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N Engl J Med. 2019 Jul 25;381(4):307-316. doi: 10.1056/NEJMoa1903765. Epub 2019 Jun 4.

Overall Survival with Ribociclib plus Endocrine Therapy in Breast Cancer.

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From Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (S.-A.I.), the Yonsei Cancer Center, Yonsei University Health System (J.S.), and the Asan Medical Center, University of Ulsan College of Medicine (K.-H.J.), Seoul, and the Center for Breast Cancer, National Cancer Center, Gyeonggi-do (K.-S.L.) - all in South Korea; National Taiwan University Hospital, Taipei, Taiwan (Y.-S.L.); Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston (A.B.); the Breast Center, Department of Obstetrics and Gynecology, Ludwig-Maximilians-University Munich, Munich, Germany (N.H.); the Division of Medical Senology, Istituto Europeo di Oncologia, Milan (M.C.); Hospital de Caridade de Ijuí, CACON, Ijuí, Brazil (F.F.); the Organisation for Oncology and Translational Research, Hong Kong (L.C.); Centro Oncológico Estatal, Instituto de Seguridad Social del Estado de México y Municipios, Toluca, Mexico (S.C.-G.); Institut Català d'Oncologia, Hospital de Sant Joan Despí Moisès Broggi, Barcelona (R.V.-V.); Novartis Pharmaceuticals, East Hanover, NJ (A.C., K.R.-L., T.T.); Novartis, Basel, Switzerland (G.H., I.G.); the UCLA Jonsson Comprehensive Cancer Center, Los Angeles (S.H.); and the University of Texas M.D. Anderson Cancer Center, Houston (D.T.).



An earlier analysis of this phase 3 trial showed that the addition of a cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor to endocrine therapy provided a greater benefit with regard to progression-free survival than endocrine therapy alone in premenopausal or perimenopausal patients with advanced hormone-receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer. Here we report the results of a protocol-specified interim analysis of the key secondary end point of overall survival.


We randomly assigned patients to receive either ribociclib or placebo in addition to endocrine therapy (goserelin and either a nonsteroidal aromatase inhibitor or tamoxifen). Overall survival was evaluated with the use of a stratified log-rank test and summarized with the use of Kaplan-Meier methods.


A total of 672 patients were included in the intention-to-treat population. There were 83 deaths among 335 patients (24.8%) in the ribociclib group and 109 deaths among 337 patients (32.3%) in the placebo group. The addition of ribociclib to endocrine therapy resulted in significantly longer overall survival than endocrine therapy alone. The estimated overall survival at 42 months was 70.2% (95% confidence interval [CI], 63.5 to 76.0) in the ribociclib group and 46.0% (95% CI, 32.0 to 58.9) in the placebo group (hazard ratio for death, 0.71; 95% CI, 0.54 to 0.95; P = 0.00973 by log-rank test). The survival benefit seen in the subgroup of 495 patients who received an aromatase inhibitor was consistent with that in the overall intention-to-treat population (hazard ratio for death, 0.70; 95% CI, 0.50 to 0.98). The percentage of patients who received subsequent antineoplastic therapy was balanced between the groups (68.9% in the ribociclib group and 73.2% in the placebo group). The time from randomization to disease progression during receipt of second-line therapy or to death was also longer in the ribociclib group than in the placebo group (hazard ratio for disease progression or death, 0.69; 95% CI, 0.55 to 0.87).


This trial showed significantly longer overall survival with a CDK4/6 inhibitor plus endocrine therapy than with endocrine therapy alone among patients with advanced hormone-receptor-positive, HER2-negative breast cancer. No new concerns regarding toxic effects emerged with longer follow-up. (Funded by Novartis; MONALEESA-7 number, NCT02278120.).

[Indexed for MEDLINE]

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