BREAST MEASURE SPECIFICATIONS Last Update: 08/06/2019

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BREAST MEASURE SPECIFICATIONS Last update: 08/06/2019

Cancer Programs Practice Profile Reports (CP3R) Rapid Quality Reporting System (RQRS)

Introduction The Commission on Cancer’s (CoC) National Cancer Data Base (NCDB) staff has undertaken an effort to improve the transparency with which the measures in the CP3R and RQRS reporting systems are calculated. To this end, for each measure, supporting information, three tables and a flow-diagram are provided: • The measure type, clinical rationale and references are provided. • The Measure Item List table provides each cancer registy data item used in the assessment of the indicated measure. This includes the STORE data item name, the North American Association of Central Cancer Registry (NAACCR) item number and a brief description of each item. • The Case Eligibility Criteria table itemizes the steps taken to determine whether cases belong in the measure denominator for cases diagnosed 2010 and later. Each condition is described and is accompanied by the data item and code values used in the assesment. • The Numerator Criteria table illustrates how cases are assessed to determine whether they qualify for the numerator of the measure, in other words are concordant for the standard of care. • A flow-diagram is provided to illustrate the steps through which cases pass as they are evaluted for the indicated measure. The number appearing in each flow-diagram element corresponds to the assessment criteria appearing in the Case Eligibility Criteria and Numerator Criteria tables.

Measure Descriptions This document provides specifications for the following measures: Measure Measure Measure Type Abbreviation (NQF #0219) Radiation therapy is administered within 1 year (365 days) of diagnosis for women under age 70 receiving breast BCSRT Accountability conserving surgery for breast cancer. (NQF #0559) Combination chemotherapy or chemo-immunotherapy (if HER2 positive) is recommended or administered within 4 months MAC Accountability (120 days) of diagnosis for women under 70 with AJCC T1cN0M0 or Stage IB - III hormone receptor negative breast cancer. (NQF #0220) Tamoxifen or third generation aromatase inhibitor is recommended or administered within 1 year (365 days) of diagnosis HT Accountability for women with AJCC T1cN0M0 or Stage IB - III hormone receptor positive breast cancer. Radiation therapy is recommended or administered following any mastectomy within 1 year (365 days) of diagnosis of breast cancer MASTRT Accountability for women with ≥ 4 positive regional lymph nodes. Image or palpation-guided needle biopsy to the primary site is nBx Quality Improvement performed to establish diagnosis of breast cancer. Breast conservation surgery rate for women with AJCC clinical BCS Surveillance stage 0, I, or II breast cancer.

1 Released March 2015

Measure Type

There are several types of measures approved by the CoC. Evidence-based measures or accountability measures promote improvements in care delivery and are the highest standard for measurement. These measures demonstrate provider accountability, influence payment for services and promote transparency. The quality improvement measure function is to monitor the need for quality improvement or remediation. Generally, these measures are for individual program use. Surveillance measures are used to identify the status quo, generate information for decision making, and/or to monitor patterns and trends of care. The following Table summarizes the purposes and use of these measures:

Measure Type Measure definition and use Accountability High level of evidence supports the measure, including multiple randomized control trials. These measures can be used for such purposes as public reporting, payment incentive programs, and the selection of providers by consumers, health plans, or purchasers. Quality Improvement Evidence from experimental studies, not randomized control trials supports the measure. These are intended for internal monitoring of performance within an organization. Surveillance Limited evidence exist that supports the measure or the measure is used for informative purposes to accredited programs. These measures can be used for to identify the status quo as well as monitor patterns and trends of care in order to guide decision-making and resource allocation.

2 Released March 2015 Last Update 6/30/19

BCSRT – Breast measure: Radiation therapy is administered within 1 year (365 days) of diagnosis for women under age 70 receiving breast conserving surgery for breast cancer.

Measure Type: Accountability NQF # 0219

Clinical Rationale:

There is extensive evidence from randomized clinical trials demonstrating the impact of radiation with breast conservation surgery. It reduces the risk of local recurrence in the breast and may have a small impact on survival. The limitation for the purpose of a measure for provider accountability to women under the age of 70 is because of high-level evidence that women with small, estrogen receptor positive cancer (the majority of women over age 70 with breast cancer) gain only a very small reduction in local recurrence and no difference in lifetime mastectomy rate and no difference in survival. The impact as measured by performance gap, improvement in outcome, and numbers of cases affected has been specifically examined by Hasset et al.

References: Early Breast Cancer Trialists Collaborative Group (EBCTCG), et al. Effect of radiotherapy after breast-conserving surgery on 10-year recurrence and 15-year breast cancer death: Meta-analysis of individual patient data for 10,801 women in 17 randomized trials. Lancet. 2011;378 (9804):1707-1716. Hassett MJ, Hughes ME, Niland JC, et al. Selecting high priority quality measures for breast cancer quality improvement. Med Care. 2008;46:762-770. Hughes KS, Schnaper LA, Berry D, et al. Lumpectomy plus Tamoxifen with or without irradiation in women 70 years of age or older with early breast cancer. New Engl J Med. 2004;351:971-977.

3 BCSRT - Radiation therapy is administered within 1 year (365 days) of diagnosis for women under age 70 receiving breast conserving surgery for breast cancer.

Measure Item List STORE Data Item NAACCR # Description Sex 220 Sex of patient Age at Diagnosis 230 Age of patient at diagnosis Sequence Number 560 Sequence of malignant and nonmalignant neoplasms over the lifetime Class of Case 610 Indicates the reporting facility’s role in managing the cancer Primary Site 400 Anatomic site of origin of the cancer Date of Initial Diagnosis 390 Date of initial diagnosis of cancer by a physician Histology 522 Microscopic or cellular anatomy of the cancer Behavior Code 523 Neoplastic behavior of the cancer Clinical M 960 Clinical M - AJCC7 Pathologic M 900 Pathologic M - AJCC7 Clinical Stage Group 970 Clinical Stage Group - AJCC7 Pathologic Stage Group 910 Pathologic Stage Group - AJCC7 AJCC TNM Clin M 1003 AJCC Clinical M - AJCC8 AJCC TNM Path M 1013 AJCC Pathologic M - AJCC8 AJCC TNM Clin Stage Group 1004 AJCC Clinical Stage Group - AJCC8 AJCC TNM Path Stage Group 1014 AJCC Pathologic Stage Group - AJCC8 Surgical Procedure of Primary Site 1290 Surgical procedure performed on the primary site of the cancer Dominant modality of radiation therapy administered as first course treatment Regional Treatment Modality 1570 for the cancer, at the reporting facility and all other facilities - NAACCRv16 Radiation modality administered during the first phase of radiation treatment Phase I Radiation Treatment Modality 1506 delivered during the first course of treatment - NAACCRv18 Phase I Radiation Primary Treatment Primary treatment volume or primary anatomic target treated during the first 1504 Volume phase of radiation therapy during the first course of treatment - NAACCRv18 Date Radiation Started 1210 Date of initiation of radiation Date of Last Contact or Death 1750 Date of last contact with the patient, or date of patient death Vital Status 1760 Vital status of the patient, as of the date of last contact or death Exclusion N/A Field used to manually exclude cases (This is a user field, it is not a STORE item)

4 BCSRT - Radiation therapy is administered within 1 year (365 days) of diagnosis for women under age 70 receiving breast conserving surgery for breast cancer.

