase II Randomized Study Comparing Two Doses
of Carfilzomib (NSC-XXXX) with Dexamethasone for Multiple
Myeloma Patients with Relapsed or Refractory Disease.” Dr.
Ailawadhi. Activated: 10/18/13.
■■ CTSU/E3A06, “Genomic and Immunology Studies for E3A06,
“Randomized Phase III Trial of Lenalidomide versus Observation
Alone in Patients with Asymptomatic Smoldering Multiple
Myeloma.” Dr. Dhodapkar. Activated: 2/1/11.
■■ CTSU/E1A11, “Randomized Phase III Trial of Bortezomib,
Lenalidomide and Dexamethasone (VRd) Versus Carfilzomib,
Lenalidomide and Dexamethasone (CRd) Followed by Limited
or Indefinite Lenalidomide Maintenance in Patients with Newly
Diagnosed Symptomatic Multiple Myeloma.” Dr. Zonder.
Activated: 2/1/14.
Closed Studies
■■ S0777, “A Randomized Phase III Trial of CC-5013 (Lenalidomide,
NSC-703813) and Low Dose Dexamethasone (LLD) versus
Bortezomib (PS-341, NSC-681239), Lenalidomide and Low Dose
Dexamethasone (BLLD) for induction, in Patients with Previously
Untreated Multiple Myeloma without an Intent for Immediate
Autologous Stem Cell Transplant.” Dr. Durie. Activated:
2/28/08; Closed: 2/1/12.
■■ S0702, “A Prospective Observational Multicenter Cohort Study
to Assess The Incidence of Osteonecrosis of the Jaw (ONJ) in
Cancer Patients with Bone Metastases Starting Zoledronic Acid
Treatment.” Dr. Van Poznak. Activated: 12/15/08; Closed:
12/13/13.
■■ CTSU/CTN0702, “A Trial of Single Autologous Transplant with
or without Consolidation Therapy versus Tandem Autologous
Transplant with Lenalidomide Maintenance for Patients with
Multiple Myeloma.” Dr. Somlo. Activated: 3/15/10; Closed
11/15/13.
Proposed Studies
■■ S1412, “Randomized Phase III Study of Lenalidomide (L) vs.
Lenalidomide + Ixazomib (LI) (NSC-XXXX) as Maintenance
Therapy Post-Autologous Stem Cell Transplant in Patients with
Multiple Myeloma (MM).” Dr. Shah.
■■ SXXXX, “A Randomized Phase I/II Study Comparing Bortezomib,
Rituximab and Dexamethasone with or without Ibrutinib in
Previously Untreated Waldenstrom’s Macroglobulinemia.” Dr.
Ailawadhi.
■■ SXXXX, “Single Arm Phase II Multicenter Trial of Apixaban 2.5
mg BID for Prevention of Thromboembolism in Patients Being
Treated with an Immunomodulatory-Based Regimen for Multiple
Myeloma (MM).” Dr. Calverley.
SWOG • Leading Cancer Research. Together.
26 Fall 2014
BARLOGIE-SALMON MYELOMA COMMITTEE
Working Groups
1. Amyloidosis Working Group update
2. Waldenström’s Working Group update
3. Myeloma Translational Medicine Subcommittee update
Publications
The publications below are those that have been received in published,
submitted or accepted form by the Group Chair’s Office since the
Spring 2014 meeting agenda booklet publication list.
Published/Accepted Manuscripts
■■ S0434 A phase II trial of Bay 43-9006 (Sorafenib) (NSC724772) in patients with relapsing and resistant multiple
myeloma: SWOG S0434. G Srkalovic, M Hussein, A Hoering, J
Zonder, L Popplewell, H Trivedi, S Mazzoni, R Sexton, R Orlowski,
B Barlogie. Cancer Medicine, 2014 Jun 10. [Epub ahead of print]
http://www.ncbi.nlm.nih.gov/pubmed/24913924
Submitted Manuscripts
No publication information for this cycle.
SWOG • Leading Cancer Research. Together.
SWOG Group Meeting Agenda
27
BREAST COMMITTEE
Committee Leadership
Chair: Gabriel N. Hortobagyi, M.D.
Vice-Chair: Debasish Tripathy, M.D.
Executive Officer:
Julie R. Gralow, M.D.
Statisticians:
William E. Barlow, Ph.D.
Danika Lew, M.A.
Scientific Leadership
Translational Medicine: Daniel F. Hayes, M.D.
Radiation Oncology: Reshma Jagsi, M.D.
Surgery: Christine Lee, M.D.
Imaging:
Anne F. Schott, M.D.
Wei Tse Yang, M.B.B.S.
Pathology:
Allen M. Gown, M.D.
Peggy L. Porter, M.D.
Early Therapeutics:
George Somlo, M.D.
Designates
Cancer Control Liaisons: Carol J. Fabian, M.D. (Cancer Survivorship)
Dawn L. Hershman, M.D. (Outcomes)
Melanie R. Palomares, M.D. (Prevention)
Helen K. Chew, M.D. (Symptom Control & QOL)
CCOP Representative: David A. Decker, M.D.
Data Coordinators:
Jean Barce
Jennie Barrett
Larry Kaye
Louise Highleyman
Iris Syquia
Oncology Research Professionals:
CRAs: Karyn N. Hart, C.C.R.P.
Pamela A. Williams, R.N., M.S.N.
Nurses:
Dorothy Coleman, R.N., M.S.
Kathy L. Czaplicki, R.N., M.S.N.
Patient Advocate:
Nancy Singleton
Pharmaceutical Science: Jessie Modlin, Pharm.D.
Rivka Siden, Pharm.D.
Protocol Coordinator:
Megan Hardin
Time/Location
Friday, October 24, 2014
Room: Regency B (Gold Level, West Tower)
2:00 p.m. - 5:00 p.m.
Agenda
2:00 – 2:05 p.m. Welcome and introductions - Debu Tripathy, M.D.
Breast Committee Mini-Symposium “Advances and
Opportunities in Immunotherapy for Breast Cancer”
(2:05 - 3:05 p.m.)
2:05 – 2:25 p.m. Update on Immunological Approaches for Breast Cancer: from Vaccines to Checkpoint Blockade - Mary Disis, M.D., University of Washington
2:25 – 2:35 p.m. Adjuvant HER2 Peptide Vaccine for High Risk HER2+ Breast Cancer – Elizabeth Mittendorf, M.D.
2:35 – 2:45 p.m. Adjuvant PDL-1 Antibody for High Risk Triple Negative Breast Cancer – Lajos Pusztai, M.D., Ph.D.
2:45 – 3:05 p.m. Panel Discussion and Q&A
3:05 – 3:10 p.m. Publications update - Bill Barlow, Ph.D.
3:10 – 3:45 p.m. Update of open SWOG and CTSU trial - All
3:45 – 4:15 p.m. Studies in Development - All
4:15 – 4:30 p.m. Reports from Committee Liaisons
Radiotherapy - Reshma Jagsi, M.D.
Surgery - Christine Lee, M.D.
Cancer Survivorship - Carol Fabian, M.D.
Health Disparities - Dawn Hershman, M.D.
Prevention - Melanie Palomares, M.D.
NCORP (NCI Community Oncology Research Program) Update – Louis Fehrenbacher, M.D.
Patient Advocate – Nancy Singleton
4:30 – 5:00 p.m. Translational Medicine Sub-Committee – Daniel Hayes, M.D.
Active Adjuvant Studies
■■ S1007, “A Phase III, Randomized Clinical Trial of Standard
Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with
1-3 Positive Nodes, Hormone-Receptor-Positive and HER2Negative Breast Cancer with Recurrence Score (RS) of 25 or
Less.” Drs. Gralow, Meric-Bernstam, Hortobagyi, Albain and
Barlow. Activated: 1/15/11.
■■ S1207, “Phase III Randomized, Placebo-Controlled Clinical Trial
Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year
of Everolimus in Patients with High-Risk, Hormone ReceptorPositive and HER2/neu Negative Breast Cancer.” Drs. ChavezMacGregor, and Pusztai. Activated: 9/3/13.
SWOG • Leading Cancer Research. Together.
28 Fall 2014
BREAST COMMITTEE
■■ CTSU/ A011106, “Alternate Approaches for Clinical Stage II
or III Estrogen Receptor Positive Breast Cancer Neoadjuvant
Treatment (ALTERNATE) in Postmenopausal Women: A Phase III
Study.” Dr. Massarweh. Activated: 2/15/14.
■■ CTSU/NSABP B-43, “A Phase III Clinical Trial Comparing
Trastuzumab Given Concurrently with Radiation Therapy and
Radiation Therapy Alone for Women with HER 2-Positive
Ductal Carcinoma in Situ Resected by Lumpectomy.” Dr. Chung.
Activated: 11/22/08.
■■ CTSU/NSABP B-47, “A Randomized Phase III Trial of Adjuvant
Therapy Comparing Chemotherapy Alone (Six Cycles of TC or
Four Cycles of AC followed by Four Cycles of Weekly Paclitaxel)
to Chemotherapy Plus Trastuzumab in Women with NodePositive or High-Risk Node-Negative HER2-Normal Invasive
Breast Cancer.” Dr. Albain. Activated: 1/7/11.
Active Advanced Disease Studies
■■ S1222, “Fulvestrant Alone Versus Fulvestrant and Everolimus
Versus Fulvestrant, Everolimus and Anastrozole: A Phase III
Randomized Placebo-Controlled Trial in Postmenopausal Patients
with Hormone-Receptor Positive Stage IV Breast Cancer.” Drs.
Somlo, Moore, Hayes, Kuhn and Hicks. Activated: 5/9/14.
■■ CTSU/E2108, “A Randomized Phase III Trial of the Value of Early
Local Therapy for the Intact Primary Tumor in Patients with
Metastatic Breast Cancer.” Dr. Lee. Activated: 2/28/11.
■■ CTSU/E3108, “A Phase II Prospective Trial Correlating PFS with
CYP2D6 Activity in Patients with Metastatic Breast Cancer
Treated with Single Agent Tamoxifen.” Dr. Lohrisch. Activated:
10/08/10.
Active Cancer Control Studies
■■ S1200, “Randomized Blinded Sham- and Waitlist-Controlled
Trial of Acupuncture for Joint Symptoms Related to Aromatase
Inhibitors in Women with Early Stage Breast Cancer.” Drs.
Hershman and Crew. Activated: 3/27/12.
■■ S1202, “A Randomized Placebo-Controlled Phase III Study of
Duloxetine for Treatment of Aromatase Inhibitor-Associated
Musculoskeletal Symptoms in Women with Early Stage Breast
Cancer.” Drs. Henry and Schott. Activated: 5/15/13.
■■ S1204, “A Sero-Epidemiologic Survey and Cost-Effectiveness
Study of Screening for Human Immunodeficiency Virus (HIV),
Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) Among
SWOG • Leading Cancer Research. Together.
Newly Diagnosed Cancer Patients.” Drs. Ramsey, Loomba,
Chugh, Hershman and Hwang. Activated: 8/29/13.
■■ E1Z11, “A Cohort Study to Evaluate Genetic Predictors for
Aromatase Inhibitor Musculoskeletal Symptoms (AIMSS).” Dr.
Henry. Activated: 5/31/13.
Closed Studies
■■ S0812, “A Randomized Double-Blind Placebo-Controlled
Biomarker Modulation Study of Vitamin D in Premenopausal
Women at High Risk for Breast Cancer, Phase IIB.” Drs. Crew
and Hershman. Activated: 11/1/11; Closed: 8/15/14.
■■ S1008, “Feasibility Study of a Physical Activity and Dietary
Change Weight Loss Intervention in Breast and Colorectal Cancer
Survivors Phase II.” Drs. Greenlee and Hershman. Activated:
3/1/12; Closed: 7/1/14.
Studies in Development
■■ S1311, “Phase II Randomized Study of Trastuzumab Emtansine
(T-DM1) Plus Pertuzumab With or Without Paclitaxel in Her2+
Metastatic Breast Cancer (MBC).” Dr. Elias.
■■ S1315, “A Randomized Phase II Study of Liposomal Doxorubicin
vs Combination Therapy with Liposomal Doxorubicin and
Temsirolimus (+/- Bevacizumab) for the Treatment of Patients
with Locally Advanced or Metastatic Metaplastic/Mesenchymal
Breast Cancer for which Curative Therapy is not Available.” Dr.
Moulder.
■■ S1410, “Randomized Trial of Interval Increase in Exercise
Intensity vs Moderate Intensity Exercise to Improve
Cardiopulmonary Fitness in Breast Cancer Survivors
Participating in a Weight Loss Intervention.” Dr. Klemp.
■■ S1411, “Phase II Randomized Trial of Adjuvant Vaccine Therapy
in Patients with High-Risk HER2-Positive Breast Cancer.” Dr.
Mittendorf.
■■ S1416, “Phase II Randomized Trial of Cisplatin/Vinorelbine with
or without Veliparib (ABT-888) in Metastatic Triple Negative
Breast Cancer (TNBC) and BRCA Mutation-Associated Breast
Cancer.” Drs. Rodler and Sharma.
■■ S1418, “A Randomized Phase III Trial to Evaluate the Efficacy
and Safety of MK-3475 as Adjuvant Therapy for Triple
Receptor-Negative Breast Cancer with >1 cm Residual Invasive
SWOG Group Meeting Agenda
29
BREAST COMMITTEE
Cancer or Positive Lymph Nodes (pNmic) After Neoadjuvant
Chemotherapy.” Drs. Pusztai, Sharma and Mammen.
of Clinical Oncology, 32(22):2311-2317, 2014. http://www.
ncbi.nlm.nih.gov/pubmed/24934787
New Proposals
■■ “Randomized Phase II Study of TDM-1 vs. TDM-1 and Continuous
Low-Dose Temozolomide in 1-4 HER-2+ Breast Cancer Brain
Metastases Following Stereotactic Radiosurgery with Phase 1
Lead-in Study.” Drs. Tsien and Conlin.
■■ C40603 Impact of the addition of carboplatin and/or
bevacizumab to neoadjuvant weekly paclitaxel followed by
dose-dense doxorubicin and cyclophosphamide on pathologic
complete response rates in stage II-III triple-negative breast
cancer: CALGB 40603 (Alliance). WM Sikov, DA Berry, CM
Perou, B Singh, CT Cirrincione, SM Tolaney, CS Kuzma, TJ
Pluard, G Somlo, ER Port, M Golshan, JR Bellon, D Collyar, OM
Hahn, LA Carey, C Hudis, EP Winer. Journal of Clinical Oncology
2014 Aug 4 [Epub ahead of print]. http://www.ncbi.nlm.nih.gov/
pubmed/25092775
■■ “S1207 Aging Substudy” Dr. Extermann.
Publications
The publications listed below are those that have been received in
published, submitted or accepted form by the Group Chair’s Office
since the Spring 2014 meeting agenda booklet publication list.
