AI Article Synopsis
- This study analyzed the effectiveness of abemaciclib combined with nonsteroidal aromatase inhibitors as a first treatment for advanced breast cancer in a Japanese population of postmenopausal women.
- Results showed that the median progression-free survival was significantly longer for the abemaciclib group (29.1 months) compared to the placebo group (14.9 months), with a higher objective response rate (62.1% vs. 50.0%).
- While abemaciclib had a generally manageable safety profile, common side effects included high rates of diarrhea and neutropenia, but quality of life scores were comparable between the two treatments, except for better scores in the placebo group
Article Abstract
Background: This was a Japanese subpopulation analysis of MONARCH 3, a randomized, double-blind, placebo-controlled phase 3 study of abemaciclib plus nonsteroidal aromatase inhibitors (NSAIs) for initial therapy for advanced breast cancer (ABC).
Methods: Eligibility included postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative ABC who had no prior systemic therapy in the advanced disease setting. Patients (N = 493) were randomized 2:1 to receive abemaciclib or placebo (150 mg) plus either 1 mg anastrozole or 2.5 mg letrozole (physician's choice). The primary endpoint was progression-free survival (PFS). Secondary endpoints included objective response rate (ORR), pharmacokinetics (PK), safety, and health-related quality of life (HRQoL).
Results: In Japan, 53 patients were randomized (abemaciclib, n = 38; placebo, n = 15). At final PFS analysis (November 3, 2017), median PFS was 29.1 and 14.9 months in the abemaciclib and placebo groups, respectively (hazard ratio 0.537; 95% confidence interval 0.224-1.289). ORR in measurable disease was 62.1 and 50.0% in the abemaciclib and placebo groups, respectively. The Japanese PK profile was comparable to that of the overall population. Consistent with prior studies, the most frequent adverse events reported were diarrhea (abemaciclib: any grade, 94.7%; grade ≥ 3, 10.5%; placebo: any grade, 46.7%; grade ≥ 3, 0%) and neutropenia (abemaciclib: any grade, 68.4%; grade ≥ 3, 21.1%; placebo: any grade, 0%). HRQoL outcomes were generally similar between treatments except for the diarrhea score, which favored placebo.
Conclusions: Consistent with findings in the overall population, abemaciclib plus NSAI was an effective initial treatment in the Japanese subpopulation, with a manageable safety profile.
Clinical Trial Registration: NCT02246621; U.S. National Library of Medicine: https://clinicaltrials.gov/ct2/show/NCT02246621 .
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8732856 | PMC |
| http://dx.doi.org/10.1007/s12282-021-01295-0 | DOI Listing |
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