Breast Cancer
Measurability of Quality Performance Indicators
Version 1.0: April 2012
(to be read in conjunction with the Breast Cancer Clinical Quality
Performance Indicators Engagement Document v1.0 and the
Breast Cancer Data Definitions v1.0)
July 2011
1
Quality Performance Indicators for Breast Cancer
QPI 1 Non-Operative Diagnosis
QPI Title:
Patients with breast cancer should have a non-operative histological diagnosis.
Description:
Proportion of patients with invasive or in-situ breast cancer who have a non-operative diagnosis (core biopsy / large volume
biopsy).
Rationale and Evidence:
Diagnosis of patients non-operatively allows them to have only one definitive procedure, where possible.
Specifications:
A lesion considered malignant should have histopathological confirmation of malignancy before any definitive surgical
procedure takes place4.
Number of patients with a non-operative diagnosis of breast cancer (core biopsy / large volume biopsy).
Numerator:
(
Histological opinion (Breast Core Biopsy)coded as ‘Malignant Not assessable’ or ‘Malignant In-situ’ or
‘Malignant invasive’ [NEEDBIO = B5 OR B5a OR B5b]
AND
Date of breast core biopsy before or on Date of first surgery [NBIODATE ≤ BSURGDATE]
)
OR
(
Histological opinion (Nodal Core Biopsy) coded as ‘Malignant breast’ [NODEBIO = 5]
AND
Date of nodal core biopsy on or before Date of first surgery [NODEBIODATE ≤ BSURGDATE]
)
Denominator:
All patients with invasive or in-situ breast cancer.
Date of Diagnosis [DIAGDATE] in range specified for comparative analysis
Exclusions:
Not
recorded:
July 2011
•
All breast cancer patients with lobular carcinoma in situ (LCIS).
Type of tumour coded as ‘LCIS non-invasive’ [TUMOUR = 19]
Patients with any aspect of their numerator, denominator or exclusion criteria coded as ‘not recorded’
should be entered into the separate not recorded category and included in the denominator for
measurement against the target
1) Denominator criteria coded as not recorded:
2
Date of Diagnosis coded as ‘Not recorded’ [DIAGDATE = 09/09/0909]
2) Exclusion criteria coded as not recorded (for patients already selected for inclusion in denominator
only):
Type of tumour coded as ‘Not known’ [TUMOUR = 99]
3) Numerator criteria coded as not recorded (for patients who would otherwise be selected for
inclusion in the numerator):
Histological opinion (Breast Core Biopsy)coded as ‘Not recorded’ [NEEDBIO = 99]
OR
Date of breast core biopsy coded as ‘Not recorded’ [NBIODATE = 09/09/0909]
OR
Date of first surgery coded as ‘Not recorded’ [BSURGDATE = 09/09/0909]
OR
Histological opinion (Nodal Core Biopsy) coded as ‘Not recorded’ [NODEBIO = 99]
OR
Date of nodal core biopsy coded as ‘Not recorded’ [NODEBIODATE = 09/09/0909]
Target:
July 2011
95%
The tolerance within this target accounts for the fact that it may not always be technically possible to undertake a biopsy and
factors of patient choice.
3
QPI 2 Pre-Operative Assessment of Axilla
QPI Title:
Patients with breast cancer should have pre-operative assessment of the axilla.
Description:
Proportion of patients with invasive breast cancer who undergo assessment of the axilla: (i) ultrasound (ii) +/- FNA/core biopsy if
suspicious morphology is reported on ultrasound, before surgery.
Please note:
This QPI measures 2 distinct elements:
(i)
All patients with invasive breast cancer should undergo ultrasound assessment of the axilla; and
(ii)
If findings of ultrasound are suspicious of cancer spread to nodes all patients should undergo FNA/core biopsy
Rationale and Evidence:
Specifications (i):
The specifications are therefore separated to ensure clear measurement of both these factors.
“A preoperative diagnosis of nodal disease enables definitive treatment of the axilla at the time of initial breast surgery” 5.
Patients with invasive breast cancer should undergo pre-treatment ultrasound assessment of the axilla. If morphologically
suspicious nodes are identified these should be sampled, using FNA or core biopsy 5 6.
Number of patients with invasive breast cancer who undergo assessment of the axilla by ultrasound before
Numerator:
surgery.
Ultrasound Examination of Axilla coded as ‘Yes’ [ULTRAXIL = 1]
Denominator:
All patients with invasive breast cancer undergoing surgery.
Date of Diagnosis [DIAGDATE] in range specified for comparative analysis
AND
Type of tumour coded as ‘'Ductal'/no specific type (NST)’ or ‘Lobular carcinoma’ or ‘Medullary
carcinoma’ or ‘Mucinous carcinoma’ or ‘Tubular carcinoma’ or ‘Mixed (invasive)’ or ‘Other invasive’
[TUMOUR = 11 OR 12 OR 13 OR 14 OR 15 OR 16 OR 17]
AND
Final Definitive Surgery coded as ‘Mastectomy’ or ‘Other’ or ‘Axillary surgery alone’ or ‘Mastectomy
plus immediate reconstruction’ or ‘Localising or excision biopsy’ or ‘Conservation surgery’ [SURGBRST
= 4 OR 5 OR 6 OR 7OR 11 OR 12]
Exclusions:
Not
recorded:
• No exclusions.