Published/Accepted Manuscripts
■■ S0221 SWOG S0221: A phase III trial comparing chemotherapy
schedules in high-risk early breast cancer. GT Budd, W Barlow,
HCF Moore, T Hobday, JA Stewart, C Isaacs, M Salim, J Cho, K
Rinn, K Albain, H Chew, GV Burton, TD Moore, G Srkalovic, BA
McGregor, LE Flaherty, RB Livingston, DL Lew, JR Gralow, GN
Hortobagyi. Journal of Clinical Oncology, accepted 9/8/14.
■■ S0500 SWOG S0500: circulating tumor cells and response
to chemotherapy in metastatic breast cancer. JB Smerage,
WE Barlow, GN Hortobagyi, EP Winer, B Leyland-Jones, G
Srkalovic, S Tejwani, AF Schott, MA O’Rourke, DL Lew, J R
Gralow, RB Livingston, DF Hayes. Journal of Clinical Oncology,
2014 Jun 2 [Epub ahead of print] http://www.ncbi.nlm.nih.gov/
pubmed/2488881
■■ S0800 Image registration for quantitative parametric response
mapping of cancer treatment response. JL Boes, BA Hoff, N
Hylton, MD Pickles, LW Turnbull, AF Schott, A Rehemtulla, R
Chamberlain, TL Chenevert, CJ Galbán, CR Meyer, BD Ross.
Translational Oncology 7(1):101-110, 2014. http://www.ncbi.
nlm.nih.gov/pubmed/24772213
■■ C40101 Comparison of doxorubicin and cyclophosphamide
(AC) versus single agent paclitaxel (T) as adjuvant therapy
for breast cancer in women with 0-3 positive axillary nodes:
CALGB 40101 (Alliance). LN Shulman, DA Berry, C Cirrincione,
HP Becker, EA Perez, R O’Regan, S Martino, CL Shapiro, CJ
Schneider, G Kimmick, HJ Burstein, L Norton, H Mus, CA Hudis,
EP Winer, for the Alliance for Clinical Trials in Oncology. Journal
■■ E2197/E1199 Prognostic value of tumor-infiltrating lymphocytes
in triple-negative breast cancers from two phase III randomized
adjuvant breast cancer trials: ECOG 2197 and ECOG 1199. S
Adams, RJ Gray, S Demaria, L Goldstein, EA Perez, LN Shulman,
S Martino, M Wang, VE Jones, TJ Saphner, AC Wolff, WC Wood,
NE Davidson, GW Sledge, JA Sparano, SS Badve. Journal of
Clinical Oncology 2014 Jul 28 [Epub ahead of print]. http://
www.ncbi.nlm.nih.gov/pubmed/25071121
■■ E5103/E2100 Genetic variant predicts bevacizumab-induced
hypertension in ECOG-5103 and ECOG-2100. BP Schneider, L
Li, F Shen, KD Miller, M Radovich, A O’Neill, RJ Gray, D Lane,
DA Flockhart, G Jiang, Z Wang, D Lai, D Koller, JH Pratt, CT
Dang, D Northfelt, E Perez, T Shenkier, M Cobleigh, ML Smith, E
Railey, A Partridge, J Gralow, J Sparano, N Davidson, T Foroud,
GW Sledge, Jr. British Journal of Cancer, 111(6):1241-1248.
2014. http://www.ncbi.nlm.nih.gov/pubmed/25117820
■■ IBCSG 24/25-02 Adjuvant exemestane with ovarian suppression
in pre-menopausal breast cancer. O Pagani, MM Regan, BA
Walley, GF Fleming, M Colleoni, I Láng, H L Gomez, C Tondini,
HJ Burstein, EA Perez, E Ciruelos, V Stearns, HR Bonnefoi,
S Martino, CE Geyer, Jr., G Pinotti, F Puglisi, D Crivellari, T
Ruhstaller, EP Winer, M Rabaglio-Poretti, R Maibach, B Ruepp,
A Giobbie-Hurder, KN Price, J Bernhard, W Luo, K Ribi, G Viale,
AS Coates, RD Gelber, A Goldhirsch, PA. Francis, for the TEXT
and SOFT Investigators and the International Breast Cancer
Study Group. New England Journal of Medicine 371(2):107-118,
2014. http://www.ncbi.nlm.nih.gov/pubmed/24881463
■■ N9831 EGFR expression is associated with decreased benefit
from trastuzumab in the NCCTG N9831 (Alliance) trial. H
Cheng, K Ballman, M Vassilakopoulou, AC Dueck, MM Reinholz,
SWOG • Leading Cancer Research. Together.
30 Fall 2014
BREAST COMMITTEE
K Tenner, J Gralow, C Hudis, NE Davidson, G Fountzilas, AE
McCullough, B Chen, A Psyrri, DL Rimm, EA Perez. British
Journal of Cancer 111(6):1065-71. 2014. http://www.ncbi.nlm.
nih.gov/pubmed/25117817
■■ R9804 Web based pathology assessment in RTOG 98-04.
WA Woodward, N Sneige, K Winter, HM Kuerer, C Hudis, E
Rakovitch, BL Smith, LJ Pierce, I Germano, AT Pu, EM Walker,
DL Grisell, JR White, B McCormick, for the Radiation Therapy
Oncology Group (RTOG). Journal of Clinical Pathology 2014
Jul 2 [Epub ahead of print]. http://www.ncbi.nlm.nih.gov/
pubmed/24989024
Submitted Manuscripts
■■ C9741 Body mass index, PAM50 subtype, and outcomes in
node-positive breast cancer patients receiving chemotherapy:
results from CALGB 9741 (ALLIANCE). JA Ligibel, CT Cirrincione,
M Liu, M Citron, J Ingle, W Gradishar, S Martino, W Sikov, R
Michaelson, E Winer, CA Hudis, D Berry, WT Barry. Journal of
Clinical Oncology, revised/resubmitted,8/14.
■■ C9741 PAM50 gene signatures are prognostic for breast
cancer based chemotherapy in C9741 (Alliance). MC Liu, BN
Pitcher, ER Mardis, SR Davies, JE Snider, TL Vickery, JP Reed,
K DeSchryver, B Singh, PN Friedman, WJ Gradishar, EA Perez,
S Martino, ML Citron, L Norton, EP Winer, CA Hudis, LA Carey,
TO Nielsen, CM Perou, MJ Ellis, WT Barry. Journal of Clinical
Oncology, revised/resubmitted 8/14.
SWOG • Leading Cancer Research. Together.
SWOG Group Meeting Agenda
31
CANCER CONTROL & PREVENTION COMMITTEES
Committee Leadership
Assoc. Chair for Cancer
Control & Prevention: Frank L. Meyskens, Jr. M.D.*
Committee Co-Chairs:
Cancer Care Delivery Committee: Dawn L. Hershman, M.D., M.S.
Scott D. Ramsey, M.D., Ph.D.
Cancer Survivorship Committee: Carol J. Fabian, M.D.
Robert S. Krouse, M.D.
Prevention Committee: Powel Brown, M.D., Ph.D.
Marian Neuhouser, Ph.D.
Symp Control & QOL Committee: Carol M. Moinpour, Ph.D./Michael Fisch, M.D., Ph.D.
James L. Wade III, M.D.
Executive Officer:
Craig R. Nichols, M.D.*
Statisticians: Garnet Anderson, Ph.D.*
Cathy Tangen, Ph.D.*
William E. Barlow, Ph.D.*
Joseph M. Unger, Ph.D.*
Danika Lew, M.A.*
Kathryn B. Arnold, M.S.*
Amy K. Darke, M.S.
Katherine Guthrie, Ph.D.
Phyllis Goodman, M.S. *
Cathy Till, M.S.
Administrative Lead (Stat Ctr): Monica Yee, C.C.R.P.
Administrative Lead (UCI): Alicia Paramo*
Scientific Leadership
CCOP Representative: Mark A. O’Rourke, M.D.*
Radiation Oncolgoy Committee: Louis “Sandy” Constine, M.D.
Surgery Committee: Robert S. Krouse, M.D.FACS*
Translational Medicine: James (Jimmy) Rae, Ph.D.
Liaisons:
Breast Committee: Carol J. Fabian, M.D. (Survivorship)*
Helen Chew, M.D. (Symptom Control & QOL)
Dawn Hershman, M.D, M.S. (CCDC)*
Melanie Palomares, M.D. (Prevention)
Gastrointestinal Committee: Afsaneh Barzi, M.D.
Gastrointestinal Committee Colon: Jason, Zell, D.O.
Genitourinary Committee: Peter J. Van Veldhuizen, Jr., M.D.
International Liaison: Kathy S. Albain, M.D.*
Lung Committee: Gary E. Goodman, M.D.*
Lymphoma Committee: John W. Hayslip, M.D.
Melanoma Committee: Sancy Leachman, M.D., Ph.D.
Designates
Oncology Research Professionals
CRAs: Connie Szczepanek, R.N., B.S.N.
Joyce N. Tull, R.N., B.S.N.
Micheal F. Stephens, C.C.R.A.
Mindy Whisnant, C.C.R.P.
Nurses: Joan Long, R.N.
Michaela S. Sherbec, R.N., B.S.N.
Pharmaceutical Science: Manj Randhawa, Pharm.D.
Siu-Fun Wong, Pharm.D.*
Susan A. Kadlubar, Ph.D.
Statistical Center Support: Karen Anderson
Monica Yee, C.C.R.P.*
Dona Marrah, C.C.R.P.
Diane Liggett
Roxanne Topacio, C.C.R.P.
Patient Advocates: Anna Gottlieb
Amy Geschwender, Ph.D.
Protocol Coordinator (Cancer Care
Delivery; Prevention): Patricia O’Kane*
Protocol Coordinator
(Cancer Survivorship; Symptom
Control and Quality of Life):
Kimberly Kaberle*
*Executive Committee Members and Staff
SWOG • Leading Cancer Research. Together.
32 Fall 2014
CANCER CONTROL & PREVENTION COMMITTEES
Harry E. Hynes Symposium
(Updates to the CCOPs)
Time/Location
Friday, October 24, 2014
Room: Michigan (Bronze Level, East Tower)
10:30 a.m. – 12:30 p.m.
Agenda
10:00 – 10:05 a.m.
Welcome
Mark O’Rourke, M.D.
10:05 – 10:15 a.m.
Associate Chair Report
Frank L. Meyskens, Jr., M.D.
10:15 – 1050 a.m.
10:50 – 11:00 a.m.
Obesity, Metabolisim and Cancer:
mechanistic insights from
transdisciplinary studies
Stephen Hursting, Ph.D.
Univ. of NC, Chapel Hill
Questions
11:00 – 11:20 a.m.
The long and winding road of Cancer Prevention
Marian Neuhouser, Ph.D.
Fred Hutchinson CRC
11:20 – 11:30 a.m. Questions
11:30 – 11:45 a.m.
Highlighted studies by CC&P co-Chairs
Frank Meyskens, Jr., M.D.
11:45 a.m. – 12:00 p.m. Open Forum for NCORP Investigators
Mark O’Rourke, M.D.
SWOG • Leading Cancer Research. Together.
SWOG Group Meeting Agenda
33
CANCER CARE DELIVERY COMMITTEE
Cancer Care Delivery Committee Co-Chairs:
Dawn L. Hershman, M.D., M.S.
Scott D. Ramsey, M.D., Ph.D.
Time/Location
Thursday, October 23, 2014
Room: Michigan (Bronze Level, East Tower)
12:30 p.m. - 2:30 p.m.
Agenda
Presentations/Concepts
“Project ECHO (Extension for Community Healthcare Outcomes):
Telementoring in Cancer Research”. Michael J. Fisch, M.D., M.P.H.
Chair, Department of General Oncology, Division of Cancer Medicine,
The University of Texas MD Anderson Cancer Center.
“Cancer Associated Thrombosis: From Clinical Trials To Real World
Data”. Gary Lyman, M.D. Co-Director, Hutchinson Institute for Cancer
Outcomes Research, University of Washington.
“Improve Cancer Outcomes: Can Researchers Be Change Agents”.
Cary Gross, M.D., Professor of Medicine and Epidemiology, Yale
University.
Update on NCI CCDR NCORP meeting. Dawn Hershman, M.D., M.S.
Active Studies
■■ S1007, “Update on Quality of Life and Economic Analysis Substudy of Breast protocol S1007.” Bill Barlow, Ph.D.
■■ S1204, “A Sero-Epidemiologic Survey and Cost-Effectiveness
Study of Screening for Human Immunodeficiency Virus
(HIV), Hepatitis B (HBV) and Hepatitis C (HCV) Among Newly
Diagnosed Cancer Patients.” Drs. Ramsey, Loomba, Chugh,
Hershman, and Hwang. Activated: 8/29/13.
■■ S1207, Cost Effectiveness Analysis of “Phase III Randomized,
placebo-controlled clinical trial evaluating the use of adjuvant
endocrine therapy +/- one year of everolimus in patients with
high-risk, hormone receptor-positive and HER2/neu negative
breast cancer.” Drs. Chavez-MacGregor and Gonzalez-Angulo.
Concepts submitted to DCP.
Ongoing Database projects
■■ Medicare claims data as a core resource for comparative
effectiveness studies. Dr. Hershman and Joseph M. Unger, Ph.D.
■■ Value of Information and SWOG Trials, PCORI Project. Drs.
Ramsey and Carlson.
Studies Closed To Accrual
■■ S1105, “Randomized Controlled Trial of a Behavioral
Intervention to Improve Adherence to Adjuvant Aromatase
Inhibitor Therapy in Women with Early Stage Breast Cancer”.
Drs. Hershman and Neugut.
Publications
The publications listed below are those that have been received in
published, submitted or accepted form by the Group Chair’s Office
since the Spring 2014 meeting agenda booklet publication list.
Published/Accepted Manuscripts
■■ S0000 Retention of black and white participants in the Selenium
and Vitamin E Cancer Prevention Trial (SWOG-Coordinated
Intergroup Study S0000). KB Arnold, J Hermos, K Anderson,
L Minasian, CM Tangen, J Probstfield, E Cook. Cancer
Epidemiology, Biomarkers and Prevention, accepted 9/17/14.
■■ S1007 Tumor Marker Usage and Medical Care Costs Among
Older Early-Stage Breast Cancer Survivors. SD Ramsey, NL
Henry, J Gralow, D Mirick, W Barlow, R Etzioni, D Mummy, R
Thariani, DL Veenstra. Journal Clinical Oncology, in press.
■■ The diffusion of docetaxel use in patients presenting with
metastatic prostate cancer. J Unger, D Hershman, D Martin,
R Etzioni, WE Barlow, M LeBlanc, SR Ramsey. Journal of the
National Cancer Institute, in press.
Submitted Manuscripts
No publication information for this cycle.
■■ S1417, “Implementation of a Prospective Financial Toxicity
Assessment Tool in Patients with Metastatic Colorectal Cancer”.
Update on Concept. - Dr. Shankaran.
SWOG • Leading Cancer Research. Together.
34 Fall 2014
CANCER SURVIVORSHIP COMMITTEE
Cancer Survivorship Committee Co-Chairs:
Carol J. Fabian, M.D.
