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JOURNAL of CLINICAL ONCOLOGY
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Volume 32, Issue 34
December 1, 2014
Current Abstracts
................................................................................................................................................................................................
Long-Term Outcomes in Patients With
Muscle-Invasive Bladder Cancer After Selective
Bladder-Preserving Combined-Modality Therapy:
A Pooled Analysis of Radiation Therapy Oncology
Group Protocols 8802, 8903, 9506, 9706, 9906,
and 0233
Raymond H. Mak, Daniel Hunt, William U. Shipley, et al
pp 3801-3809
Purpose: Multiple prospective Radiation Therapy Oncology Group
(RTOG) protocols have evaluated bladder-preserving combinedmodality therapy (CMT) for muscle-invasive bladder cancer (MIBC),
reserving cystectomy for salvage treatment. We performed a
pooled analysis of long-term outcomes in patients with MIBC
enrolled across multiple studies.
Patients and Methods: Four hundred sixty-eight patients with MIBC
were enrolled onto six RTOG bladder-preservation studies,
including five phase II studies (RTOG 8802, 9506, 9706, 9906,
and 0233) and one phase III study (RTOG 8903). Overall survival
(OS) was estimated using the Kaplan-Meier method, and diseasespecific survival (DSS), muscle-invasive and non–muscle-invasive
local failure (LF), and distant metastasis (DM) were estimated by
the cumulative incidence method.
Results: The median age of patients was 66 years (range, 34 to 93
years), and clinical T stage was T2 in 61%, T3 in 35%, and T4a in
4% of patients. Complete response to CMT was documented in
69% of patients. With a median follow-up of 4.3 years among all
patients and 7.8 years among survivors (n ⫽ 205), the 5- and 10year OS rates were 57% and 36%, respectively, and the 5- and
10-year DSS rates were 71% and 65%, respectively. The 5- and
10-year estimates of muscle-invasive LF, non–muscle-invasive LF,
and DM were 13% and 14%, 31% and 36%, and 31% and 35%,
respectively.
Conclusion: This pooled analysis of multicenter, prospective RTOG
bladder-preserving CMT protocols demonstrates long-term DSS
comparable to modern immediate cystectomy studies, for patients
with similarly staged MIBC. Given the low incidence of late
recurrences with long-term follow-up, CMT can be considered as
an alternative to radical cystectomy, especially in elderly patients
not well suited for surgery.
J Clin Oncol 32:3801-3809
© 2014 by American Society of Clinical Oncology
■ ■ ■
continued
Volume 32, Issue 34
December 1, 2014
Current Abstracts
................................................................................................................................................................................................
Preservation of Memory With Conformal Avoidance of
the Hippocampal Neural Stem-Cell Compartment
During Whole-Brain Radiotherapy for Brain
Metastases (RTOG 0933): A Phase II
Multi-Institutional Trial
Vinai Gondi, Stephanie L. Pugh, Wolfgang A. Tome, et al
pp 3810-3816
Purpose: Hippocampal neural stem-cell injury during whole-brain
radiotherapy (WBRT) may play a role in memory decline.
Intensity-modulated radiotherapy can be used to avoid
conformally the hippocampal neural stem-cell compartment during
WBRT (HA-WBRT). RTOG 0933 was a single-arm phase II study of
HA-WBRT for brain metastases with prespecified comparison with
a historical control of patients treated with WBRT without
hippocampal avoidance.
Patients and Methods: Eligible adult patients with brain metastases
received HA-WBRT to 30 Gy in 10 fractions. Standardized
cognitive function and quality-of-life (QOL) assessments were
performed at baseline and 2, 4, and 6 months. The primary end
point was the Hopkins Verbal Learning Test–Revised Delayed
Recall (HVLT-R DR) at 4 months. The historical control
demonstrated a 30% mean relative decline in HVLT-R DR from
baseline to 4 months. To detect a mean relative decline ⱕ 15% in
HVLT-R DR after HA-WBRT, 51 analyzable patients were required
to ensure 80% statistical power with ␣ ⫽ 0.05.
