KEY TAKEAWAYS
- Phase III MONALEESA-7 trial investigated the use of ribociclib in pre-/perimenopausal patients with HR-positive, HER2-negative, and ABC.
- The trial’s primary aim was to evaluate the effect of ribociclib in combination with ET on PFS and OS.
- The patients were randomly assigned to receive ribociclib or placebo in combination with ET.
- The trial found that ribociclib, combined with ET, significantly increased median OS to 58.7 months from 48.0 months with placebo (95% CI: hazard ratio = 0.76).
- Ribociclib did not appear to interact with NSAI. After treatment was stopped, more patients on placebo used cyclin-dependent kinase 4/6 inhibitor.
- The study concluded that ribociclib, in combination with ET, demonstrated significantly longer OS than placebo in pre-/perimenopausal patients.
In the phase III MONALEESA-7 trial, pre-/perimenopausal patients with hormone receptor (HR)-positive, HER2-negative, advanced breast cancer (ABC) showed a statistically significant progression-free survival (PFS) and overall survival (OS) benefit with ribociclib plus endocrine therapy (ET). As the ribociclib arm did not attain the median OS in the protocol-required final analysis, the investigators conducted an exploratory OS and extra outcomes analysis with a longer median follow-up (53.5 months). Patients were randomly assigned to receive either ribociclib or placebo in combination with ET [goserelin plus nonsteroidal aromatase inhibitor (NSAI) or tamoxifen]. Kaplan-Meier techniques and a stratified Cox proportional hazard model were used to analyze OS.
There were 672 patients in the “intent to treat” group. Ribociclib increased median OS to 58.7 months from 48.0 months with a placebo (95% CI: hazard ratio = 0.76). At 48 months, Kaplan-Meier estimated a 60% OS with ribociclib and a 50% OS with placebo. The OS effect was held throughout subgroup analyses, including those focusing on patients who got NSAI and those younger than 40. After treatment was stopped, there was no significant difference between the ribociclib and placebo groups regarding subsequent antineoplastic therapies. After stopping treatment, more patients on placebo (26%) than on ribociclib (13%) used cyclin-dependent kinase 4/6 inhibitors. Ribociclib significantly slowed the onset of chemotherapy compared to placebo. Ribociclib did not appear to interact with either NSAI. With a median follow-up of 53.5 months (ClinicalTrials.gov, NCT02278120), ribociclib in combination with ET continued to demonstrate significantly longer OS than et al. one in pre-/perimenopausal patients, including patients younger than 40 years old, with HR+/HER2- ABC.
Source:https://pubmed.ncbi.nlm.nih.gov/34965945/
Clinical Trial:https://clinicaltrials.gov/ct2/show/NCT02278120
Lu YS, Im SA, Colleoni M, Franke F, Bardia A, Cardoso F, Harbeck N, Hurvitz S, Chow L, Sohn J, Lee KS, Campos-Gomez S, Villanueva Vazquez R, Jung KH, Babu KG, Wheatley-Price P, De Laurentiis M, Im YH, Kuemmel S, El-Saghir N, O’Regan R, Gasch C, Solovieff N, Wang C, Wang Y, Chakravartty A, Ji Y, Tripathy D. Updated Overall Survival of Ribociclib plus Endocrine Therapy versus Endocrine Therapy Alone in Pre- and Perimenopausal Patients with HR+/HER2- Advanced Breast Cancer in MONALEESA-7: A Phase III Randomized Clinical Trial. Clin Cancer Res. 2022 Mar 1;28(5):851-859. doi: 10.1158/1078-0432.CCR-21-3032. PMID: 34965945; PMCID: PMC9377723.
