Measure Specs Breast - American College of Surgeons

1 Released March 2015

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

Abbreviation Measure Type

(NQF #0219) Radiation therapy is administered within 1 year (365 days) of diagnosis for women under age 70 receiving breast conserving surgery for breast cancer.

BCSRT Accountability

(NQF #0559) Combination chemotherapy or chemo-immunotherapy (if HER2 positive) is recommended or administered within 4 months (120 days) of diagnosis for women under 70 with AJCC T1cN0M0 or Stage IB - III hormone receptor negative breast cancer.

MAC Accountability

(NQF #0220) 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 - III hormone receptor positive breast cancer.

HT Accountability

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.

MASTRT Accountability

Image or palpation-guided needle biopsy to the primary site is performed to establish diagnosis of breast cancer. nBx Quality Improvement

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

https://www.facs.org/quality-programs/cancer/ncdb/registrymanuals/cocmanuals/fordsmanual

2 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.

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.

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.


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

Regional Treatment Modality 1570 Dominant modality of radiation therapy administered as first course treatment for the cancer, at the reporting facility and all other facilities - NAACCRv16

Phase I Radiation Treatment Modality 1506 Radiation modality administered during the first phase of radiation treatment delivered during the first course of treatment - NAACCRv18

Phase I Radiation Primary Treatment Volume 1504 Primary treatment volume or primary anatomic target treated during the first

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

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


Case Eligibility Criteria Diagram

Reference Assessment STORE Item Code Definitions

0 All dates of diagnosis are included in this measure Date of Initial Diagnosis Any Dx_Year

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

2 Exclude manually censored cases Exclusion

(This is a user field, it is not a STORE item)

Exclude: 80 - Patient enrolled in a clinical trial that directly impacts delivery of the standard of care

3 Female patients only Sex 2

4 Adult patient under the age of 70 at diagnosis Age at Diagnosis 018-069

5 First or only diagnosis of malignant neoplasm Sequence Number 00 or 01

6 Epithelial tumors which can be staged according to AJCC Histology

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, 8200, 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

8

Exclude cases with Pathologic evidence of in situ or metastatic disease

Pathologic Stage Group For Dx Year ≤2017 AJCC7 For Dx Year ≥ 2018 AJCC8

Stage Group≠0,4; M≠1

AJCC TNM Path Stage Group

Pathologic M

AJCC TNM Path M

9

Exclude cases with Clinical evidence of in situ or metastatic disease

Clinical Stage Group

For Dx Year ≤2017 AJCC7 For Dx Year ≥ 2018 AJCC8


AJCC TNM Clin Stage Group

Clinical M

AJCC TNM Clin M

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

11 Receipt of Breast Conserving Surgery Surgical Procedure of Primary Site 20-24

12 Patient reported living within the

treatment timeframe period of 365 days from date of diagnosis

Date of Initial Diagnosis # Elapsed days between Dx and Last Contact > 365

OR Vital Status=1

Date of Last Contact or Death

Vital Status


*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

Numerator Criteria Diagram

Reference Assessment STORE Item STORE Codes

13

Radiation Therapy Administered within 365 days

following Diagnosis

(radiation recommended or unknown is not administered in this measure*)

Regional Treatment Modality Radiation Treatment Modality= 20-32, 40-43, 50-55, 60-62, 98; or

Phase I Radiation Treatment Modality=01-16; or (Phase I Radiation Treatment Modality=99 and Phase I Radiation Primary Treatment Volume=

40,41)

AND # Elapsed days between Dx and Rx

≤ 365

Phase I Radiation Treatment Modality

Phase I Radiation Primary Treatment Volume

Date of Initial Diagnosis

Date Radiation Started


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

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


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.


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

Range 3826 Percent of cells staining estrogen receptor positive measured by IHC – NAACCRv18

Progesterone Receptor Percent Positive or Range 3914 Percent of cells staining progesterone receptor positive measured by IHC –

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


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


Surgical Procedure of Primary Site 1290 Surgical procedure performed on the primary site of the cancer Date of Most Definitive Surgical

Resection of the Primary Site 3170 Date of Most Definitive Surgical Resection of the Primary Site performed as part of the first course of treatment

Chemotherapy 1390 Chemotherapy at any facility

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


Case Eligibility Criteria Diagram Reference Assessment STORE Item Code Definitions






3 Female patients Sex 2

4 Adult patient under 70 at diagnosis Age at Diagnosis 018-069


6 Epithelial tumors which can be staged according to AJCC Histology

For Dx Year 2010-2017 AJCC 7th ed: 8000-8199, 8201-8576, 8941-8949

For Dx Year ≥ 2018 AJCC 8th ed: 8000, 8010, 8022, 8032, 8035, 8041, 8070, 8140, 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