Results: Of 113 patients accrued from March 2011 through November
2012, 42 patients were analyzable at 4 months. Mean relative
decline in HVLT-R DR from baseline to 4 months was 7.0% (95%
CI, ⫺4.7% to 18.7%), significantly lower in comparison with the
historical control (P ⬍ .001). No decline in QOL scores was
observed. Two grade 3 toxicities and no grade 4 to 5 toxicities
were reported. Median survival was 6.8 months.
Conclusion: Conformal avoidance of the hippocampus during WBRT
is associated with preservation of memory and QOL as compared
with historical series.
J Clin Oncol 32:3810-3816
© 2014 by American Society of Clinical Oncology
■ ■ ■
continued
Volume 32, Issue 34
December 1, 2014
Current Abstracts
................................................................................................................................................................................................
Surveillance for Stage I Nonseminoma Testicular
Cancer: Outcomes and Long-Term Follow-Up in a
Population-Based Cohort
Gedske Daugaard, Maria Gry Gundgaard, Mette Saksø Mortensen, et al
pp 3817-3823
Purpose: To describe treatment results in a large cohort with stage
I nonseminoma germ cell cancer (NSGCC) treated in a
surveillance program.
Patients and Methods: From January 1, 1984, to December 31, 2007,
1,226 patients with stage I NSGCC, including high-risk patients
with vascular invasion, were observed in a surveillance program.
Results: The relapse rate after orchiectomy alone was 30.6% at 5
years. Presence of vascular invasion together with embryonal
carcinoma and rete testis invasion in the testicular primary
identified a group with a relapse risk of 50%. Without risk factors,
the relapse risk was 12%. Eighty percent of relapses were
diagnosed within the first year after orchiectomy. The median time
to relapse was 5 months (range, 1 to 308 months). Early relapses
were mainly detected by increase in tumor markers, and late
relapses were detected by computed tomography scans. Relapses
after 5 years were seen in 0.5% of the whole cohort or in 1.6% of
relapsing patients. The majority of relapses (94.4%) belonged to
the good prognostic group according to the International Germ
Cell Cancer Collaborative Group classification. The disease-specific
survival at 15 years was 99.1%.
Conclusion: A surveillance policy for patients with stage I NSGCC is
a safe approach associated with an excellent cure rate and an
overall low treatment burden despite a high relapse rate in a small
group of patients. We recommend surveillance for patients with
stage I NSGCC with immediate systemic treatment at relapse.
Clearly defined risk factors for relapse are presented if an option
of risk-adapted treatment is preferred.
J Clin Oncol 32:3817-3823
© 2014 by American Society of Clinical Oncology
■ ■ ■
continued
Volume 32, Issue 34
December 1, 2014
Current Abstracts
................................................................................................................................................................................................
Phase II Trial of Stereotactic Body Radiation Therapy
Combined With Erlotinib for Patients With Limited but
Progressive Metastatic Non–Small-Cell Lung Cancer
Puneeth Iyengar, Brian D. Kavanagh, Zabi Wardak, et al
pp 3824-3830
Purpose: Patients with stage IV non–small-cell lung cancer (NSCLC)
who progress through first-line therapy have poor progressionfree survival (PFS) and overall survival (OS), most commonly
failing in original sites of gross disease. Cytoreduction with
stereotactic body radiation therapy (SBRT) may help systemic
agents delay relapse.
Patients and Methods: Patients in our single arm phase II study had
stage IV NSCLC with no more than six sites of extracranial disease
who failed early systemic chemotherapy and were able to receive
SBRT and concurrent erlotinib until disease progression. After
erlotinib commencement, SBRT with equipotent fractionation was
delivered to all sites of disease. PFS, OS, and other end points
were evaluated.