Patients with any aspect of their numerator, denominator or exclusion criteria coded as ‘not recorded’
should be entered into the separate not recorded category and included in the denominator for
measurement against the target
1) Denominator criteria coded as not recorded, and where patient would otherwise be selected for
inclusion in the denominator:
July 2011
4
Date of Diagnosis coded as ‘Not recorded’ [DIAGDATE = 09/09/0909]
OR
Type of tumour coded as ‘Not recorded’ [TUMOUR = 99]
OR
Final Definitive Surgery coded as ‘Not known’ [SURGBRST = 99]
2) Exclusion criteria coded as not recorded (for patients already selected for inclusion in denominator
only):
***No exclusions***
4) Numerator criteria coded as not recorded (for patients who have been selected for inclusion in the
denominator):
Ultrasound Examination of Axilla coded as ‘Not known’ [ULTRAXIL =99]
Target:
95%
The tolerance within this target accounts for the fact that some patients may refuse investigation and/or treatment.
Specifications (ii):
Numerator:
Number of patients with invasive breast cancer with suspicious morphology reported on ultrasound who
undergo a FNA/core biopsy of the axilla before surgery.
(
Date Nodal Cytology of Axilla Performed [NODEDATE]
OR
Date Nodal Core Biopsy of Axilla Performed [AXILBIODATE]
)
< (before)
Date of First Definitive Breast Surgery [BSURGDATE]
July 2011
5
Denominator:
All patients with invasive breast cancer undergoing surgery with suspicious morphology reported on
ultrasound.
Date of Diagnosis [DIAGDATE] in range specified for comparative analysis
AND
Type of tumour coded as ‘'Ductal'/no specific type (NST)’ or ‘Lobular carcinoma’ or ‘Medullary
carcinoma’ or ‘Mucinous carcinoma’ or ‘Tubular carcinoma’ or ‘Mixed (invasive)’ or ‘Other invasive’
[TUMOUR = 11 OR 12 OR 13 OR 14 OR 15 OR 16 OR 17]
AND
Final Definitive Surgery coded as ‘Mastectomy’ or ‘Other’ or ‘Axillary surgery alone’ or ‘Mastectomy
plus immediate reconstruction’ or ‘Localising or excision biopsy’ or ‘Conservation surgery’ [SURGBRST
= 4 OR 5 OR 6 OR 7OR 11 OR 12]
AND
Ultrasound findings {Breast cancer} coded as ‘Indeterminate’ or ‘Suspicious’ or ‘Malignant’ [ULTRA =
U3 OR U4 OR U5]
Exclusions:
July 2011
•
No exclusions.
6
Not
recorded:
Patients with any aspect of their numerator, denominator or exclusion criteria coded as ‘not recorded’
should be entered into the separate not recorded category and included in the denominator for
measurement against the target
3) Denominator criteria coded as not recorded, and where patient would otherwise be selected for
inclusion in the denominator:
Date of Diagnosis coded as ‘Not recorded’ [DIAGDATE = 09/09/0909]
OR
Type of tumour coded as ‘Not recorded’ [TUMOUR = 99]
OR
Final Definitive Surgery coded as ‘Not known’ [SURGBRST = 99]
OR
Ultrasound findings {Breast cancer} coded as ‘Not known’ [ULTRA = 99]
4) Exclusion criteria coded as not recorded (for patients already selected for inclusion in denominator
only):
***No exclusions***
5) Numerator criteria coded as not recorded (for patients who would otherwise be selected for
inclusion in the numerator):
Date Nodal Cytology of Axilla Performed coded as ‘Not known’ [NODEDATE=09/09/0909]
OR
Date Nodal Core Biopsy of Axilla Performed coded as ‘Not known’ [AXILBIODATE =09/09/0909]
OR
Date of First Definitive Breast Surgery coded as ‘Not known’ [BSURGDATE =09/09/0909]
Target:
85 %
The tolerance within this target accounts for the fact that FNA/core biopsy of the axilla it is not always technically possible.
July 2011
7
QPI 3 Conservation Rate
QPI Title:
Patients with small breast cancers should undergo breast conservation whenever appropriate*.
Description:
Proportion of surgically treated patients with breast cancer less than 20mm whole tumour size on histology who achieve breast
conservation.
Rationale and Evidence:
Breast conservation is appropriate for small breast cancers. Randomised trials have shown no difference in survival for
tumours treated by conservation surgery followed by radiotherapy to mastectomy 4.
*Breast conservation may not be appropriate for all patients for a variety of reasons including patient choice, genetic risk and
small breast size 7.
Specifications:
Numerator:
Number of surgically treated breast cancer patients with tumour less than 20mm whole tumour size on
histology (invasive plus in situ disease) treated by breast conservation surgery.
Final Definitive (or Only) Surgery Performed to Breast coded as ‘Localising or excision biopsy’ or
‘conservation surgery’ [SURGBRST = 11 OR 12]
Denominator:
All surgically treated patients with breast cancer with tumour less than 20mm whole tumour size on histology
(invasive plus in situ disease).
Date of Diagnosis [DIAGDATE] in range specified for comparative analysis
AND
Final Definitive Surgery coded as ‘Mastectomy’ or ‘Other’ or ‘Axillary surgery alone’ or ‘Mastectomy
plus immediate reconstruction’ or ‘Localising or excision biopsy’ or ‘Conservation surgery’ [SURGBRST
= 4 OR 5 OR 6 OR 7OR 11 OR 12]
AND
Maximum microscopic Whole Tumour Diameter less than 20mm [WHOLEDIAM < 20]
July 2011
8
Exclusions:
•
•
All patients with multifocal breast cancer.
