ASCO 2018: Ribociclib Plus Fulvestrant for Postmenopausal Patients With Advanced Breast Cancer
Posted: Wednesday, June 13, 2018
Ribociclib used with fulvestrant for treatment of postmenopausal patients with hormone receptor–positive and HER2-negative advanced breast cancer significantly prolonged progression-free survival, compared with fulvestrant and placebo. This finding from the MONALEESA-3 trial, which was presented at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract 1000) in Chicago, suggests the treatment combination may prove to be an option for this patient population. Dennis J. Slamon, MD, PhD, of the UCLA Jonsson Comprehensive Cancer Center, was the lead author.
In this phase III randomized, double-blind, placebo-controlled study, the investigators enrolled 726 patients. Women were stratified 2:1 to receive ribociclib plus fulvestrant or a placebo plus fulvestrant. Baseline characteristics were generally balanced between the arms. Patients participating in this trial had received no or up to one line of prior endocrine therapy for their advanced disease.
Dr. Slamon and colleagues observed a median progression-free survival of 20.5 months in the ribociclib/fulvestrant group, versus 12.8 months in the placebo group, with “consistent progression-free benefit” found in those with no and up to one line of prior endocrine therapy. For patients with measurable disease at baseline, overall response rates were 41% versus 29, and the clinical benefit rate was 69% versus 60% for the ribociclib/fulvestrant and placebo cohorts, respectively.
The combination therapy showed a manageable safety profile, according to the investigators. Common all-grade adverse events in the ribociclib/fulvestrant and placebo groups were neutropenia (70% vs. 2%, respectively), nausea (45% vs. 28%), and fatigue (31% vs. 33%).
