The oncologist · 2026
A prospective post-marketing observational study of abemaciclib in patients with HR+, HER2- breast cancer in China.
СтатьяНаблюдательное исследованиеМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Ouyang Quchang, Yuan Peng, Liu Jianxia, Teng Yuee, