Matching-Adjusted Indirect Comparison of Ribociclib Plus Fulvestrant versus Palbociclib Plus Letrozole as First-Line Treatment of HR+/HER2-Advanced Breast Cancer
Fasching P, Delea TE, Lu YS, De Boer R, Hurvitz SA, Moynahan A, Chandiwana D, Lanoue B, Hu H, Thuerigen A, O'Shaughnessy J (2021)
Publication Type: Journal article
Publication year: 2021
Journal
Book Volume: 13
Pages Range: 8179-8189
DOI: 10.2147/CMAR.S325043
Abstract
Purpose: Cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) plus endocrine therapy are recommended for first-line treatment of hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer (ABC). However, not all CDK4/6i trials have reported significant overall survival (OS) benefit, and there have been no head-to-head trials. Two trials have reported OS outcomes in first-line patients: MONALEESA-3 reported significant OS benefit with first-or second-line ribociclib plus fulvestrant (RIB+FUL) versus placebo plus fulvestrant (PBO+FUL), while PALOMA-1 reported no significant OS benefit for palbociclib plus letrozole (PAL+LET) versus LET in first-line postmenopausal patients. Matched-adjusted indirect comparisons (MAICs) are an established method for comparing efficacy of treatments from different trials. We used an MAIC to compare first-line patients from MONALEESA-3 and PALOMA-1. Patients and Methods: An unanchored MAIC of progression-free survival (PFS) and OS in first-line patients with HR+/HER2- ABC treated with RIB+FUL versus PAL+LET was con-ducted using individual patient data from MONALEESA-3 and aggregated data from PALOMA-1. To match patients in PALOMA-1, patients in MONALEESA-3 were limited to those with no prior endocrine therapy for ABC and no (neo) adjuvant LET <= 12 months before enrollment. PFS and OS were compared using Kaplan-Meier estimators and Cox regression. Results: A total of 329 and 178 patients from RIB+FUL and PBO+FUL arms, respectively, of MONALEESA-3 were matched to 84 and 81 patients from PAL+LET and LET arms of PALOMA-1. After weighting, OS was significantly longer for RIB+FUL versus PAL+LET (hazard ratio [HR], 0.50; 95% CI, 0.32-0.77; p = 0.0020). PFS favored RIB+FUL versus PAL+LET, although the difference was not statistically significant (HR, 0.77; 95% CI, 0.54-1.10; p = 0.1553). Conclusion: Using MAIC to adjust for trial differences, OS comparisons favored RIB+FUL over PAL+LET as first-line treatment in postmenopausal patients with HR+/HER2- ABC. These exploratory results suggest a significant increase in OS benefit with RIB treatment compared with PAL.
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Involved external institutions
Policy Analysis Inc (PAI)
United States (USA) (US)
National Taiwan University Hospital (NTUH) / 國立台灣大學醫學院附設醫院
Taiwan (TW)
Peter MacCallum Cancer Centre
Australia (AU)
University of California Los Angeles (UCLA)
United States (USA) (US)
Novartis AG
Switzerland (CH)
Baylor University (BU)
United States (USA) (US)
United States (USA) (US)
National Taiwan University Hospital (NTUH) / 國立台灣大學醫學院附設醫院
Taiwan (TW)
Peter MacCallum Cancer Centre
Australia (AU)
University of California Los Angeles (UCLA)
United States (USA) (US)
Novartis AG
Switzerland (CH)
Baylor University (BU)
United States (USA) (US)
How to cite
APA:
Fasching, P., Delea, T.E., Lu, Y.-S., De Boer, R., Hurvitz, S.A., Moynahan, A.,... O'Shaughnessy, J. (2021). Matching-Adjusted Indirect Comparison of Ribociclib Plus Fulvestrant versus Palbociclib Plus Letrozole as First-Line Treatment of HR+/HER2-Advanced Breast Cancer. Cancer Management and Research , 13, 8179-8189. https://doi.org/10.2147/CMAR.S325043
MLA:
Fasching, Peter, et al. "Matching-Adjusted Indirect Comparison of Ribociclib Plus Fulvestrant versus Palbociclib Plus Letrozole as First-Line Treatment of HR+/HER2-Advanced Breast Cancer." Cancer Management and Research 13 (2021): 8179-8189.
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