All patients with breast cancer who have received neoadjuvant systemic therapy for ≥6 weeks
(hormonal therapy or chemotherapy).
Tumour extent coded as ‘Multiple invasive foci’ or ‘Multiple DCIS foci’ or ‘Multiple foci includes Invasive
& DCIS’ [EXTENT = 2 OR 3 OR 4]
OR
Type of hormone therapy coded as ‘Neo-adjuvant’ [HORMON = 2]
OR
(
Type of chemotherapy 1 coded as ‘Neo-adjuvant’[CHEM1 = 2]
AND
‘Date treatment completed (chemotherapy) 1’ minus ‘Date treatment started (chemotherapy) 1’ greater
than or equal to 6 weeks [CHEMENDATE1– CHEMDATE1 ≥ 42 (days)]
)
OR
(
Type of chemotherapy 2 coded as ‘Neo-adjuvant’ [CHEM2 = 2]
AND
‘Date treatment completed (chemotherapy) 1’ minus ‘Date treatment started (chemotherapy) 1’
plus
‘Date treatment completed (chemotherapy) 2’ minus ‘Date treatment started (chemotherapy) 2’
greater than or equal to 6 weeks
[(CHEMENDATE1– CHEMDATE1) + (CHEMENDATE2– CHEMDATE2) ≥ 42 (days)]
)
Not
recorded:
Patients with any aspect of their numerator, denominator or exclusion criteria coded as ‘not recorded’
should be entered into the separate not recorded category and included in the denominator for
measurement against the target
1) Denominator criteria coded as not recorded, and where patient would otherwise be selected for
inclusion in the denominator:
Date of Diagnosis coded as ‘not recorded’ [DIAGDATE = 09/09/0909]
OR
Final Definitive (or only) Surgery Performed to Breast coded as ‘Not known’ [SURGBRST = 99]
July 2011
9
OR
Maximum microscopic Whole Tumour Diameter coded as ‘Not recorded’ [WHOLEDIAM = 9999]
2) Exclusion criteria coded as not recorded (for patients who would otherwise be selected for inclusion in
denominator):
Tumour extent coded as ‘Not known’ [EXTENT = 99]
OR
Type of hormone therapy coded as ‘Not known’ [HORMON = 99]
OR
Type of chemotherapy 1 coded as ‘Not known’ [CHEM1 = 99]
OR
‘Date treatment completed (chemotherapy) 1’ coded as ‘Not recorded’ [CHEMENDATE1 = 09/09/0909]
OR
‘Date treatment started (chemotherapy) 1’ coded as ‘Not recorded’ [CHEMDATE1 = 09/09/0909]
OR
Type of chemotherapy 2 coded as ‘Not known’ [CHEM2 = 99]
OR
‘Date treatment completed (chemotherapy) 2’ coded as ‘Not recorded’ [CHEMENDATE2 =
09/09/0909]
OR
‘Date treatment started (chemotherapy) 2’ coded as ‘Not recorded’ [CHEMDATE2 = 09/09/0909]
Target:
July 2011
85%
The tolerance within this target accounts for the fact that breast conservation may not always be an appropriate treatment
option for a variety of reasons, primarily patient choice.
10
QPI 4 Surgical Margins
QPI Title:
Breast cancers which are surgically treated should be adequately excised.
Description:
Proportion of surgically treated patients with breast cancer (invasive or ductal carcinoma in situ) with final radial excision
margins of less than 1mm.
Rationale and Evidence:
There is an increased risk of local recurrence if radial surgical excision margins is less than 1mm after breast cancer surgery 4.
Number of patients with breast cancer (invasive or ductal carcinoma in situ) having breast conservation
Numerator:
surgery with final radial (i.e. superior, inferior, medial or lateral) excision margins less than 1mm (on pathology
report).
Distance from Final Radial Excision Margin coded as ‘<1mm’ [DISTEX = 1 ]
Denominator:
All patients with breast (invasive or ductal carcinoma in situ) cancer having breast conservation surgery.
Date of Diagnosis [DIAGDATE] in range specified for comparative analysis
AND
Final Definitive (or Only) Surgery Performed to Breast coded as ‘Localising or excision biopsy’ or
‘conservation surgery’ [SURGBRST = 11 OR 12]
Exclusions:
•
LCIS alone
Type of tumour coded as ‘LCIS (non-invasive)’ [TUMOUR = 19]
July 2011
11
Not
recorded:
Patients with any aspect of their numerator, denominator or exclusion criteria coded as ‘not recorded’
should be entered into the separate not recorded category and included in the denominator for
measurement against the target
1) Denominator criteria coded as not recorded:
Date of Diagnosis coded as ‘Not recorded’ [DIAGDATE = 09/09/0909]
OR
Final Definitive (or Only) Surgery Performed to Breast coded as ‘Not known’ [SURGBRST = 99]
2) Exclusion criteria coded as not recorded (for patients already selected for inclusion in denominator
only):
Type of tumour coded as ‘Not known’ [TUMOUR = 99]
3) Numerator criteria coded as not recorded (for patients who would otherwise be selected for inclusion in
the numerator only):
Distance from Final Radial Excision Margin coded as ‘Not recorded’ [DISTEX = 99]
Target:
<5%
This QPI is measuring the proportion of patients who undergo surgery where the tumour has not been completely
excised, a ‘less than’ target level has therefore been set.