Robert S. Krouse, M.D.
Time/Location
Thursday, October 23, 2014
Room: Michigan (Bronze Level, East Tower)
8:00 a.m. - 10:00 a.m.
Agenda
Welcome New Members to Cancer Survivorship
Presentation
Sarcoma Survivorship: Opportunities for Research. Laurence H. Baker,
D.O., University of Michigan.
Update of Concepts Previously Proposed
■■ S1410, “Randomized Trial of Interval Increase in Exercise
Intensity vs Moderate Intensity Exercise to Improve
Cardiopulmonary Fitness in Breast Cancer Survivors.” Drs.
Klemp, Porter, and Floyd. (Secondary Committee Breast).
Present revised schema.
■■ Carvedilol vs Placebo to Decrease the Incidence of Left
Ventricular Myocardial Dysfunction in High Risk Patients with
Metastatic Breast Cancer on Trastuzumab Therapy. (Secondary
Committee Breast). Drs. Floyd and Leja. Present final schema
and triage status.
■■ Cancer Survivorship Registry. Drs. O’Rourke, Klemp, and
Neuhouser. Update proposal and timeline for triage submission.
■■ Docosahexaonoic Acid (DHA) vs Placebo during Adjuvant
Therapy for Prevention of Cognitive Dysfunction. (Secondary
Committee Breast). Drs. Fabian and Wefel.
Activated Studies
■■ C70807, “The Men’s Eating and Living (MEAL) Study: A
Randomized Trial of Diet to Alter Disease Progression in
Prostate Cancer Patients on Active Surveillance. Dr. Van
Veldhuizen. Cancer Control Credits: 0.2 ($400) at preregistration, 0.8($1,600) at enrollment. Activated: 6/11/11.
Accrual Update
SWOG • Leading Cancer Research. Together.
■■ S1316 Prospective Comparative Effectiveness Trial for
Malignant Bowel Obstruction. Dr. Krouse. Activated: TBD
Closed Studies
■■ S0230 POEMS Study, Submitted to NEJM. Update Publication
Status. Dr. Moore. Activated: 10/1/03; Closed: 6/1/11.
■■ S0702, “A Prospective Observational Multicenter Cohort Study
to Assess the Incidence of Osteonecrosis of the Jaw (ONJ) in
Cancer Patients with Bone Metastasis Starting Zoledronic Acid
Treatment.” Drs. Van Poznak and Gralow. Activated: 12/15/08;
Closed: 12/15/13. (Primary Committee Symptom Control).
■■ S1008, “Pilot and Feasibility Study of a Physical Activity
and Dietary Change Weight Loss Intervention in Breast and
Colorectal Cancer Patients.” Dr. Greenlee. Activated: 3/1/12;
Closed: 7/1/14. Cancer Control Credits: 1.0
New Concepts
Other Business
■■ Special Projects/ Presentations
■■ Rick Bangs and Anna Gottlieb: Advocate Update.
■■ Nursing Committee Update
■■ International Survivorship Update: Dr. Kathy Albain
No publication information for this cycle.
SWOG Group Meeting Agenda
35
PREVENTION COMMITTEE
Prevention Committee Co-Chairs:
Powel Brown, M.D., Ph.D.
Marian Neuhouser, Ph.D.
Time/Location
Thursday, October 23, 2014
Room: Michigan (Bronze Level, East Tower)
10:15 a.m. - 12:15 p.m.
Agenda
Introduction
Presentations
1. Opening Comments - Powel Brown, M.D., Ph.D.
2. Cancer Prevention Opportunities within SWOG - Marian Neuhouser,
Ph.D.
3. Vaccines to prevent the development of common solid tumors - Mary
“Nora” Disis, M.D.
Active Studies
■■ S0820, “A Double-Blind Placebo-Controlled Trial of Eflornithine
and Sulindac to Prevent Recurrence of High Risk Adenomas and
Second Primary Colorectal Cancers in Patients With Stage 0-III
Colon Cancer, Phase III.” Drs. Zell, Brown, Lance, Krouse and
Lipkin. Activated: 3/1/13.
■■ S0000B, Prevention of Cataract and Age-Related Macular
Degeneration with Vitamin E and Selenium – SELECT Eye Endpoints
(SEE) Phase III Ancillary to S0000 – SELECT”. Drs. Christen, Glynn
and Gaziano. Activated: 7/1/04.
Closed Studies
■■ S0812, “A Randomized Double-Blind Placebo-Controlled Biomarker
Modulation Study of Vitamin D in Premenopausal Women at HighRisk For Breast Cancer, Phase IIB.” Dr. Crew. Activated: 11/1/11;
Closed: 8/15/14.
New Business / Concepts under discussion
■■ Nonavalent HPV vaccine for prevention of cervical cancer. Dr.
Baker.
■■ Combination therapy for the prevention of breast cancer:
Bazedoxifene plus estrogen. Dr. Fabian.
■■ Omega-3 plus metformin for breast cancer prevention. Dr. Crew.
■■ Ovarian Cancer Early Detection Study. Dr. Palomares.
Publications
The publications listed below are those that have been received in
published, submitted or accepted form by the Group Chair’s Office
since the Spring 2014 meeting agenda booklet publication list.
Published/Accepted Manuscripts
■■ S0000 Is there a role for body mass index in assessment
of prostate cancer risk on biopsy? Y Liang, NS Ketchum, P
Goodman, E Klein, IM Thompson. Journal of Urology, 2014
Apr 17 [Epub ahead of print] http://www.ncbi.nlm.nih.gov/
pubmed/24747090
■■ S0000 Plasma vitamin D and prostate cancer risk: results
from the Selenium and Vitamin E Cancer Prevention Trial. AR
Kristal, C Till, X Song, CM Tangen, PJ Goodman, ML Neuhauser,
IM Thompson, FL Meyskens, GE Goodman, LM Minasian,
HL Parnes, EA Klein. Cancer Epidemiology Biomarkers &
Prevention 23(8):1494-504, 2014. http://www.ncbi.nlm.nih.
gov/pubmed/24732629
■■ S0000 A functional variant in NKX3.1 associated with prostate
cancer risk in the SELECT Trial. E Martinez, A Darke, C Tangen,
P Goodman, J Fowke, EA Klein, S Abdulkadir. Cancer Prevention
Research 7(9):950-957. 2014. http://www.ncbi.nlm.nih.gov/
pubmed/24894197
■■ S0000 Generalizability of established prostate cancer risk
variants in men of African-ancestry. Y Han, L Signorello, S
Strom, R Kittles, B Rybicki, J Stanford, P Goodman, S Berndt, J
Carpten, G Casey, L Chu, D Conti, K Rand, R Driver, A Hennis,
E John, A Kibel, EA Klein, S Kolb, L Le Marchand, M Leske, A
Murphy, C Neslund-Dudas, JY Park, C Pettaway, S Gapster,
SL Zheng, S-Y Wu, J Witte, J Xu, W Isaacs, SA Ingles, A Hsing,
the PRACTICAL Consortium, D Easton, R Eeles, F Schumacher,
S Chanock, B Nemesure, W Blot, DO Stram, B Henderson, C
Haiman. International Journal of Cancer 2014 Jul 8 [Epub ahead
of print]. http://www.ncbi.nlm.nih.gov/pubmed/25044450
■■ S0000 Plasma tocopherols and risk of prostate cancer in the
Selenium and Vitamin E Cancer Prevention Trial (SELECT). D
Albanes, C Till, EA Klein, PJ Goodman, AM Mondul, SJ Weinstein,
PR Taylor, HL Parnes, JM Gaziano, X Song, NE Fleshner,
FL Meyskens, P Brown, IM Thompson. Cancer Prevention
SWOG • Leading Cancer Research. Together.
36 Fall 2014
PREVENTION COMMITTEE
Research, (9):886-895.2014. http://www.ncbi.nlm.nih.gov/
pubmed/24961880
■■ S0000 Genome-wide association study identifies multiple
susceptibility loci for pancreatic cancer. BM Wolpin, C Rizzato,
P Kraft, C Kooperberg, GM Petersen, Z Wang, AA Arslan, L
Beane-Freeman, PM Bracci, J Buring, F Canzian, EJ Duell, S
Gallinger, GG Giles, GE Goodman, PJ Goodman, EJ Jacobs, A
Kamineni, AP Klein, LN Kolonel, MH Kulke, D Li, N Malats, SH
Olson, HA Risch, HD Sesso, K Visvanathan, E White, W Zheng,
CC Abnet, D Albanes, G Andriotti, MA Austin, R Barfield, D
Basso, SI Berndt, M-C Boutron-Ruault, M Brotzman, MW Büchler,
H Bas Bueno-de-Mesquita, P Bugert, L Burdette, D Campa, NE
Caporaso, G Capurso, C Chung, M Cotterchio, E Costello, J
Elena, N Funel, JM Gaziano, N Giese, EL Giovannucci, M Goggins,
MJ Gorman, M Gross, CA Haiman, M Hassan, K Helzlsouer, BE
Henderson, EA Holly, N Hu, DJ Hunter, F Innocenti, M Jenab, R
Kaaks, TJ Key, K-T Khaw, EA Klein, M Kogevinas, J Kupcinskas,
RC Kurtz, A LaCroix, MT Landi, S Landi, L Le Marchand, A
Mambrini, S Mannisto, RL Milne, Y Nakamura, AL Oberg, K
Owzar, S Panico, AV Patel, PHM Peeters, U Peters, A Piepoli,
M Porta, FX Real, E Riboli, N Rothman, A Scarpa, X-O Shu, DT
Silverman, P Soucek, M Sund, R Talar-Wojnarowska, PR Taylor,
GE Theodoropoulos, M Thornquist, A Tjønneland, GS Tobias, D
Trichopoulos, P Vodicka, J Wactawski-Wende, N Wentzensen, C
Wu, H Yu, K Yu, A Zeleniuch-Jacquotte, R Hoover, P Hartge, C
Fuchs, S Chanock, RS Stolzenberg-Solomon, L Amundadottir.
Nature Genetics 46(9):994-1000. http://www.ncbi.nlm.nih.gov/
pubmed/25086665
■■ S0000B Age-related cataract in a randomized trial of selenium
and vitamin E in men: The SELECT Eye Endpoints (SEE) Study.
W Christen, R Glynn, JM Gaziano, C Tangen, J Crowley, P
Goodman, A Darke, SM Lippman, TE Lad, JD Bearden, GE
Goodman, LM Minasian, IM Thompson, CD Blanke, EA Klein.
JAMA Ophthalmology, 2014 Sep 18 [Epub ahead of print]. http://
www.ncbi.nlm.nih.gov/pubmed/25232809.
■■ S0000/S9217 Circulating fatty acids and prostate cancer risk:
individual participant meta-analysis of prospective studies.
FL Crowe, P Appleby, R Travis, M Barnett, T Brasky, H Bas
Bueno-de-Mesquita, J Chavarro, D English, R Gibson, G Giles, G
Goodman, S Henning, R Kaaks, I King, L Kolonel, A Kristal, M
Neuhouser, S-Y Park, G Severi, A Siddiq, M Stampfer, P Stattin,
C Tangen, A Tjønneland, D Trichopoulos, R Tumino, L Wilkens, T
Key, N Allen on behalf of the Endogenous Hormones, Nutritional
Biomarkers and Prostate Cancer Collaborative Group. Journal of
the National Cancer Institute, in press.
SWOG • Leading Cancer Research. Together.
■■ S9217 Chronic inflammation in benign prostate tissue is
associated with high-grade prostate cancer in the placebo arm
of the prostate cancer prevention trial. B Gurel, MS Lucia, IM
Thompson, PJ Goodman, CM Tangen, AR Kristal, HL Parnes,
SM Lippman, S Sutcliffe, SB Peskoe, CG Drake, WG Nelson,
AM DeMarzo, EA Platz. Cancer Epidemiology, Biomarkers &
Prevention, 23(5):847-56, 2014. http://www.ncbi.nlm.nih.gov/
pubmed/24748218
■■ S9217 Prostate Cancer Prevention Trial risk calculator 2.0: for
the prediction of low- vs high-grade prostate cancer. D Ankerst,
J Hoefler, S Bock, P Goodman, A Vickers, J Hernandez, LJ Sokoll,
M Sanda, J Wei, R Leach, IM Thompson. Urology 83(6):13621368, 2014. http://www.ncbi.nlm.nih.gov/pubmed/24862395
■■ S9217 Factors associated with adherence to an end-of-study
biopsy: lessons from the Prostate Cancer Prevention Trial
(SWOG-Coordinated Intergroup Study S9217). ER Gritz, KB
Arnold, CM Moinpour, AM Burton-Chase, CM Tangen, JF
Probstfield, WA See, MM Lieber, V Caggiano, SM Thomas,
C Szczepanek, A Ryan, S Carlin, S Hill, P Goodman, RM
Padberg, L Minasian, FL Meyskens, IM Thompson. Cancer
Epidemiology, Biomarkers & Prevention 23(8):1638-1648,
2014. PMID25028457; PMC4119542. http://www.ncbi.nlm.nih.
gov/pubmed/25028457
■■ S9217 Serum 25-hydroxyvitamin D concentrations and risk of
prostate cancer: results from the Prostate Cancer Prevention
Trial. JM Schenk, C Till, CM Tangen, P Goodman, X Song,
KC Torkko, AR Kristal, U Peters, ML Neuhouser. Cancer
Epidemiology, Biomarkers & Prevention 23(8):1484-1493, 2014.
http://www.ncbi.nlm.nih.gov/pubmed/25085836
Submitted Manuscripts
■■ S0000 Vitamin D metabolic pathway genes and pancreatic
cancer risk. H Arem, D Maeder, K Yu, X Xiong, K Moy, N
Freedman, ST Mayne, D Albanes, A Arslan, M Austin, WR
Bamlet, L Beane-Freeman, P Bracci, F Canzian, M Cotterchio,
E Duell, S Gallinger, GG Giles, M Goggins, PJ Goodman, P
Hartge, M Hassan, K Helzlsouer, B Henderson, E Holly, R Hoover,
EJ Jacobs, A Kamineni, A Klein, E Klein, L Kolonel, D Li, S
Männistö, ML McCullough, SH Olson, I Orlow, U Peters, GM
Petersen, P Real, F Severi, X-O Shu, K Visvanathan, E White, H
Yu, A Zeleniuch-Jacquotte, W Zheng, Ha Risch, JN Sampson,
RZ Stolzenberg-Solomon. PLOS ONE, revised and resubmitted,
9/23/14.
SWOG Group Meeting Agenda
PREVENTION COMMITTEE
■■ S0000C A randomized controlled trial of vitamin E and selenium
on rate of decline in lung function. P Cassano, K Guertin, A
Kristal, K Ritchie, M Bertoia, K Arnold, J Crowley, J Hartline,
P Goodman, C Tangen, L Minasian, S Lippman, E Klein.
Respiratory Research, under review.
