Breast Cancer. Measurability of Quality Performance Indicators Version 1.0: April 2012

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1 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

2 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: Rationale and Evidence: Specifications: Proportion of patients with invasive or in-situ breast cancer who have a non-operative diagnosis (core biopsy / large volume biopsy). Diagnosis of patients non-operatively allows them to have only one definitive procedure, where possible. A lesion considered malignant should have histopathological confirmation of malignancy before any definitive surgical procedure takes place 4. Numerator: Number of patients with a non-operative diagnosis of breast cancer (core biopsy / large volume biopsy). ( Histological opinion (Breast Core Biopsy)coded as Malignant Not assessable or Malignant In-situ or Malignant invasive [NEEDBIO = B5 B5a B5b] Date of breast core biopsy before or on Date of first surgery [NBIODATE BSURGDATE] ) ( Histological opinion (Nodal Core Biopsy) coded as Malignant breast [NODEBIO = 5] 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: All breast cancer patients with lobular carcinoma in situ (LCIS). Not recorded: 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: July

3 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] Date of breast core biopsy coded as Not recorded [NBIODATE = 09/09/0909] Date of first surgery coded as Not recorded [BSURGDATE = 09/09/0909] Histological opinion (Nodal Core Biopsy) coded as Not recorded [NODEBIO = 99] Date of nodal core biopsy coded as Not recorded [NODEBIODATE = 09/09/0909] Target: 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. July

4 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 The specifications are therefore separated to ensure clear measurement of both these factors. Rationale and Evidence: 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. Specifications (i): Numerator: Number of patients with invasive breast cancer who undergo assessment of the axilla by ultrasound before 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 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 = ] 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 = ] 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, and where patient would otherwise be selected for inclusion in the denominator: July

5 Date of Diagnosis coded as Not recorded [DIAGDATE = 09/09/0909] Type of tumour coded as Not recorded [TUMOUR = 99] 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] Date Nodal Core Biopsy of Axilla Performed [AXILBIODATE] ) < (before) Date of First Definitive Breast Surgery [BSURGDATE] July

6 Denominator: All patients with invasive breast cancer undergoing surgery with suspicious morphology reported on ultrasound. Exclusions: No exclusions. Date of Diagnosis [DIAGDATE] in range specified for comparative analysis 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 = ] 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 = ] Ultrasound findings {Breast cancer} coded as Indeterminate or Suspicious or Malignant [ULTRA = U3 U4 U5] July

7 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] Type of tumour coded as Not recorded [TUMOUR = 99] Final Definitive Surgery coded as Not known [SURGBRST = 99] 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] Date Nodal Core Biopsy of Axilla Performed coded as Not known [AXILBIODATE =09/09/0909] 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

8 QPI 3 Conservation Rate QPI Title: Description: Rationale and Evidence: Patients with small breast cancers should undergo breast conservation whenever appropriate*. Proportion of surgically treated patients with breast cancer less than 20mm whole tumour size on histology who achieve breast conservation. 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: Denominator: 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 12] 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 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 = ] Maximum microscopic Whole Tumour Diameter less than 20mm [WHOLEDIAM < 20] July

9 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 3 4] Type of hormone therapy coded as Neo-adjuvant [HMON = 2] ( Type of chemotherapy 1 coded as Neo-adjuvant [CHEM1 = 2] Date treatment completed (chemotherapy) 1 minus Date treatment started (chemotherapy) 1 greater than or equal to 6 weeks [CHEMENDATE1 CHEMDATE1 42 (days)] ) ( Type of chemotherapy 2 coded as Neo-adjuvant [CHEM2 = 2] 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 July ) 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] Final Definitive (or only) Surgery Performed to Breast coded as Not known [SURGBRST = 99]

10 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] Type of hormone therapy coded as Not known [HMON = 99] Type of chemotherapy 1 coded as Not known [CHEM1 = 99] Date treatment completed (chemotherapy) 1 coded as Not recorded [CHEMENDATE1 = 09/09/0909] Date treatment started (chemotherapy) 1 coded as Not recorded [CHEMDATE1 = 09/09/0909] Type of chemotherapy 2 coded as Not known [CHEM2 = 99] Date treatment completed (chemotherapy) 2 coded as Not recorded [CHEMENDATE2 = 09/09/0909] Date treatment started (chemotherapy) 2 coded as Not recorded [CHEMDATE2 = 09/09/0909] Target: 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. July