Results: Twenty-four patients (13 men and 11 women) with a median
age of 67 years (range, 56-86 years) were enrolled with median
follow-up of 11.6 months. All patients had progressed through
platinum-based chemotherapy. A total of 52 sites were treated
with 16 of 24 patients receiving SBRT to more than one site. Lung
parenchyma was most often irradiated. Median PFS was 14.7
months, and median OS was 20.4 months. Most patients
progressed in new distant sites with only three of 47 measurable
lesions recurring within the SBRT field. Two grade 3 toxicities
were radiation related. Zero of 13 patients tested were positive for
an EGFR mutation.
Conclusion: Use of SBRT with erlotinib for unselected patients with
stage IV NSCLC as a second- or subsequent line therapy resulted
in dramatic changes in patterns of failure, was well tolerated, and
resulted in high PFS and OS, substantially greater than historical
values for patients who only received systemic agents.
J Clin Oncol 32:3824-3830
© 2014 by American Society of Clinical Oncology
■ ■ ■
continued
Volume 32, Issue 34
December 1, 2014
Current Abstracts
................................................................................................................................................................................................
Increased Risk for Depression After Breast Cancer:
A Nationwide Population-Based Cohort Study of
Associated Factors in Denmark, 1998-2011
Nis P. Suppli, Christoffer Johansen, Jane Christensen, et al
pp 3831-3839
Purpose: To investigate the risk for first depression, assessed as
incident hospital contacts for depression and incident use of
antidepressants, among women with breast cancer.
Patients and Methods: Danish national registries were used to
identify 1,997,669 women with no diagnosis of cancer or a major
psychiatric disorder. This cohort was followed from 1998 to 2011
for a diagnosis of breast cancer and for the two outcomes,
hospital contact for depression and redeemed prescriptions for
antidepressants. Rate ratios for incident hospital contacts for
depression and incident use of antidepressants were estimated
with Poisson regression models. Multivariable Cox regression was
used to evaluate factors associated with the two outcomes among
patients with breast cancer.
Results: We identified 44,494 women with breast cancer. In the
first year after diagnosis, the rate ratio for a hospital contact for
depression was 1.70 (95% CI 1.41 to 2.05) and that for use of
antidepressants was 3.09 (95% CI 2.95 to 3.22); these rate ratios
were significantly increased after 3 and 8 years, respectively.
Comorbidity, node-positive disease, older age, basic and vocational
educational levels, and living alone were associated with use of
antidepressants.
Conclusion: Women with breast cancer are at long-term increased
risk for first depression, including both severe episodes leading to
hospital contact and use of antidepressants. Clinicians should be
aware that the risk is highest in women with comorbid conditions,
node-positive disease, and age of 70 years or more. We found no
clear association between type of surgery or adjuvant treatment
and risk for depression.
J Clin Oncol 32:3831-3839
© 2014 by American Society of Clinical Oncology
■ ■ ■
continued
Volume 32, Issue 34
December 1, 2014
Current Abstracts
................................................................................................................................................................................................
Phase III Study of Iniparib Plus Gemcitabine
and Carboplatin Versus Gemcitabine and Carboplatin
in Patients With Metastatic Triple-Negative
Breast Cancer
Joyce O’Shaughnessy, Lee Schwartzberg, Michael A. Danso, et al
pp 3840-3847
Purpose: There is a lack of treatments providing survival benefit for
patients with metastatic triple-negative breast cancer (mTNBC),
with no standard of care. A randomized phase II trial showed
significant benefit for gemcitabine, carboplatin, and iniparib (GCI)
over gemcitabine and carboplatin (GC) in clinical benefit rate,
response rate, progression-free survival (PFS), and overall survival
(OS). Here, we formally compare the efficacy of these regimens in
a phase III trial.
Patients and Methods: Patients with stage IV/locally recurrent TNBC
who had received no more than two previous chemotherapy
regimens for mTNBC were randomly allocated to gemcitabine
1,000 mg/m2 and carboplatin area under the curve 2 (days 1 and
8) alone or GC plus iniparib 5.6 mg/kg (days 1, 4, 8, and 11) every
3 weeks. Random assignment was stratified by the number of
prior chemotherapies. The coprimary end points were OS and PFS.