8

If pathologically staged (no neoadjuvant therapy):

Exclude cases with pathologic evidence of In-Situ or metastatic

disease

Pathologic Stage Group

Dx Year 2017 AJCC7 Dx Year≥ 2018 AJCC8



Pathologic M

AJCC TNM Path M

9

If not pathologically staged, (neoadjuvant therapy administered):

Exclude cases with clinical evidence of In-Situ or metastatic disease

Clinical Stage Group Dx Year 2017 AJCC7

Dx Year≥ 2018 AJCC8



Clinical M

AJCC TNM Clin M

10 All or part of the first course of treatment was performed at the

reporting facility Class of Case 10 - 22

11 Surgically treated cases at any facility

Surgical Procedure of Primary Site 20-90


treatment timeframe period of 120 days from diagnosis

Date of Initial Diagnosis #Elapsed days between Dx and Last Contact >120 OR

Vital Status = 1 Date of Last contact or death

Vital Status


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.

13

Select AJCC T1cN0M0 or AJCC Stage IB-IIIC

tumors. (Exclude T1m,T1a,T1b,N0)

(Cases with neo-adjuvant

chemo or BRM are eligible by default*)

Pathologic N (AJCC6 allowable values used for cases

diagnosed ˂2010, AJCC7 for 2010-2017) Dx Year 2017 AJCC7

Dx Year≥ 2018 AJCC8

(Pathologic N= 0 and Tumor Size >10mm; or Pathologic N= 1-3)

OR Neo-adjuvant treatment administered:

(Date Chemotherapy Started < Date of Most Definitive Surgical Resection of the Primary Site

or Date Immunotherapy Started < Date of Most Definitive

Surgical Resection of the Primary Site)

AJCC TNM Path N (AJCC8 for ≥2018) CS Tumor Size

(AJCC7 for Dx Year<2016) Tumor Size Summary

(AJCC8 for Dx Year ≥2016) Date of Most Definitive Surgical

Resection of the Primary Site Date Chemotherapy Started

Date Immunotherapy Started

14 Hormone Receptor Negative

CS Site Specific Factor 1 (ER - Estrogen Receptor)

For Dx Year ≤2017: ER (ssf1) = 020 and PR (ssf2) = 020, 030

OR ER (ssf1) = 030 and PR (ssf2) = 020 CS Site Specific Factor 2

(PR - Progesterone Receptor)

Estrogen Receptor Percent Positive or Range

For Dx Year ≥2018: ER Percent Positive or Range =000 and

PR Percent Positive or Range = 000, 001-010, R10 OR

ER Percent Positive or Range = 001-010, R10 and PR Percent Positive or Range = 000

Progesterone Receptor Percent Positive or Range


Numerator Criteria Diagram Reference

Assessment STORE Item

STORE Codes

15

Combination Chemotherapy administered within 120 following

diagnosis OR

Chemotherapy Recommended, but not administered

OR Starting in 2013, for HER2 positive

cases: Single Agent or unknown Chemotherapy, and Immunotherapy, both administered within 120 days

following diagnosis, or chemo within 120 days of diagnosis and BRM

recommended

Chemotherapy Chemotherapy =03 and

#Elapsed Days between Dx and Rx≤120 OR

Chemotherapy =82, 85, 86, 87 OR

[Starting in Dx Year 2013: (For NAACCRv16: HER2 (ssf15) = 010, or

For NAACCRv18: HER2 Overall Summary = 1) AND

(Chemotherapy =01,02 and Immunotherapy =01 and #Elapsed Days between Dx and Rx ≤120; or Chemotherapy =01,02 and #Elapsed Days

between Dx and Rx ≤120 and Immunotherapy =82, 85, 86, 87)]

Date Chemotherapy started


CS Site Specific Factor 15

HER2 Overall Summary

Immunotherapy



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.


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

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


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.



