超过70%的乳腺癌为激素受体阳性HER2阴性，其中80%以上为复发风险较低的早期局部区域病变，手术、放疗、内分泌治疗能够获益，化疗能否获益仍然存在争议。对于此类乳腺癌，21基因复发评分已被大样本随机对照前瞻研究TAILORx证实并被指南推荐可预测淋巴结阴性患者对化疗能否获益（复发评分26～100为高风险，化疗能够获益），目前仍在等待大样本随机对照前瞻研究RxPONDER证实可预测淋巴结阳性患者对化疗能否获益。不过，部分回顾研究数据已证实并提倡根据21基因复发评分决定淋巴结阳性患者是否需要化疗。
Oncotype DX Breast Recurrence Score TAILORx
2020年10月18日，自然施普林格旗下《乳腺癌研究与治疗》在线发表美国德克萨斯大学、休斯顿卫理公会医院、芝加哥西北大学的大数据分析报告，探讨了21基因复发评分能否预测激素受体阳性HER2阴性乳腺癌淋巴结阳性患者是否需要化疗。
该研究首先对美国全国癌症数据库进行分析，确定2010～2016年早期未远处转移（I～III期）、肿瘤分期为T1～T3、淋巴结分期为N1、激素受体阳性HER2阴性乳腺癌且复发评分≤25的女性共计2万8591例。随后通过单因素和多因素分析，确定化疗与5年生存的相关因素。最后进行亚组分析，确定哪些患者对化疗的生存获益较大。
结果发现，2010～2016年化疗用量减少35%。化疗的影响因素包括：年龄较小、复发评分较高、肿瘤较大、淋巴结阳性、乳房切除术、腋窝淋巴结清扫、放疗。
未化疗与化疗相比，5年死亡风险高63%（风险比：1.63，95%置信区间：1.28～2.07）。
根据亚组分析，未化疗与化疗相比：
年龄>70岁、复发评分0～11的患者：5年死亡风险相似
年龄≤70岁、复发评分12～25的患者：5年死亡风险高91%（风险比：1.91，95%置信区间：1.42～2.57）绝对值高2.96个百分点
因此，该大数据回顾分析结果表明，对于年龄≤70岁、淋巴结分期为N1的激素受体阳性HER2阴性乳腺癌患者，即使复发评分为12～25，临床医师考虑不化疗时也应谨慎，至少应等到RxPONDER研究结果揭晓（预计2022年2月1日）。
Breast Cancer Res Treat. 2020 Oct 18. Online ahead of print.
The 21-gene recurrence score in node-positive, hormone receptor-positive, HER2-negative breast cancer: a cautionary tale from an NCDB analysis.
Roi Weiser, Waqar Haque, Efstathia Polychronopoulou, Sandra S. Hatch, Yong-fang Kuo, William J. Gradishar, V. Suzanne Klimberg.
University of Texas Medical Branch, Galveston, TX, USA; Houston Methodist Hospital, Houston, TX, USA; Northwestern University, Chicago, IL, USA.
PURPOSE: The 21-gene recurrence score assay (RS) has not been prospectively validated to predict adjuvant chemotherapy benefit in hormone receptor-positive (HR+), HER2-negative (HER2-), node-positive breast cancer patients. Nevertheless, de-escalation based on RS has been demonstrated and partially advocated by retrospective data. The purpose of this study was to identify subgroups of node-positive patients with low to intermediate RS who still benefit from adjuvant chemotherapy.
METHODS: The National Cancer Database was used to identify 28,591 women with stage I-III, T1-T3, N1, HR+, HER2- breast cancer and a RS≤25 between 2010 and 2016. Univariate and multivariate analyses were used to identify variables correlating with chemotherapy use and 5-year survival. Subgroup analysis was performed to discern patients in whom the use of adjuvant chemotherapy correlated with better survival.
RESULTS: A 35% decline in chemotherapy use was observed from 2010 to 2016. Patients with younger age, higher RS, larger tumors and more positive lymph nodes, and those treated by mastectomy, axillary lymph node dissection and radiation, were more likely to receive chemotherapy. Chemotherapy use was associated with an improved 5-year survival (HR=1.63, 95% CI 1.28-2.07). Upon subgroup analysis, this association was lost in patients>70 years and those with a RS≤11, while patients≤70 with a RS of 12-25 treated with chemotherapy had an absolute 5-year survival advantage of 3.0% (HR=1.91, 95% CI 1.42-2.57).
CONCLUSION: Clinicians should be cautious when considering omission of adjuvant chemotherapy in patients≤70 years, with HR+, HER2-, N1 tumors and a RS 12-25, at least until the results of the anticipated RxPONDER trial become available.
KEYWORDS: De-escalating; Chemotherapy; Breast cancer; 21-Gene recurrence score; Node positive; Estrogen receptor
DOI: 10.1007/s10549-020-05971-1
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