Abstract | BACKGROUND: 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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Authors | Masato Takahashi, Eriko Tokunaga, Joji Mori, Yoshinori Tanizawa, Jan-Stefan van der Walt, Tsutomu Kawaguchi, Matthew P Goetz, Masakazu Toi |
Journal | Breast cancer (Tokyo, Japan)
(Breast Cancer)
Vol. 29
Issue 1
Pg. 174-184
(Jan 2022)
ISSN: 1880-4233 [Electronic] Japan |
PMID | 34661821
(Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial)
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Copyright | © 2021. The Author(s). |
Chemical References |
- Aminopyridines
- Aromatase Inhibitors
- Benzimidazoles
- Receptors, Progesterone
- Anastrozole
- abemaciclib
- Letrozole
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Topics |
- Aged
- Aminopyridines
(therapeutic use)
- Anastrozole
(therapeutic use)
- Aromatase Inhibitors
(therapeutic use)
- Benzimidazoles
(therapeutic use)
- Breast Neoplasms
(drug therapy, mortality)
- Female
- Humans
- Japan
- Letrozole
(therapeutic use)
- Middle Aged
- Progression-Free Survival
- Quality of Life
- Receptors, Progesterone
(metabolism)
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