Ribociclib Prolongs Progression-Free Survival in Premenopausal Breast Cancer
MONALEESA-7 assessed ribociclib plus endocrine therapy in premenopausal women with HR-positive, HER2-negative advanced breast cancer.
|The following article is part of The Clinical Advisor's coverage from the 2018 American Association of Nurse Practitioners' annual meeting in Denver. Our staff will be reporting live on original research, case studies, and professional outreach and advocacy news from leading NPs in various therapeutic areas. Check back for ongoing updates from AANP 2018.|
DENVER – For premenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor-2 negative (HER2-) advanced breast cancer, ribociclib significantly prolongs progression-free survival, according to research presented at the American Association of Nurse Practitioners 2018 National Conference.
The study included premenopausal and perimenopausal women with HR+/HER2- advanced breast cancer having received at least 1 line of chemotherapy and no prior endocrine therapy (n=672). Participants were randomly assigned to ribociclib 600 mg/d for 3 weeks on/1 week off or placebo plus tamoxifen 20 mg/d or a nonsteroidal aromatase inhibitor (letrozole 2.5 mg/d or anastrozole 1 mg/d) plus goserelin 3.6 mg every 28 days. The primary end point was progression-free survival, and secondary end points were overall response rate (ORR), clinical benefit rate (CBR), and safety.
The ribociclib group had a median progression-free survival of 23.8 months compared with 12.0 months for the placebo group (P=9.83 x 10-8).
Among participants with measurable baseline disease, the ORR was 51% in the ribociclib group compared with 36% for placebo (P=3.17 x 10-4). The CBR was 80% in the ribociclib group compared with 67% in the placebo group (P=3.40 x 10-4).
The most frequently reported adverse events were neutropenia (76% in the ribociclib group vs 8% in the placebo group), hot flush (34% vs 34%), nausea (32% vs 20%), leukopenia (31% vs 6%), and arthralgia (30% vs 27%). In the ribociclib group, adverse events led to permanent treatment discontinuation in 4% of participants compared with 3% in the placebo group.
In light of these findings, the investigators conclude that “nurse practitioners are likely to see growing use of ribociclib in premenopausal women with HR+/HER2- [advanced breast cancer].”
For more coverage of AANP 2018, click here.
Tripathy D, Im S-A, Colleoni M, et al. First-line ribociclib vs placebo with goserelin and tamoxifen or a nonsteroidal aromatase inhibitor in premenopausal women with hormone receptor-positive, HER2-ngeative advanced breast cancer: results from the randomized phase 3 MONALEESA-7 trial. Presented at the American Association of Nurse Practitioners 2018 National Conference. June 26-July 1, 2018; Denver, CO. Poster 15.