Case Eligibility Criteria Diagram Assessment STORE Item Code Definitions Reference All dates of diagnosis are included in this 0 Date of Initial Diagnosis Any Dx_Year measure 1 Diagnosis of breast cancer Primary Site C50.0 - C50.9 Exclude: Exclusion 80 - Patient enrolled in a clinical trial 2 Exclude manually censored cases (This is a user field, it is not a STORE item) that directly impacts delivery of the standard of care 3 Female patients only Sex 2 Adult patient under the age of 70 at 4 Age at Diagnosis 018-069 diagnosis First or only diagnosis of malignant 5 Sequence Number 00 or 01 neoplasm For Dx Year 2010-2017 AJCC 7th ed: 8000-8576, 8941-8949 For Dx Year ≥ 2018 AJCC 8th ed: 8000, 8010, 8022, 8032, 8035, 8041, Epithelial tumors which can be staged 8070, 8140, 8200, 8201, 8211, 8246, 6 Histology according to AJCC 8255, 8290, 8314, 8315, 8401, 8410, 8430, 8480, 8500, 8501- 8504, 8507, 8509, 8510, 8513, 8520- 8525, 8530, 8540, 8541, 8543, 8550, 8570, 8571, 8572, 8574, 8575, 8982, 8983

5 BCSRT - Radiation therapy is administered within 1 year (365 days) of diagnosis for women under age 70 receiving breast conserving surgery for breast cancer. 7 Invasive tumors Behavior Code 3 Pathologic Stage Group AJCC TNM Path Stage For Dx Year ≤2017 AJCC7 Group For Dx Year ≥ 2018 AJCC8 Exclude cases with Pathologic evidence 8 of in situ or metastatic disease Pathologic M Stage Group≠0,4; M≠1

AJCC TNM Path M

Clinical Stage Group AJCC TNM Clin Stage For Dx Year ≤2017 AJCC7 Exclude cases with Clinical evidence of in Group For Dx Year ≥ 2018 AJCC8 9 situ or metastatic disease Clinical M Stage Group≠0,4; M≠1

AJCC TNM Clin M All or part of the first course of treatment 10 Class of Case 10-22 was performed at the reporting facility Surgical Procedure of 11 Receipt of Breast Conserving Surgery 20-24 Primary Site Date of Initial Diagnosis Patient reported living within the # Elapsed days between Dx and Last Contact > 365 12 treatment timeframe period of 365 days Date of Last Contact or OR from date of diagnosis Death Vital Status=1 Vital Status

6 BCSRT - Radiation therapy is administered within 1 year (365 days) of diagnosis for women under age 70 receiving breast conserving surgery for breast cancer. Numerator Criteria Diagram Assessment STORE Item STORE Codes Reference

Regional Treatment Modality Radiation Treatment Modality= Phase I Radiation Treatment 20-32, 40-43, 50-55, 60-62, 98; or Radiation Therapy Modality Phase I Radiation Treatment Modality=01-16; or Administered within 365 days Phase I Radiation Primary Treatment (Phase I Radiation Treatment Modality=99 and Phase I Radiation Primary Treatment Volume= 13 following Diagnosis Volume 40,41) (radiation recommended or unknown Date of Initial Diagnosis is not administered in this measure*) AND # Elapsed days between Dx and Rx Date Radiation Started ≤ 365

*This measure calculates the percentage of Radiation Therapy Administered within 365 of diagnosis regardless of Reason for No Radiation.

Note: 1) No changes have been made to the measure specifications for the BCSRT measure with the March 2015. 2) August 2015 release: Exclude rare tumors: 8940 - Mixed tumor, malignant, NOS 8950 - Mullerian mixed tumor 8980 - Carcinosarcoma 8981 - Carcinosarcoma, embryonal) 3) November 2015 release: a. Allow for manual exclusion with censor 80. 4) August 2016 release: a. NAACCRv16 add c or p prefix to TNM. 5) June 2019 release: a. AJCC8/NAACCRv18 update histology, Radiation, cM, pM, and clin/path Stage Group codes for dx year ≥2018. b. For NAACCRv18, add Phase I Radiation Treatment Volume to identify “radiation administered”. c. NAACCRv18 STORE Manual

7 BCSRT - Radiation therapy is administered within 1 year (365 days) of diagnosis for women under age 70 receiving breast conserving surgery for breast cancer.

8 BCSRT - Radiation therapy is administered within 1 year (365 days) of diagnosis for women under age 70 receiving breast conserving surgery for breast cancer. Last Updated 8/06/19 MAC – Breast measure: Combination chemotherapy or chemo-immunotherapy (if HER2 positive), is recommended or administered within 4 months (120 days) of diagnosis for women under the age of 70 with AJCC T1cN0M0 or Stage IB - III hormone receptor negative breast cancer

Measure Type: Accountability NQF # 0559

Clinical Rationale:

There is extensive documentation of the benefit of multi-agent chemotherapy (or chemo-immunotherapy if HER2 positive) in women with hormone receptor negative breast cancer. Chemotherapy reduces the risk of distant disease recurrence and death by about one-third. The restriction to women under age 70 is because this measure is for the purpose of provider accountability. There are limited data in women over age 70 to guide recommendations, and a higher fraction of these women have reasons to omit chemotherapy, including co-morbidity.

References:

1. Early Breast Cancer Trialists Collaborative Group (EBCTCG), et al. Comparisons between different polychemotherapy regimens for early breast cancer: Meta-analysis of long- term outcome among 100,000 women in 123 randomized trials. Lancet. 2012;379(9814):432-444. 2. Early Breast Cancer Trialists Collaborative Group (EBCTCG), et al. Adjuvant chemotherapy in estrogen-receptor-poor breast cancer: Patient level meta-analysis of randomized trials. Lancet. 2008;371(9606):29-40. 3. Early Breast Cancer Trialists Collaborative Group (EBCTCG). Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: An overview of the randomized trials. Lancet. 2005;365(9472):1687-1717. 4. Haslett MJ, Hughes ME, Inland JC, et al. Selecting high priority quality measures for breast cancer quality improvement. Med Care. 2008;46:762- 770.

9 MAC – Breast measure: Combination chemotherapy or chemo-immunotherapy (if HER2 positive), is recommended or administered within 4 months (120 days) of diagnosis for women under the age of 70 with AJCC T1cN0M0 or Stage IB - III hormone receptor negative breast cancer

Measure Item List STORE Data Item NAACCR# Description Sex 220 Gender Age at Diagnosis 230 Age of Patient at the time of diagnosis Sequence Number 560 Sequence of malignant or nonmalignant neoplasm over the lifetime Class of Case 610 Indicates the reporting facility’s role in managing the cancer Primary Site 400 Anatomic site of origin of the cancer Date of Initial Diagnosis 390 Date of initial diagnosis of cancer by physician Histology 522 Microscopic or cellular anatomy of the cancer Behavior Code 523 Neoplastic behavior of the cancer CS Site-Specific Factor 1 2880 Estrogen Receptor Assay - AJCC7 CS Site-Specific Factor 2 2890 Progesterone Receptor Assay- AJCC7 CS Site-Specific Factor 15 2869 HER2 Result - AJCC7 Estrogen Receptor Percent Positive or Percent of cells staining estrogen receptor positive measured by IHC – 3826 Range NAACCRv18 Progesterone Receptor Percent Positive or Percent of cells staining progesterone receptor positive measured by IHC – 3914 Range NAACCRv18 HER2 Overall Summary 3855 HER2 Overall Summary – AJCC8 Clinical M 960 Clinical M - AJCC7 Pathologic N 890 Pathologic N- AJCC7 Pathologic M 900 Pathologic M - AJCC7 Clinical Stage Group 970 Clinical Stage Group - AJCC7 Pathologic Stage Group 910 Pathologic Stage Group - AJCC7 AJCC TNM Clin M 1003 AJCC Clinical M - AJCC8 AJCC TNM Path N 1012 AJCC Pathologic N - AJCC8 AJCC TNM Path M 1013 AJCC Pathologic M - AJCC8 AJCC TNM Clin Stage Group 1004 AJCC Clinical Stage Group - AJCC8 AJCC TNM Path Stage Group 1014 AJCC Pathologic Stage Group - AJCC8 CS Tumor Size 2800 Largest dimension of the primary tumor, in millimeters - AJCC7 Tumor Size Summary 756 Most accurate measurement of solid primary tumor - AJCC8