July 2011
12
QPI 5 Immediate Reconstruction Rate
QPI Title:
Patients undergoing mastectomy for breast cancer should have access to immediate breast reconstruction.
Description:
Proportion of patients who undergo immediate breast reconstruction at the time of mastectomy for breast cancer.
Rationale and Evidence:
Evidence suggests that breast reconstruction is not associated with an increase in the rate of local recurrence, nor does it affect
the ability to detect recurrence, and it can yield psychological benefit. There may be good reasons for individual patients not to
undergo immediate breast reconstruction but this indicator is intended to demonstrate that mastectomy patients have access to
a reconstructive service4 7.
Access to immediate breast reconstruction is very difficult to measure accurately therefore uptake is utilised within this QPI as a
proxy for access. Although it will not provide an absolute measure of patient access to this procedure it will give an indication of
access across NHS Boards and highlight any areas of variance which can then be further examined.
Specifications:
Numerator:
Number of patients with breast cancer undergoing immediate breast reconstruction at the time of mastectomy.
‘Final definitive (or only) surgery performed to breast’ coded as ‘Mastectomy plus immediate
reconstruction‘ [SURGBRST = 7]
Denominator:
All patients with breast cancer undergoing mastectomy.
Date of Diagnosis [DIAGDATE] in range specified for comparative analysis
AND
Final Definitive (or Only) Surgery Performed to Breast coded as ‘mastectomy’ or ‘Mastectomy plus
immediate reconstruction‘ [SURGBRST = 4 OR 7]
Exclusions:
•
All patients with M1 disease 1 .
TNM Metastasis Classification (pre-operative) {breast cancer} coded as ‘Distant metastasis present’
[CM = M1]
1
The exclusion of patients with M1 disease is not intended to imply that mastectomy and immediate reconstruction is not a valid treatment option for patients
with metastatic disease. The development group recommend that all patients are discussed on an individual basis to determine the most appropriate
treatment.
July 2011
13
Not
recorded:
Patients with any aspect of their numerator, denominator or exclusion criteria coded as ‘not recorded’
should be entered into the separate not recorded category and included in the denominator for
measurement against the target
1) Denominator criteria coded as not recorded:
Date of Diagnosis coded as ‘Not recorded’ [DIAGDATE = 09/09/0909]
OR
Final Definitive (or Only) Surgery Performed to Breast coded as ‘Not known’ [SURGBRST = 99]
2) Exclusion criteria coded as not recorded (for patients already selected for inclusion in denominator
only):
TNM Metastasis Classification (pre-operative) {breast cancer} coded as ‘Not known’ [CM = 99]
Target:
>10%
The tolerance within this target accounts for the fact that patient choice is a key factor in the number of patients who undergo
immediate breast reconstruction at the time of mastectomy.
July 2011
14
QPI 6 Negative Axillary Clearance Rate
QPI Title:
Over treatment of the axilla should be minimised.
Description:
Proportion of patients with breast cancer undergoing axillary clearance with no pathological evidence of nodal metastatic
disease*.
Rationale/ and Evidence:
Surgical axillary clearance is associated with increased arm morbidity compared with other surgical staging procedures and
should therefore not be utilised unless there is evidence of nodal metastatic disease 4.
Preoperative investigation of the axilla should minimise the need for surgical axillary clearance as a staging procedure 7.
Specifications:
Numerator:
Number of breast cancer patients undergoing surgical axillary clearance found to have no nodal metastasis*
(including nodes taken at any previous sampling procedure).
Total Number of Lymph Nodes Involved equals ‘0’: [INVNODES = 0]
Denominator:
All patients with breast cancer undergoing surgical axillary clearance.
Date of Diagnosis [DIAGDATE] in range specified for comparative analysis
AND
(
First Axillary Surgery coded as ‘Clearance’ [FIRSTAXIL = 2]
OR
Final Axillary Surgery coded as ‘Clearance’ [FINALAXIL = 2]
)
July 2011
15
Exclusions:
•
All patients with breast cancer who have received neoadjuvant systemic therapy for ≥6 weeks
(hormonal therapy or chemotherapy.
