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William J. Gradishar, MD, FACP, FASCO
William J. Gradishar, MD, FACP, FASCO
Posted: Thursday, April 14, 2022
In a previous analysis of the phase III MONALEESA-2 trial, Gabriel N. Hortobagyi, MD, of The University of Texas MD Anderson Cancer Center, Houston, and colleagues evaluated progression-free survival of first-line ribociclib plus letrozole in patients with advanced breast cancer—and reported a significant benefit with the combination therapy. Now, an updated analysis showed a median overall survival benefit of more than 12 months with the combination therapy compared with letrozole and placebo. These findings were published in The New England Journal of Medicine.
“Taken together, the MONALEESA trials of ribociclib have shown a consistent overall survival benefit regardless of accompanying endocrine therapy, line of therapy, or menopausal status,” concluded the investigators. “These findings underscore the substantial benefit of ribociclib as upfront therapy in patients with advanced breast cancer.”
This study enrolled 668 patients with hormone receptor–positive, HER2-negative advanced breast cancer. Participants were randomly assigned to receive either ribociclib (n = 334) or placebo (n = 334) in combination with letrozole. After 400 deaths occurred, overall survival was assessed via Kaplan-Meier methods and a stratified log-rank test.
At a median follow-up of 6.6 years, 181 patients (54.2%) given ribociclib/letrozole and 219 patients (65.6%) given placebo/letrozole died. A significant overall survival benefit was observed among patients given ribociclib/letrozole versus placebo/letrozole, with a median overall survival of 63.9 and 51.4 months, respectively (hazard ratio [HR] = 0.67; P = .008). Additionally, the Kaplan-Meier estimate of overall survival at 60 months was 52.3% with and 43.9% without ribociclib; 72-month rates were 44.2% and 32.0%.
The median chemotherapy-free survival was 39.9 months with and 30.1 months without ribociclib (HR = 0.74). Adverse events in both treatment arms were consistent with previously reported results. Of note, the most common grade 3 or 4 event was neutropenia, affecting significantly more patients given ribociclib than not(63.8% vs. 1.2%).
Disclosure: For full disclosures of the study authors, visit www.nejm.org.
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