Patients receiving GC could cross over to iniparib on progression.
Results: Five hundred nineteen patients were randomly assigned
(261 GCI; 258 GC). In the primary analysis, no statistically
significant difference was observed for OS (hazard ratio [HR] ⫽
0.88; 95% CI, 0.69 to 1.12; P ⫽ .28) nor PFS (HR ⫽ 0.79; 95% CI,
0.65 to 0.98; P ⫽ .027). An exploratory analysis showed that
patients in the second-/third-line had improved OS (HR ⫽ 0.65;
95% CI, 0.46 to 0.91) and PFS (HR ⫽ 0.68; 95% CI, 0.50 to 0.92)
with GCI. The safety profile for GCI was similar to GC.
Conclusion: The trial did not meet the prespecified criteria for the
coprimary end points of PFS and OS in the ITT population. The
potential benefit with iniparib observed in second-/third-line
subgroup warrants further evaluation.
J Clin Oncol 32:3840-3847
© 2014 by American Society of Clinical Oncology
■ ■ ■
continued
Volume 32, Issue 34
December 1, 2014
Current Abstracts
................................................................................................................................................................................................
Clinical Outcome With Correlation to Disseminated
Tumor Cell (DTC) Status After DTC-Guided Secondary
Adjuvant Treatment With Docetaxel in Early
Breast Cancer
Bjørn Naume, Marit Synnestvedt, Ragnhild Sørum Falk, et al
pp 3848-3857
Purpose: The presence of disseminated tumor cells (DTCs) in bone
marrow (BM) predicts survival in early breast cancer. This study
explores the use of DTCs for identification of patients
insufficiently treated with adjuvant therapy so they can be offered
secondary adjuvant treatment and the subsequent surrogate
marker potential of DTCs for outcome determination.
Patients and Methods: Patients with early breast cancer who had
completed six cycles of adjuvant fluorouracil, epirubicin, and
cyclophosphamide (FEC) chemotherapy underwent BM aspiration 2
to 3 months (BM1) and 8 to 9 months (BM2) after FEC. Presence
of DTCs in BM was determined by immunocytochemistry using
pan-cytokeratin monoclonal antibodies. If one or more DTCs were
present at BM2, six cycles of docetaxel (100 mg/m2, once every 3
weeks) were administered, followed by DTC analysis 1 and 13
months after the last docetaxel infusion (after treatment). Cox
regression analysis was used to evaluate disease-free interval
(DFI).
Results: Of 1,066 patients with a DTC result at BM2 and available
follow-up information (median follow-up, 71.9 months from the
time of BM2), 7.2% were DTC positive. Of 72 docetaxel-treated
patients analyzed for DTCs after treatment, 15 (20.8%) had
persistent DTCs. Patients with remaining DTCs had markedly
reduced DFI (46.7% experienced relapse) compared with patients
with no DTCs after treatment (adjusted hazard ratio, 7.58; 95%
CI, 2.3 to 24.7). The docetaxel-treated patients with no DTCs after
treatment had comparable DFI (8.8% experienced relapse)
compared with those with no DTCs both at BM1 and BM2 (12.7%
experienced relapse; P ⫽ .377, log-rank test).
Conclusion: DTC status identifies high-risk patients after FEC
chemotherapy, and DTC monitoring status after secondary
treatment with docetaxel correlated strongly with survival. This
emphasizes the potential for DTC analysis as a surrogate marker
for adjuvant treatment effect in breast cancer.
J Clin Oncol 32:3848-3857
© 2014 by American Society of Clinical Oncology
■ ■ ■
continued
Volume 32, Issue 34
December 1, 2014
Current Abstracts
................................................................................................................................................................................................
Randomized Phase III Trial to Test Accelerated
Versus Standard Fractionation in Combination With
Concurrent Cisplatin for Head and Neck Carcinomas
in the Radiation Therapy Oncology Group 0129 Trial:
Long-Term Report of Efficacy and Toxicity
Phuc Felix Nguyen-Tan, Qiang Zhang, K. Kian Ang, et al
pp 3858-3866
Purpose: We tested the efficacy and toxicity of cisplatin plus
accelerated fractionation with a concomitant boost (AFX-C) versus
standard fractionation (SFX) in locally advanced head and neck
carcinoma (LA-HNC).