Type of hormone therapy coded as ‘Neo-adjuvant’ [HORMON = 2]
OR
(
Type of chemotherapy 1 coded as ‘Neo-adjuvant’[CHEM1 = 2]
AND
‘Date treatment completed (chemotherapy) 1’ minus ‘Date treatment started (chemotherapy) 1’ greater
than or equal to 6 weeks [CHEMENDATE1– CHEMDATE1 ≥ 42 (days)]
)
OR
(
Type of chemotherapy 2 coded as ‘Neo-adjuvant’ [CHEM2 = 2]
AND
‘Date treatment completed (chemotherapy) 1’ minus ‘Date treatment started (chemotherapy) 1’
plus
‘Date treatment completed (chemotherapy) 2’ minus ‘Date treatment started (chemotherapy) 2’
greater than or equal to 6 weeks
[(CHEMENDATE1– CHEMDATE1) + (CHEMENDATE2– CHEMDATE2) ≥ 42 (days)]
)
Not
recorded:
Patients with any aspect of their numerator, denominator or exclusion criteria coded as ‘not recorded’
should be entered into the separate not recorded category and included in the denominator for
measurement against the target
1) Denominator criteria coded as not recorded (where patients meet all other denominator criteria):
Date of Diagnosis coded as ‘Not recorded’ [DIAGDATE = 09/09/0909]
OR
(
First Axillary Surgery coded as ‘Not known’ [FIRSTAXIL = 99]
AND
Final Axillary Surgery NOT coded as ‘Clearance’ [FINALAXIL NOT 2]
)
OR
July 2011
16
(
Final Axillary Surgery coded as ‘‘Not known’ [FINALAXIL = 99]
AND
First Axillary Surgery NOT coded as ‘Clearance’ [FIRSTAXIL NOT 2]
)
2) Exclusion criteria coded as not recorded (for patients who would otherwise be selected for inclusion in
denominator only):
Type of hormone therapy coded as ‘Not known’ [HORMON = 99]
OR
Type of chemotherapy 1 coded as ‘Not known’ [CHEM1 = 99]
OR
‘Date treatment completed (chemotherapy) 1’ coded as ‘Not recorded’ [CHEMENDATE1 = 09/09/0909]
OR
‘Date treatment started (chemotherapy) 1’ coded as ‘Not recorded’ [CHEMDATE1 = 09/09/0909]
OR
Type of chemotherapy 2 coded as ‘Not known’ [CHEM2 = 99]
OR
‘Date treatment completed (chemotherapy) 2’ coded as ‘Not recorded’ [CHEMENDATE2 =
09/09/0909]
OR
‘Date treatment started (chemotherapy) 2’ coded as ‘Not recorded’ [CHEMDATE2 = 09/09/0909]
3) Numerator criteria coded as not recorded (for patients already selected for inclusion in denominator
only):
Total Number of Lymph Nodes Involved coded as ‘Not known or not recorded’ [INVNODES = 9999]
Target:
<10%
This QPI is measuring the number of patients who undergo surgical axillary clearance who have no nodal metastases, i.e.
patients who have over treatment of the axilla, therefore a ‘less than’ target has been set.
* see data item Total Number of Lymph Nodes Involved in the national minimum core dataset for full definition of nodal metastasis
July 2011
17
QPI 7: Minimising Hospital Stay -“23 Hour” Surgery
QPI Title:
Patients should have the opportunity for “23 hour” surgery (a maximum of 1 overnight stay following surgery) wherever
appropriate.
Description:
Proportion of patients undergoing wide excision and/or an axillary sampling procedure for breast cancer with a maximum of 1
night hospital stay following their procedure.
Rationale and Evidence:
It is safe to perform wide excision and axillary staging as a short stay procedure in the majority of patients and clinical quality
has been shown to be improved utilising this model, resulting in better patient outcomes.
Benefits of short stay following surgery include: reduction in re-admissions, reduction in complications, improved patient
mobility and enhanced recovery 8.
Specifications:
Numerator:
Number of patients with breast cancer undergoing wide excision and/or axillary sampling procedure (sentinel
node biopsy or node sample (≥4 nodes) with a maximum hospital stay of 1 night following their procedure.
Denominator:
All patients with breast cancer undergoing wide excision and/or axillary sampling procedure (sentinel node
biopsy or node sample (≥4 nodes).
Exclusions:
Target:
•
All patients with breast cancer undergoing partial breast reconstruction.
80%
The tolerance within this target takes account of the fact that “23 hour” surgery may not be appropriate for all patients due to
social circumstances, co-morbidities and/or the geographical area in which they live. It may not always be safe or practical for
patients to go home immediately after surgery; this may therefore affect short-stay surgery rates across NHS Scotland.
Please note:
SMR01 data will be utilised to support reporting and monitoring of this QPI rather than clinical audit. This will maximise the use of data which
are already collected and remove the need for any duplication of data collection. Standard reports are currently being specified and direct
access for each Board to run these reports is being investigated to ensure nationally consistent analysis and reporting.
July 2011
18
QPI 8 HER2 Status for Decision Making
QPI Title:
HER2 status should be available to inform treatment decision making.
Description:
Proportion of patients with invasive breast cancer for whom the HER2 status, as defined by ImmunoHistoChemistry (IHC), is
known at the initial multidisciplinary team (MDT) meeting to decide first treatment.
Rationale and Evidence:
HER2 status has a significant impact on survival and so has a significant influence on decisions on neoadjuvant and adjuvant
treatment 5.
Delay in the availability of a HER2 result may lead to a delay in appropriate neoadjuvant or adjuvant therapy and make
communication of a clear plan to the patient more difficult.
Specifications:
At present HER2 testing is undertaken in all relevant cases; however the point of the patient pathway at which this takes
place varies across NHS Scotland. The purpose of this indicator is to synchronise practice across Scotland by ensuring the
availability of HER2 status to inform treatment decision making.
Number of patients with invasive breast cancer for whom the HER2 status (as defined by IHC) is known at
Numerator:
initial MDT meeting to decide first treatment.
Human Epidermal Growth Factor Receptor-2 (HER2) Status Available at Initial MDT {Breast Cancer}
coded as ‘Yes’ [HER2AVAIL = 1]
Denominator:
Exclusions:
Not
recorded:
All patients with invasive breast cancer.
