Abstract
The 21-gene recurrence score (RS) assay is prognostic and predictive for hormone receptor (HR)+/HER2-/node- breast cancer (BC) patients. However, its clinical value in node + patients hasn’t been elucidated. HR+/HER2-/pN1 patients operated in Comprehensive Breast Health Center, Shanghai Ruijin Hospital from January 2014 to December 2018, with available RS results were retrospectively included. Clinico-pathological characteristics were compared. Adjuvant chemotherapy recommendations pre-/post- RS assay and actual usage were analyzed. A total of 303 patients were included, with 59, 178, 66 RS < 18, 18–30 and ≥ 31. Age (P < 0.001), comorbidity (P = 0.013), and RS category (P < 0.001) were independently associated with chemotherapy recommendation. Compared with low RS patients, those with intermediate (OR 6.58, 95% CI 2.37–18.31, P < 0.001) or high (OR 54.14, 95% CI 3.77–776.54, P = 0.003) RS were more likely to be recommended with chemotherapy. RS independently influence chemotherapy decision in postmenopausal population as well. Chemotherapy recommendation changed for 9.57% patients after RS assay. Patient adherence rate to chemotherapy recommendation was 94.72% (287/303). The 21-gene RS independently influenced chemotherapy recommendation in pN1 BC patients, which could provide additional information to guide chemotherapy decision with relatively good treatment adherence rate.
Highlights
21-gene recurrence score (RS) is the most frequently applied multigene assay in clinical practice to provide individualized information other than routine clinico-pathological features, which can predict chemotherapy benefit and guide adjuvant treatment decision in hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, and node-negative breast cancer (BC) patients
While the current guidelines suggest the routine use of 21-gene RS testing in node-negative patients, results from several clinical trials have extended its application in patients with 1–3 histologically proven involved axillary lymph nodes (ALNs)[10,11,12]
We aim to evaluate whether 21-gene RS can influence adjuvant chemotherapy choice for patients with HR-positive, HER2-negative and pN1 BC, and to further analyze the adherence rate of adjuvant chemotherapy after 21-gene RS testing in clinical practice
Summary
21-gene recurrence score (RS) is the most frequently applied multigene assay in clinical practice to provide individualized information other than routine clinico-pathological features, which can predict chemotherapy benefit and guide adjuvant treatment decision in HR-positive, human epidermal growth factor receptor 2 (HER2)-negative, and node-negative BC patients. According to the results of the prospective TAILORx trial[5,7], the 2018 NCCN Clinical Practice Guidelines in Oncology for Breast Cancer suggest to spare selective low risk patients from adjuvant chemotherapy[8]. The WGS Plan B trial found an excellent survival outcome in node-positive, RS < 11 low risk patients treated with endocrine therapy alone, indicating a satisfactory prognostic value of RS12,13. We aim to evaluate whether 21-gene RS can influence adjuvant chemotherapy choice for patients with HR-positive, HER2-negative and pN1 BC, and to further analyze the adherence rate of adjuvant chemotherapy after 21-gene RS testing in clinical practice
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