21-Gene Assay to Inform Chemotherapy Benefit in Node-Positive Breast Cancer.
21-Gene Assay to Inform Chemotherapy Benefit in Node-Positive Breast Cancer.
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21-基因检测告知化疗对淋巴结阳性乳腺癌的益处。
DOI：
10.1056/nejmoa2108873
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发表时间：
2021-12-16
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基于21基因乳腺癌检测的复发评分在临床上可用于预测乳腺癌受体阳性、人表皮生长因子受体2（HER 2）阴性、腋窝淋巴结阴性乳腺癌的化疗获益。在淋巴结阳性的妇女中，复发评分在预测辅助化疗获益方面的作用尚不清楚。在一项前瞻性试验中，我们将乳腺癌患者随机分为两组，一组为乳腺癌受体阳性，另一组为HER 2阴性，腋窝淋巴结1 ~ 3个阳性，复发评分为25分或更低（评分范围为0 ~ 100分，评分越高，预后越差），分别接受单纯内分泌治疗或化疗加内分泌（化学内分泌）治疗。主要目的是确定化疗对无侵袭性疾病生存的影响，以及这种影响是否受复发评分的影响。次要终点包括远端无复发生存率。共有5083名女性（33.2%绝经前和66.8%绝经后）接受了随机分组，5018人参加了试验。在预先规定的第三次中期分析中，根据绝经状态，增加无侵袭性疾病生存期的化疗获益不同（绝经前和绝经后受试者的化疗获益比较P = 0.008），并进行单独的预先规定的分析。在绝经后妇女中，单纯内分泌组5年无浸润性疾病生存率为91.9%，化学内分泌组为91.3%，无化疗获益（浸润性疾病复发、新发原发癌[乳腺癌或其他类型]或死亡的风险比为1.02; 95%置信区间[CI]为0.82 - 1.26; P = 0.89）。在绝经前妇女中，单纯内分泌治疗5年无侵袭性疾病生存率为89.0%，内分泌化疗为93.9（风险比，0.60; 95%CI，0.43至0.83; P = 0.002），无远处复发生存率也有类似的增加（风险比，0.58; 95% CI，0.39至0.87; P = 0.009）。相对化疗获益并不随复发评分的增加而增加。在绝经前女性中，有1 ~ 3个阳性淋巴结，复发评分为25或更低，接受化学内分泌治疗的患者比接受内分泌治疗的患者有更长的无侵袭性疾病生存期和无远处复发生存期，而具有相似特征的绝经后女性没有从辅助化疗中获益。（由国家癌症研究所和其他机构资助; RxPONDER ClinicalTrials.gov编号，NCT 01272037。
The recurrence score based on the 21-gene breast-cancer assay has been clinically useful in predicting a chemotherapy benefit in hormone-receptor–positive, human epidermal growth factor receptor 2 (HER2)–negative, axillary lymph-node–negative breast cancer. In women with positive lymph-node disease, the role of the recurrence score with respect to predicting a benefit of adjuvant chemotherapy is unclear. In a prospective trial, we randomly assigned women with hormone-receptor–positive, HER2-negative breast cancer, one to three positive axillary lymph nodes, and a recurrence score of 25 or lower (scores range from 0 to 100, with higher scores indicating a worse prognosis) to endocrine therapy only or to chemotherapy plus endocrine (chemoendocrine) therapy. The primary objective was to determine the effect of chemotherapy on invasive disease–free survival and whether the effect was influenced by the recurrence score. Secondary end points included distant relapse–free survival. A total of 5083 women (33.2% premenopausal and 66.8% postmenopausal) underwent randomization, and 5018 participated in the trial. At the prespecified third interim analysis, the chemotherapy benefit with respect to increasing invasive disease–free survival differed according to menopausal status (P = 0.008 for the comparison of chemotherapy benefit in premenopausal and postmenopausal participants), and separate prespecified analyses were conducted. Among postmenopausal women, invasive disease–free survival at 5 years was 91.9% in the endocrine-only group and 91.3% in the chemoendocrine group, with no chemotherapy benefit (hazard ratio for invasive disease recurrence, new primary cancer [breast cancer or another type], or death, 1.02; 95% confidence interval [CI], 0.82 to 1.26; P = 0.89). Among premenopausal women, invasive disease–free survival at 5 years was 89.0% with endocrine-only therapy and 93.9% with chemoendocrine therapy (hazard ratio, 0.60; 95% CI, 0.43 to 0.83; P = 0.002), with a similar increase in distant relapse–free survival (hazard ratio, 0.58; 95% CI, 0.39 to 0.87; P = 0.009). The relative chemotherapy benefit did not increase as the recurrence score increased. Among premenopausal women with one to three positive lymph nodes and a recurrence score of 25 or lower, those who received chemoendocrine therapy had longer invasive disease–free survival and distant relapse–free survival than those who received endocrine-only therapy, whereas postmenopausal women with similar characteristics did not benefit from adjuvant chemotherapy. (Funded by the National Cancer Institute and others; RxPONDER ClinicalTrials.gov number, NCT01272037.)