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


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

Estrogen Receptor Percent Positive or Range 3826 Percent of cells staining estrogen receptor positive measured by IHC – NAACCRv18

Progesterone Receptor Percent Positive or Range 3914 Percent of cells staining progesterone receptor positive measured by IHC –

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


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


Surgical Procedure of Primary Site 1290 Surgical procedure performed on the primary site of the cancer Date of Most Definitive Surgical

Resection of the Primary Site 3170 Date of Most Definitive Surgical 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

Hormone Therapy 1400 Type of hormone therapy administered as first course treatment for the cancer, 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

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










4 Adult patient at diagnosis Age at Diagnosis ≥ 018


6 Epithelial tumors which can be staged, according to AJCC Histology


For Dx Year ≥ 2018 AJCC 8th ed: 8000, 8010, 8022, 8032, 8035, 8041, 8070, 8140, 8200, 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


8

If pathologically staged (no neoadjuvant therapy):

Exclude cases with pathologic evidence of in situ or metastatic

disease

Pathologic Stage Group Dx Year 2017 AJCC7

Dx Year ≥ 2018 AJCC8



Pathologic M

AJCC TNM Path M

9

If not pathologically staged, (neoadjuvant therapy administered):

Exclude cases with clinical evidence of in situ or metastatic

disease

Clinical Stage Group

Dx Year 2017 AJCC7 Dx Year ≥ 2018 AJCC8



Clinical M

AJCC TNM Clin M


reporting facility Class of Case 10-22

11 Surgically treated Surgical Procedure of Primary Site 20-90


treatment timeframe period of 365 days from date of diagnosis

Date of Initial Diagnosis # Elapsed days between Dx and Last Contact >365 OR

Vital Status=1 Date of Last Contact or Death

Vital Status


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.

13

Select AJCC T1cN0M0 or AJCC Stage IB - IIIC

tumors: (Exclude T1m,T1a,T1b,N0)

(Cases with neo-adjuvant

chemo or BRM are eligible by default*)

Pathologic N (AJCC6 allowable values are used for cases

diagnosed before 2010, AJCC7 for 2010-2017)

Dx Year 2017 AJCC7 Dx Year≥ 2018 AJCC8

(Pathologic N= 0 and Tumor Size >10mm; or Pathologic

N= 1-3) OR

Neo-adjuvant treatment administered: (Date Chemotherapy Started < Date of Most Definitive

Surgical Resection of the Primary Site or

Date Immunotherapy Started < Date of Most Definitive Surgical Resection of the Primary Site)

AJCC TNM Path N (AJCC8 for ≥2018)

CS Tumor Size (AJCC7 for Dx Year<2016) Tumor Size Summary

(AJCC8 for Dx Year ≥2016) Date of Most Definitive Surgical

Resection of the Primary Site Date Chemotherapy Started


14

Hormone Receptor Positive

CS Site Specific Factor 1 (ER - Estrogen Receptor) For Dx Year ≤2017:

Estrogen Receptor (ssf1) = 10, 30 OR

Progesterone Receptor (ssf2) = 10, 30 CS Site Specific Factor 2 (PR - Progesterone Receptor)

Estrogen Receptor Percent Positive or Range

For Dx Year ≥2018: ER Percent Positive or Range = 001-100, R10-R99

OR PR Percent Positive or Range = 001-100, R10-R99

Progesterone Receptor Percent Positive or Range


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



15

Hormone Therapy Administered within 365 days following Diagnosis

OR Hormone Therapy Recommended, but not

Administered

Hormone Therapy

Hormone Therapy = 01 and # Elapsed days between Dx and Rx ≤ 365

OR Hormone Therapy = 82, 85, 86, 87


Date Hormone Therapy Started


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.


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.

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


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

http://www.nccn.org/professionals/physician_gls/f_guidelines.asp



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 of the patient

Class of Case 610 Indicates the reporting facility’s role in managing the cancer Primary Site 400 Organ of origin 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


Surgical Procedure of Primary Site 1290 Surgical procedure performed on the primary site of the cancer

Regional Lymph Nodes Examined 830 The total number of regional lymph nodes that were removed and examined by the pathologist

Regional Lymph Nodes Positive 820 The exact number of regional lymph nodes that were examined by the pathologist and found to contain metastases


Regional Treatment Modality 1570 Dominant modality of radiation therapy administered as first course treatment for the cancer, at the reporting facility and all other facilities

Phase I Radiation Treatment Modality 1506 Radiation modality administered during the first phase of radiation treatment delivered during the first course of treatment - NAACCRv18

Phase I Radiation Primary Treatment Volume 1504 Primary treatment volume or primary anatomic target treated during the first

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











4 Adult patient at diagnosis Age at Diagnosis > 018

5 First or only diagnosis of malignant or non-malignant neoplasm Sequence Number 00 or 01

6 Tumors which can be staged, according to AJCC Histology


For Dx Year ≥ 2018 AJCC 8th ed: 8000, 8010, 8022, 8032, 8035, 8041, 8070, 8140, 8200, 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