10 MAC – Breast measure: Combination chemotherapy or chemo-immunotherapy (if HER2 positive), is recommended or administered within 4 months (120 days) of diagnosis for women under the age of 70 with AJCC T1cN0M0 or Stage IB - III hormone receptor negative breast cancer

Date Chemotherapy started 1220 Date of initiation of chemotherapy Immunotherapy 1410 Immunotherapy at any facility Date Immunotherapy Started 1240 Date of the initiation of immunotherapy

Date of Last Contact or Death 1750 Date of last contact with the patient or date of death

Vital Status 1760 Vital Status as of the date of last contact

Exclusion N/A Field used to manually exclude cases (This is a user field, it is not a STORE item)

11 MAC – Breast measure: Combination chemotherapy or chemo-immunotherapy (if HER2 positive), is recommended or administered within 4 months (120 days) of diagnosis for women under the age of 70 with AJCC T1cN0M0 or Stage IB - III hormone receptor negative breast cancer

Case Eligibility Criteria Diagram A ssessment STORE Item Code Definitions Reference All dates of diagnosis are included in 0 Date of Initial Diagnosis Any Dx_Year this measure

1 Diagnosis of breast cancer Primary Site C50.0 - C50.9

Exclusion Exclude: 2 Exclude manually censored cases (This is a user field, it is not a 80 - Patient enrolled in a clinical trial that directly impacts STORE item) delivery of the standard of care 3 Female patients Sex 2 4 Adult patient under 70 at diagnosis Age at Diagnosis 018-069 First or only diagnosis of malignant 5 Sequence Number 00 or 01 neoplasm

For Dx Year 2010-2017 AJCC 7th ed: 8000-8199, 8201-8576, 8941-8949 th Epithelial tumors which can be staged For Dx Year ≥ 2018 AJCC 8 ed: 6 Histology 8000, 8010, 8022, 8032, 8035, 8041, 8070, 8140, 8201, 8211, according to AJCC 8246, 8255, 8290, 8314, 8315, 8401, 8410, 8430, 8480, 8500, 8501-8504, 8507, 8509, 8510, 8513, 8520-8525, 8530, 8540, 8541, 8543, 8550, 8570, 8571, 8572, 8574, 8575, 8982, 8983

7 Invasive tumors Behavior Code 3

12 MAC – Breast measure: Combination chemotherapy or chemo-immunotherapy (if HER2 positive), is recommended or administered within 4 months (120 days) of diagnosis for women under the age of 70 with AJCC T1cN0M0 or Stage IB - III hormone receptor negative breast cancer

Pathologic Stage Group If pathologically staged (no neoadjuvant therapy): AJCC TNM Path Stage Dx Year 2017 AJCC7 Exclude cases with pathologic Group Dx Year≥ 2018 AJCC8 8 evidence of In-Situ or metastatic Pathologic M Stage Group≠0,4; M≠1 disease AJCC TNM Path M

Clinical Stage Group If not pathologically staged, Dx Year 2017 AJCC7 AJCC TNM Clin Stage Group (neoadjuvant therapy administered): Dx Year≥ 2018 AJCC8 9 Exclude cases with clinical evidence of In-Situ or metastatic disease Clinical M Stage Group≠0,4; M≠1

AJCC TNM Clin M All or part of the first course of 10 treatment was performed at the Class of Case 10 - 22 reporting facility

Surgically treated cases at any Surgical Procedure of 11 20-90 facility Primary Site Date of Initial Diagnosis Patient reported living within the #Elapsed days between Dx and Last Contact >120 12 treatment timeframe period of 120 Date of Last contact or death OR days from diagnosis Vital Status = 1 Vital Status

13 MAC – Breast measure: Combination chemotherapy or chemo-immunotherapy (if HER2 positive), is recommended or administered within 4 months (120 days) of diagnosis for women under the age of 70 with AJCC T1cN0M0 or Stage IB - III hormone receptor negative breast cancer

Pathologic N (AJCC6 allowable values used for cases Dx Year 2017 AJCC7 diagnosed ˂2010, AJCC7 for 2010-2017) Dx Year≥ 2018 AJCC8 Select AJCC T1cN0M0 or AJCC Stage IB-IIIC AJCC TNM Path N (Pathologic N= 0 and Tumor Size >10mm; (AJCC8 for ≥2018) tumors. or Pathologic N= 1-3) CS Tumor Size OR 13 (Exclude T1m,T1a,T1b,N0) (AJCC7 for Dx Year<2016) Neo-adjuvant treatment administered: (Cases with neo-adjuvant Tumor Size Summary (Date Chemotherapy Started < Date of Most Definitive chemo or BRM are eligible by (AJCC8 for Dx Year ≥2016) Surgical Resection of the Primary Site default*) Date of Most Definitive Surgical or Resection of the Primary Site Date Immunotherapy Started < Date of Most Definitive Surgical Resection of the Primary Site) Date Chemotherapy Started Date Immunotherapy Started

CS Site Specific Factor 1 For Dx Year ≤2017: (ER - Estrogen Receptor) ER (ssf1) = 020 and PR (ssf2) = 020, 030 OR CS Site Specific Factor 2 ER (ssf1) = 030 and PR (ssf2) = 020 Hormone Receptor (PR - Progesterone Receptor) 14 Negative For Dx Year ≥2018: Estrogen Receptor Percent Positive or ER Percent Positive or Range =000 and Range PR Percent Positive or Range = 000, 001-010, R10 OR Progesterone Receptor Percent Positive ER Percent Positive or Range = 001-010, R10 and

or Range PR Percent Positive or Range = 000

Note: *It is assumed that if a patient received neo-adjuvant treatment and they are ER/PR- they should receive combination chemo therapy independent of tumor size.

14 MAC – Breast measure: Combination chemotherapy or chemo-immunotherapy (if HER2 positive), is recommended or administered within 4 months (120 days) of diagnosis for women under the age of 70 with AJCC T1cN0M0 or Stage IB - III hormone receptor negative breast cancer

Numerator Criteria Diagram STORE Item Reference Assessment STORE Codes Chemotherapy Combination Chemotherapy Chemotherapy =03 and administered within 120 following #Elapsed Days between Dx and Rx≤120 diagnosis Date Chemotherapy started OR OR Chemotherapy =82, 85, 86, 87 Chemotherapy Recommended, but Date of Initial Diagnosis OR not administered [Starting in Dx Year 2013: OR (For NAACCRv16: HER2 (ssf15) = 010, or CS Site Specific Factor 15 Starting in 2013, for HER2 positive For NAACCRv18: HER2 Overall Summary = 1) 15 cases: Single Agent or unknown HER2 Overall Summary AND Chemotherapy, and Immunotherapy, (Chemotherapy =01,02 and Immunotherapy =01 both administered within 120 days Immunotherapy and #Elapsed Days between Dx and Rx ≤120; following diagnosis, or chemo within or Chemotherapy =01,02 and #Elapsed Days 120 days of diagnosis and BRM between Dx and Rx ≤120 and recommended Date Immunotherapy Started Immunotherapy =82, 85, 86, 87)]