■■ S9217 Prospective study of human herpes virus type 8
serostatus and prostate cancer risk in the placebo arm of the
Prostate Cancer Prevention Trial. S Sutcliffe, C Till, FJ Jenkins,
CA Gaydos, PJ Goodman, AM Hoque, AW Hsing, IM Thompson,
WG Nelson, AM DeMarzo, EA Platz. Cancer Causes and Control,
under revision for resubmission, 9/24/14.
■■ S9217 Finasteride concentrations and prostate cancer risk:
results from the Prostate Cancer Prevention Trial. CH Chau, DK
Price, C Till, PJ Goodman, X Chen, RJ Leach, TL Johnson-Pais,
AW Hsing, A Hoque, CM Tangen, L Chu, HL Parnes, JM Schenk,
JKV Reichardt, IM Thompson, WD Figg. European Urology, under
review, 9/24/14.
SWOG • Leading Cancer Research. Together.
37
38 Fall 2014
SYMPTOM CONTROL & QUALITY OF LIFE COMMITTEE
Symptom Control and QOL Committee Co-Chairs:
Carol M. Moinpour, Ph.D.
James L. Wade, III, M.D.
Time/Location
Thursday, October 23, 2014
Room: Michigan (Bronze Level, East Tower)
5:00 p.m. - 7:00 p.m.
Agenda
Introductions
New Co-Chair Replacing Dr. Moinpour: Michael Fisch, M.D., MD
Anderson Cancer Center
Active Studies
■■ S1013, “A Phase II Prospective Study of Epidermal Growth
Factor Receptor (HER-1/EGFR) Inhibitor-Induced Dermatologic
Toxicity: Validation of the Functional Assessment of Cancer
Therapy – EGFRI 18 (FACT-EGFRI 18) Questionnaire for EGFRIinduced Skin Toxicities.” Dr. Wong. Activated: 11/15/11.
■■ S1200, “Randomized Blinded Sham- and Waitlist-Controlled
Trial of Acupuncture for Joint Symptoms Related to Aromatase
Inhibitors in Women with Early Stage Breast Cancer.” Drs.
Hershman and Crew. Activated: 4/1/12.
■■ S1202, “Phase III Study of Duloxetine for Treatment of
Aromatase Inhibitor-Associated Musculoskeletal Symptoms in
Women with Early Stage Breast Cancer.” Drs. Henry and Schott.
Activated: 5/15/13.
Closed Studies
■■ S0702, “A Prospective Observational Multicenter Cohort Study
to Assess the Incidence of Osteonecrosis of the Jaw (ONJ) in
Cancer Patients with Bone Metastasis Starting Zoledronic Acid
Treatment.” Drs. Gralow and Van Poznak. Activated: 12/15/08;
Closed: 12/13/13.
Concepts in Development
■■ “A Phase II Randomized Placebo-Controlled Study to Evaluate
the Use of vitamin K1(Reconval® k1) Topical Lotion in Patients
with Cutaneous Toxicity Caused by Epidermal Growth Factor
Receptor (HER1/EGFR) Inhibitors”. Drs. Wong, Ryan, Wade, and
Moinpour.
SWOG • Leading Cancer Research. Together.
■■ “Cognitive Rehabilitation Intervention During Cancer Treatment:
Emerging from the Haze”. Drs. Asher and Myers. Dr. Asher
has pilot data from a quality improvement project at CedarsSinai Medical Center with plans for a pilot study at this
institution.
■■ “Enhanced Recovery After surgery (ERAS) Following Radical
Cystectomy and Urinary Diversion”. Dr. Daneshmand and Jamie
Myers, R.N., Ph.D. Possible companion study to an ongoing
SWOG bladder cancer surgical trial.
■■ S1311, “Phase II Randomized Study of Trastuzumab Emtansine
(T-DM1) Plus Pertuzumab With or Without Paclitaxel in Her2+
Metastatic Breast Cancer (MBC)”. Dr. Elias.
■■ S1409, “A Phase III Biomarker Trial Examining the Benefit of
Plasma Markers to Predict Response to Targeted Therapy in
Frontline Treatment of Poor Risk Renal Cell Cancer”. Drs. Mims,
Heath, Zurita, Heymach, and Lara. This study is being reviewed
by the GU Steering Committee.
■■ S1412, Randomized Phase III Study of Lenalidomide (L) and
Ixazomib (NSC-XXXXX) (LI) as Maintenance Therapy PostAutologous Stem Cell Transplant in Patients with Multiple
Myeloma (MM). Dr. Shaw. This concept is being reviewed at
CTEP.
■■ “Effect of Immune-Enhancing Nutrition on Radical Cystectomy
Outcomes.” Dr. Hamilton-Reeves, Ph.D.
Other Studies with Symptom Control and QOL Component
■■ S1007, “A Phase III, Randomized Clinical Trial of Standard
Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with
1-3 Positive Nodes, Hormone-responsive and Her2-Negative
Breast Cancer according to Recurrence Score (RS).” Drs.
Gonzales-Angulo, Meric-Bernstam, Hortobagyi, and Albain.
Activated: 1/15/11: Quality of Life and Economic Substudy
permanently closed to accrual 12/1/12.
■■ S1207 “Phase III Randomized, Placebo-Controlled Clinical Trial
Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year
of Everolimus in Patients with High-Risk, Hormone ReceptorPositive and HER2/neu Negative Breast Cancer.” Drs. ChavezMac Gregor and Pusztai. Activated: 9/3/13.
SWOG Group Meeting Agenda
39
SYMPTOM CONTROL & QUALITY OF LIFE COMMITTEE
■■ S1216, “A Phase III Randomized Trial Comparing Androgen
Deprivation Therapy + TAK-700 with Androgen Deprivation
Therapy + Bicalutamide in Patients with Newly Diagnosed
Metastatic Hromone Sensitive Prostate Cancer.” Drs. Ajarwal,
Hussain, Lara, and Crispino (SWOG); Vaena (Alliance); MacVicar
(ECOG/ACRIN). Quality of Life Companion Study being
developed by Jeff Sloan, PhD (Alliance).
Other Business
■■ Committee Process
■■ Sign meeting attendance list
■■ Communication issues
■■ Announcements
- NCORP Updates
No publication information for this cycle.
SWOG • Leading Cancer Research. Together.
40 Fall 2014
EARLY THERAPEUTICS AND RARE CANCERS
COMMITTEE
Committee Leadership
Razelle Kurzrock, M.D.
Chair: Executive Officer:
Christopher W. Ryan, M.D.
Statisticians: Megan Othus, Ph.D.
Melissa Plets, M.S.
Designates
Laura Kingsbury, M.R.T.
Data Coordinators:
Christine McLeod
Oncology Research Professionals:
CRAs:
Corrine Turrell, C.C.R.P.
Nurse:
Margaret Ward, R.N., B.S.N
Pharmaceutical Science: Siu-Fun Wong, Pharm.D.
Protocol Coordinator:
Sandi Fredette
Early Therapeutics Liaisons
Breast Committee:
George Somlo, M.D.
GU Committee:
Neeraj Agarwal, M.D.
Lung Committee:
Shirish M. Gadgeel, M.D.
Lymphoma Committee:
Daruka Mahadevan, M.D., Ph.D.
Melanoma Committee:
Jeffrey A. Sosman, M.D.
Myeloma Committee:
Frits van Rhee, M.D., Ph.D.
Time/Location
Thursday, October 23, 2014
Room: Regency A (Gold Level, West Tower)
10:00 a.m – 12:15 p.m..
Agenda
Introduction to Early Therapeutics
Presentations
Immunotherapy of Solid Tumors - Sandip Patel, M.D.
New Targeted Molecules Update - Monica Mita, M.D.
Rare Tumors Orientation Discussion - TBD
Discussion of S0711 - Dr. Sarantopoulos
Proposed Studies
■■ ”A Histology-Independent Study of the Fibroblast Growth Factor
Receptor (FGFR) Inhibitor Lenvatinib in Patients with Advanced
Cancer and Aberrations in FGF/FGFR Signaling.
SWOG • Leading Cancer Research. Together.
Active Studies
■■ S0711, “A Phase I Trial of Dasatinib (BMS-354825) in Patients with
Advanced Malignancies and Varying Levels of Liver Dysfunction.”
Dr. Sarantopoulos. Activated: 10/15/08.
Open Discussion
No publication informatin for this cycle.
SWOG Group Meeting Agenda
41
GASTROINTESTINAL COMMITTEE
Committee Leadership
Chair: Howard S. Hochster, M.D.
Vice-Chair: Heinz-Josef Lenz, M.D.
Executive Officer:
Christopher W. Ryan, M.D.
Statisticians: Katherine Guthrie, Ph.D.
Shannon McDonough, M.S.
Cathryn Rankin, M.S.
Scientific Leadership
Gastroesophageal:
Syma Iqbal, M.D.
Lawrence P. Leichman, M.D.
Scott A. Hundahl, M.D. (Surgical)
Pancreatic:
Philip A. Philip, M.D., Ph.D.
Andrew M. Lowy, M.D. (Surgical)
Hepatobiliary:
Anthony B. El-Khoueiry, M.D.
Abby B. Siegel, M.D.
Syed Ahmad, M.D. (Surgical)
Colon:
Philip J. Gold, M.D.
Anthony F. Shields, M.D., Ph.D.
Kevin G. Billingsley, M.D. (Surgical)
Rectal:
Lisa A. Kachnic, M.D.
Cathy Eng, M.D.
Translational Medicine: Wells A. Messersmith, M.D.
Heinz-Josef Lenz, M.D.
Tanios Bekaii-Saab, M.D. (Pancreatic)
Drug Development:
Ramesh Ramanathan, M.D.
Sunil Sharma, M.D.
Imaging:
Anthony F. Shields, M.D., Ph.D.
David Shin-Kuo Lu, M.D.
Radiation Oncology:
Lisa A. Kachnic, M.D.
Designates
Cancer Control Liaison:
Jason A. Zell, D.O.
Data Coordinators:
Stephanie Edwards
Christine McLeod
Rodney Sutter
Oncology Research Professionals:
CRA:
Sandy Annis, C.C.R.P.
Nurses: Rita Kaul, R.N., B.S.N.
Valerie A. Parks, R.N.
Patient Advocate (Pancreatic): Porsha James, M.P.H.
Patient Advocate (Colon):
Florence Kurttila
Pharmaceutical Science:
Craig Elg, Pharm.D.
Linda Lee-Gabel, Pharm.D.
Protocol Coordinator:
Kimberly Kaberle
Time/Location
Agenda
Introduction - Howard Hochster, M.D., Yale University.
Presentations
■■ Translational Medicine on C80405. Heinz-Josef Lenz, M.D.,
University of Southern California.
■■ Introduction to Value of Information Analysis. Josh Carlson, M.P.H.,
Ph.D. and Carrie Bennette, M.P.H., Ph.D. Student, University of
Washington.
■■ S1406, “Randomized Phase II Study of Irinotecan and Cetuximab
with or without Vemurafenib in BRAF Mutant Metastatic Colorectal
Cancer.” Scott Kopetz, M.D., MD Anderson Cancer Center.
Gastroesophageal
Active Studies
■■ S1201, “A Randomized Phase II Pilot Study Prospectively Assigning
Treatment for Patients Based on ERCC1 (Excision Repair CrossComplementing 1) for Advanced/Metastatic Esophageal, Gastric
or Gastroesophageal Junction (GEJ) Cancer.” Drs. Iqbal and Lenz.
Activated: 2/8/12.
■■ CTSU/RTOG 1010, “A Phase II Trial Evaluating the Addition of
Trastuzumab to Trimodality Treatment of HER2-Overexpressing
Esophageal Adenocarcinoma.” Dr. L. Leichman. Activated: 9/1/11.
Pancreatic
Active Studies
■■ S1313, “A Phase II Randomized Study of FOLFIRINOX + Pegylated
Recombinant Human Hyaluronidase (PEGPH20) versus FOLFIRINOX
Alone in Patients with Metastatic Pancreatic Adenocarcinoma”. Dr.
Ramanathan. Activated: 1/15/14.
■■ CTSU/E2211, “ A Randomized Phase II Study of Temozolomide
or Temozolomide and Capecitabine in Patients with Advanced
Pancreatic Neuroendocrine Tumors.” Dr. Wolin. Activated: 3/1/12.
■■ CTSU/RTOG 0848, “A Phase III Trial Evaluating Both Erlotinib and
Chemoradiation as Adjuvant Treatment for Patients with Resected
Head of Pancreas Adenocarcinoma.” Dr. Philip. Activated:
12/15/09.
Saturday, October 25, 2014
Room: Crystal C (Green Level, West Tower)
9:30 a.m. - 12:30 p.m.
SWOG • Leading Cancer Research. Together.
42 Fall 2014
GASTROINTESTINAL COMMITTEE
Closed Studies
■■ S1115, “Randomized Phase II Clinical Trial of AZD-6244 (NSC741078) and MK-2206 (NSC-749607) vs mFOLFOX in Patients
with Metastatic Pancreatic Cancer After Prior Chemotherapy.” Drs.
Chung and Philip. Activated: 8/15/12; Closed: 5/15/14.
■■ CTSU/A021101, “Neoadjuvant FOLFIRINOX and Chemoradiation
Followed by Definitive Surgery and Postoperative Gemcitabine for
Patients with Borderline Resectable Pancreatic Adenocarinoma: An
Intergroup Single-Arm Pilot Study.” Dr. Ahmad. Activated: 5/15/13;
Temporary Closure: 2/21/14.
Hepatobiliary
Active Studies
■■ S1310, “Randomized Phase II Trial of Single Agent MEK Inhibitor
GSK11200212 vs. 5-Fluorouracil or Capecitabine in Refractory
Advanced Biliary Cancer.” Dr. Kim. Activated: 2/15/14.
■■ CTSU/C80802, “Phase III Randomized Study of Sorafenib
Plus Doxorubicin Versus Sorafenib in Patients with Advanced
Hepatocellular Carcinoma (HCC).” Dr. Siegel. Activated: 6/1/11.
■■ CTSU/E1208, “A Phase III Randomized, Double-Blind Trial of
Chemoembolization with or without Sorafenib in Unresectable
Hepatocellular Carcinoma (HCC) in Patients with and without
Vascular Invasion.” Dr. El-Khoueiry. Activated: 7/15/10.
Colon
Active Studies
■■ S0820, “A Double Blind Placebo-Controlled Trial of Eflornithine and
Sulindac to Prevent Recurrence of High Risk Adenomas and Second
Primary Colorectal Cancers in Patients with Stage 0-III Colon
Cancer, Phase III.” Dr. Zell. Activated: 3/1/13.
■■ S1406, “Randomized Phase II Study of Irinotecan and Cetuximab
with or without Vemurafenib in BRAF Mutant Metastatic Colorectal
Cancer.” Dr. Kopetz. Distributed for IRB Review: 9/24/14.
■■ CTSU/C80702, “A Phase III Trial of 6 versus 12 Treatments of
Adjuvant FOLFOX plus Celecoxib or Placebo for Patients with
Resected Stage III Colon Cancer.” Dr. Shields. Activated: 8/15/10.