Patients and Methods: Patients had stage III to IV carcinoma of the
oral cavity, oropharynx, hypopharynx, or larynx. Radiation therapy
schedules were 70 Gy in 35 fractions over 7 weeks (SFX) or 72 Gy
in 42 fractions over 6 weeks (AFX-C). Cisplatin doses were 100
mg/m2 once every 3 weeks for two (AFX-C) or three (SFX) cycles.
Toxicities were scored by using National Cancer Institute Common
Toxicity Criteria 2.0 and the Radiation Therapy Oncology Group/
European Organisation for Research and Treatment of Cancer
criteria. Overall survival (OS) and progression-free survival (PFS)
rates were estimated by using the Kaplan-Meier method and were
compared by using the one-sided log-rank test. Locoregional
failure (LRF) and distant metastasis (DM) rates were estimated by
using the cumulative incidence method and Gray’s test.
Results: In all, 721 of 743 patients were analyzable (361, SFX; 360,
AFX-C). At a median follow-up of 7.9 years (range, 0.3 to 10.1
years) for 355 surviving patients, no differences were observed in
OS (hazard ratio [HR], 0.96; 95% CI, 0.79 to 1.18; P ⫽ .37; 8-year
survival, 48% v 48%), PFS (HR, 1.02; 95% CI, 0.84 to 1.24; P ⫽
.52; 8-year estimate, 42% v 41%), LRF (HR, 1.08; 95% CI, 0.84 to
1.38; P ⫽ .78; 8-year estimate, 37% v 39%), or DM (HR, 0.83;
95% CI, 0.56 to 1.24; P ⫽ .16; 8-year estimate, 15% v 13%). For
oropharyngeal cancer, p16-positive patients had better OS than
p16-negative patients (HR, 0.30; 95% CI, 0.21 to 0.42; P ⬍ .001;
8-year survival, 70.9% v 30.2%). There were no statistically
significant differences in the grade 3 to 5 acute or late toxicities
between the two arms and p-16 status.
Conclusion: When combined with cisplatin, AFX-C neither improved
outcome nor increased late toxicity in patients with LA-HNC.
Long-term high survival rates in p16-positive patients with
oropharyngeal cancer support the ongoing efforts to
explore deintensification.
J Clin Oncol 32:3858-3866
© 2014 by American Society of Clinical Oncology
■ ■ ■
continued
Volume 32, Issue 34
December 1, 2014
Current Abstracts
................................................................................................................................................................................................
Impact of Reirradiation of Painful Osseous
Metastases on Quality of Life and Function:
A Secondary Analysis of the NCIC CTG SC.20
Randomized Trial
Edward Chow, Ralph M. Meyer, Bingshu E. Chen, et al
pp 3867-3873
Purpose: We previously demonstrated that 48% of patients with
pain at sites of previously irradiated bone metastases benefit from
reirradiation. It is unknown whether alleviating pain also improves
patient perception of quality of life (QOL).
Patients and Methods: We used the database of a randomized trial
comparing radiation treatment dose fractionation schedules to
evaluate whether response, determined using the International
Consensus Endpoint (ICE) and Brief Pain Inventory pain score
(BPI-PS), is associated with patient perception of benefit, as
measured using the European Organisation for Resesarch and
Treatment of Cancer (EORTC) Quality of Life Questionnaire Core
30 (QLQ-C30) and functional interference scale of the BPI (BPIFI). Evaluable patients completed baseline and 2-month follow-up
assessments.
Results: Among 850 randomly assigned patients, 528 were
evaluable for response using the ICE and 605 using the BPI-PS.
