Article (Scientific journals)
Overall Survival with Ribociclib plus Fulvestrant in Advanced Breast Cancer.
Slamon, Dennis J.; Neven, Patrick; Chia, Stephen et al.
2020In The New England journal of medicine, 382 (6), p. 514-524
Peer reviewed


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Keywords :
Aged; Aminopyridines/administration & dosage/adverse effects; Antineoplastic Combined Chemotherapy Protocols/adverse effects/therapeutic use; Breast Neoplasms/drug therapy/mortality; Drug Administration Schedule; Female; Fulvestrant/administration & dosage/adverse effects; Humans; Kaplan-Meier Estimate; Middle Aged; Postmenopause; Progression-Free Survival; Purines/administration & dosage/adverse effects; Receptor, ErbB-2; Receptors, Estrogen; Receptors, Progesterone; oncology
Abstract :
[en] BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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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Author, co-author :
Slamon, Dennis J.
Neven, Patrick
Chia, Stephen
Fasching, Peter A.
De Laurentiis, Michelino
Im, Seock-Ah
Petrakova, Katarina
Bianchi, Giulia V.
Esteva, Francisco J.
Martin, Miguel
Nusch, Arnd
Sonke, Gabe S.
De la Cruz-Merino, Luis
Beck, J. Thaddeus
Pivot, Xavier
Sondhi, Manu
Wang, Yingbo
Chakravartty, Arunava
Rodriguez-Lorenc, Karen
Taran, Tetiana
Jerusalem, Guy  ;  Université de Liège - ULiège > Département des sciences cliniques > Oncologie
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Title :
Overall Survival with Ribociclib plus Fulvestrant in Advanced Breast Cancer.
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The New England journal of medicine
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Peer reviewed
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Copyright (c) 2019 Massachusetts Medical Society.
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