■■ CTSU/E7208, “A Randomized Phase II Study of Irinotecan
and Cetuximab With or Without the Anti-Angiogenic Antibody,
Ramucirumab (IMC-1121B), in Advanced, K-ras Wild-Type
Colorectal Cancer Following Progression on Bevacizumab-Containing
Chemotherapy.” Dr. Hochster. Activated: 7/1/14.
SWOG • Leading Cancer Research. Together.
Rectal
Active Studies
■■ CTSU/N1048, “A Phase II/III Trial of Neoadjuvant FOLFOX with
Selective Use of Combined Modality Chemoradiation versus
Preoperative Combined Modality Chemoradiation for Locally
Advanced Rectal Cancer Patients Undergoing Low Anterior
Resection with Total Mesorectal Excision.” Dr. Eng. Activated:
4/15/12.
Other
Active Studies
■■ S1013, “A Phase II Prospective Study of Epidermal Growth Factor
Receptor (Her01/EGFR) Inhibitor-Induced Dermatologic Toxicity:
Validation of the Functional Assessment of Cancer Therapy –
EGFRI 18 (FACT-EGFRI 18) Questionnaire for EGFRI-Induced Skin
Toxicities.” Drs. Wong, Moinpour, and Wade. Activated: 11/15/11.
■■ S1204, “A Sero-Epidemiologic Survey and Cost-Effectiveness Study
of Screening for Human Immunodeficiency Virus (HIV), Hepatitis B
Virus (HBV), and Hepatitis C Virus (HCV) Among Newly Diagnosed
Cancer Patients.” Drs. Ramsey, Loomba, Chugh, Hershman and
Hwang. Activated: 8/29/13.
■■ CTSU/A021202, “Prospective Randomized Phase II Trial of
Pazopanib versus Placebo in Patients with Progressive Carcinoid
Tumors.” Dr. Phan. Activated: 1/15/14.
Closed Studies
■■ S1008, “Pilot and Feasibility Study of a Physical Activity and
Dietary Change Weight Loss Intervention in Breast and Colorectal
Cancer Patients.” Dr. Greenlee. Activated: 3/1/12; Closed: 7/1/14.
Correlative Studies
■■ S9008A, “Trial of Adjuvant Chemoradiation after Gastric Resection
Adenocarcinoma, Phase III”. Dr. Shridhar.
■■ S-C80405-A, “Analysis of EGFR and ERCC1 Markers and
Progression-Free Survival in Patients with Advanced Colorectal
Cancer Enrolled on C80405”. Drs. Shields and Lenz.
Other Proposed Studies
■■ A Randomized Phase II/III Study of Adjuvant Gemcitabine and
Cisplatin versus Gemcitabine and Cisplatin Followed by Capecitabine
and XRT for Patients with High Risk EHCC and GB Carcinoma. Dr.
El-Khoueiry.
■■ A Phase II Randomized Study of First and Second Line Therapy
in HER2 Positive Metastatic/Locally Advanced (non-operable)
Gastroesophageal Cancer. Dr. Barzi.
SWOG Group Meeting Agenda
43
GASTROINTESTINAL COMMITTEE
■■ Randomized Phase II Study of 2nd Line Therapy with FOLFIRI and
PARPi ABT888 in Metastatic Pancreatic Cancer. Dr. Chiorean.
■■ Preoperative Chemotherapy for Resectable Pancreatic
Adenocarcinoma: A Randomized Phase II Study. Dr. Sohal.
■■ Safety Run In Followed by Randomized Phase II Trial of
Rilotumumab+Sorafenib versus Sorafenib in Advanced
Hepatocellular Carcinoma (HCC) in the First Line. Dr. El-Khoueiry.
■■ Neo-adjuvant study for HCC (PAF+Afilbercept). Drs. Kaseb and
Siegel.
Publications
The publications listed below are those that have been received in
published, submitted or accepted form by the Group Chair’s Office since
the Spring 2014 Meeting agenda booklet publication list.
Published/Accepted Manuscripts
■■ S0713 Consequences of anorectal cancer atlas implementation
in the cooperative group setting: radiobiologic analysis of a
prospective randomized in silico target delineation study. P
Mavroidis, D Giantsoudis, MJ Awan, J, CRN Rasch, JC Duppen , CR
Thomas, Jr., P Okunieff, WE Jones, III, LA Kachnic, N Papanikolaou,
CD Fuller, on Behalf of the Southwest Oncology Group Radiation
Oncology Committee. Radiotherapy and Oncology 2014 Jul 1 [Epub
ahead of print]. http://www.ncbi.nlm.nih.gov/pubmed/24996454
■■ S0727 Dual blockade of epidermal growth factor receptor (EGFR)
and insulin-like growth factor receptor-1 (IGF-1R) signaling in
metastatic pancreatic cancer: phase Ib and randomized phase II trial
of gemcitabine, erlotinib, and cixutumumab versus gemcitabine plus
erlotinib (SWOG S0727). PA Philip, B Goldman, RK Ramanathan,
H-J Lenz, AM Lowy, RP Whitehead, W Zhang, S Iqbal, R Gaur, JK
Benedetti, CD Blanke. Cancer 120(19):2980-2985. 2014. http://
www.ncbi.nlm.nih.gov/pubmed/25041791
■■ S9304 Polymorphisms in folate-metabolizing enzymes and response
to 5-fluorouracil among stage II or III rectal cancer patients (INT0144; SWOG 9304). CM Ulrich, C Rankin, AT Toriola, KW Makar,
Ö Altug-Teber, JK Benedetti, RS Holmes, SR Smalley, CD Blanke,
H-J Lenz. Cancer 2014 Jul 15 [Epub ahead of print]. http://www.
ncbi.nlm.nih.gov/pubmed/25041994
■■ C89803 Sugar-sweetened beverage intake and cancer recurrence
and survival in CALGB 89803 (Alliance). MA Fuchs, K Sato, D
Niedzwiecki, X Ye, LB Saltz, RJ Mayer, RB Mowat, R Whittom, A
Hantel, A Benson, D Atienza, M Messino, H Kindler, A Venook,
S Ogino, K Wu, WC Willett, EL Giovannucci, JA Meyerhardt.
PLOS ONE 9(6):e99816, 2014. http://www.ncbi.nlm.nih.gov/
pubmed/24937507
■■ NSAPB R-04 Capecitabine and oxaliplatin in the preoperative
multimodality treatment of rectal cancer: surgical end points from
national surgical adjuvant breast and bowel project trial R-04.
MJ O’Connell, LH Colangelo, RW Beart, NJ Petrelli, CJ Allegra, S
Sharif, HC Pitot, AF Shields, JC Landry, DP Ryan, DS Parda, M
Mohiuddin, A Arora, LS Evans, N Bahary, GS Soori, J Eakle, JM
Robertson, DF Moore Jr, MR Mullane, BT Marchello, PJ Ward,
TF Wozniak, MS Roh, G Yothers, N Wolmark. Journal of Clinical
Oncology 32(18):1927-34, 2014. http://www.ncbi.nlm.nih.gov/
pubmed/24799484
■■ Z9001 Pathologic and molecular features correlate with long-term
outcome after adjuvant therapy of resected primary GI stromal
tumor: the ACOSOG Z9001 trial. CL Corless, KV Ballman, CR
Antonescu, V Kolesnikova, RG Maki, PWT Pisters, ME Blackstein,
CD Blanke, GD Demetri, MC Heinrich, M von Mehren, S Patel,
MD McCarter, K Owzar, RP DeMatteo. Journal of Clinical
Oncology 32(15):1563-1570, 2014. http://www.ncbi.nlm.nih.gov/
pubmed/24638003
■■ Multiple Studies* Historical controls for metastatic pancreatic
cancer: benchmarks for planning and analyzing single arm phase II
trials. PA Philip, K Chansky, L Rubinstein, M Leblanc, L Seymour, SP
Ivy, SR Alberts, PJ Catalano, J Crowley. Clinical Cancer Research
20(16):4176-4185, 2014. *Multiple cooperative groups and
multiple studies, including SWOG: S0107, S0205, S8916, S8933,
S9100, S9135, S9313, S9629, S9924. http://www.ncbi.nlm.nih.
gov/pubmed/24914040
Submitted Manuscripts
■■ S9304 SWOG S9304 phase III intergroup trial’s pharmacogenetic
analysis: association of polymorphisms with survival and toxicity
in stage II/III rectal cancer patients treated with 5-fluorouracil
and pelvic radiation. P Bohanes, CJ Rankin, CD Blanke, T Winder,
CM Ulrich, SR Smalley, K Danenberg, KW Makar, W Zhang, JK
Benedetti, H-J Lenz. Clinical Cancer Research, revised and pending
resubmission.
■■ C89803 Aspirin and COX-2 inhibitor use in patients with stage III
colon cancer. K Ng, JA Meyerhardt, A Chan, K Sato, J Chan, D
Niedzwiecki, L Saltz, R Mayer, A Benson, P Schaefer, R Whittom,
A Hantel, R Goldberg, A Venook, S Ogino, E Giovannucci, C Fuchs.
Journal of the National Cancer Institute, under review 9/24/14.
SWOG • Leading Cancer Research. Together.
44 Fall 2014
GENITOURINARY COMMITTEE
Committee Leadership
Chair: Ian M. Thompson, Jr., M.D.
Vice-Chair:
Nicholas J. Vogelzang, M.D.
Executive Officer:
Christopher W. Ryan, M.D.
Statisticians:
Cathy M. Tangen, Dr.P.H.
Melissa Plets, M.S.
Scientific Leadership
Translational Medicine:
David J. McConkey, Ph.D.
Radiation Oncology:
David Raben, M.D.
Surgery:
Daniel J. Culkin, M.D.
Imaging:
Daniel W. Lin, M.D.
John D. Hazle, Ph.D.
Medical Oncology:
Celestia S. Higano, M.D.
Pathology:
M. Scott Lucia, M.D.
Liaison to the SPORES:
Colin P.N. Dinney, M.D.
Early Therapeutics:
Neeraj Agarwal, M.D.
Designates
Cancer Control:
Peter J. Van Veldhuizen, M.D.
Data Coordinators:
Jean Barce
Austin Hamm
Brian Zeller
Oncology Research Professionals:
CRAs:
Debra W. Christie, M.B.A.
Nurses:
Deborah A. Halk, R.N.
Patient Advocates:
Rick Bangs (Bladder)
Tony Crispino (Prostate)
Pharmaceutical Science:
Jorge G. Avila, Pharm.D.
Jesse Modlin, Pharm.D.
Protocol Coordinator:
Gilbert R. Carrizales, M.S.
Time/Location
Friday, October 24, 2014
Room: Regency D (Gold Level, West Tower)
4:00 p.m. - 7:00 p.m.
Agenda
Renal Cell
Organ Site Chairs: Drs. Primo N. Lara, Jr. (Advanced) and Edward M.
Messing (Local)
Priority Studies
■■ “A Randomized, Phase II Efficacy Assessment of Multiple MET/
HGF Inhibitors in Metastatic Type 1 Papillary Renal Carcino-ma
(PAPMET)”. Dr. Pal.
SWOG • Leading Cancer Research. Together.
■■ S0931 (EVEREST) replacement trial . Drs. Ryan and Lara.
Active Studies
■■ S0931, “EVEREST: EVErolimus for Renal Cancer Ensuing
Surgical Therapy, A Phase III Study.” Drs. Ryan, Heath, Lara,
Palapattu, and Mack. Activated: 4/1/11.
■■ CTSU/E2810, “Randomized Double-Blind Phase III Study of
Pazopanib vs. Placebo in Patients with Metastatic Renal
Cell Carcinoma Who Have No Evidence of Disease Following
Metastatectomy.” Dr. Pal. Activated: 9/1/12.
Closed Studies
■■ S1107, “Parallel (Randomized) Phase II Evaluation of ARQ
197 and ARQ 197 in Combination with Erlotinib in Papillary
Renal Cell Carcinoma.” Drs. Twardowski and Lara. Activated:
8/20/12; Closed: 5/29/14.
■■ CTSU/C90802, “Randomized Phase III Trial Comparing
Everolimus Versus Everolimus Plus Bevacizumab for Advanced
Renal Cell Carcinoma Progressing After Treatment with Tyrosine
Kinase Inhibitors.” Dr. Vaishampayan. Activated: 5/15/12;
Closed: 1/31/13.
Bladder
Organ Site Chairs: Drs. Daniel P. Petrylak (Advanced) and Seth P.
Lerner (Local)
Priority Studies
■■ “PRIME: A Study of T-cell Priming With Intradermal BCG Before
Standard BCG Induction Therapy for BCG Naïve Non-Muscle
Invasive Bladder Cancer.” Dr. Svatek.
■■ Translational medicine projects for S1314. Drs. Flaig and
McConkey.
Active Studies
■■ S1314, “A Randomized Phase II Study of CO-eXpression
ExtrapolatioN (COXEN) With Neoadjuvant Chemotherapy
for Local-ized, Muscle-Invasive Bladder Cancer.” Drs. Flaig,
Daneshmand, Lerner, Lucia, McConkey, and Theodorescu.
Activated: 7/9/14.
■■ S1011, “A Phase III Surgical Trial to Evaluate the Benefit of
a Standard Versus an Extended Pelvic Lymphadenectomy Performed at Time of Radical Cystectomy for Muscle Invasive
SWOG Group Meeting Agenda
45
GENITOURINARY COMMITTEE
Urothelial Cancer.” Drs. Lerner, Koppie, Alva, and Svatek; R.
Bangs. Activated: 8/1/11.
■■ CTSU/C90601, “A Randomized Double-Blinded, Phase III
Study Comparing Gemcitabine, Cisplatin, and Bevacizumab to
Gemcitabine, Cisplatin, and Placebo in Patients with Advanced
Transitional Cell Carcinoma.” Dr. Flaig. Activated: 8/15/09.
Closed Studies
■■ S0337, “A Phase III Blinded Study of Immediate Post-TURBT
Instillation of Gemcitabine Versus Saline in Patients with Newly
Diagnosed or Occasionally Recurring Grade I/II Superficial
Bladder Cancer.” Drs. Messing, Sahasrabudhe, Koppie, Wood
and Mack. Activated: 7/15/07; Closed: 8/15/12.
■■ CTSU/R0524, “A Phase I/II Trial of a Combination of Paclitaxel
and Trastuzumab with Daily Irradiation or Paclitaxel Alone
with Daily Irradiation Following Transurethral Surgery for NonCystectomy Candidates with Muscle-Invasive Bladder Can-cer.”
Dr. Swanson. Activated: 12/15/06; Closed: 2/22/13.
Prostate
Organ Site Chairs: Drs. David I. Quinn (Advanced) and Martin E.
Gleave and David Raben (Local)
Priority Studies
■■ “A Randomized Phase III Study of Dutasteride Alone Versus
Dutasteride plus Pulsatile Enzalutamide in Men With Low
to Intermediate Risk Adenocarcinoma of the Prostate.” Dr.
