• 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, ChiaStephen K LSKLFrom the Winship Cancer Institute at Emory University, Atlanta (K.K.); Southwest Oncology Group Statistics and Data Management Center (W.E.B., D.L.L., J.M.) and the University of Washington School of Medicine-Seattle Cancer Care Alliance, 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, and Gabriel N Hortobagyi.
• From the Winship Cancer Institute at Emory University, Atlanta (K.K.); Southwest Oncology Group Statistics and Data Management Center (W.E.B., D.L.L., J.M.) and the University of Washington School of Medicine-Seattle Cancer Care Alliance (J.R.G.) - both in Seattle; the University of Texas M.D. Anderson Cancer Center, Houston (F.M.-B., D.T., G.N.H.); Loyola University Chicago, Maywood, IL (K.S.A.); the University of Michigan, Ann Arbor (D.F.H., A.F.S.); Dana-Farber Cancer Institute, Boston (N.U.L.); Mayo Clinic, Jacksonville, FL (E.A.P.); Fox Chase Cancer Center, Philadelphia (L.J.G.), and the University of Pittsburgh, Pittsburgh (P.R.) - both in Pennsylvania; BC Cancer-Vancouver Cancer Centre, Vancouver (S.K.L.C.), and Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, ON (S.D.-T.) - both in Canada; UGCI Medical Oncology Hospital Virgen de la Victoria, Instituto de Investigación Biomédica de Málaga, Malaga (E.A.), Instituto de Investigación Sanitaria Gregorio Marañón, Centro de Investigación Biomédica en Red Cáncer-Instituto de Salud Carlos III, Universidad Complutense, Madrid (M.M.), Hospital Universitario Virgen del Rocío, Seville (M.R.-B.), Institut Català d'Oncologia, Barcelona (M.G.-G.), Hospital Clínico Universitario de Valencia, Biomedical Research Institute Investigación del Hospital Clínico de la Comunidad Valenciana, Valencia (B.B.), and Centro Oncológico de Galicia, A Coruña (M.R.-V.) - all in Spain; Institut Gustave Roussy (S.D.) and Institut Curie (J.-Y.P.), Paris, Institut Curie-Centre Réné Huguenin, Saint-Cloud (E.G.C.B.), and Centre Antoine Lacassagne, Nice (J.-M.F.) - all in France; Mater Misericordiae University Hospital, Dublin (C.M.K.); Instituto Nacional de Cancerología de México, Mexico City (C.H.A.-S.); the National Cancer Center Korea, Goyang-si (E.-S.L.), and Asa Medical Center, University of Ulsan College of Medicine, Seoul (K.-H.J.) - both in South Korea; Exact Sciences, Redwood City, CA (S.S.); the University of Kansas Medical Center, Kansas City (P.S.); and Yale University, New Haven, CT (L.P.).
• N. Engl. J. Med. 2021 Dec 16; 385 (25): 233623472336-2347.

BackgroundThe 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.MethodsIn 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.ResultsA 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.ConclusionsAmong 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.).Copyright © 2021 Massachusetts Medical Society.

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