21-Gene Assay to Inform Chemotherapy Benefit in Node-Positive Breast Cancer

作者：Kevin Kalinsky, William E. Barlow, Julie R. Gralow, Funda Meric-Bernstam, Kathy S. Albain, Daniel F. Hayes, Nancy U. Lin, Edith A. Perez, Lori J. Goldstein, Stephen K.L. Chia, Sukhbinder Dhesy-Thind, Priya Rastogi, Emilio Alba, Suzette Delaloge, Miguel Martin, Catherine M. Kelly, Manuel Ruiz-Borrego, Miguel Gil-Gil, Claudia H. Arce-Salinas, Etienne G.C. Brain, Eun-Sook Lee, Jean-Yves Pierga, Begoña Bermejo, Manuel Ramos-Vazquez, Kyung-Hae Jung, Jean-Marc Ferrero, Anne F. Schott, Steven Shak, Priyanka Sharma, Danika L. Lew, Jieling Miao, Debasish Tripathy, Lajos Pusztai, Gabriel N. Hortobagyi · 发表于：New England Journal of Medicine · 年份：2021 · DOI：10.1056/nejmoa2108873 · 被引用次数：889 · 研究领域：Breast Cancer Treatment Studies、BRCA gene mutations in cancer、Estrogen and related hormone effects

BACKGROUND: 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. METHODS: 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. RESULTS: 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,...