Abstract
Purpose: Hormone receptor (HR)-positive breast cancer patients with tumor size ≤1.0 cm and negative node have favorable outcomes. The 21-gene Recurrence Score (RS) could predict response to chemotherapy for HR+ breast cancer, but its role in T1bN0 disease is challenging.Methods: T1bN0 breast cancer patients diagnosed between January 2014 and June 2019 with RS results were included and categorized as Low- (RS < 18), Intermediate- (RS 18–30), or High-risk (RS > 30) groups. Univariate and multivariate analysis were used to assess factors associated with RS distribution and chemotherapy recommendation. Chemotherapy decisions change and patient adherence after 21-gene RS testing were also evaluated.Results: Among 237 patients with T1bN0 tumors, proportions of Low-, Intermediate-, and High-risk RS were 19.8, 63.3, and 16.9%, respectively. Multivariate analysis found that ER expression (P = 0.011), PR expression (P < 0.001), and Ki-67 index (P = 0.001) were independently associated with RS distribution. Adjuvant chemotherapy was recommended for 31.6% of patients, which was more frequently given to patients with higher tumor grade [Odds ratio (OR) = 2.99 for grade II, OR = 59.19 for grade III, P = 0.006], lymph vascular invasion (OR = 8.22, P = 0.032), Luminal-B subtype (OR = 5.68, P < 0.001), and Intermediate-to High-risk RS (OR = 10.01 for Intermediate-risk, OR = 192.42 for High-risk, P < 0.001). Chemotherapy decision change was found in 18.6% of patients, mainly in those with Intermediate- to High-risk RS tumor with the majority from no-chemotherapy to chemotherapy. The treatment compliance rate after the 21-gene RS testing with MDT was 95.4%.Conclusion: RS category was related to ER, PR, and Ki-67 expression, which was recognized as an independent factor of chemotherapy recommendation in T1bN0 breast cancer. The 21-gene RS testing would lead to a chemotherapy decision change rate of 18.6% as well as a high treatment adherence, which can be applied in T1bN0 patients.
Highlights
Breast cancer, the most common cancer diagnosed in women, is characterized by molecularly heterogeneous
The hormone receptor (HR)-positive breast cancer accounts for 60–75% of all cases [1, 2], which always shows a favorable prognosis with adjuvant endocrine therapy and might avoid the cytotoxicity of chemotherapy
Adjuvant chemotherapy decision was changed in 18.6% of patients after physicians knowing the 21-gene RS results, which was mainly from non-chemotherapy to chemotherapy and mostly occurred to patients with Intermediate- to High-risk RS, indicating that physician-intended recommendation would be influenced by the 21-gene RS testing
Summary
The most common cancer diagnosed in women, is characterized by molecularly heterogeneous. The hormone receptor (HR)-positive breast cancer accounts for 60–75% of all cases [1, 2], which always shows a favorable prognosis with adjuvant endocrine therapy and might avoid the cytotoxicity of chemotherapy. Several gene-based assays shed light on the genetic feature of breast cancer, among which the 21-gene RS testing is a reliable and widely used one [3]. The original study categorized RS < 18 as Lowrisk, RS 18–30 as Intermediate-risk, and RS > 30 as High-risk, in order to predict the distant recurrence rate of HR-positive, lymph-node negative patients treated with tamoxifen [4]. The treatment benefit of chemotherapy was certified in patients with High-risk RS in the NSABP B-20 cohort [5]. The pivotal study TAILORx demonstrated that patients with RS < 25 derive a little survival benefit from adjuvant chemotherapy, especially for the elderly [6]
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