Lowrance.
Active Studies
■■ S1216, “A Phase III Randomized Trial Comparing Androgen
Deprivation Therapy + TAK-700 With Androgen Deprivation
Therapy + Bicalutamide in Patients With Newly Diagnosed
Metastatic Hormone Sensitive Prostate Cancer.” Drs. Agarwal,
Hussain, and Lara; T. Crispino. Activated: 3/1/13.
■■ CTSU/A031201, “Phase III Trial of Enzalutamide Versus
Enzalutamide, Abiraterone and Prednisone for Castration
Resistant Metastatic Prostate Cancer.” Dr. Goldkorn.
Activated: 2/1/14.
■■ CTSU/C90203, “A Randomized Phase III Study of NeoAdjuvant Docetaxel and Androgen Deprivation Prior to Radical
Prostatectomy versus Immediate Radical Prostatectomy in
Patients with High-Risk, Clinically Localized Prostate Cancer.”
Dr. Kim. Activated: 7/1/07.
Closed Studies
■■ S1014, “Abiraterone Acetate Treatment for Prostate Cancer
Patients with a PSA of More Than Four Following Initial Androgen Deprivation Therapy, Phase II.” Drs. Flaig and Hussain.
Activated: 8/9/11; Closed 8/1/13.
■■ S0925, “A Phase II Randomized Study of Androgen Deprivation
Combined with IMC-A12 versus Androgen Deprivation Alone
for Patients with New Hormone-Sensitive Metastatic Prostate
Cancer.” Drs. Yu and Higano. Activated: 12/15/10; Closed:
12/1/12.
■■ CTSU/C90202, “A Randomized Double-Blind, Placebo-Controlled
Phase III Study of Early Versus Standard Zoledronic Acid to
Prevent Skeletal Related Events in Men with Prostate Cancer
Metastatic to Bone.” Dr. Bhoopalam. Activated: 8/1/04;
Closed: 4/4/12.
■■ CTSU/E3805, “CHAARTED: ChemoHormonal Therapy versus
Androgen Ablation Randomized Trial for Extensive Disease
in Prostate Cancer.” Dr. Garcia. Activated: 9/1/08; Closed:
11/21/12.
Cancer Control
Organ Site Chair: Dr. Peter J. Van Veldhuizen
Active Studies
■■ S1204, “A Sero-Epidemiologic Survey and Cost-Effectiveness
Study of Screening for Human Immunodeficiency Virus (HIV),
Hepatitis B virus (HBV) and Hepatitis C Virus (HCV) Among
Newly Diagnosed Cancer Patients. Drs. Ramsey, Loomba, Chugh,
Hershman and Hwang. Activated: 8/29/13.
■■ CTSU/C70807, “The Men’s Eating and Living (MEAL) Study:
A Randomized Trial of Diet to Alter Disease Progression in
Prostate Cancer Patients on Active Surveillance.” Dr. Van
Veldhuizen. Activated: 6/1/11.
Closed Studies
■■ S0702, “A Prospective Observational Multicenter Cohort Study
to Assess the Incidence of Osteonecrosis of the Jaw (ONJ) in
Cancer Patients with Bone Metastases Starting Zoledronic Acid
Treatment.” Drs. Van Poznak, Gralow, Bagramian, and Schubert;
Lisa Hansen, R.N. Activated: 12/15/08; Closed: 12/13/13.
SWOG • Leading Cancer Research. Together.
46 Fall 2014
GENITOURINARY COMMITTEE
Publications
The publications listed below are those that have been received in
published, submitted or accepted form by the Group Chair’s Office
since the Spring 2014 Meeting agenda booklet publication list.
All PCPT and SELECT publications are listed under Cancer Control &
Prevention Committees
Published/Accepted Manuscripts
■■ S0421 Circulating tumor cell telomerase activity as a prognostic
marker for overall survival in SWOG 0421: a phase 3 metastatic
castration resistant prostate cancer trial. A Goldkorn, B Ely, C
Tangen, Y-C Tai, T Xu, H Li, P Twardowski, P Van Veldhuizen, N
Agarwal, M Carducci, J Monk, M Garzotto, P Mack, P Lara, C
Higano, M Hussain, N Vogelzang, IM Thompson, R Cote, D Quinn.
International Journal of Cancer 2014 Sep 13 [Epub ahead of
print]. http://www.ncbi.nlm.nih.gov/pubmed/25219358
Submitted Manuscripts
■■ 4B951 Variability in surgical quality in a phase III prospective
clinical trial of radical cystectomy in patients with organconfined, node-negative urothelial carcinoma of the bladder. DA
Mata, S Groshen, F-C von Rundstedt, DG Skinner, WM Stadler,
RJ Cote, JP Stein, SP Lerner. European Urology, submitted 8/14.
SWOG • Leading Cancer Research. Together.
SWOG Group Meeting Agenda
47
LEUKEMIA COMMITTEE
Committee Leadership
Chair: Vice-Chair: Executive Officer:
Statisticians: Scientific Leadership
Translational Medicine: Pathology: Cytogenetics Liaison: Designates
Data Coordinators:
Oncology Research Professionals:
CRAs: Nurses:
Patient Advocate:
Pharmaceutical Science:
Protocol Coordinator:
Harry P. Erba, M.D., Ph.D.
Steven E. Coutre, M.D.
Susan M. O’Brien, M.D.
Megan Othus, Ph.D.
Hongli Li, M.S.
Shannon McDonough, M.S.
Jerald P. Radich, M.D.
David R. Head, M.D.
Diane Roulston, Ph.D.
Min Fang, M.D., Ph.D.
Jean Barce
Laura Kingsbury, M.R.T.
Tracy Maher, C.C.R.P.
Mary Lynn Rush, R.N., B.S.N.
Keisha C. Humphries, R.N., B.S.N.
Laura N. Kassel, R.N., M.S.
Michelle J. Worman, L.V.N.
Holly O. Chan, Pharm.D.
Joyce Lee, Pharm.D.
Sandi Fredette
Time/Location
Friday, October 24, 2014
Room: Regency D (Gold Level, West Tower)
10:15 a.m. – 12:15 p.m.
Agenda
Introduction
Current Status of the Leukemia Committee
■■ S1203, “A Randomized Phase III Study of Standard Cytarabine
plus Daunomycin (7+3) Therapy versus Idarubicin with High
Dose Cytarabine (IA) with or without Vorinostat in Younger
Patients with Previously Untreated Acute Myeloid Leukemia
(AML).” Dr. Garcia-Manero. Activated: 12/15/12.
■■ CTSU/E2905, “Randomized Phase III Trial Comparing the
Frequency of Major Erythroid Response (MER) to Treatment
with Lenalidomide (Revlimid) Alone and in Combination with
Epoetin Alpha (Procrit®) in Subjects with Low-or Intermediate-1
Risk MDS and Symptomatic Anemia.” Dr. Schiffer. Activated by
ECOG: 1/29/09; Activated by SWOG: 2/15/09.
■■ CTSU/E2906, “Phase III Randomized Trial of Clofarabine
as Induction and Post-Remission Therapy vs. Standard
Daunorubicin & Cytarabine Induction and Intermediate Dose
Cytarabine Post-Remission Therapy, Followed by Decitabine
Maintenance vs. Observation in Newly-Diagnosed Acute Myeloid
Leukemia in Older Adults (Age ≥ 60 Years.” Dr. Godwin.
Activated by ECOG: 12/28/10; Activated by SWOG: 7/20/12.
ALL Studies
Active Studies
■■ S1312, “A Phase I Study of Inotuzumab (NSC-772518)
in Combination with CVP (Cyclophosphamide, Vincristine,
Prednisone) for Patients with Relapsed/Refractory CD22Positive Acute Leukemia (including B-ALL, Mixed Phenotypic
Leukemia and Burkitt’s Leukemia.” Dr. Advani. Activated:
4/1/14; Temporary Closure: 8/18/14.
■■ CTSU/E1910, “A Phase III Randomized Trial of Blinatumomab
for Newly Diagnosed BCR-ABL-Negative B Lineage Acute
Lymphoblastic Leukemia in Adults.” Dr. Liedtke. Activated by
ECOG: 12/23/13. Activated by SWOG: 1/15/14.
Active Studies
■■ S0919, “A Phase II Study of Idarubicin and Ara-C in Combination
with Pravastatin for Poor-Risk Acute Myelogenous Leukemia
(AML).” Dr. Advani. Activated: 8/15/09.
■■ CTSU/C10701, “A Phase II Study of Dasatinib (Sprycel®)
(IND #73969, NSC #732517) as Primary Therapy Followed by
Transplantation for Adults >= 50 Years with Newly Diagnosed
Ph+ Acute Lymphoblastic Leukemia by CALGB, ECOG, SWOG
and NCIC CTG(CALGB 10701). Dr. Liedtke. Activated by
CALGB: 12/14/10. Activated by SWOG: 6/1/12.
■■ S1117, “A Randomized Phase II Study of Azacitidine in
Combination with Lenalidomide (NSC-703813) vs. Azacitidine
Alone vs. Azacitidine in Combination with Vorinostat (NSC701852) for Higher-Risk Myelodysplastic Syndromes (MDS).”
Dr. Sekeres. Activated: 3/1/12.
Proposed Studies
■■ S1318, “A Phase II Study of Blinatumomab and POMP
(Prednisone, Vincristine, Methotrexate, 6-Mercaptopurine) for
Elderly Patients with Newly Diagnosed Philadelphia Chromosome
Negative Acute Lymphocytic Leukemia (ALL).” Dr. Advani.
AML/MDS Studies
SWOG • Leading Cancer Research. Together.
48 Fall 2014
LEUKEMIA COMMITTEE
Closed Studies
■■ S0805, “Phase II Study of Combination of Hyper-CVAD and
Dasatinib (NSC-732517) with or without allogenic stem cell
transplant in Patients with Philadelphia (Ph) Chromosome
Positive and/or BCR-ABL Positive Acute Lymphoblastic Leukemia
(ALL) (A BMT Study).” Dr. Ravandi. Activated: 9/1/09; Closed:
10/1/13.
CLL Studies
Active Studies
■■ CTSU/A041202, “A Randomized Phase III Study of
Bendamustine plus Rituximab versus Ibrutinib plus Rituximab
versus Ibrutinib Alone in Untreated Older Patients (≥ 65 Years
of Age) with Chronic Lymphocytic Leukemia (CLL).” Dr. Coutre.
Activated by Alliance: 12/9/13. Activated by SWOG: 12/15/13.
■■ CTSU/E1912, “A Randomized Phase III Study of Ibrutinib
(PCI-32765)-based Therapy vs. Standard Fludarabine,
Cyclophosphamide, and Rituximab (FCR) Chemoimmunotherapy
in Untreated Younger Patients with Chronic Lymphocytic
Leukemia (CLL).” Dr. O’Brien. Activated by ECOG: 1/31/13.
Activated by SWOG: 2/15/14.
Publications
The publications listed below are those that have been received in
published, submitted or accepted form by the Group Chair’s Office
since the Spring 2014 Meeting agenda booklet publication list.
Published/Accepted Manuscripts
■■ S0106B Heterogeneity of clonal expansion and maturation-linked
mutation acquisition in hematopoietic progenitors in human
acute myeloid leukemia. R Walter, GS Laszlo, JM Lionberger, JA
Pollard, KH Harrington, C Gudgeon, M Othus, S Rafii, S Meshinchi, F Appelbaum, ID Bernstein. Leukemia 2014 Mar 18 [Epub
ahead of print]. http://www.ncbi.nlm.nih.gov/pubmed/24721792
■■ S0106/other Co-expression of NUP98/NSD1 and FLT3/ITD is
more prevalent in younger AML patients and leads to high-risk of
induction failure: a COG and SWOG report. F Ostronoff, M Othus,
RB Gerbing, MR Loken, SC Raimondi, BA Hirsch, BJ Lange, S
Petersdorf, J Radich, FR Appelbaum, AS Gamis, TA Alonzo, S
Meshinchi. Blood 2014 Aug 21 [Epub ahead of print]. http://
www.ncbi.nlm.nih.gov/pubmed/25145343
SWOG • Leading Cancer Research. Together.
■■ S0919 SWOG0919: a phase 2 study of idarubucin and cytarabine in combination with pravastatin for relapsed acute myeloid
leukemia. A Advani, S McDonough, E Copelan, C Willman, DA
Mulford, AF List, MA Sekeres, M Othus, HP Erba, FR Appelbaum.
British Journal of Haematology, 2014 Jul 18 [Epub ahead of
print]. http://www.ncbi.nlm.nih.gov/pubmed/25039477
■■ E1905 Prolonged administration of azacitidine with our without
entinostat for myelodysplastic syndrome and acute myeloid
leukemia with myelodysplasia-related changes: results of the US
Leukemia Intergroup trial E1905. T Prebet, Z Sun, ME Figueroa,
R Kettering, A Melnick, P Greenberg, M Juckett, M Smith, L
Malick, E Paietta, M Czader, J Gabrilove, H Erba, S Gore, M
Tallman. Journal of Clinical Oncology 32(12):1242-2348, 2014.
http://www.ncbi.nlm.nih.gov/pubmed/24663049
■■ E1905 Comparison of the prognostic utility of the revised
International Prognostic Scoring System and the French
Prognostic Scoring System in azacitidine-treated patients with
myelodysplastic syndromes. AM Zeidan, J-W Lee, T Prebet, P
Greenberg, Z Sun, M Juckett, MR Smith, E Paietta, J Gabrilove,
HP Erba, MS Tallman, SD Gore. British Journal of Haematology 166(3):352-359, 2014. http://www.ncbi.nlm.nih.gov/
pubmed/24712482
■■ E1905 Platelet count doubling after the first cycle of azacitidine
therapy predicts eventual response and survival in patients with
myelodysplastic syndromes and oligoblastic acute myeloid leukaemia but does not add to prognostic utility of the revised IPSS.
AM Zeidan, J-W Lee, T Prebet, P Greenberg, Z Sun, M Juckett,
MR Smith, E Paietta, J Gabrilove, HP Erba, RP Katterling, MS
Tallman, SD Gore on behalf of the Eastern Cooperative Oncology
Group (ECOG) and North American Leukemia Intergroup. British
Journal of Haematology 167(1):62-68. 2014. http://www.ncbi.
nlm.nih.gov/pubmed/24995683
■■ Multiple Studies* Resistance prediction AML: Analysis of
4,565 Patients from MRC/NCRI, HOVON/SAKK, SWOG, and
MD Anderson Cancer Center. R Walter, M Othus, AK Burnett, B
Lowenberg, H Kantarjian, G Ossenkoppele, R Hills, F Ravandi,
A Evans, SA Pierce, F Appelbaum, EH Estey. Leukemia 2014
Aug 12 [Epub ahead of print].*Studies: S0106, S0112, S8600,
S9031, S9034, S9333, S9500, S9617, S9918. http://www.
ncbi.nlm.nih.gov/pubmed/25113226
SWOG Group Meeting Agenda
LEUKEMIA COMMITTEE
■■ Multiple Studies* The addition of gemtuzumab ozogamicin to
induction chemotherapy improves survival in acute myeloid leukaemia by reducing relapse risk: A source data meta-analysis of
randomised trials in adults. R Hills, S Castaigne, F Applebaum, J
Delaunay, S Petersdorf, M Othus, E Estey, H Dombret, S Chevret,
N Ifrah, J-Y Cahn, C Recher, L Chilton, A Moorman, A Burnett.