Using the ICE, 253 patients experienced a response and 275 did
not. Responding patients had superior scores on all items of the
BPI-FI (ie, general activity, mood, walking ability, normal work,
relations with other people, sleep, and enjoyment of life) and
improved QOL, as determined by scores on the EORTC QLQ-C30
scales of physical, role, emotional and social functioning, global
QOL, fatigue, pain, and appetite. Similar results were obtained
using the BPI-PS; observed improvements were typically of lesser
magnitude.
Conclusion: Patients responding to reirradiation of painful bone
metastases experience superior QOL scores and less functional
interference associated with pain. Patients should be offered retreatment for painful bone metastases in the hope of reducing
pain severity as well as improving QOL and pain interference.
J Clin Oncol 32:3867-3873
© 2014 by American Society of Clinical Oncology
■ ■ ■
continued
Volume 32, Issue 34
December 1, 2014
Current Abstracts
................................................................................................................................................................................................
Pharmacokinetic and Pharmacodynamic Properties of
Calaspargase Pegol Escherichia coli L-Asparaginase in
the Treatment of Patients With Acute Lymphoblastic
Leukemia: Results From Children’s Oncology Group
Study AALL07P4
Anne L. Angiolillo, Reuven J. Schore, Meenakshi Devidas, et al
pp 3874-3882
Purpose: Asparaginase is a critical agent used to treat acute
lymphoblastic leukemia (ALL). Pegaspargase (SS-PEG), a
pegylated form of Escherichia coli L-asparaginase with a
succinimidyl succinate (SS) linker, is the first-line asparaginase
product used in Children’s Oncology Group (COG) ALL trials.
Calaspargase pegol (SC-PEG) replaces the SS linker in SS-PEG
with a succinimidyl carbamate linker, creating a more stable
molecule. COG AALL07P4 was designed to determine the
pharmacokinetic and pharmacodynamic comparability of SC-PEG
to SS-PEG in patients with newly diagnosed high-risk (HR) B-cell
ALL.
Patients and Methods: A total of 165 evaluable patients were
randomly assigned at a 2:1 ratio to receive SC-PEG at 2,100 (SCPEG2100; n ⫽ 69) or 2,500 IU/m2 (SC-PEG2500; n ⫽ 42) versus
SS-PEG 2,500 IU/m2 (SS-PEG2500; n ⫽ 54) as part of an
otherwise identical chemotherapy regimen. The groups were
similar demographically, except more female patients received SCPEG2500.
Results: The mean half-life of plasma asparaginase activity for both
SC-PEG doses was approximately 2.5⫻ longer than that of SSPEG2500. The total systemic exposure, as defined by induction
area under the curve from time 0 to 25 days, was greater with
SC-PEG2500 than with SS-PEG2500 or SC-PEG2100. The
proportion of patients with plasma asparaginase activity ⱖ 100
mIU/mL and ⱖ 400 mIU/mL was higher in patients who received
SC-PEG as compared with SS-PEG2500. After one dose of
pegylated asparaginase on induction day 4, plasma asparagine was
undetectable for 11 days for SS-PEG2500 and 18 days for both SCPEG groups.
Conclusion: SC-PEG2500 achieves a significantly longer period of
asparaginase activity above defined thresholds and asparagine
depletion compared with SS-PEG2500 and has a comparable
toxicity profile in children with HR B-cell ALL.
J Clin Oncol 32:3874-3882
© 2014 by American Society of Clinical Oncology
■ ■ ■
continued
Volume 32, Issue 34
December 1, 2014
Current Abstracts
................................................................................................................................................................................................
Pathologic Complete Response As a Potential
Surrogate for the Clinical Outcome in Patients
With Breast Cancer After Neoadjuvant Therapy:
A Meta-Regression of 29 Randomized
Prospective Studies
Alfredo Berruti, Vito Amoroso, Fabio Gallo, et al
pp 3883-3891
Purpose: To assess the role of pathologic complete response (pCR)
after neoadjuvant therapy as surrogate end point of disease-free
survival (DFS) and overall survival (OS) in patients with breast
cancer, we performed a trial-based meta-regression of randomized
studies comparing different neoadjuvant systemic treatments.
