Overall Survival with Ribociclib plus Endocrine Therapy in Breast Cancer
- Study type
- Clinical trial
- Study name
- MONALEESA-7
- Phase
- Phase 3
- Design
- Randomised, placebo-controlled trial; prespecified interim analysis of the key secondary endpoint of overall survival
- Sample size
- 672 patients (intention-to-treat population)
- Source
- N Engl J Med · 2019
- Trial registration
- NCT02278120
In plain words
This study looked at women before or around menopause who had advanced hormone-sensitive, HER2-negative breast cancer. Adding the drug ribociclib to hormone therapy helped patients live longer: after 42 months about 70% of patients in the ribociclib group and about 46% in the placebo group were alive. With longer follow-up, no new concerns about the drug's side effects were seen.
Key results
Treatment arms and regimens
Ribociclib plus endocrine therapy (goserelin and a non-steroidal aromatase inhibitor or tamoxifen). Number of patients: 335.
Ribociclib 600 mg orally daily, days 1 to 21 of each 28-day cycle + letrozole 2.5 mg or anastrozole 1 mg or tamoxifen 20 mg orally daily continuously + goserelin 3.6 mg subcutaneously on day 1 of each 28-day cycle; until progression or unacceptable toxicity. (Under the current label, ribociclib with tamoxifen is not recommended because of QT prolongation.)
Placebo plus endocrine therapy (goserelin and a non-steroidal aromatase inhibitor or tamoxifen). Number of patients: 337.
Placebo on days 1 to 21 every 28 days + the same endocrine therapy and goserelin.
Source of the regimen details: FDA label for Kisqali (DailyMed, section 14, MONALEESA-7) and the abstract of the primary report (Lancet Oncol 2018; goserelin 3.6 mg)
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Study population
Premenopausal or perimenopausal patients with hormone receptor-positive, HER2-negative advanced breast cancer. A subgroup of 495 patients received an aromatase inhibitor as endocrine therapy.
Endpoints
Key secondary endpoint: overall survival (in a prespecified interim analysis). Overall survival was assessed with a stratified log-rank test and summarised with the Kaplan–Meier method. Time from randomisation to disease progression during second-line therapy or death was also reported.
Safety and side effects
According to the abstract, no new toxicity concerns emerged with longer follow-up. Details of grade 3 or higher adverse events are not given in the abstract and are available in the full text.
Clinical significance and place in guidelines
These results show that adding a CDK4/6 inhibitor (ribociclib) to endocrine therapy in premenopausal or perimenopausal patients with HR-positive/HER2-negative advanced breast cancer improves overall survival as well as progression-free survival. Regulatory approvals and guideline recommendations should be checked in current sources.
Limitations
This report is an interim analysis of overall survival (a secondary endpoint). The confidence interval for the 42-month survival estimate in the placebo group was wide (32.0–58.9). The study was funded by Novartis. Other limitations should be checked in the full text.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.