11 QPI 4 Surgical Margins QPI Title: Description: Breast cancers which are surgically treated should be adequately excised. 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. Numerator: Number of patients with breast cancer (invasive or ductal carcinoma in situ) having breast conservation 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. Exclusions: LCIS alone Date of Diagnosis [DIAGDATE] in range specified for comparative analysis Final Definitive (or Only) Surgery Performed to Breast coded as Localising or excision biopsy or conservation surgery [SURGBRST = 11 12] Type of tumour coded as LCIS (non-invasive) [TUMOUR = 19] July

12 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] 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

13 QPI 5 Immediate Reconstruction Rate QPI Title: Patients undergoing mastectomy for breast cancer should have access to immediate breast reconstruction. Description: Rationale and Evidence: Proportion of patients who undergo immediate breast reconstruction at the time of mastectomy for breast cancer. 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 service 4 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: Denominator: 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] All patients with breast cancer undergoing mastectomy. Date of Diagnosis [DIAGDATE] in range specified for comparative analysis Final Definitive (or Only) Surgery Performed to Breast coded as mastectomy or Mastectomy plus immediate reconstruction [SURGBRST = 4 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

14 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] 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

15 QPI 6 Negative Axillary Clearance Rate QPI Title: Over treatment of the axilla should be minimised. Description: Rationale/ and Evidence: Proportion of patients with breast cancer undergoing axillary clearance with no pathological evidence of nodal metastatic disease*. 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: Denominator: 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] All patients with breast cancer undergoing surgical axillary clearance. Date of Diagnosis [DIAGDATE] in range specified for comparative analysis ( First Axillary Surgery coded as Clearance [FIRSTAXIL = 2] Final Axillary Surgery coded as Clearance [FINALAXIL = 2] ) July

16 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 [HMON = 2] ( Type of chemotherapy 1 coded as Neo-adjuvant [CHEM1 = 2] Date treatment completed (chemotherapy) 1 minus Date treatment started (chemotherapy) 1 greater than or equal to 6 weeks [CHEMENDATE1 CHEMDATE1 42 (days)] ) ( Type of chemotherapy 2 coded as Neo-adjuvant [CHEM2 = 2] 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 July ) Denominator criteria coded as not recorded (where patients meet all other denominator criteria): Date of Diagnosis coded as Not recorded [DIAGDATE = 09/09/0909] ( First Axillary Surgery coded as Not known [FIRSTAXIL = 99] Final Axillary Surgery NOT coded as Clearance [FINALAXIL NOT 2] )

17 ( Final Axillary Surgery coded as Not known [FINALAXIL = 99] 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 [HMON = 99] Type of chemotherapy 1 coded as Not known [CHEM1 = 99] Date treatment completed (chemotherapy) 1 coded as Not recorded [CHEMENDATE1 = 09/09/0909] Date treatment started (chemotherapy) 1 coded as Not recorded [CHEMDATE1 = 09/09/0909] Type of chemotherapy 2 coded as Not known [CHEM2 = 99] Date treatment completed (chemotherapy) 2 coded as Not recorded [CHEMENDATE2 = 09/09/0909] 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

18 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: All patients with breast cancer undergoing partial breast reconstruction. Target: 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

19 QPI 8 HER2 Status for Decision Making QPI Title: HER2 status should be available to inform treatment decision making. Description: Rationale and Evidence: 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. 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. Numerator: Number of patients with invasive breast cancer for whom the HER2 status (as defined by IHC) is known at 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: All patients with invasive breast cancer. Date of Diagnosis [DIAGDATE] in range specified for comparative analysis 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 = ] 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: Date of Diagnosis coded as Not recorded [DIAGDATE = 09/09/0909] Type of tumour coded as Not known [TUMOUR = 99] 2) Exclusion criteria coded as not recorded (for patients already selected for inclusion in denominator July

20 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

21 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% Specifications: Numerator: Denominator: 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] All patients with invasive breast cancer having conservation surgery. Date of Diagnosis [DIAGDATE] in range specified for comparative analysis Type of Tumour coded as: [TUMOUR = 11 Or 12 Or 13 Or 14 Or 15 Or 16 Or 17] 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] TNM Metastases Classification (Pre-operative) coded as Distant metastases present [cm = M1] 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 (for patients who otherwise meet all other denominator criteria): July