Lancet Oncology 15(9):986-996, 2014. *Multiple studies/
groups pooled analysis, including S0106 http://www.ncbi.nlm.
nih.gov/pubmed/25008258
Submitted Manuscripts
■■ S0106 The fate of patients with newly diagnosed acute myeloid
leukemia who fail primary induction therapy. M Othus, FR
Appelbaum, SH Petersdorf, KJ Kopecky, M Slovak, T Nevill, J
Brandwein, RA Larson, PJ Stiff, RB Walter, MS Tallman, L
Stenke, HP Erba. Leukemia, under review.
■■ S0333 Minimal residual disease detection by high throughput
sequencing in adult-B cell acute lymphoblastic leukemia (ALL)
patients treated on SWOG Trial S0333. O Sala, M Othus, D
Williamson, B Wood, I Kirsch, H Robins, H Erba, F Appelbaum, J
Radich. Blood, under review.
■■ Multiple Studies* Cell signaling-based classifier predicts
response to induction therapy in elderly patients with acute
myeloid leukemia. A Cesano, C Willman, K Kopecky, U Gayko, S
Putta, B Louie, M Westfall, N Purvis, D Spellmeyer, C Marimpiketri, J Hackett, J Shi, M Walker, Z Sun, E Paietta, M Tallman, L
Cripe, S Atwater, F Appelbaum, J Radich. PLOS ONE, under review. *Studies: S9031, S9333, S0112, S0301; E3993, E3999
■■ Multiple Studies* Prediction of CR on reinduction in patients
with newly diagnosed acute myeloid leukemia given intensive
induction regimens: A report from SWOG and Cleveland Clinic. M
Othus, S Mukherjee, MA Sekeres, J Godwin, S Petersdorf, F Appelbaum, H Erba, Eli Estey. Clinical Cancer Research, submitted
9/14. *Studies: S0106, S8600, S9031, S9333.
SWOG • Leading Cancer Research. Together.
49
50 Fall 2014
LUNG COMMITTEE
Committee Leadership
Chair: David R. Gandara, M.D.
Vice-Chair: Stephen G. Swisher, M.D.
Executive Officer:
Julie R. Gralow, M.D.
Statisticians: Mary Redman, Ph.D.
James Moon, M.S.
Shannon McDonough, M.S. (Lung MAP Protocol)
Scientific Leadership
Translational Medicine:
Philip C. Mack, Ph.D.
Fred R. Hirsch, M.D., Ph.D.
Radiation Oncology:
Laurie E. Gaspar, M.D.
Surgery:
Stephen G. Swisher, M.D.
Imaging:
Anthony F. Shields, M.D., Ph.D.
Friedrich D. Knollmann, M.D., Ph.D.
Medical Oncology:
Karen Kelly, M.D.
Pathology:
Ignacio I. Wistuba, M.D.
Developmental Therapeutics: Roy S. Herbst, M.D., Ph.D.
Early Therapeutics:
Shirish M. Gadgeel, M.D.
Designates
Cancer Control Liaison: Gary E. Goodman, M.D.
Community Affiliate:
Paul J. Hesketh, M.D.
Data Coordinators:
Larry Kaye
Brian Zeller
Austin Hamm
Vicki Green
Oncology Research Professionals:
CRAs: Courtney L. Williamson
Nurses: Kimberly M. Belzer, M.S., P.A.-C
Rosalie Zablocki, R.N.
Patient Advocate:
Bonnie J. Addario
Pharmaceutical Science:
Joyce Lee, Pharm.D.
Daniel L. Hertz, Pharm.D.
Protocol Coordinator:
Jennifer I. Scott
Crystal Miwa (Lung MAP Protocol)
Time/Location
Saturday, October 25, 2014
Room: Regency A (Gold Level, West Tower)
9:30 a.m. - 12:30 p.m.
Agenda
Opening Remarks
Translational Medicine Session - Dr. Mack
Surgery Session - Dr. Swisher
SWOG • Leading Cancer Research. Together.
Scientific Session: “ALCHEMIST: A Genomic Assessment and
Biomarker-driven Adjuvant Therapy Protocol in Early Stage NSCLC” John V. Heymach, M.D., Ph.D.
Proposals in Development
■■ “Phase III Randomized Trial of Adjuvant MEDI3746 Maintenance
versus Placebo in Resected Early Stage PD-L1 Positive NonSmall Cell Lung Cancer (ALCHEMIST).” Drs. Heymach and
Gibbons.
■■ “Randomized Phase II Trial to Test the Efficacy of BIBF1120
in Combination with Cisplatin and Etoposide for Subjects with
Previously Untreated Extensive Stage Small Cell Lung Cancer.”
Drs. Heymach and Glisson.
■■ “Strategies to Improve Lymph Node Examination of Non-Small Cell
Lung Tumors (SILENT).” Dr. Osarogiagbon.
■■ “Minimally Invasive Surgery vs. Surgery Including Open
Lobectomy in Non-Small Cell Lung Cancer (MISSION).” Drs. Rice
and Swisher.
■■ “A Randomized Phase II Trial of Neoadjuvant CisplatinPemetrexed with or without MPDL3280A in Resectable
Malignant Pleural Mesothelioma.” Dr. Tsao.
■■ “Multicenter, Randomized, Placebo-Controlled, Phase II Study of
Neoadjuvant Cisplatin and Docetaxel +/- Nintedanib (BIBF1120)
for Stage IB-IIIA Non-Small Cell Lung Cancer Amenable for
Surgical Resection.” Dr. William.
■■ “A Lung Cancer Registry of Patients Being Treated for Non-Small
Cell Lung Cancer (NSCLC) at SWOG Institutions.” Dr. Wozniak.
■■ “Randomized Phase II Trial of the TGF Beta TKI LY2157299
versus Placebo in Reducing Radiation Pneumonitis and Fibrosis
Damage.” Dr. Gaspar.
■■ “Ganetespib Plus Erlotinib Trial in Previously Treated NSCLC.” Dr.
Kelly.
■■ “A Randomized Phase II Study of Anti-PD-1 or Anti-CTLA-4 or in
Combination of Anti-PD-1 and Anti-CTLA-4 in the Neoadjuvant
Setting for Resectable Stage IB-IIIA Non-Small Cell Lung
Cancers.” Dr. Lou (Young Investigator Workshop Participant).
SWOG Group Meeting Agenda
51
LUNG COMMITTEE
■■ ECOG-ACRIN “Randomized Phase III Study of Resected Stage
III Invasive Thymoma with or without Postoperative Radiation
Therapy.” Dr. Thomas.
Active Studies
■■ S1400, “Phase II/III Biomarker-Driven Master Protocol for
Second Line Therapy of Squamous Cell Lung Cancer.” Drs.
Papadimitrakopoulou, Hirsch, Herbst, Schwartz, Gandara and
Mack. Activated: 6/16/14.
■■ S1300, “A Randomized Phase II Trial of Crizotinib Plus
Pemetrexed Versus Pemetrexed Monotherapy in ALK-Positive
Non-Squamous NSCLC Patients Who Have Progressed
Systemically After Previous Clinical Benefit From Crizotinib
Monotherapy.” Drs. Camidge, Li and Doeble. Activated: 8/1/14.
■■ S1206 (8811), “A Dose Finding Study Followed by Phase II
Randomized, Placebo-Controlled Study of Veliparib (ABT-888)
Added to Chemoradiotherapy with Carboplatin and Paclitaxel
for Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC),
(NCI Study Number 8811).” Drs. Argiris, Cristea and Chen.
Activated: 10/1/12.
■■ S1204, “A Sero-Epidemiologic Survey and Cost-Effectiveness
Study of Screening for Human Immunodeficiency Virus (HIV),
Hepatitis B virus (HBV) and Hepatitis C Virus (HCV) Among Newly
Diagnosed Cancer Patients.” Drs. Ramsey, Loomba, Chugh,
Hershman and Hwang. Activated: 8/29/13.
■■ S1013, “A Phase II Prospective Study of Epidermal Growth
Factor Receptor (Her-1/EGFR) Inhibitor-Induced Dermatologic
Toxicity: Validation of the Functional Assessment of Cancer
Therapy – EGFRI 18 (FACT-EGFRI 18) Questionnaire for EGFRIinduced Skin Toxicities.” Dr. Wong. Activated: 11/15/11.
■■ S0905, “A Phase I / Randomized Phase II Study of Cediranib
(NSC #732208) Versus Placebo in Combination with Cisplatin
and Pemetrexed in Chemonaive Patients with Malignant Pleural
Mesothelioma.” Drs. Tsao, Vogelzang and Wistuba. Activated:
3/15/10, Phase I Closed: 8/1/11, Phase II Activated: 10/1/11.
■■ S0819, “A Randomized, Phase III Study Comparing Carboplatin
/ Paclitaxel or Carboplatin / Paclitaxel / Bevacizumab with or
without Concurrent Cetuximab in Patients with Advanced NonSmall Cell Lung Cancer (NSCLC).” Drs. Herbst, Kim, Gandara,
Semrad and Hirsch. Activated: 7/15/09.
■■ CTSU/CALGB 30610, “Phase III Comparison of Thoracic
Radiotherapy Regimens in Patients with Limited Small Cell Lung
Cancer also Receiving Cisplatin and Etoposide.” Drs. Gadgeel
and Gaspar. Activated: 4/1/08.
■■ CTSU/CALGB 140503, “A Phase III Randomized Trial of
Lobectomy versus Sublobar Resection for Small (≤ 2 cm)
Peripheral Non-Small Cell Lung Cancer.” Dr. Mitchell. Activated:
1/15/08.
■■ CTSU/N107C, “A Phase III Trial of Post-Surgical Stereotactic
Radiosurgery (SRS) Compared with Whole Brain Radiotherapy
(WBRT) for Resected Metastatic Brain Disease.” Dr. Gaspar.
Activated: 12/1/2011.
■■ CTSU/R1306, “A Randomized Phase II Study of Individualized
Combined Modality Therapy for Stage III Non-Small Cell Lung
Cancer.” Drs. Tsao and Daly. Activated: 9/1/13.
Proposed Studies
■■ S1403, “A Randomized Phase II/III Trial of Afatinib Plus
Cetuximab Versus Afatinib Alone in Treatment-Naïve Patients
with Advanced, EGFR Mutation Positive Non-Small Cell Lung
Cancer (NSCLC).” Drs. Goldberg, Lilenbaum, and Politi.
■■ S1408, “A Randomized, Phase II Selection Design Trial of
GSK1120212B (Trametinib Dimethly Sulfoxide) with Docetaxel
or with GSK2141795 in Patients with Progressive Kras Mutation
Positive Non-Small Cell Lung Cancer (NSCLC) Following At Least
One Prior Systemic Therapy.” Dr. Gadgeel.
Closed Studies
■■ S0709, “A Phase II Selection Design of Pharmacodynamic
Separation of Carboplatin / Paclitaxel / OSI-774 (Erlotinib; NSC718781) or OSI-774 Alone in Advanced Non-Small Cell Lung
Cancer (NSCLC) Patients with Performance Status 2 (PS-2)
Selected by Serum Proteomics.” Drs. Lara, Hesketh, Mack and
Hirsch. Activated: 12/1/08, Closed: 9/15/14.
Publications
The publications listed below are those that have been received in
published, submitted or accepted form by the Group Chair’s Office
since the Spring 2014 meeting agenda booklet publication list.
Published/Accepted Manuscripts
■■ S0220 Trimodality Therapy for Superior Sulcus Non-Small Cell
Lung Cancer: Southwest Oncology Group-Intergroup Trial S0220.
SWOG • Leading Cancer Research. Together.
52 Fall 2014
LUNG COMMITTEE
KH Kernstine, J Moon, MJ Kraut, KMW Pisters, JR Sonett, VW
Rusch, CR Thomas, T Waddell, JR Jett, AP Lyss, SM Keller, DR
Gandara. Annals of Thoracic Surgery 98(2): 402-410, 2014.
http://www.ncbi.nlm.nih.gov/pubmed/24980603
■■ S0720 A phase II, cooperative group, adjuvant trial using a
biomarker-based decision algorithm in stage I non-small-cell
lung cancer (SWOG-0720, NCT00792701). G Bepler, RG Zinner,
J Moon, R Calhoun, K Kernstine, CC Williams, PC Mack, V
Oliveira, Z Zheng, PJ Stella, MW Redman, DR Gandara. Cancer
120(15):2343-2351, 2014. http://www.ncbi.nlm.nih.gov/
pubmed/24752945
■■ S0722 Phase II study of mTOR inhibitor everolimus (RAD0001)
in advanced malignant pleural mesothelioma (MPM): SWOG
S0722. S-H I Ou, J Moon, LL Garland, PC Mack, JR Testa, A
Tsao, AJ Wozniak, DR Gandara. Journal of Thoracic Oncology, in
press.
■■ S0802 SWOG S0802: A randomized phase II trial of weekly
topotecan with and without afibercept in patients with platinumtreated extensive state small cell lung cancer. J Allen, J Moon, S
Gadgeel, K Kelly, P Mack, H Saba, M Mohamed, M Jahanzeb, D
Gandara. Journal of Clinical Oncology, 32(23):2463-2470, 2014.
http://www.ncbi.nlm.nih.gov/pubmed/25002722
■■ Multiple Studies* The effect of the UGT1A1*28 allele on
survival after irinotecan-based chemotherapy: a collaborative
meta-analysis. MM Dias, J-P Pignon, CS Karapetis, V Boige, B
Glimelius, DM Kweekel, PN Lara, P Laurent-Puig, E MartinezBalibrea, D Pa´ez, CJA Punt, MW Redman, G Toffoli, M
Wadelius, RA McKinnon, MJ Sorich. Pharmacogenomics
Journal 14(5):424-431. 2014. *Meta-analysis of various group
studies including SWOG S0124. http://www.ncbi.nlm.nih.gov/
pubmed/24709690
■■ Multiple Studies* Relevance of platinum sensitivity status in
relapsed/refractory extensive stage small cell lung cancer (ESSCLC) in the modern era: a patient level analysis of SWOG trials.
PN Lara, Jr., J Moon, MW Redman, TJ Semrad, K Kelly, J Allen,
BJ Gitlitz, PC Mack, DR Gandara. Journal of Thoracic Oncology,
accepted 9/7/14. *pooled analysis of studies: S0327, S0435,
S0802.