Methods: The systematic literature search included electronic
databases and proceedings of oncologic meetings. Endocrine
therapy trials were excluded. Treatment effects on DFS and OS
were expressed as hazard ratios (HRs), and treatment effects on
pCR were expressed as odds ratios (ORs). A weighted regression
analysis was performed on log-transformed treatment effect
estimates to test the association between treatment effects on
the surrogate outcome and treatment effects on the clinical
outcome.
Results: Twenty-nine trials, 59 arms, and 30 comparisons, for a
total of 14,641 patients, were included in the analysis. Using the
complete set of data, the regression of either the log(HR) for DFS
or the log(HR) for OS on the log(OR) for pCR demonstrated only
weak associations (R2 ⫽ 0.08; 95% CI, 0 to 0.47; and R2 ⫽ 0.09;
95% CI, 0.01 to 0.41, respectively). Better associations were found
in an exploratory analysis assessing a subset of trials comparing
intensified/dose-dense chemotherapy versus standard-dose
regimens (DFS: R2 ⫽ 0.79; 95% CI, 0.26 to 0.95; P ⫽ .003;
and OS: R2 ⫽ 0.57; 95% CI, 0.19 to 0.93; P ⫽ .03).
Conclusion: This meta-regression analysis of 29 heterogeneous
neoadjuvant trials does not support the use of pCR as a surrogate
end point for DFS and OS in patients with breast cancer. However,
pCR may potentially meet the criteria of surrogacy with specific
systemic therapies.
J Clin Oncol 32:3883-3891
© 2014 by American Society of Clinical Oncology
■ ■ ■
continued
Volume 32, Issue 34
December 1, 2014
Current Abstracts
................................................................................................................................................................................................
Adjuvant and Salvage Radiotherapy After
Prostatectomy: American Society of Clinical Oncology
Clinical Practice Guideline Endorsement
Stephen J. Freedland, R. Bryan Rumble, Antonio Finelli, et al
pp 3892-3898
Purpose: To endorse the American Urological Association (AUA)/
American Society for Radiation Oncology (ASTRO) guideline on
adjuvant and salvage radiotherapy after prostatectomy. The
American Society of Clinical Oncology (ASCO) has a policy and set
of procedures for endorsing clinical practice guidelines developed
by other professional organizations.
Methods: The guideline on adjuvant and salvage radiotherapy after
prostatectomy was reviewed for developmental rigor by
methodologists. An ASCO endorsement panel then reviewed the
content and recommendations.
Results: The panel determined that the guideline recommendations
on adjuvant and salvage radiotherapy after prostatectomy,
published in August 2013, are clear, thorough, and based on the
most relevant scientific evidence. ASCO endorsed the guideline on
adjuvant and salvage radiotherapy after prostatectomy, adding
one qualifying statement that not all candidates for adjuvant or
salvage radiotherapy have the same risk of recurrence or disease
progression, and thus, risk-benefit ratios are not the same for all
men. Those at the highest risk for recurrence after radical
prostatectomy include men with seminal vesicle invasion, Gleason
score 8 to 10, extensive positive margins, and detectable
postoperative prostate-specific antigen (PSA).
Recommendations: Physicians should discuss adjuvant radiotherapy
with patients with adverse pathologic findings at prostatectomy
(ie, seminal vesicle invasion, positive surgical margins,
extraprostatic extension) and salvage radiotherapy with patients
with PSA or local recurrence after prostatectomy. The discussion
of radiotherapy should include possible short- and long-term
adverse effects and potential benefits. The decision to administer
radiotherapy should be made by the patient and multidisciplinary
treatment team, keeping in mind that not all men are at equal risk
of recurrence or clinically meaningful disease progression. Thus,
the risk-benefit ratio will differ for eachqj? patient.
J Clin Oncol 32:3892-3898
© 2014 by American Society of Clinical Oncology
■ ■ ■
FORTHCOMING REPORTS
................................................................................................................................................................................................
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