Matching-adjusted indirect comparison of PFS and OS comparing ribociclib plus letrozole versus palbociclib plus letrozole as first-line treatment of HR+/HER2− advanced breast cancer
Jhaveri K, O’Shaughnessy J, Fasching PA (2023)
Publication Type: Journal article
Publication year: 2023
Journal
Book Volume: 15
DOI: 10.1177/17588359231216095
Abstract
Background: Current standard-of-care first-line treatment of patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2−) advanced breast cancer (ABC) is cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) + endocrine therapy. In the MONALEESA-2 trial, first-line ribociclib + letrozole demonstrated statistically significant overall survival (OS) benefit versus placebo + letrozole in postmenopausal patients with HR+/HER2− ABC. In the PALOMA-2 trial, first-line palbociclib + letrozole did not show OS benefit versus placebo + letrozole in a similar patient population. Understanding OS outcomes in the respective trials is critical for treatment decisions; however, there are no head-to-head clinical trial data comparing ribociclib and palbociclib. Objectives: To conduct a matching-adjusted indirect comparison (MAIC) to compare progression-free survival (PFS) and OS of first-line ribociclib + letrozole versus palbociclib + letrozole in postmenopausal patients with HR+/HER2− ABC. Design: Letrozole-anchored MAIC using individual patient data from MONALEESA-2 and published summary data from PALOMA-2. Methods: Using individual data, patients from MONALEESA-2 who matched inclusion criteria from PALOMA-2 were selected, and weighting was conducted to ensure baseline characteristics were similar to those in published aggregated data from PALOMA-2. The Bucher method was used to generate corresponding hazard ratios (HRs). Results: The final effective sample size compared n = 150 (ribociclib) and n = 112 (placebo) MONALEESA-2 patients with n = 444 (palbociclib) and n = 222 (placebo) PALOMA-2 patients. After matching and weighting, patient characteristics were well balanced. MAIC analysis showed a numerical PFS benefit [HR, 0.80; 95% confidence interval (CI), 0.58–1.11; p = 0.187] and significant OS benefit (HR, 0.68; 95% CI, 0.48–0.96; p = 0.031) with ribociclib + letrozole versus palbociclib + letrozole. Conclusion: Results of this cross-trial MAIC analysis showed a numerical PFS benefit and significantly greater OS benefit with first-line ribociclib + letrozole versus palbociclib + letrozole. These results support letrozole + ribociclib as the preferred first-line CDK4/6i for postmenopausal patients with HR+/HER2− ABC. Trial registration: NCT01958021; https://www.clinicaltrials.gov/study/NCT01958021 (MONALEESA-2) and NCT01740427; https://clinicaltrials.gov/study/NCT01740427 (PALOMA-2).
Involved external institutions
Memorial Sloan Kettering Cancer Center
United States (USA) (US)
Baylor University Medical Center
United States (USA) (US)
United States (USA) (US)
Baylor University Medical Center
United States (USA) (US)
How to cite
APA:
Jhaveri, K., O’Shaughnessy, J., & Fasching, P.A. (2023). Matching-adjusted indirect comparison of PFS and OS comparing ribociclib plus letrozole versus palbociclib plus letrozole as first-line treatment of HR+/HER2− advanced breast cancer. Therapeutic Advances in Medical Oncology, 15. https://dx.doi.org/10.1177/17588359231216095
MLA:
Jhaveri, Komal, Joyce O’Shaughnessy, and Peter A. Fasching. "Matching-adjusted indirect comparison of PFS and OS comparing ribociclib plus letrozole versus palbociclib plus letrozole as first-line treatment of HR+/HER2− advanced breast cancer." Therapeutic Advances in Medical Oncology 15 (2023).
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