Date of Diagnosis [DIAGDATE] in range specified for comparative analysis
AND
Type of tumour coded as ‘'Ductal'/no specific type (NST)’ or ‘Lobular carcinoma’ or ‘Medullary
carcinoma’ or ‘Mucinous carcinoma’ or ‘Tubular carcinoma’ or ‘Mixed (invasive)’ or ‘Other invasive’
[TUMOUR = 11 OR 12 OR 13 OR 14 OR 15 OR 16 OR 17]
• No exclusions.
Patients with any aspect of their numerator, denominator or exclusion criteria coded as ‘not recorded’
should be entered into the separate not recorded category and included in the denominator for
measurement against the target
1) Denominator criteria coded as not recorded:
Date of Diagnosis coded as ‘Not recorded’ [DIAGDATE = 09/09/0909]
OR
Type of tumour coded as ‘Not known’ [TUMOUR = 99]
July 2011
2) Exclusion criteria coded as not recorded (for patients already selected for inclusion in denominator
19
only):
***No exclusions***
3) Numerator criteria coded as not recorded (for patients already selected for inclusion in denominator
only):
Human Epidermal Growth Factor Receptor-2 (HER2) Status Available at Initial MDT {Breast Cancer}
coded as ‘Not known’ [HER2AVAIL = 99]
Target:
90%
The tolerance within this target accounts for the fact that it is not always possible to undertake IHC on a core biopsy, e.g. due
to tumour size.
July 2011
20
QPI 9 Radiotherapy for Breast Conservation
QPI Title:
After wide local excision patients with breast cancer should receive radiotherapy.
Description:
Proportion of patients with breast cancer who receive radiotherapy to the breast after conservation for invasive cancer.
Rationale and Evidence:
Trials have demonstrated a significant reduction in local recurrence with the use of radiotherapy after breast conservation 9.
Clinical trials of radiotherapy have shown it can produce a reduction in local recurrence would produce an absolute increase
in 20-year survival of about 2-4% 10 11 12.
Specifications:
Numerator:
Number of breast cancer patients with invasive breast cancer having conservation surgery receiving
radiotherapy to the breast.
Site of external beam radiotherapy coded as ‘Breast’ [RADSITE1 or RADSITE 2 or RADSITE 3 or
RADSITE 4 or RADSITE 5 = 1]
Denominator:
All patients with invasive breast cancer having conservation surgery.
Date of Diagnosis [DIAGDATE] in range specified for comparative analysis
AND
Type of Tumour coded as: [TUMOUR = 11 Or 12 Or 13 Or 14 Or 15 Or 16 Or 17]
AND
Final definitive (or only) surgery performed to breast coded as ‘Localising or excision biopsy or
conservation surgery’ [SURGBRST = 11 or 12]
Exclusions:
•
•
All patients with breast cancer taking part in clinical trials of radiotherapy treatment.
All patients with M1 disease.
Patient Entered into Clinical Trial coded as ‘Yes, radiotherapy’ [TRIAL = 1A]
OR
TNM Metastases Classification (Pre-operative) coded as ‘Distant metastases present’ [cM = M1]
Not
recorded:
July 2011
Patients with any aspect of their numerator, denominator or exclusion criteria coded as ‘not recorded’
should be entered into the separate not recorded category and included in the denominator for
measurement against the target
1) Denominator criteria coded as not recorded (for patients who otherwise meet all other denominator
criteria):
21
Date of Diagnosis coded as ‘Not recorded’ [DIAGDATE = 09/09/0909]
OR
Type of Tumour coded as ‘Not known’ [TUMOUR = 99]
OR
Final definitive (or only) surgery performed to breast coded as ‘Not known’ [SURGBRST = 99]
2) Exclusion criteria coded as not recorded (for patients already selected for inclusion in denominator
only):
Patient Entered into Clinical Trial coded as ‘Not known’ [TRIAL = 99]
OR
TNM Metastases Classification (Pre-operative) coded as ‘Not known’ [cM = 99]
3) Numerator criteria coded as not recorded (for patients who would otherwise be selected for inclusion
in the numerator only):
Site of external beam radiotherapy coded as ‘Not known’ [RADSITE1 or RADSITE 2 or RADSITE 3
or RADSITE 4 or RADSITE 5 = 99]*
*only where all other ‘Site of external beam radiotherapy’ sites [RADSITE1-5] are NOT coded as
‘breast’
Target:
95%
The tolerance within this target accounts for factors of patient choice and fitness for treatment.
July 2011
22
QPI 10 Adjuvant Chemotherapy
QPI Title:
Patients with higher risk breast cancer should receive chemotherapy post operatively.
Description:
Proportion of patients between 50 and 70 years of age at diagnosis with surgically proven node positive or at least G3 >20mm
breast cancer who receive adjuvant chemotherapy.
Rationale/ and Evidence:
Large randomised trials have confirmed that adjuvant systemic therapy improves relapse-free survival and overall survival.9
Clinical trials have demonstrated that adjuvant drug treatments substantially reduce 5-year recurrence rates and 15-year
mortality rates 13.
Treatment is not restricted by age and is considered on an individual patient basis. Treatment may be restricted by comorbidities, which are more common in the older patient group. Due to the difficulties associated with accurate measurement of
co-morbidities and patient fitness these cannot be utilised as exclusions within this QPI. To ensure focussed measurement and
a QPI examining expected outcomes the age range of 50-70 years has been selected. This represents the majority of patients
and therefore provides a good proxy for access to adjuvant chemotherapy in the whole patient population.