15 MAC – Breast measure: Combination chemotherapy or chemo-immunotherapy (if HER2 positive), is recommended or administered within 4 months (120 days) of diagnosis for women under the age of 70 with AJCC T1cN0M0 or Stage IB - III hormone receptor negative breast cancer

Note: 1) Beginning with the March 2015 release, ER/ PR negative HER2 positive cases diagnosed in 2013 and later will be considered compliant with this measure if single agent chemotherapy is administered and immunotherapy is recommended or administered within 120 days of diagnosis. 2) August 2015 release: Excluding 8200 - adenoid cystic carcinoma, Exclude rare tumors: 8940 - Mixed tumor, malignant, NOS 8950 - Mullerian mixed tumor 8980 - Carcinosarcoma 8981 - Carcinosarcoma, embryonal) 3) November 2015 release: a. Allow for manual exclusion with censor 80. 4) August 2016 release: a. NAACCRv16 add c or p prefix to TNM. b. Added AJCC8 Tumor Size Summary for Dx Year>=2016 5) June 2019 release: a. AJCC8/NAACCRv18 update histology codes, cM, pM, pN, HER2, and clin/path Stage Group codes for dx year ≥2018. b. AJCC8/NAACCRv18 use ER/PR percent to include borderline. c. Add chemo 01 with BRM as compliant d. Rule name update. Include chemo-immuno therapy (if HER2 positive). e. NAACCRv18 STORE Manual f. Bypass Path N/Tumor Size selection for neoadjuvant cases. 6) August 2019 release: a. Use Date of Most Definitive Surgical Resection of Primary Site for determination of neo-adjuvant therapy.

16 MAC – Breast measure: Combination chemotherapy or chemo-immunotherapy (if HER2 positive), is recommended or administered within 4 months (120 days) of diagnosis for women under the age of 70 with AJCC T1cN0M0 or Stage IB - III hormone receptor negative breast cancer 17 MAC – Breast measure: Combination chemotherapy or chemo-immunotherapy (if HER2 positive), is recommended or administered within 4 months (120 days) of diagnosis for women under the age of 70 with AJCC T1cN0M0 or Stage IB - III hormone receptor negative breast cancer

Last Updated 8/06/19

HT – Breast measure: Tamoxifen or third generation aromatase inhibitor is recommended or administered within 1 year (365 days) of diagnosis for women with AJCC T1cN0M0 or Stage IB -Stage III hormone receptor positive breast cancer

Measure Type: Accountability NQF # 0220

Clinical Rationale:

There is extensive evidence that hormone (endocrine) therapy with hormone receptor positive breast cancer reduces the risk of local recurrence, contralateral breast cancer, distant recurrence, and death. Measure specifies use of Tamoxifen or third-generation aromatase inhibitor rather than specifying Tamoxifen for premenopausal and aromatase inhibitor for postmenopausal because of (a) difficulty in clearly identifying from records or administrative data the menopause status, and (b) variation in appropriate use of Tamoxifen in postmenopausal women and some reasonable use of aromatase inhibitor in premenopausal women with the use of ovarian suppression.

References: 1. Early Breast Cancer Trialists Collaborative Group (EBCTCG), et al. Relevance of breast cancer hormone receptors and other factors to the efficacy of adjuvant tamoxifen: Patient-level meta-analysis of randomized trials. Lancet. 2011;378(9793):771-784. 2. Cuzick J, Sestak I, Baum M, et al. Effect of anastrozole and tamoxifen as adjuvant treatment for early-stage breast cancer: 10-year analysis of the ATAC trail. Lancet Oncol. 2010;11:1135-1141. 3. Burstein JH, Prestrud AA, Seidenfeld J, et al. American Society of Clinical Oncology clinical practice guidelines: Update on adjuvant endocrine therapy for women with hormone receptor positive breast cancer. J Clin Oncol. 2010;28:3784-3796.

18 HT – Breast measure: Tamoxifen or third generation aromatase inhibitor is recommended or administered within 1 year (365 days) of diagnosis for women with AJCC T1cN0M0 or Stage IB -Stage III hormone receptor positive breast cancer

Measure Item List STORE Data Item NAACCR # Description Sex 220 Sex of patient Age at diagnosis 230 Age of patient at diagnosis Sequence Number 560 Sequence of malignant and nonmalignant neoplasms over the lifetime Class of Case 610 Indicates the reporting facility’s role in managing the cancer Primary Site 400 Organ of origin of the cancer Date of Initial Diagnosis 390 Date of initial diagnosis of cancer by a physician Histology 522 Microscopic or cellular anatomy of the cancer Behavior Code 523 Neoplastic behavior of the cancer CS Site-Specific Factor 1 2880 Estrogen Receptor Assay - AJCC7 CS Site-Specific Factor 2 2890 Progesterone Receptor Assay - AJCC7 Percent of cells staining estrogen receptor positive measured by IHC – Estrogen Receptor Percent Positive or Range 3826 NAACCRv18 Progesterone Receptor Percent Positive or Percent of cells staining progesterone receptor positive measured by IHC – 3914 Range NAACCRv18 Clinical M 960 Clinical M - AJCC7 Pathologic N 890 Pathologic N - AJCC7 Pathologic M 900 Pathologic M - AJCC7 Clinical Stage Group 970 Clinical Stage Group - AJCC7 Pathologic Stage Group 910 Pathologic Stage Group - AJCC7 AJCC TNM Clin M 1003 AJCC Clinical M - AJCC8 AJCC TNM Path N 1012 AJCC Pathologic N - AJCC8 AJCC TNM Path M 1013 AJCC Pathologic M - AJCC8 AJCC TNM Clin Stage Group 1004 AJCC Clinical Stage Group - AJCC8 AJCC TNM Path Stage Group 1014 AJCC Pathologic Stage Group - AJCC8 CS Tumor Size 2800 Largest dimension of the primary tumor, in millimeters – AJCC7 Tumor Size Summary 756 Most accurate measurement of solid primary tumor – AJCC8

19 HT – Breast measure: Tamoxifen or third generation aromatase inhibitor is recommended or administered within 1 year (365 days) of diagnosis for women with AJCC T1cN0M0 or Stage IB -Stage III hormone receptor positive breast cancer

Surgical Procedure of Primary Site 1290 Surgical procedure performed on the primary site of the cancer Date of Most Definitive Surgical Date of Most Definitive Surgical Resection of the Primary Site 3170 Resection of the Primary Site performed as part of the first course of treatment Date Chemotherapy Started 1220 Date of the initiation of chemotherapy Date Immunotherapy Started 1240 The date of the initiation of immunotherapy or BRM Type of hormone therapy administered as first course treatment for the cancer, Hormone Therapy 1400 at the reporting facility and all other facilities Date Hormone Therapy Started 1230 Date of initiation of hormone therapy Date of Last Contact or Death 1750 Date of last contact with the patient, or date of patient death

Vital Status 1760 Vital status of the patient, as of the date of last contact or death

Exclusion N/A Field used to manually exclude cases (This is a user field, it is not a STORE item)

20 HT – Breast measure: Tamoxifen or third generation aromatase inhibitor is recommended or administered within 1 year (365 days) of diagnosis for women with AJCC T1cN0M0 or Stage IB -Stage III hormone receptor positive breast cancer

