Background: The 21-gene RS assay is used to assess prognosis and to predict response to adjuvant chemotherapy in patients with early stage hormone receptor positive, Her2 negative invasive breast cancer. The National Comprehensive Cancer Network (NCCN) first recommended consideration of testing of appropriate patients with the RS assay in 2008. We examined trends in the use of testing with the RS assay in hospitals across Michigan from 2006 through 2013 using data from the Michigan Breast Oncology Quality Initiative (MiBOQI), a Blue Cross Blue Shield of Michigan/Blue Care Network-sponsored quality initiative. Methods: Demographic, pathologic, and treatment data for women with breast cancer treated at all 25 hospitals participating in MiBOQI were abstracted from the medical record. Patients were excluded if they had stage 0 or IV disease at diagnosis, received neoadjuvant therapy, had bilateral breast cancer, or had a prior history of breast cancer. The primary outcome was the percentage of patients eligible for testing according to NCCN criteria (version 2010) who underwent testing with the RS assay. Analyses were performed using the statistical software R, Version 3.0.1. Results: Of the 18,046 patients in the MiBOQI Registry from 2006-2013 who met inclusion and exclusion criteria, 7133 (39.5%) met the NCCN criteria for testing (eligible). The rate of testing increased from 2006 to 2013 in both the eligible and ineligible cohorts, and varied by site. 21-Gene Recurrence Score (RS) Testing in MiBOQI, 2006-2013FactorEligible (n=7133)Ineligible (n=10913)Tested with RS assay3920 (55.5%)1424 (13.0%)Testing rate in 200643.8%7.3%Testing rate in 201362.3%19.6%Testing by site, 2006-2013 (range)35.8% - 73.3%6.8% - 26.2% Testing of the eligible cohort was statistically significantly associated with younger age, lower tumor grade, and lack of nodal involvement. Overall, 73.4% of patients whose tumors were tested with the RS assay met the NCCN criteria for testing and were deemed appropriately tested. This rate of appropriate testing ranged from 60.8% to 85.4% across sites. Of all patients who underwent testing, 498 (9.3%) had 1 or more positive lymph nodes (>0.2 cm). Receipt of chemotherapy was lower in eligible patients who were tested compared to those not tested (25.5% vs 29.9%, p<0.001). Of the 2387 eligible patients with RS < 18, 117 (5.5%) received chemotherapy, which ranged from 0% - 13.6% across the 25 sites. Of the 341 patients with RS > 30, 56 (9.8%) did not receive treatment with chemotherapy, which ranged from 0% - 50% across the sites. Of the 1192 patients with RS 18-30, 502 (45.7%) received chemotherapy, ranging from 14.5% for RS 18 to 72.5% for RS 30. Conclusions: In sites across Michigan the majority of patients whose tumors were tested with the RS assay were in accordance with the NCCN guidelines, although there was considerable variability across sites. The rate of testing for patients who do not meet the NCCN criteria is increasing. There is very low inappropriate use of the recurrence score for making chemotherapy treatment decisions. Citation Format: Ali HY, Munir K, Braun T, Griggs JJ, Silver SM, Gorski DH, Breslin TM, Henry NL. Appropriate use of the 21-gene recurrence score (RS) assay across Michigan. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr P5-08-07.
Background: Standard of care for women with lymph node positive breast cancer includes treatment with chemotherapy. The 21-gene RS assay is indicated to assess prognosis and to predict response to adjuvant chemotherapy in patients with early stage hormone receptor-positive, HER2-negative invasive breast cancer. Findings from the SWOG S8814 clinical trial, published in 2010, suggested utility for using the RS assay for treatment decision making in node-positive patients in order to withhold chemotherapy. The Center for Medicare and Medicaid Services subsequently approved coverage for the use of the RS assay in women with up to 3 involved lymph nodes, and the National Comprehensive Cancer Network recently recommended consideration of testing in this population. We examined trends in the use of testing of patients with node positive breast cancer with the RS assay in hospitals across Michigan from 2006 through 2013 using data from the Michigan Breast Oncology Quality Initiative (MiBOQI), a Blue Cross Blue Shield of Michigan/Blue Care Network-sponsored quality initiative. Methods: Demographic, pathologic, and treatment data for women with breast cancer treated at all 25 hospitals participating in MiBOQI were abstracted from the medical record. Patients were excluded if they had stage 0 or IV disease at diagnosis, received neoadjuvant therapy, had bilateral breast cancer, or had a prior history of breast cancer. The primary endpoint was the percentage of patients with lymph node positive, hormone receptor-positive, HER2-negative breast cancer who underwent testing with the RS assay. Analyses were performed using the statistical software R, Version 3.0.1. Results: Of the 30,992 patients included in the MiBOQI Registry from 2006-2013, 2526 (10.7%) had hormone receptor positive, HER2 negative, lymph node positive disease and met the eligibility criteria. The rate of testing with the RS assay in this patient cohort increased from 0% in 2006 to 32.5% in 2013, including an increase from 15.4% in 2010 to 28.3% in 2011. Median age of the tested cohort was 60 (range 26-87). On multivariate analysis, testing was statistically significantly associated with older age, smaller tumor size, 1-3 involved lymph nodes, and lower Charlson Comorbidity Index. Receipt of chemotherapy was lower in those patients who underwent testing compared with those not tested (40.0% vs 82.0%, p<0.001). Chemotherapy was administered to 105 (27.4%) of the patients with RS < 18, 91 (51.4%) of the patients with RS 18-30, and 49 (92.4%) of the patients with RS > 30. Conclusions: Use of the RS assay for assessment of women with involved lymph nodes is increasing over time, primarily in older patients and patients with lower risk disease, and is associated with decreased treatment with chemotherapy. Results of the ongoing SWOG S1007 clinical trial, which is assessing the impact of use of the RS assay on breast cancer outcomes, are eagerly awaited. Citation Format: Henry NL, Ali H, Braun T, Munir K, Silver SM, Griggs JJ, Breslin TM, Gorski DH. Use across Michigan of the 21-gene recurrence score (RS) assay in lymph node positive patients with breast cancer. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr P5-08-08.
Background: Evidence-based guidelines for locoregional therapy of invasive breast cancer treated with mastectomy include adjuvant PMRT for: ≥4 positive axillary lymph nodes (LN); T3 or above; or a positive surgical margin. We assessed PMRT uptake using data from the Michigan Breast Oncology Quality Initiative (MiBOQI), a Blue Cross Blue Shield of Michigan/Blue Care Network-sponsored collaborative quality initiative, and identified factors influencing its use in Michigan. Methods: We prospectively collected clinical data on all patients with stage I-III breast cancer in 25 health systems belonging to MiBOQI and identified patients who underwent mastectomy from 2008 to 2013. Patients with previous cancer, bilateral disease, or treated with neoadjuvant chemotherapy were excluded. Univariate and multivariate analyses were performed to identify independent factors associated with the use of PMRT in patients with 0, 1-3, and 4+ positive LNs. Covariates included age, hormone receptor status, HER2 status, surgical margin, T category, Charlson comorbidity index, and immediate reconstruction. Two-tailed p-values <0.05 were considered significant. Analyses were carried out using SAS software, version 9.4 (SAS Institute, Cary, NC). Results: We identified 6,596 patients with stage I-III invasive breast cancer. Of these, 4,455 had no positive axillary LNs; 1,481, 1-3 positive LNs; and 660, ≥4 positive LNs. There was wide variation in PMRT use across MiBOQI sites, from 13% to 63.% in patients with 1-3 positive LNs (overall 42%) and from 35% to 91% in patients with 4+ positive LNs (overall 69%). In multivariate analyses stratified by nodal status (0, 1-3, 4+), age ≥ 70 yrs was negatively associated with PMRT. We also noted lower PMRT use in women aged 51-69 with 0 and 1-3 positive LNs (Table 1). Table 1. Multivariate analysis: PMRT and age (+)LNs = 0(+)LNs = 1-3(+)LNs ≥ 4AgeOdds ratiop-valueOdds ratiop-valueOdds ratiop-value≤50 y (reference)1.0 1.0 1.0 51-69 y0.70 (0.49 - 0.98)0.030.69 (0.54 - 0.88)<0.00011.03 (0.63 - 1.65)<0.0001≥70 y0.60 (0.37 - 0.96) 0.26 (0.18 - 0.37) 0.31 (0.18 - 0.54) In the 0 and 1-3 positive node groups, PMRT use was strongly associated with T category and close or positive margin status (Table 2). Table 2: Surgical characteristics and PMRT uptake (+)LNs = 0(+)LNs = 1-3(+)LNs ≥4VARIABLEOdds ratiop-valueOdds ratiop-valueOdds ratiop-valueMargin status Negative (reference)1.0 1.0 1.0 Positive16.7 (10.5 - 26.7)<0.00012.27 (1.32 - 3.90)0.0010.69 (0.32 - 1.47)0.90Close (<1 mm)4.63 (3.03 - 7.10) 1.90 (1.29 - 2.80) 0.97 (0.55 - 1.69) T category T0 to T2 (reference)1.0 1.0 1.0 T3 to T426.2 (16.4 - 41.8)<0.00013.24 (2.19 - 4.78)<0.00010.86 (0.57 - 1.28)0.45 Finally, there was no association between PMRT use and hormone receptor status, HER2 status, Charlson comorbidity index, or reconstructive surgery at the time of mastectomy. Conclusions: PMRT use across Michigan was lower than the American College of Surgeons Commission on Cancer target of 90% in patients with 4 or more positive LNs. Contrary to common belief, immediate reconstructive surgery was not independently associated with decreased PMRT uptake. Understanding reasons for nonuse of PMRT may lead to interventions to increase its use by MiBOQI member institutions in patients for whom it is indicated. Citation Format: Gorski DH, Braun T, Munir K, Griggs JJ, Breslin TM, Henry NL. Factors affecting the administration of post-mastectomy radiation therapy (PMRT) in Michigan [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P1-10-08.
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