Overall Survival with Ribociclib plus Letrozole in Advanced Breast Cancer.
N Engl J Med
; 386(10): 942-950, 2022 03 10.
Article
em En
| MEDLINE
| ID: mdl-35263519
ABSTRACT
BACKGROUND:
In a previous analysis of this phase 3 trial, first-line ribociclib plus letrozole resulted in significantly longer progression-free survival than letrozole alone among postmenopausal patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer. Whether overall survival would also be longer with ribociclib was not known.METHODS:
Here we report the results of the protocol-specified final analysis of overall survival, a key secondary end point. Patients were randomly assigned in a 11 ratio to receive either ribociclib or placebo in combination with letrozole. Overall survival was assessed with the use of a stratified log-rank test and summarized with the use of Kaplan-Meier methods after 400 deaths had occurred. A hierarchical testing strategy was used for the analysis of progression-free survival and overall survival to ensure the validity of the findings.RESULTS:
After a median follow-up of 6.6 years, 181 deaths had occurred among 334 patients (54.2%) in the ribociclib group and 219 among 334 (65.6%) in the placebo group. Ribociclib plus letrozole showed a significant overall survival benefit as compared with placebo plus letrozole. Median overall survival was 63.9 months (95% confidence interval [CI], 52.4 to 71.0) with ribociclib plus letrozole and 51.4 months (95% CI, 47.2 to 59.7) with placebo plus letrozole (hazard ratio for death, 0.76; 95% CI, 0.63 to 0.93; two-sided P = 0.008). No new safety signals were observed.CONCLUSIONS:
First-line therapy with ribociclib plus letrozole showed a significant overall survival benefit as compared with placebo plus letrozole in patients with HR-positive, HER2-negative advanced breast cancer. Median overall survival was more than 12 months longer with ribociclib than with placebo. (Funded by Novartis; MONALEESA-2 ClinicalTrials.gov number, NCT01958021.).
Texto completo:
1
Bases de dados:
MEDLINE
Assunto principal:
Purinas
/
Neoplasias da Mama
/
Protocolos de Quimioterapia Combinada Antineoplásica
/
Letrozol
/
Aminopiridinas
Tipo de estudo:
Clinical_trials
/
Guideline
Limite:
Aged
/
Female
/
Humans
/
Middle aged
Idioma:
En
Revista:
N Engl J Med
Ano de publicação:
2022
Tipo de documento:
Article