Case Eligibility Criteria Diagram Assessment STORE Item Code Definitions Reference All dates of diagnosis are included in this 0 Date of Initial Diagnosis Any Dx_Year measure 1 Diagnosis of breast cancer Primary Site C50.0 - C50.9 Exclusion Exclude: 2 Exclude manually censored cases (This is a user field, it is not a 80 - Patient enrolled in a clinical trial that STORE item) directly impacts delivery of the standard of care 3 Female patients only Sex 2 4 Adult patient at diagnosis Age at Diagnosis ≥ 018 First or only diagnosis of malignant 5 Sequence Number 00 or 01 neoplasm For Dx Year 2010-2017 AJCC 7th ed: 8000-8576, 8941-8949 For Dx Year ≥ 2018 AJCC 8th ed: 8000, 8010, 8022, 8032, 8035, 8041, 8070, 8140, Epithelial tumors which can be staged, 6 Histology 8200, 8201, 8211, 8246, 8255, 8290, 8314, 8315, according to AJCC 8401, 8410, 8430, 8480, 8500, 8501- 8504, 8507, 8509, 8510, 8513, 8520- 8525, 8530, 8540, 8541, 8543, 8550, 8570, 8571, 8572, 8574, 8575, 8982, 8983 7 Invasive tumors Behavior Code 3

21 HT – Breast measure: Tamoxifen or third generation aromatase inhibitor is recommended or administered within 1 year (365 days) of diagnosis for women with AJCC T1cN0M0 or Stage IB -Stage III hormone receptor positive breast cancer

If pathologically staged (no Pathologic Stage Group neoadjuvant therapy): AJCC TNM Path Stage Group Dx Year 2017 AJCC7 Exclude cases with pathologic Dx Year ≥ 2018 AJCC8 8 evidence of in situ or metastatic Pathologic M disease Stage Group≠0,4; M≠1 AJCC TNM Path M

Clinical Stage Group If not pathologically staged, Dx Year 2017 AJCC7 (neoadjuvant therapy administered): AJCC TNM Clin Stage Group Exclude cases with clinical Dx Year ≥ 2018 AJCC8

9 evidence of in situ or metastatic Clinical M Stage Group≠0,4; M≠1 disease AJCC TNM Clin M All or part of the first course of 10 treatment was performed at the Class of Case 10-22 reporting facility 11 Surgically treated Surgical Procedure of Primary Site 20-90 Date of Initial Diagnosis Patient reported living within the # Elapsed days between Dx and Last Contact >365 12 treatment timeframe period of Date of Last Contact or Death OR 365 days from date of diagnosis Vital Status=1 Vital Status

22 HT – Breast measure: Tamoxifen or third generation aromatase inhibitor is recommended or administered within 1 year (365 days) of diagnosis for women with AJCC T1cN0M0 or Stage IB -Stage III hormone receptor positive breast cancer

Pathologic N (AJCC6 allowable values are used for cases diagnosed before 2010, Dx Year 2017 AJCC7 AJCC7 for 2010-2017) Dx Year≥ 2018 AJCC8 Select AJCC T1cN0M0 or AJCC TNM Path N (Pathologic N= 0 and Tumor Size >10mm; or Pathologic AJCC Stage IB - IIIC (AJCC8 for ≥2018) tumors: N= 1-3) OR (Exclude T1m,T1a,T1b,N0) CS Tumor Size 13 Neo-adjuvant treatment administered: (AJCC7 for Dx Year<2016) (Cases with neo-adjuvant (Date Chemotherapy Started < Date of Most Definitive Tumor Size Summary chemo or BRM are eligible by Surgical Resection of the Primary Site (AJCC8 for Dx Year ≥2016) default*) or Date of Most Definitive Surgical Date Immunotherapy Started < Date of Most Definitive Resection of the Primary Site Surgical Resection of the Primary Site) Date Chemotherapy Started

Date Immunotherapy Started CS Site Specific Factor 1 (ER - Estrogen Receptor) For Dx Year ≤2017: Estrogen Receptor (ssf1) = 10, 30 CS Site Specific Factor 2 OR Progesterone Receptor (ssf2) = 10, 30 (PR - Progesterone Receptor) 14 Hormone Receptor Positive Estrogen Receptor Percent Positive For Dx Year ≥2018: or Range ER Percent Positive or Range = 001-100, R10-R99 Progesterone Receptor Percent OR Positive or Range PR Percent Positive or Range = 001-100, R10-R99 Note: *It is assumed that if a patient received neo-adjuvant chemo/BRM and they are ER/PR+ they should receive hormone therapy independent of tumor size.

23 HT – Breast measure: Tamoxifen or third generation aromatase inhibitor is recommended or administered within 1 year (365 days) of diagnosis for women with AJCC T1cN0M0 or Stage IB -Stage III hormone receptor positive breast cancer

Numerator Criteria Diagram Assessment STORE Item STORE Codes Reference

Hormone Therapy

Hormone Therapy Administered within Hormone Therapy = 01 and 365 days following Diagnosis Date of Initial Diagnosis # Elapsed days between Dx and Rx ≤ 365 15 OR OR Hormone Therapy Recommended, but not Hormone Therapy = 82, 85, 86, 87 Administered

Date Hormone Therapy Started

Notes: 1) August 2015 release: Exclude rare tumors: 8940 - Mixed tumor, malignant, NOS 8950 - Mullerian mixed tumor 8980 - Carcinosarcoma 8981 - Carcinosarcoma, embryonal 2) November 2015 release: d. Allow for manual exclusion with censor 80. 3) August 2016 release: a. NAACCRv16 add c or p prefix to TNM. b. Added AJCC8 Tumor Size Summary for Dx Year>=2016 4) June 2019 release: a. AJCC8/NAACCRv18 update histology, cM, pM, pN, clin/path Stage Group codes for dx year ≥2018. b. AJCC8/NAACCRv18 use ER/PR Percent to include borderline. c. NAACCRv18 STORE Manual

24 HT – Breast measure: Tamoxifen or third generation aromatase inhibitor is recommended or administered within 1 year (365 days) of diagnosis for women with AJCC T1cN0M0 or Stage IB -Stage III hormone receptor positive breast cancer d. Bypass Path N/Tumor Size selection for AJCC8 neoadjuvant cases. 5) August 2019 release: a. Use Date of Most Definitive Surgical Resection of Primary Site for determination of neo-adjuvant therapy.

25 HT – Breast measure: Tamoxifen or third generation aromatase inhibitor is recommended or administered within 1 year (365 days) of diagnosis for women with AJCC T1cN0M0 or Stage IB -Stage III hormone receptor positive breast cancer 26 HT – Breast measure: Tamoxifen or third generation aromatase inhibitor is recommended or administered within 1 year (365 days) of diagnosis for women with AJCC T1cN0M0 or Stage IB -Stage III hormone receptor positive breast cancer Last Updated 6/30/19

MASTRT – Breast measure: Radiation therapy is recommended or administered following any mastectomy within 1 year (365 days) of diagnosis of breast cancer for women with ≥ 4 positive regional lymph nodes.

Measure Type: Accountability

Clinical Rationale:

There is consensus that post-mastectomy radiation should be recommended for women with breast cancer and with >=4 positive regional lymph nodes (1). Numerous studies have shown a significant reduction in locoregional recurrence rates, disease-free survival rates, and even overall survival with this adjuvant therapy (2-8). As a result of this proven benefit, guidelines from both the American Society of Clinical Oncology (ASCO) (9) and the National Comprehensive Cancer Network (NCCN) (10) include this recommendation, which was also adopted by the Quality Integration Committee of the Commission on Cancer in May of 2012.

