Adjuvant Chemotherapy Guided by a 21-Gene Expression Assay in Breast Cancer.
Adjuvant Chemotherapy Guided by a 21-Gene Expression Assay in Breast Cancer.
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DOI：
10.1056/nejmoa1804710
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发表时间：
2018-07-12
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影响因子：
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通讯作者：
Sledge GW Jr
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作者：
Sparano JA;Gray RJ;Makower DF;Pritchard KI;Albain KS;Hayes DF;Geyer CE Jr;Dees EC;Goetz MP;Olson JA Jr;Lively T;Badve SS;Saphner TJ;Wagner LI;Whelan TJ;Ellis MJ;Paik S;Wood WC;Ravdin PM;Keane MM;Gomez Moreno HL;Reddy PS;Goggins TF;Mayer IA;Brufsky AM;Toppmeyer DL;Kaklamani VG;Berenberg JL;Abrams J;Sledge GW Jr
基于21基因乳腺癌检测的复发评分，如果评分高则预示化疗有益，如果评分低则预示在不进行化疗的情况下复发风险低；然而，对于大多数复发评分处于中间范围的患者，化疗的益处并不确定。
我们进行了一项前瞻性试验，涉及10273名激素受体阳性、人表皮生长因子受体2（HER2）阴性、腋窝淋巴结阴性的乳腺癌女性。在9719名有随访信息的符合条件的患者中，6711名（69%）复发评分处于中间范围，为11 - 25分，她们被随机分配接受化疗 - 内分泌治疗或单纯内分泌治疗。该试验旨在证明单纯内分泌治疗在无侵袭性疾病生存期（定义为无侵袭性疾病复发、无第二原发癌或无死亡）方面不劣于化疗 - 内分泌治疗。
在无侵袭性疾病生存期的分析中，内分泌治疗不劣于化疗 - 内分泌治疗（侵袭性疾病复发、第二原发癌或死亡的风险比[内分泌治疗与化疗 - 内分泌治疗相比]，1.08；95%置信区间，0.94 - 1.24；P = 0.26）。在9年时，两个治疗组的无侵袭性疾病生存率相似（内分泌治疗组为83.3%，化疗 - 内分泌治疗组为84.3%），远处部位无疾病复发率（94.5%和95.0%）或远处或局部 - 区域部位无疾病复发率（92.2%和92.9%）以及总生存率（93.9%和93.8%）相似。无侵袭性疾病生存期的化疗益处因复发评分和年龄的组合而异（P = 0.004），在复发评分为16 - 25分且年龄在50岁及以下的女性中发现化疗有一定益处。
在激素受体阳性、HER2阴性、腋窝淋巴结阴性且21基因复发评分处于中间范围的乳腺癌女性中，辅助内分泌治疗和化疗 - 内分泌治疗具有相似的疗效，尽管在一些50岁及以下的女性中发现化疗有一定益处。（由美国国家癌症研究所及其他机构资助；TAILORx临床试验注册号，NCT00310180）
The recurrence score based on the 21-gene breast cancer assay predicts chemotherapy benefit if it is high and a low risk of recurrence in the absence of chemotherapy if it is low; however, there is uncertainty about the benefit of chemotherapy for most patients, who have a midrange score. We performed a prospective trial involving 10,273 women with hormone-receptor–positive, human epidermal growth factor receptor 2 (HER2)–negative, axillary node–negative breast cancer. Of the 9719 eligible patients with follow-up information, 6711 (69%) had a midrange recurrence score of 11 to 25 and were randomly assigned to receive either chemoendocrine therapy or endocrine therapy alone. The trial was designed to show noninferiority of endocrine therapy alone for invasive disease–free survival (defined as freedom from invasive disease recurrence, second primary cancer, or death). Endocrine therapy was noninferior to chemoendocrine therapy in the analysis of invasive disease–free survival (hazard ratio for invasive disease recurrence, second primary cancer, or death [endocrine vs. chemoendocrine therapy], 1.08; 95% confidence interval, 0.94 to 1.24; P = 0.26). At 9 years, the two treatment groups had similar rates of invasive disease–free survival (83.3% in the endocrine-therapy group and 84.3% in the chemoendocrine-therapy group), freedom from disease recurrence at a distant site (94.5% and 95.0%) or at a distant or local–regional site (92.2% and 92.9%), and overall survival (93.9% and 93.8%). The chemotherapy benefit for invasive disease–free survival varied with the combination of recurrence score and age (P = 0.004), with some benefit of chemotherapy found in women 50 years of age or younger with a recurrence score of 16 to 25. Adjuvant endocrine therapy and chemoendocrine therapy had similar efficacy in women with hormone-receptor–positive, HER2-negative, axillary node–negative breast cancer who had a midrange 21-gene recurrence score, although some benefit of chemotherapy was found in some women 50 years of age or younger. (Funded by the National Cancer Institute and others; TAILORx ClinicalTrials.gov number, NCT00310180.)