Department of Surgery, Oncology and Gastroenterology, University of Padova, Padova, Italy.
Medical Oncology 2, Istituto Oncologico Veneto IOV - IRCCS, Padova, Italy.
Oncologist. 2019 Nov;24(11):1424-1431. doi: 10.1634/theoncologist.2019-0103. Epub 2019 May 31.
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 ( < .001) and higher Ki67 ( = .001) and were more frequently progesterone receptor negative ( = .012) as compared with N1 patients. RS results were as follows: <11, = 63 (25.1%); 11-25, = 143 (57%); and ≥26, = 45 (17.9%). Higher RS was found in N0 vs. N1 patients ( = .001) and in cases of G3 ( < .001) and higher Ki67 ( < .001). The rate of change in treatment decision was 30% ( = 75), mostly from chemotherapy (CT) plus hormone therapy (CT + HT) to hormone therapy (HT; 76%, = 57/75). The proportion of patients recommended to CT + HT was significantly reduced from pre-RS to post-RS (52% to 36%, < .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.
背景：ROXANE 意大利前瞻性研究评估了 21 基因复发评分 (RS) 结果对早期乳腺癌患者辅助治疗决策的影响。
材料和方法：9 家中心参与。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 期早期乳腺癌患者，当医生对辅助治疗建议不确定时，使用 RS 试验。收集了 RS 检测前后的治疗建议。
结果：共纳入 251 例患者。N0 患者（61%）的分级更高（<0.001），Ki67 更高（=0.001），孕激素受体阴性更常见（=0.012），与 N1 患者相比。RS 结果如下：<11，=63（25.1%）；11-25，=143（57%）；≥26，=45（17.9%）。N0 患者的 RS 高于 N1 患者（=0.001），G3 患者的 RS 更高（<0.001），Ki67 更高（<0.001）。治疗决策变化率为 30%（=75），主要为从化疗（CT）联合激素治疗（CT+HT）变为激素治疗（HT；76%，=57/75）。RS 检测前，建议接受 CT+HT 治疗的患者比例从 52%降至 36%（<0.0001）。与 N0 患者（50%至 42%）相比，N1 患者（55%至 27%）的 CT 使用率降低更为明显，仅见于 RS≤17 患者。
结论：医生主要在生物学行为更具侵袭性的 N0 患者或生物学行为更惰性的 N1 患者中使用 21 基因检测。在这一选择的患者人群中，RS 检测导致 30%的治疗决策发生变化。在 N1 患者亚组中，RS 检测有助于将 CT 使用率降低一半以上。
意义：本研究表明，即使在医生推荐很大比例的患者在了解复发评分（RS）检测结果之前单独接受内分泌治疗的情况下，在对辅助治疗建议存在不确定时使用 RS 检测，也能显著有助于进一步减少化疗的应用，尤其是对 N1 患者。
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