References:

1. Gnant M, Harbeck N, Thomssen C. St. Gallen 2011: Summary of the consensus discussion. Breast Care. 2011;6:136–41. 2. Ragaz J, Jackson SM, Le N, Plenderleith IH, Spinelli JJ, Basco VE, et al. Adjuvant radiotherapy and chemotherapy in node-positive premenopausal women with breast cancer. N Engl J Med. 1997;337:956–62. 3. Overgaard M, Jensen MB, Overgaard J, Hansen PS, Rose C, Andersson M, et al. Postoperative radiotherapy in high-risk postmenopausal breast-cancer patients given adjuvant tamoxifen: Danish Breast Cancer Cooperative Group DBCG 82c randomised trial. Lancet. 1999;353:1641–8. 4. Overgaard M, Hansen PS, Overgaard J, Rose C, Andersson M, Bach F, et al. Postoperative radiotherapy in high-risk premenopausal women with breast cancer who receive adjuvant chemotherapy. Danish Breast Cancer Cooperative Group 82b Trial. N Engl J Med. 1997;337:949–55. 5. Gebski V, Lagleva M, Keech A, Simes J, Langlands AO. Survival effects of post-mastectomy adjuvant radiation therapy using biologically equivalent doses: a clinical perspective. J Natl Cancer Inst. 2006;98:26–38. 6. Van de Steene J, Vinh-Hung V, Cutuli B, Storme G. Adjuvant radiotherapy for breast cancer: effects of longer follow-up. Radiother Oncol. 2004;72:35–43

27 MASTRT – Breast measure: Radiation therapy is recommended or administered following any mastectomy within 1 year (365 days) of diagnosis of breast cancer for women with ≥ 4 positive regional lymph nodes.

7. Ragaz J, Olivotto IA, Spinelli JJ, Phillips N, Jackson SM, Wilson KS, et al. Locoregional radiation therapy in patients with high-risk breast cancer receiving adjuvant chemotherapy: 20-year results of the British Columbia randomized trial. J Natl Cancer Inst. 2005;97:116–26. 8. Whelan TJ, Julian J, Wright J, Jadad AR, Levine ML. Does locoregional radiation therapy improve survival in breast cancer? A meta- analysis. J Clin Oncol. 2000;18:1220–9. 9. Recht A, Edge SB, Solin LJ, Robinson DS, Estabrook A, Fine RE, et al. Postmastectomy radiotherapy: clinical practice guidelines of the American Society of Clinical Oncology. J Clin Oncol. 2001;19:1539–69. 10. http://www.nccn.org/professionals/physician_gls/f_guidelines.asp

28 MASTRT – Breast measure: Radiation therapy is recommended or administered following any mastectomy within 1 year (365 days) of diagnosis of breast cancer for women with ≥ 4 positive regional lymph nodes.

Measure Item List STORE Data Item NAACCR # Description Sex 220 Sex of patient Age at Diagnosis 230 Age of patient at diagnosis Sequence of malignant and nonmalignant neoplasms over the lifetime of the Sequence Number 560 patient Class of Case 610 Indicates the reporting facility’s role in managing the cancer Primary Site 400 Organ of origin of the cancer Date of Initial Diagnosis 390 Date of initial diagnosis of cancer by a physician Histology 522 Microscopic or cellular anatomy of the cancer Behavior Code 523 Neoplastic behavior of the cancer Clinical M 960 Clinical M - AJCC7 Pathologic M 900 Pathologic M - AJCC7 Clinical Stage Group 970 Clinical Stage Group - AJCC7 Pathologic Stage Group 910 Pathologic Stage Group - AJCC7 AJCC TNM Clin M 1003 AJCC Clinical M - AJCC8 AJCC TNM Path M 1013 AJCC Pathologic M - AJCC8 AJCC TNM Clin Stage Group 1004 AJCC Clinical Stage Group - AJCC8 AJCC TNM Path Stage Group 1014 AJCC Pathologic Stage Group - AJCC8 Surgical Procedure of Primary Site 1290 Surgical procedure performed on the primary site of the cancer The total number of regional lymph nodes that were removed and examined by Regional Lymph Nodes Examined 830 the pathologist The exact number of regional lymph nodes that were examined by the Regional Lymph Nodes Positive 820 pathologist and found to contain metastases

29 MASTRT – Breast measure: Radiation therapy is recommended or administered following any mastectomy within 1 year (365 days) of diagnosis of breast cancer for women with ≥ 4 positive regional lymph nodes.

Dominant modality of radiation therapy administered as first course treatment Regional Treatment Modality 1570 for the cancer, at the reporting facility and all other facilities Radiation modality administered during the first phase of radiation treatment Phase I Radiation Treatment Modality 1506 delivered during the first course of treatment - NAACCRv18 Phase I Radiation Primary Treatment Primary treatment volume or primary anatomic target treated during the first 1504 Volume phase of radiation therapy during the first course of treatment - NAACCRv18 Reason for No Radiation 1430 The reason that no regional radiation therapy was administered to the patient Date Radiation Started 1210 Date of initiation of radiation Date of Last Contact or Death 1750 Date of last contact with the patient, or date of patient death Vital Status 1760 Vital status of the patient, as of the date of last contact or death

Exclusion N/A Field used to manually exclude cases (This is a user field, it is not a STORE item)

30 MASTRT – Breast measure: Radiation therapy is recommended or administered following any mastectomy within 1 year (365 days) of diagnosis of breast cancer for women with ≥ 4 positive regional lymph nodes.

Exclusion Exclude: 2 Exclude manually censored cases (This is a user field, it is not a STORE 80 - Patient enrolled in a clinical trial that directly item) impacts delivery of the standard of care 3 Female patients only Sex 2 4 Adult patient at diagnosis Age at Diagnosis > 018 First or only diagnosis of malignant or 5 Sequence Number 00 or 01 non-malignant neoplasm For Dx Year 2010-2017 AJCC 7th ed: 8000-8576, 8941-8949 For Dx Year ≥ 2018 AJCC 8th ed: Tumors which can be staged, according 6 Histology 8000, 8010, 8022, 8032, 8035, 8041, 8070, 8140, 8200, to AJCC 8201, 8211, 8246, 8255, 8290, 8314, 8315, 8401, 8410, 8430, 8480, 8500, 8501- 8504, 8507, 8509, 8510, 8513, 8520- 8525, 8530, 8540, 8541, 8543, 8550, 8570, 8571, 8572, 8574, 8575, 8982, 8983 7 Invasive tumors Behavior Code 3

31 MASTRT – Breast measure: Radiation therapy is recommended or administered following any mastectomy within 1 year (365 days) of diagnosis of breast cancer for women with ≥ 4 positive regional lymph nodes.

Pathologic Stage Group Dx Year 2010-2017 AJCC7 AJCC TNM Path Stage Group Exclude cases with Pathologic evidence Dx Year ≥ 2018 AJCC8 of metastatic disease Pathologic M Stage Group ≠4, M≠1

AJCC TNM Path M 8 Clinical Stage Group Dx Year 2010-2017 AJCC7 Exclude cases with Clinical evidence of AJCC TNM Clin Stage Group Dx Year ≥ 2018 AJCC8 metastatic disease Clinical M Stage Group ≠4, M≠1 AJCC TNM Clin M All or part of the first course of 9 treatment was performed at the Class of Case 10-22 reporting facility Surgical Procedure of the 10 Surgically Treated Mastectomy Cases 30-80 Primary Site Date of Initial Diagnosis Patient reported living within the # Elapsed days between Dx and Last Contact > 365

treatment timeframe period of 365 days OR 11 Date of Last Contact or Death from date of diagnosis Vital Status=1 Vital Status

The number of regional lymph nodes Regional Lymph Nodes that were examined by the pathologist Examined 12 #Regional Lymph Nodes Positive > 4 and found to contain metastases is 4 or Regional Lymph Nodes more Positive

32 MASTRT – Breast measure: Radiation therapy is recommended or administered following any mastectomy within 1 year (365 days) of diagnosis of breast cancer for women with ≥ 4 positive regional lymph nodes.