Patients over 70 years of age have been poorly represented in previous clinical trials meaning that the evidence base for
benefit in the over 70 age group is extremely limited. This does not affect clinical practice, as patients are considered for
treatment on an individual basis.
Specifications:
Numerator:
Number of patients between 50 and 70 years of age at diagnosis with surgically proven node positive or at
least G3 >20mm breast cancer who receive adjuvant chemotherapy.
Type of Chemotherapy 1-2 coded as ‘Adjuvant’ [CHEM1 OR CHEM2 = 1]
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Denominator:
All patients between 50 and 70 years of age at diagnosis with surgically proven node positive or at least G3
>20mm breast cancer.
Date of Diagnosis [DIAGDATE] – (minus) Date of birth [DOB] > (greater than) 50 years and < (less
than) 70 years
AND
Exclusions:
Not
recorded:
•
•
•
(
Total Number of Lymph Nodes Involved not coded as ‘inapplicable’ [INVNODES >0 AND NOT 1010]
OR
(
Tumour Grade coded as ‘Grade III’ [TGRADE = 3]
AND
Maximum Microscopic Whole Tumour Diameter {Cancer} greater than 20mm and not ‘not assessable’
or ‘inapplicable’ [WHOLEDIAM > 20 AND NOT (8888 OR 1010)]
)
)
All patients with breast cancer taking part in trials of chemotherapy treatment.
All patients with breast cancer who have had neo-adjuvant chemotherapy
All patients with M1 disease.
Patient entered into Clinical Trial coded as ‘Chemotherapy’ [TRIAL = 1B]
OR
Type of Chemotherapy 1-2 coded as ‘Neoadjuvant’ [CHEM1 OR CHEM2 = 2]
OR
TNM Metastases Classification (Pre-operative) coded as ‘Distant metastases present’ [cM = M1]
Patients with any aspect of their numerator, denominator or exclusion criteria coded as ‘not recorded’
should be entered into the separate not recorded category and included in the denominator for
measurement against the target
1) Denominator criteria coded as not recorded (where all other denominator criteria has been met):
Date of Diagnosis coded as ‘Not recorded’ [DIAGDATE = 09/09/0909]
OR
Date of birth coded as ‘Not recorded’ [DOB = 09/09/0909]
OR
Total Number of Lymph Nodes Involved coded as ‘not recorded’ [INVNODES = 9999]
OR
Tumour Grade coded as ‘Not known’ [TGRADE = 99]
OR
Maximum Microscopic Whole Tumour Diameter {Cancer} coded as ‘Not recorded’ [WHOLEDIAM =
9999]
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2) Exclusion criteria coded as not recorded (for patients already selected for inclusion in denominator
only):
Patient entered into Clinical Trial coded as ‘Not known’ [TRIAL = 99]
OR
Type of Chemotherapy 1-2 coded as ‘Not known’ [CHEM1 OR CHEM2 = 99]
OR
TNM Metastases Classification (Pre-operative) coded as ‘Not known’ [M = 99]
3) Numerator criteria coded as not recorded (for patients already selected for inclusion in denominator
only):
Type of Chemotherapy 1-2 coded as ‘Not known’ [CHEM1 OR CHEM2 = 99]
Target:
July 2011
85%
The tolerance within this target accounts for factors of patient choice, co-morbidities and fitness for treatment.
25
QPI 11 Anti-HER2 Positive Therapy
QPI Title:
Patients with HER2 positive intermediate or high risk breast cancer should receive anti-HER2 positive therapy.
Description:
Proportion of patients with breast cancer (who are between 50 and 70 years of age at diagnosis) with HER2 positive cancer
greater than 10 mm or node-positive who receive anti-HER2 positive therapy.
Rationale/ and Evidence:
Women with intermediate or high risk-disease who are HER2 positive show benefit when they receive trastuzumab in addition
to chemotherapy 9.
Clinical trails have shown a highly significant increase in 3yr disease-free survival with the use of adjuvant trastuzumab14 15.
Treatment is not restricted by age and is considered on an individual patient basis. Treatment may be restricted by comorbidities, which are more common in the older patient group. Due to the difficulties associated with accurate measurement of
co-morbidities and patient fitness these cannot be utilised as exclusions within this QPI. To ensure focussed measurement and
a practically useful QPI the age range of 50-70 years has been selected as the population of measurement, this represents the
majority of patients and therefore provides a good proxy for patient’s receiving adjuvant chemotherapy in the whole patient
population.
Patients over 70 years of age have been poorly represented in previous clinical trials meaning that the evidence base for
benefit in the over 70 age group is extremely limited. This does not affect clinical practice, as patients are considered for
treatment on an individual basis.
Specifications:
Numerator:
Number of patients with breast cancer who are between 50 and 70 years of age at diagnosis with HER2
positive (by 3+ on IHC &/or FISH +ve) tumours >10mm (or ≤10mm and node positive) who receive adjuvant
anti-HER2 positive therapy.
Biological agent coded as ‘Anti-HER2 positive therapy’ [BIOAGENT = 1]
AND
Date Treatment Started {Cancer} (Biological Therapy) after ‘Date of first treatment’ [BIODATE >
FIRSTTREATDATE]
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Denominator:
All patients with breast cancer who are between 50 and 70 years of age at diagnosis with HER2 positive (by
3+ on IHC &/or FISH +ve). tumours >10mm (or ≤10mm and node positive).
