Background: The ROXANE Italian prospective study evaluated the impact of the 21-gene Recurrence Score (RS) results on adjuvant treatment decision for patients with early breast cancer.
Materials and methods: Nine centers participated. Physicians used the RS test whenever unsure about adjuvant treatment recommendation for patients with estrogen receptor-positive/human epidermal growth receptor 2-negative, T1-T3, N0-N1 early breast cancer. Pre-RS and post-RS treatment recommendations were collected.
Results: A total of 251 patients were included. N0 patients (61%) showed higher grade (p < .001) and higher Ki67 (p = .001) and were more frequently progesterone receptor negative (p = .012) as compared with N1 patients. RS results were as follows: <11, n = 63 (25.1%); 11-25, n = 143 (57%); and ≥26, n = 45 (17.9%). Higher RS was found in N0 vs. N1 patients (p = .001) and in cases of G3 (p < .001) and higher Ki67 (p < .001). The rate of change in treatment decision was 30% (n = 75), mostly from chemotherapy (CT) plus hormone therapy (CT + HT) to hormone therapy (HT; 76%, n = 57/75). The proportion of patients recommended to CT + HT was significantly reduced from pre-RS to post-RS (52% to 36%, p < .0001). CT use reduction was more evident for N1 patients (55% to 27%) than for N0 patients (50% to 42%) and was observed only in cases of RS ≤17.
Conclusion: Physicians predominantly used the 21-gene assay in N0 patients with a more aggressive biology or in N1 patients showing more indolent biology. In this selected patient population, the use of RS testing led to a 30% rate of change in treatment decision. In the N1 patient subgroup, the use of RS testing contributed to reduce CT use by more than half.
Implications for practice: This study shows that, even in a context in which physicians recommend a high proportion of patients to endocrine treatment alone before knowing the results of the Recurrence Score (RS) assay, the use of the RS test, whenever uncertainty regarding adjuvant treatment recommendation is present, significantly contributes in further reducing the use of chemotherapy, especially for N1 patients.
关键词。早期乳腺癌 • 辅助化疗 • 雌激素受体阳性 • 复发评分 • 21 基因检测 • Oncotype DX • 治疗方案调整 • 决策影响
摘要
背景。意大利 ROXANE 前瞻性研究评估了 21 基因复发评分 (RS) 结果对早期乳腺癌患者的辅助治疗决策的影响。
材料和方法。9 家中心参与了此项研究。对于雌激素受体阳性/人表皮生长因子受体2阴性、T1–T3、N0–N1 的早期乳腺癌患者，医师在不确定辅助治疗建议时，会采用RS检测。收集了得出RS前后的治疗建议。
结果。共纳入 251 名患者。与 N1 患者相比，N0 患者 (61%) 的分级更高(P<0.001)、Ki67 更高(P=0.001)及孕激素受体阴性(P=0.012)的频率更高。RS的结果如下所示:< 11 的患者，n = 63 (25.1%)；11–25, n = 143 (57%)；以及≥26 的患者，n = 45 (17.9%)。与 N1 患者相比，N0的RS较高(p = 0.001)，在G3 (p<0.001)及较高Ki67 (p <0.001)中的RS较高。治疗决策的调整率为 30% (n = 75)，主要是从化疗 (CT) 加内分泌疗法 (CT + HT) 调整为内分泌疗法(HT；76%，n = 57/75)。推荐接受CT + HT的患者比例从RS检测前到检测后显著降低(从 52% 降至 36%，p < 0.000 1)。N1 患者(55% 至 27%)比 N0 患者(50% 至 42%)的CT使用减少更为明显，仅在RS≤17 的情况下可观察到。
结论。医师主要利用 21 基因检测法检测具有更侵袭性生物学特性的 N0 患者或具有更惰性生物学特性的 N1 患者。在选定的患者群体中，使用RS检测所导致的治疗决策调整率为 30%。在 N1 患者子组中，应用RS检测可将CT的使用减少一半以上。
实践意义:本研究表明，即使在医师知晓复发评分 (RS) 检测结果之前，仍建议高比例的患者仅接受内分泌治疗，但每当在不确定辅助治疗建议时，使用RS检测也会明显进一步减少化疗的使用，尤其是对 N1 患者。
Keywords: 21‐gene assay; Adjuvant chemotherapy; Decision impact; Early breast cancer; Estrogen receptor positive; Oncotype DX; Recurrence Score; Treatment change.
© AlphaMed Press 2019.