22 Date of Diagnosis coded as Not recorded [DIAGDATE = 09/09/0909] Type of Tumour coded as Not known [TUMOUR = 99] 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] 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

23 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 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 CHEM2 = 1] July

24 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 ( Total Number of Lymph Nodes Involved not coded as inapplicable [INVNODES >0 NOT 1010] ( Tumour Grade coded as Grade III [TGRADE = 3] Maximum Microscopic Whole Tumour Diameter {Cancer} greater than 20mm and not not assessable or inapplicable [WHOLEDIAM > 20 NOT ( )] ) ) Exclusions: 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. Not recorded: Patient entered into Clinical Trial coded as Chemotherapy [TRIAL = 1B] Type of Chemotherapy 1-2 coded as Neoadjuvant [CHEM1 CHEM2 = 2] 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 July ) 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] Date of birth coded as Not recorded [DOB = 09/09/0909] Total Number of Lymph Nodes Involved coded as not recorded [INVNODES = 9999] Tumour Grade coded as Not known [TGRADE = 99] Maximum Microscopic Whole Tumour Diameter {Cancer} coded as Not recorded [WHOLEDIAM = 9999]

25 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] Type of Chemotherapy 1-2 coded as Not known [CHEM1 CHEM2 = 99] 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 CHEM2 = 99] Target: 85% The tolerance within this target accounts for factors of patient choice, co-morbidities and fitness for treatment. July

26 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: Rationale/ and Evidence: 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. 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 trastuzumab 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 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] Date Treatment Started {Cancer} (Biological Therapy) after Date of first treatment [BIODATE > FIRSTTREATDATE] July

27 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 < 70 years] EITHER ( Human Epidermal Growth Factor Receptor-2 Status coded as Positive [HER2STATUS = 1] Maximum Invasive Pathological Diameter greater than 10 [MAXPATH > 10] ) ( Human Epidermal Growth Factor Receptor-2 Status coded as Positive [HER2STATUS = 1] Maximum Invasive Pathological Diameter less than or equal to 10 [MAXPATH 10] Number of Lymph Nodes Involved not coded as Inapplicable [INVNODES > 0 NOT 1010] ) 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 July ) Denominator criteria coded as not recorded (where all other denominator criteria are met): Date of Diagnosis coded as Not known [DIAGDATE = 09/09/0909] Date of birth coded as Not known [DOB = 09/09/0909] Human Epidermal Growth Factor Receptor-2 Status coded as Not known [HER2STATUS = 99] Maximum Invasive Pathological Diameter coded as Not known [MAXPATH = 99] Number of Lymph Nodes Involved coded as Not recorded [INVNODES = 9999]

28 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] Date Treatment Started {Cancer} (Biological Therapy)coded as Not recorded [BIODATE = 09/09/0909] 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

29 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 21 st Century National Academy Press: Washington, DC. 4. Scottish Intercollegiate Guidelines Network. Management of breast cancer in women. Edinburgh: SIGN; SIGN Publication No NICE (2009) Breast Cancer (Early and Locally Advanced) Diagnosis and Treatment. Cardiff: NICE; February CG80 6. Willett et al (2010) Best Practice Diagnostic Guidelines for Patients Presenting with Breast Symptoms 7. NHS BSP (2009) Quality Assurance Guidelines for Surgeons in Breast Cancer Screening. Sheffield: NHS Cancer screening Programmes; Publication 20 Fourth Edition 8. NHS Improvement (2010) Ambulatory breast surgical care: day case/23-hour breast care 9. NHS Quality Improvement Scotland (2008) Management of breast cancer services 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): 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): 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): 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): Romond et al (2005) Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. New England Journal of Medicine 353 (16): Piccart-Gebhart et al. (2005) Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. New England Journal of Medicine 353 (16): Sant M, Aareleid T, Berrino F, Bielska LasotaM, Carli PM, FaivreJ, et al. (2003) EUROCARE-3: survival of breast cancer patients diagnosed results and commentary. Ann Oncol. 2003;14(Suppl 5):v61-v 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): July

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