Submitted Manuscripts
■■ S0533 A pilot trial of cisplatin/etoposide/radiotherapy followed
by consolidation docetaxel and the addition of bevacizumab
(NSC-704865) in patients with inoperable locally advanced stage
SWOG • Leading Cancer Research. Together.
III non-small cell lung cancer: SWOG S0533. AJ Wozniak, J
Moon, CR Thomas, Jr., K Kelly, PC Mack, LE Gaspar, D Raben,
TJ Fitzgerald, KJ Pandya, DR Gandara. Journal of Thoracic
Oncology, submitted 9/5/14.
SWOG Group Meeting Agenda
53
LYMPHOMA COMMITTEE
Committee Leadership
Chair: Jonathan W. Friedberg, M.D.
Vice-Chair: Sonali M. Smith, M.D.
Executive Officer:
Susan M. O’Brien, M.D.
Statisticians: Michael LeBlanc, Ph.D.
Hongli Li, M.S.
Scientific Leadership
Translational Medicine:
Owen A. O’Connor, M.D., Ph.D.
Radiation Oncology: Louis S. Constine, M.D.
Imaging:
Oliver W. Press, M.D., Ph.D.
Lawrence H. Schwartz, M.D.
Pathology:
Lisa M. Rimsza, M.D.
Early Therapeutics:
Daruka Mahadevan, M.D., Ph.D.
Designates
Cancer Control:
John W. Hayslip, M.D.
Data Coordinators:
Jeri Jardine
Iris Syquia
Oncology Research Professionals:
CRAs:
Ellen Chase, B.S.
Erin M. Cebula, M.P.H.
Nurse: TBD
Patient Advocate:
Hildy Dillon, M.P.H.
Pharmaceutical Science:
Lara M. Au, Pharm.D.
Holly O. Chan, Pharm.D.
Protocol Coordinator:
Megan Hardin
Time/Location
Saturday, October 25, 2014
Room: Regency B (Gold Level, West Tower)
9:30 a.m. - 12:30 p.m.
Agenda
1. Steering Committee update and NCTN working groups: Drs.
Friedberg and S. Smith
2. Report of recently completed studies
a. S0313 Long-term follow-up: Dr. Persky
b. S9704 Double Hit subset analysis: Dr. Puvvada
c. S0410 Final results: Dr. E. Smith
d. S0601 Final results: Dr. B. Till
3. Report of ongoing studies: Dr’s Persky, Amengual, Till, Fanale
4. Update: a novel approach to high risk follicular lymphoma: Dr.
Barr
5. Accrual discussions: group
6. T-cell update and translational medicine presentation: Dr.
O’Connor
Non-Hodgkin Lymphoma
■■ S1001, “A Phase II Trial of PET-Directed Therapy for Limited
Stage Diffuse Large B-Cell Lymphoma (DLBCL).” Drs. Persky,
Constine, Rimsza, and Fitzgerald. Activated: 7/18/11.
■■ CTSU/E1411, “Intergroup Randomized Phase 2 Four Arm
Study In Patients ≥ 60 With Previously Untreated Mantle Cell
Lymphoma Of Therapy With: Arm A = Rituximab+Bendamustine
Followed By Rituximab Consolidation (RB  R); Arm
B = Rituximab + Bendamustine + Bortezomib Followed By
Rituximab Consolidation (RBV  R), Arm C = Rituximab
+ Bendamustine Followed By Lenalidomide + Rituximab
Consolidation (RB  LR) or Arm D = Rituximab +
Bendamustine + Bortezomib Followed By Lenalidomide +
Rituximab Consolidation (RBV  LR).” Dr. Till. Activated:
5/22/12.
■■ CTSU/E1412, “Randomized Phase II Open Label Study
of Lenalidomide R-CHOP (R2CHOP) vs. RCOP (Rituximab,
Cyclophosphamide, Doxorubicin, Vincristine and Prednisone) in
Patients with Newly Diagnosed Diffuse Large B Cell Lymphoma.”
Dr. Amengual. Activated: 6/1/14.
■■ CTSU/9177, “Phase II Study of Dose-Adjusted EPOCH +/Rituximab in Adults with Untreated Burkitt Lymphoma, C-Myc
Positive Diffuse Large B-Cell Lymphoma and Plasmablastic
Lymphoma.” Dr. Fanale. Activated: 4/13/12.
■■ CTSU/CALGB 51101, “A Randomized Phase II Trial of
Myeloablative versus Non-Myeloablative Consolidation
Chemotherapy for Newly Diagnosed Primary CNS B-Cell
Lymphoma.” Dr. Mohile. Activated: 6/15/12.
Cancer Control Studies
■■ S1204, “A Sero-Epidemiologic Survey and Cost-Effectiveness
Study of Screening for Human Immunodeficiency Virus (HIV),
Hepatitis B virus (HBV) and Hepatitis C Virus (HCV) Among
Newly Diagnosed Cancer Patients.” Drs. Ramsey, Loomba,
Chugh, Hershman and Hwang. Activated: 8/29/13.
Closed Studies
■■ E2410, “A Phase II Trial of Response-Adapted Therapy Based
on Positron Emission Tomography (PET) for Bulky Stage I and
II Classical Hodgkin Lymphoma (HL)”. Dr. Shustov. Activated:
4/2/12; Closed: 1/24/14.
SWOG • Leading Cancer Research. Together.
54 Fall 2014
LYMPHOMA COMMITTEE
Studies in Development
■■ S1414, “A Randomized Phase II / III Trial of Rituximabchemotherapy + Maintenance Rituximab With or Without
Ibrutinib for Treatment of Newly Diagnosed High / IntermediateRisk Follicular Lymphoma.” Drs. Barr and Puvvada.
Publications
The publications listed below are those that have been received in
published, submitted or accepted form by the Group Chair’s Office
since the Spring 2014 meeting agenda booklet publication list.
Published/Accepted Manuscripts
■■ S0433 R-CHOP with iodine-131 tositumomab consolidation
for advanced stage diffuse large B-cell lymphoma (DLBCL):
SWOG protocol S0433. J Friedberg, J Unger, WR Burack, AJ
Gopal, RN Raju, AP Nademanee, M Kaminski, M Leblanc, H Li,
OW Press, TP Miller, RI Fisher. British Journal of Haematology
166(3):382-389, 2014. http://www.ncbi.nlm.nih.gov/
pubmed/24749780
Submitted Manuscripts
■■ S0313 Effect of adding tiuxetan (zevallin) radioimmunotherapy
consolidation to three cycles of CHOP plus involved-field
radiotherapy for high risk limited stage aggressive b-cell
lymphoma (SWOG 0313). DO Persky, TP Miller, JM Unger, CM
Spier, S Puvvada, B Dino Stea, OW Press, LS Constine, KP
Barton, JW Friedberg, RI Fisher. Blood, revised and pending
resubmission, 9/14.
■■ E2496 Randomized phase III trial comparing ABVD +
radiotherapy and the Stanford V regimen in patients with stage
I/II locally extensive (bulky mediastinal) hodgkin lymphoma: a
subset analysis of the US intergroup trial E2496. RH Advani,
F Hong, RI Fisher, NL Bartlett, S Robinson, RD Gascoyne, H
Wagner, Jr., PJ Stiff, BD Cheson, D Stewart, LI Gordon, BS Kahl,
JW Friedberg, KA Blum, TM Habermann, JM Tuscano, RT Hoppe,
SJ Horning. Journal of Clinical Oncology, under review.
■■ Multiple Studies* Low serum vitamin D levels are associated
with inferior survival in follicular lymphoma: a prospective
evaluation in SWOG and LYSA studies. JL Kelly, G Salles, B
Goldman, RI Fisher, O Casasnovas, OW Press, DG Maloney, P
Soubeyran, LM Rimsza, M LeBlanc, H Tilly, JW Friedberg.
Journal of Clinical Oncology, pending revision/resubmission, 9/14.
*Studies: S9800, S9911, S0016, S8947.
SWOG • Leading Cancer Research. Together.
■■ Multiple Studies* Elevated proinflammatory cytokines are
associated with a poor prognosis in follicular lymphoma. M Mir,
MJ Maurer, SC Ziesmer, S Slager, T Habermann, W Macon, BK
Link, S Syrbu, T Witzig, J Friedberg, O Press, M LeBlanc, JR
Cerhan, A Novak, S Ansell. Blood, revised and resubmitted
9/24/14. *Studies: includes: SWOG S9800, S9911, S0016.
SWOG Group Meeting Agenda
55
MELANOMA COMMITTEE
Committee Leadership
Chair: Antoni Ribas, M.D., Ph.D.
Vice-Chair: William E. Carson III, M.D.
Executive Officer:
Christopher W. Ryan, M.D.
Statisticians: Megan Othus, Ph.D.
James Moon, M.S.
Michael Wu, Ph.D.
Scientific Leadership
Translational Medicine: Kim A. Margolin, M.D.
Radiation Oncology: Evan J. Wuthrick, M.D.
Surgery: Robert H.I. Andtbacka, M.D.
Imaging:
Kenneth F. Grossman, M.D., Ph.D.
Martin Allen-Auerbach, M.D.
Medical Oncology: Lawrence E. Flaherty, M.D.
Pathology: Jane L. Messina, M.D.
Non-Melanoma Skin Cancer: Sancy A. Leachman, M.D., Ph.D.
Early Therapeutics: Jeffrey A. Sosman, M.D.
Designates
Cancer Control Liaison: Sancy A. Leachman, M.D., Ph.D.
Data Coordinator:
Jennie Barrett
Oncology Research Professionals:
CRAs: Sandy Allten, R.N., O.C.N.
Nurses: Karen L. Mack, R.N.P.
Ann M. Lau Clarke, R.N., M.S.N.
Lisa S. Morgan, R.N., O.C.N.
Patient Advocate:
Valerie Guild
Pharmaceutical Science:
Linda Lee-Gabel, Pharm.D.
Ronald G. Kittson, Pharm.D.
Protocol Coordinator:
Patricia O’Kane
Time/Location
Friday, October 24, 2014
Room: Regency A (Gold Level, West Tower)
11:30 a.m. - 1:30 p.m.
Agenda
Scientific Presentation
“MicroRNAs in Melanoma Diagnosis and Treatment” – William E.
Carson III, M.D., Ohio State University
Group Discussion: “New biomarkers for predicting prognosis and
response to treatment: moving away from light microscopy”
Active Studies
■■ S1221, “Phase I/II Study of the Safety and Efficacy of the AKT
Inhibitor GSK2141795 in Combination with the BRAF Inhibitor
Dabrafenib (and trametinib, effective TBD) in Patients with
BRAF Mutant Cancer.” Drs. Ribas, Chmielowski, Algazi and Lo.
Activated: 7/1/13.
■■ S1320, “A Randomized Phase II Trial of Intermittent
Versus Continuous Dosing of Dabrafenib and Trametinib
in BRAFV600E/K Mutant Melanoma.” Drs. Algazi and Lo.
Activated: 7/22/14.
■■ CTSU/E2607, “A Phase II Trial of Dasatinib in KIT-Positive
Patients with Unresectable Locally Advanced or Stage IV
Mucosal, Acral and Vulvovaginal Melanomas.” Dr. Margolin.
Activated: 12/1/11.
Closed Studies
■■ CTSU/E1609, “A Phase III Randomized Study of Adjuvant
Ipilimumab Anti-CTLA4 Therapy Versus High-Dose Interferon
Alpha-2b for Resected High-Risk Melanoma.” Dr. Flaherty.
Activated: 7/15/11; Closed 8/15/14.
Approved Concepts
■■ S1404, “A Phase III Randomized Study of MK3475 versus HighDose Interferon alpha-2b for Resected High-Risk Melanoma.” Dr.
Grossmann.
Proposed Non-SWOG Coordinated Intergroup Studies
■■ ECOG EA6134, “A Randomized Phase III trial of Dabrafenib +
Trametinib followed by Ipilimumab + Nivolumab at Progression
vs. Ipilimumab + Nivolumab followed by Dabrafenib +
Trametinib at Progression in Patients With Advanced BRAFV600
Mutant Melanoma.” Drs. Atkins and Chmielowski.
■■ A Phase III, Multi-center Randomized Controlled Trial
Investigating 1cm v 2cm Wide Excision Margins for Primary
Cutaneous Melanoma: Melanoma Margins Trial (MelMarT). Dr.
Carson.
Proposed SWOG Coordinated Intergroup Studies
■■ Ipilimumab and Nivolumab for Metastatic or Locoregionally
Advanced Merkel Cell Carcinoma. Dr. Lao.
Publications
The publications listed below are those that have been received in
published, submitted or accepted form by the Group Chair’s Office
since the Spring 2014 meeting agenda booklet publication list.
SWOG • Leading Cancer Research. Together.
56 Fall 2014
MELANOMA COMMITTEE
Published/Accepted Manuscripts
■■ S0008 Phase III trial of high dose interferon alpha-2b versus
cisplatin, vinblastine, DTIC plus IL-2 and interferon in patients
with high risk melanoma (SWOG S0008): an intergroup study
of CALGB, COG, ECOG and SWOG. LE Flaherty, M Othus, MB
Atkins, RJ Tuthill, JA Thompson, JT Vetto, FG Haluska, Alberto
Pappo, JA Sosman, BG Redman, J Moon, A Ribas, JM Kirkwood,
VK Sondak. Journal of Clinical Oncology, in press.
■■ S0933 A phase II study of RO4929097 gamma-secretase
inhibitor in metastatic melanoma: SWOG 0933. SM Lee, J Moon,
BG Redman, T Chidiac, LE Flaherty, Y Zha, M Othus, A Ribas, VK
Sondak, TF Gajewski, KA Margolin. Cancer, in press.
■■ S9035 Adjuvant vaccine immunotherapy of resected, clinically
node-negative melanoma: long-term outcome and impact of
HLA class I antigen expression on overall survival. WE Carson,
JM Unger, JA Sosman, LE Flaherty, RJ Tuthill, MJ Porter, JA
Thompson, RA Kempf, M Othus, A Ribas, VK Sondak. Cancer
Immunology Research 2014 Jul 3 [Epub ahead of print]. http://
www.ncbi.nlm.nih.gov/pubmed/24994597
Submitted Manuscripts
No publication information for this cycle.
SWOG • Leading Cancer Research. Together.
SWOG Group Meeting Agenda
MEETING NOTES
SWOG • Leading Cancer Research. Together.
57
58 Fall 2014
Future Group Meeting Dates
Mark Your Calendar!
2015
— April 29-May 2 —
San Francisco, CA
— Oct 7-10 —
Chicago, IL
2016
— April 27-30 —
San Francisco, CA
— Sep 14-17 —
Chicago, IL
2017
— April 26-29 —
San Francisco, CA
— Oct 11-14 —
Chicago, IL
Check the SWOG website (swog.org) for updates!
SWOG • Leading Cancer Research. Together.
SWOG Group Meeting Agenda
Do you have a few minutes between
meetings? Stop by the SWOG registration
desk in the Regency Foyer to check your
e-mail and/or print your boarding pass!
SWOG • Leading Cancer Research. Together.
59
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