Numerator Criteria Diagram Assessment STORE Item STORE Codes Reference

Regional Treatment Modality [(Regional Treatment Modality= 20-32, 40-43, 50-55, 60-62, 98; or Phase I Radiation Treatment Phase I Radiation Treatment Modality=01-16; or Modality (Phase I Radiation Treatment Modality=99 and Phase I Radiation Primary Phase I Radiation Primary Treatment Volume= 40,41)] Treatment Volume and Radiation Therapy #Elapsed days between Dx and Rx ≤ 365 Recommended or Administered 13 within 365 days following Reason for No Radiation OR Diagnosis

(Regional Treatment Modality=00 or Date of Initial Diagnosis Phase I Radiation Treatment Modality=00 or Phase I Radiation Primary Treatment Volume= 00) and Date Radiation Started Reason for No Radiation=2-7

Note: 1) March 2015 Rules release: No changes to measure specifications. 2) August 2015 release: Exclude rare tumors: 8940 - Mixed tumor, malignant, NOS 8950 - Mullerian mixed tumor 8980 - Carcinosarcoma 8981 - Carcinosarcoma, embryonal) 3) November Rules 2015 release: b. Allow for manual exclusion with censor 80. 4) April 2016 add MASTRT to RQRS.

33 MASTRT – Breast measure: Radiation therapy is recommended or administered following any mastectomy within 1 year (365 days) of diagnosis of breast cancer for women with ≥ 4 positive regional lymph nodes. 5) August 2016 CP3R/RQRS release: a. NAACCRv16 add c or p prefix to TNM. 6) June 2019 Rules release: a. AJCC8/NAACCRv18 update histology, cM, pM, and clin/path Stage Group codes for dx year ≥2018. b. For NAACCRv18, allow new radiation codes, add Phase I Radiation Primary Treatment Volume to identify “radiation administered”. c. NAACCRv18 STORE Manual

34 MASTRT – Breast measure: Radiation therapy is recommended or administered following any mastectomy within 1 year (365 days) of diagnosis of breast cancer for women with ≥ 4 positive regional lymph nodes. 35 MASTRT – Breast measure: Radiation therapy is recommended or administered following any mastectomy within 1 year (365 days) of diagnosis of breast cancer for women with ≥ 4 positive regional lymph nodes.

Last Updated: 06/30/19

nBx – Breast measure: Image or palpation-guided needle biopsy to the primary site is performed to establish diagnosis of breast cancer

Measure Type: Quality Improvement

Clinical Rationale:

“Percutaneous needle biopsy (PNB) for breast tissue diagnosis has emerged as a quality metric for breast disease management. In 2003, the National Comprehensive Cancer Network identified needle biopsy as “preferred” over surgical excision for breast diagnosis (Bevers et al.). In 2005, a multidisciplinary international consensus conference concluded that PNB is the “optimal initial tissue-acquisition method and the procedure of choice for image-detected breast abnormalities.”(Silverstein, p588) More recently, the National Accreditation Program for Breast Centers established “palpation-guided or image-guided needle biopsy as the initial diagnostic approach rather than open biopsy” as one of 19 clinical management standards by which breast centers are measured. Thus, PNB represents an important transition in breast cancer management of specific interest to surgeons.” (Quoted from Calhoun and Anderson; p. 2191).

References: 1. Bevers TB, Anderson BO, Bonaccio E, et al: NCCN clinical practice guidelines in oncology: Breast cancer screening and diagnosis. J Natl Compr Canc Netw 7:1060-1096, 2009 2. Calhoun, K.E. and Anderson, B.O. Needle Biopsy for Breast Cancer Diagnosis: A Quality Metric for Breast Surgical Practice. JCO, 32 (21), pp. 2191-2192 3. Eberth JM, Xu Y, Smith GL, et al: Surgeon influence on use of needle biopsy in patients with breast cancer: A national Medicare study. J Clin Oncol 32:2206-2216, 2014 4. Moran MS, Kaufman C, Burgin C, et al: What currently defines a breast center? Initial data from the national accreditation program for breast centers. J Oncol Pract 9:e62-e70, 2013. 5. Silverstein MJ, Lagios MD, Recht A, et al: Image-detected breast cancer: State of the art diagnosis and treatment. J Am Coll Surg 201:586-597, 2005

36 nBx – Breast measure: Image or palpation-guided needle biopsy to the primary site is performed to establish diagnosis of breast cancer

Measure Item List STORE Data Item NAACCR # Description Sex 220 Sex of patient Age at diagnosis 230 Age of patient at diagnosis Class of Case 610 Indicates the reporting facility’s role in managing the cancer Primary Site 400 Organ of origin of the cancer Date of Initial Daignosis 390 Date of initial diagnosis of cancer by physician Histology 522 Microscopic or cellular anatomy of the cancer Behavior Code 523 Neoplastic behavior of the cancer Clinical M 960 AJCC Clinical M Pathologic M 900 AJCC Pathologic M Clinical Stage Group 970 AJCC Clinical Stage Group Pathologic Stage Group 910 AJCC Pathologic Stage Group Surgical Diagnostic and Staging 1350 Identifies the procedure(s) performed in an effort to diagnose and/or stage disease Procedure Exclusion N/A Field used to manually exclude cases (This is a user field, it is not a STORE item)

37 nBx – Breast measure: Image or palpation-guided needle biopsy to the primary site is performed to establish diagnosis of breast cancer Case Eligibility Criteria Diagram Assessment STORE Item Code Definitions Reference All dates of diagnosis are included 0 Date of Initial Diagnosis Any Dx_Year in this measure 1 Primary Site - Breast Primary Site C50.0 - C50.9 Exclude: 90 - Patient refusal 12 - Patient medically unable to hold position for image guided biopsy 13 - Patient requires sub areolar excision for nipple discharge 14 - Lesion too superficial Exclude censored cases Exclusion 15 - Breast too small 2 (This is a user field, it is not a 16 - Lesion inaccessible by needle biopsy STORE item) 17 - Cancer found in prophylactic mastectomy or through an elective procedure 18 - Benign high risk lesions diagnosed by needle biopsy, requiring excisional biopsy 19 - Discordant biopsy results compared to suspicious imaging 20 - Patient presents with co-morbid conditions that directly impacts delivery of the standard of care 21 - Diagnosed via cytology FNA only 3 Female Sex 2 4 Adult patient at diagnosis Age at Diagnosis ≥ 018

non-Phyllodes Tumors

5 (Also excluded are rare tumors: Histology ≠9020, and ≠8940, 8950, 8980, 8981 8940 - Mixed tumor, malignant, NOS 8950 - Mullerian mixed tumor 8980 – Carcinosarcoma 8981 - Carcinosarcoma, embryonal) 6 In Situ and Invasive tumors Behavior Code 2, 3 Cases Diagnosed at Staff Physician office or at the Reporting Facility 7 Class of Case 10, 11, 12, 13,14 and treated or decision not to treat at the Reporting Facility Clinical M Clinical M and Pathologic M ≠ 1 Exclude cases with metastatic Pathologic M AND 8 disease Clinical Stage Group Pathologic Stage Group ≠ 4; Pathologic Stage Group If Pathologic Stage Group is missing, Clinical Stage Group ≠ 4 Exclude cases with unknown Surgical Diagnostic and 9 ≠ 07, 09 diagnostic or staging procedure Staging Procedure 38 nBx – Breast measure: Image or palpation-guided needle biopsy to the primary site is performed to establish diagnosis of breast cancer

Numerator Criteria Diagram Assessment STORE Item STORE Codes Reference

Biopsy (incisional, needle, aspiration) to Surgical Diagnostic and Staging 10 02 the primary site Procedure

Notes: 1) Starting with the March 2015 release of CP3R, cases will be ineligible for the breast nBx measure if they are metastatic or males. An additional manual exclusion category (19) has also been added. 2) Updates for the breast nBx measure in the September 2015 CP3R release: Exclude rare tumors: 8940 - Mixed tumor, malignant, NOS 8950 - Mullerian mixed tumor 8980 - Carcinosarcoma 8981 - Carcinosarcoma, embryonal) 3) Updates in the November 2015 CP3R release: a. Allow for manual exclusion with censor 20, replace censor 11 with 90. 4) Updates in the December 2015 CP3R release: a. Modified measure title b. Modified description for censor 20 c. Added new censor 21. 5) Updates in August 2016: a. NAACCRv16, add c or p prefix to TNM. 6) June 2019 Doc only update: a. Add Eligibility steps 0 and 9 doc only clarifications.

