Overall Survival with Ribociclib plus Fulvestrant in Advanced Breast Cancer.
N Engl J Med
; 382(6): 514-524, 2020 02 06.
Article
en En
| MEDLINE
| ID: mdl-31826360
ABSTRACT
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 21 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 ClinicalTrials.gov number, NCT02422615.).
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Purinas
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Neoplasias de la Mama
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Protocolos de Quimioterapia Combinada Antineoplásica
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Fulvestrant
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Aminopiridinas
Tipo de estudio:
Clinical_trials
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Etiology_studies
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Guideline
Límite:
Aged
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Female
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Humans
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Middle aged
Idioma:
En
Revista:
N Engl J Med
Año:
2020
Tipo del documento:
Article