‘Date of Diagnosis’ minus ‘Date of birth’ greater than 50 years and less than 70 years [DIAGDATE –
DOB > 50 years AND < 70 years]
AND EITHER
(
Human Epidermal Growth Factor Receptor-2 Status coded as ‘Positive’ [HER2STATUS = 1]
AND
Maximum Invasive Pathological Diameter greater than 10 [MAXPATH > 10]
)
OR
(
Human Epidermal Growth Factor Receptor-2 Status coded as ’Positive’ [HER2STATUS = 1]
AND
Maximum Invasive Pathological Diameter less than or equal to 10 [MAXPATH ≤ 10]
AND
Number of Lymph Nodes Involved not coded as ‘Inapplicable’ [INVNODES > 0 AND NOT 1010]
)
Exclusions:
No exclusions.
Not
recorded:
Patients with any aspect of their numerator, denominator or exclusion criteria coded as ‘not recorded’
should be entered into the separate not recorded category and included in the denominator for
measurement against the target
1) Denominator criteria coded as not recorded (where all other denominator criteria are met):
‘Date of Diagnosis’ coded as ‘Not known’ [DIAGDATE = 09/09/0909]
OR
‘Date of birth’ coded as ‘Not known’ [DOB = 09/09/0909]
OR
Human Epidermal Growth Factor Receptor-2 Status coded as ‘Not known’ [HER2STATUS = 99]
OR
Maximum Invasive Pathological Diameter coded as ‘Not known’ [MAXPATH = 99]
OR
Number of Lymph Nodes Involved coded as ‘Not recorded’ [INVNODES = 9999]
July 2011
27
2) Exclusion criteria coded as not recorded (for patients already selected for inclusion in denominator
only):
***No exclusions***
3) Numerator criteria coded as not recorded (where all other numerator criteria are met):
Biological agent coded as ‘Not known’ [BIOAGENT = 99]
OR
Date Treatment Started {Cancer} (Biological Therapy)coded as ‘Not recorded’ [BIODATE =
09/09/0909]
OR
‘Date of first treatment’ coded as ‘Not recorded’ [FIRSTTREATDATE = 09/09/0909]
Target:
90%
The tolerance within this target accounts for factors of patient choice, co-morbidities and fitness for treatment.
July 2011
28
References
1. Scottish Government (2008) ‘Better Cancer Care: An Action Plan’
2. Scottish Government (2010) ‘NHS Scotland Healthcare Quality Strategy’
3. Institute Of Medicine (2001) ‘Crossing the Quality Chasm: A New Health System for the 21st Century’ National Academy Press:
Washington, DC.
4. Scottish Intercollegiate Guidelines Network. Management of breast cancer in women. Edinburgh: SIGN; 2005. SIGN Publication No. 84.
5. NICE (2009) Breast Cancer (Early and Locally Advanced) Diagnosis and Treatment. Cardiff: NICE; February 2009. CG80
6. Willett et al (2010) Best Practice Diagnostic Guidelines for Patients Presenting with Breast Symptoms
http://www.rcrbreastgroup.com/Documents/BBCDiagnosticGuidelines.pdf
7. NHS BSP (2009) Quality Assurance Guidelines for Surgeons in Breast Cancer Screening. Sheffield: NHS Cancer screening Programmes;
2009. Publication 20 Fourth Edition
8. NHS
Improvement
(2010)
Ambulatory
breast
surgical
care:
day
case/23-hour
breast
care
http://www.library.nhs.uk/qipp/SearchResults.aspx?searchText=ambulatory%20breast%20surgical%20care
9. NHS
Quality
Improvement
Scotland
(2008)
Management
of
breast
cancer
services.
http://www.healthcareimprovementscotland.org/programmes/cancer/cancer_resources/standards_for_cancer_services.aspx
10. Abe et al (2005) Effects of radiotherapy and of differences in the extent of surgery for early breast cancer on local recurrence and 15-year
survival: an overview of the randomised trials. Lancet 2005; 366 (9503): 2087–2106.
11. Fisher et al (2002) Tamoxifen, radiation therapy, or both for prevention of ipsilateral breast tumour recurrence after lumpectomy in women
with invasive breast cancers of one centimetre or less. Journal of Clinical Oncology 20 (20): 4141-4149
12. Veronesi et al (2002) Twenty-year follow-up of a randomized study comparing breast-conserving surgery with radical mastectomy for early
breast cancer.New England Journal of Medicine 347 (16): 1227-1232
13. Early Breast Cancer Trialists' Collaborative Group (EBCTCG) (2005) Effects of chemotherapy and hormonal therapy for early breast cancer
on recurrence and 15-year survival: an overview of the randomised trials. Lancet 2005; 365 (9472): 1687–1717
14. Romond et al (2005) Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. New England Journal of
Medicine 353 (16): 1673-1684.
15. Piccart-Gebhart et al. (2005) Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. New England Journal of Medicine
353 (16): 1659-1672
16. Sant M, Aareleid T, Berrino F, Bielska LasotaM, Carli PM, FaivreJ, et al. (2003) EUROCARE-3: survival of breast cancer patients
diagnosed 1990-94 – results and commentary. Ann Oncol. 2003;14(Suppl 5):v61-v118.
17. Thomson CS, Brewster DH, Dewar JA, Twelves CJ. (2004) Improvements in survival for women with breast cancer in Scotland between
1987 and 1993: impact of earlier diagnosis and changes in treatment. Eur J Cancer. 2004;40(5):743-53.
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