39 nBx – Breast measure: Image or palpation-guided needle biopsy to the primary site is performed to establish diagnosis of breast cancer 40 nBx – Breast measure: Image or palpation-guided needle biopsy to the primary site is performed to establish diagnosis of breast cancer

Last update 6/30/2019

BCS – Breast measure: Breast conservation surgery rate for women with AJCC clinical stage 0, I, or II breast cancer.

Measure Type: Surveillance

Clinical Rationale: Based on multiple prospective randomized trials (1,2) from both the United States and Europe which have demonstrated equivalent results as measured by overall patient survival, consensus exists that breast conservation treatment is an appropriate method of primary therapy for the majority of women with Stage I and II breast cancer and is preferable because it provides survival rates equivalent to those of total mastectomy and axillary dissection while preserving the breast (3). Additional trials have also determined that breast conservation treatment is a reasonable approach and is generally applicable for most women with Stage 0 breast cancer (ductal carcinoma in situ or DCIS) (4,5). However, not all patients are appropriate candidates for, or select, breast conservation treatment. The rate of breast conservation surgery will vary significantly based on patient age, stage of disease, as well as other factors, and therefore will also vary between institutions based on case mix. No ideal or expected rate of breast conservation treatment has been established, or is implied. This measure is being reported to institutions so they are aware of their individual patterns of treatment (surveillance measure) and can compare their rates of breast conservation surgery with other institutions, regionally and nationally.

References: 1. Fisher B, Anderson S, Bryant J, et al: Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer. N Engl J Med 347:1233-1241, 2002. 2. Veronesi U, Cascinelli N, Mariani L, et al: Twenty-year follow-up of a randomized study comparing breast-conserving surgery with radical mastectomy for early breast cancer. N Engl J Med 347:1227-1232, 2002. 3. NIH Consensus Conference: Treatment of Early-Stage Breast Cancer. JAMA 1991;265(3):391-395. 4. Fisher B, Dignam J, Wolmark N, et al.: Lumpectomy and radiation therapy for the treatment of intraductal breast cancer: findings from National Surgical Adjuvant Breast and Bowel Project B-17. J Clin Oncol 16 (2): 441-52, 1998.

41 BCS - Breast conservation surgery rate for women with AJCC clinical stage 0, I, or II breast cancer. 5. Bijker N, Meijnen P, Peterse JL, et al.: Breast-conserving treatment with or without radiotherapy in ductal carcinoma-in-situ: ten-year results of European Organisation for Research and Treatment of Cancer randomized phase III trial 10853--a study by the EORTC Breast Cancer Cooperative Group and EORTC Radiotherapy Group. J Clin Oncol 24 (21): 3381-7, 2006.

Measure Item List STORE Data Item NAACCR # Description Sex 220 Sex of patient Age at Diagnosis 230 Age of patient at diagnosis Sequence of malignant and nonmalignant neoplasms over the lifetime of the Sequence Number 560 patient Class of Case 610 Indicates the reporting facility’s role in managing the cancer Primary Site 400 Organ of origin of the cancer Date of Initial Diagnosis 390 Date of Initial Diagnosis of cancer Histology 522 Microscopic or cellular anatomy of the cancer Behavior Code 523 Neoplastic behavior of the cancer Clinical T 940 AJCC Clinical T Clinical N 950 AJCC Clinical N Clinical M 960 AJCC Clinical M Pathologic M 900 AJCC Pathologic M Clinical Stage Group 970 AJCC Clinical Stage Group Surgical Procedure of Primary Site at this 670 Surgical procedure performed to the primary site at this facility Facility Exclusion N/A Field used to manually exclude cases (This is a user field, it is not a STORE item)

42 BCS - Breast conservation surgery rate for women with AJCC clinical stage 0, I, or II breast cancer.

Case Eligibility Criteria Diagram Assessment STORE Item Code Definitions Reference All dates of diagnosis are included in 0 Date of Initial Diagnosis Any Dx_Year this measure 1 Diagnosis of breast cancer Primary Site C50.0 - C50.9 Exclude: Exclusion 80 - Patient enrolled in a clinical trial that directly impacts 2 Exclude manually censored cases (This is a user field, it is not a STORE item) delivery of the standard of care 90 - Patient refusal of lumpectomy 3 Female patients only Sex 2 4 Adult patient at diagnosis Age at Diagnosis ≥ 018 First or only diagnosis of malignant 5 Sequence Number 00 or 01 or non-malignant neoplasm Tumors which can be staged, 6 Histology 8000-8576, 8941-8949 according to the AJCC 7th ed. 7 In Situ and Invasive tumors Behavior Code 2, 3 Clinical T Clinical N Dx Year 2010-2017 AJCC7: AJCC7 clinical stage 0, I, or II breast Clinical stage 0, I, or II by TNM, and 8 cancer Clinical M Clinical Stage Group ≠3,4, (Exclude metastatic cases) Pathologic M Clinical and Pathologic M≠1 Clinical Stage Group

43 BCS - Breast conservation surgery rate for women with AJCC clinical stage 0, I, or II breast cancer.

All or part of the first course of treatment 9 Class of Case 10-22 was performed at the reporting facility

Surgically treated mastectomy and BCS Surgical Procedure of Primary 10 20-80 cases* Site at this Facility *Cases for patients who refused BCS lumpectomy but chose mastectomy instead, can be manually excluded from this measure with Exclusion 90.

44 BCS - Breast conservation surgery rate for women with AJCC clinical stage 0, I, or II breast cancer.

Numerator Criteria

Diagram Assessment STORE Item STORE Codes Reference

Administration of Breast conservation Surgical Procedure of Primary Site at 11 20 - 24 surgery this facility

Notes: 1) Updates for the BCS measure in the September 2015 CP3R release: Exclude rare tumors: 8940 - Mixed tumor, malignant, NOS 8950 - Mullerian mixed tumor 8980 - Carcinosarcoma 8981 - Carcinosarcoma, embryonal 2) Updates in the November 2015 CP3R release: a. Allow for manual exclusion with censor 80 and 90. b. Allow blank cT, pTis, cN0, cM0 with cStage Group 0 as Clinical Stage 0. 3) Updates in the August 2016 CP3R release: a. Add c and p TNM prefixes for NAACCRv16. 4) June 2019 doc only clarification to Exclusion 90.

45 BCS - Breast conservation surgery rate for women with AJCC clinical stage 0, I, or II breast cancer.

46 BCS - Breast conservation surgery rate for women with AJCC clinical stage 0, I, or II breast cancer.