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N Engl J Med. 2019 Dec 11. doi: 10.1056/NEJMoa1911149. [Epub ahead of print]

Overall Survival with Ribociclib plus Fulvestrant in Advanced Breast Cancer.

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From the David Geffen School of Medicine at UCLA, Los Angeles (D.J.S.); Multidisciplinary Breast Center, Universitair Ziekenhuis Leuven, Leuven (P.N.), and Centre Hospitalier Universitaire Liège and Liege University, Liege (G.J.) - all in Belgium; the British Columbia Cancer Agency, Vancouver, Canada (S.C.); University Hospital Erlangen, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, and Department of Gynecology and Obstetrics, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen (P.A.F.), and the Practice for Hematology and Internal Oncology, Velbert (A.N.) - all in Germany; Istituto Nazionale Tumori Fondazione G. Pascale, Naples (M.D.L.), and Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (G.V.B.) - both in Italy; Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea (S.-A.I.); Masaryk Memorial Cancer Institute, Brno, Czech Republic (K.P.); New York University Langone Health, New York (F.J.E.); Instituto de Investigación Sanitaria Gregorio Marañon, Centro de Investigación Biomédica en Red de Cáncer, Grupo Español de Investigación en Cáncer de Mama, Universidad Complutense, Madrid (M.M.), and Hospital Universitario Virgen Macarena, Department of Medicine, Universidad de Sevilla, Seville (L.D.C.-M.) - both in Spain; Netherlands Cancer Institute-Borstkanker Onderzoek Groep Study Center, Amsterdam (G.S.S.); Highlands Oncology Group, Fayetteville, AR (J.T.B.); Institut Régional du Cancer, Strasbourg, France (X.P.); Novartis Pharmaceuticals, East Hanover, NJ (M.S., A.C., K.R.-L.); and Novartis Pharma, Basel, Switzerland (Y.W., T.T.).



In an earlier analysis of this phase 3 trial, ribociclib plus fulvestrant showed a greater benefit with regard to progression-free survival than fulvestrant alone in postmenopausal patients with hormone-receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer. Here we report the results of a protocol-specified second interim analysis of overall survival.


Patients were randomly assigned in a 2:1 ratio to receive either ribociclib or placebo in addition to fulvestrant as first-line or second-line treatment. Survival was evaluated by means of a stratified log-rank test and summarized with the use of Kaplan-Meier methods.


This analysis was based on 275 deaths: 167 among 484 patients (34.5%) receiving ribociclib and 108 among 242 (44.6%) receiving placebo. Ribociclib plus fulvestrant showed a significant overall survival benefit over placebo plus fulvestrant. The estimated overall survival at 42 months was 57.8% (95% confidence interval [CI], 52.0 to 63.2) in the ribociclib group and 45.9% (95% CI, 36.9 to 54.5) in the placebo group, for a 28% difference in the relative risk of death (hazard ratio, 0.72; 95% CI, 0.57 to 0.92; P = 0.00455). The benefit was consistent across most subgroups. In a descriptive update, median progression-free survival among patients receiving first-line treatment was 33.6 months (95% CI, 27.1 to 41.3) in the ribociclib group and 19.2 months (95% CI, 14.9 to 23.6) in the placebo group. No new safety signals were observed.


Ribociclib plus fulvestrant showed a significant overall survival benefit over placebo plus fulvestrant in patients with hormone-receptor-positive, HER2-negative advanced breast cancer. (Funded by Novartis; MONALEESA-3 number, NCT02422615.).


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