8

Exclude cases with Pathologic evidence of metastatic disease


Dx Year 2010-2017 AJCC7 Dx Year ≥ 2018 AJCC8

Stage Group ≠4, M≠1


Pathologic M

AJCC TNM Path M

Exclude cases with Clinical evidence of metastatic disease

Clinical Stage Group Dx Year 2010-2017 AJCC7

Dx Year ≥ 2018 AJCC8

Stage Group ≠4, M≠1


Clinical M

AJCC TNM Clin M


reporting facility Class of Case 10-22

10 Surgically Treated Mastectomy Cases Surgical Procedure of the Primary Site 30-80

11

Patient reported living within the treatment timeframe period of 365 days

from date of diagnosis

Date of Initial Diagnosis # Elapsed days between Dx and Last Contact > 365 OR

Vital Status=1 Date of Last Contact or Death

Vital Status

12

The number of regional lymph nodes that were examined by the pathologist and found to contain metastases is 4 or

more

Regional Lymph Nodes Examined

#Regional Lymph Nodes Positive > 4 Regional Lymph Nodes

Positive


Note:

1) March 2015 Rules release: No changes to measure specifications. 2) August 2015 release:


3) November Rules 2015 release: b. Allow for manual exclusion with censor 80.

4) April 2016 add MASTRT to RQRS.



13

Radiation Therapy Recommended or Administered

within 365 days following Diagnosis

Regional Treatment Modality [(Regional Treatment Modality= 20-32, 40-43, 50-55, 60-62, 98; or

Phase I Radiation Treatment Modality=01-16; or (Phase I Radiation Treatment Modality=99 and

Phase I Radiation Primary Treatment Volume= 40,41)] and

#Elapsed days between Dx and Rx ≤ 365

OR

(Regional Treatment Modality=00 or Phase I Radiation Treatment Modality=00 or

Phase I Radiation Primary Treatment Volume= 00) and

Reason for No Radiation=2-7

Phase I Radiation Treatment Modality

Phase I Radiation Primary Treatment Volume

Reason for No Radiation


Date Radiation Started


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


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

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



Sex 220 Sex of patient Age at diagnosis 230 Age of patient at diagnosis


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

Procedure 1350 Identifies the procedure(s) performed in an effort to diagnose and/or stage disease






1 Primary Site - Breast Primary Site C50.0 - C50.9

2 Exclude censored cases

Exclusion (This is a user field, it is not a

STORE item)

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 15 - Breast too small 16 - Lesion inaccessible by needle biopsy 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

5

non-Phyllodes Tumors

(Also excluded are rare tumors: 8940 - Mixed tumor, malignant, NOS

8950 - Mullerian mixed tumor 8980 – Carcinosarcoma 8981 - Carcinosarcoma, embryonal)

Histology ≠9020, and ≠8940, 8950, 8980, 8981

6 In Situ and Invasive tumors Behavior Code 2, 3

7

Cases Diagnosed at Staff Physician office or at the Reporting Facility and treated or decision not to treat

at the Reporting Facility

Class of Case 10, 11, 12, 13,14

8 Exclude cases with metastatic disease

Clinical M Clinical M and Pathologic M ≠ 1 AND

Pathologic Stage Group ≠ 4; If Pathologic Stage Group is missing, Clinical Stage Group ≠ 4

Pathologic M Clinical Stage Group


9 Exclude cases with unknown diagnostic or staging procedure

Surgical Diagnostic and Staging Procedure ≠ 07, 09


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:


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.



10 Biopsy (incisional, needle, aspiration) to the primary site

Surgical Diagnostic and Staging Procedure 02


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


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.


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 of the patient


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 Facility 670 Surgical procedure performed to the primary site at this facility









Exclude: 80 - Patient enrolled in a clinical trial that directly impacts 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

5 First or only diagnosis of malignant or non-malignant neoplasm Sequence Number 00 or 01

6 Tumors which can be staged, according to the AJCC 7th ed. Histology 8000-8576, 8941-8949

7 In Situ and Invasive tumors Behavior Code 2, 3

8 AJCC7 clinical stage 0, I, or II breast

cancer (Exclude metastatic cases)

Clinical T Dx Year 2010-2017 AJCC7:

Clinical stage 0, I, or II by TNM, and Clinical Stage Group ≠3,4,

Clinical and Pathologic M≠1

Clinical N

Clinical M

Pathologic M Clinical Stage Group


*Cases for patients who refused BCS lumpectomy but chose mastectomy instead, can be manually excluded from this measure with Exclusion 90.

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

10 Surgically treated mastectomy and BCS cases*

Surgical Procedure of Primary Site at this Facility 20-80


Numerator Criteria

Diagram Reference Assessment STORE Item STORE Codes

11 Administration of Breast conservation surgery

Surgical Procedure of Primary Site at this facility 20 - 24

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.


Documents

Measure Specs Breast - American College of Surgeons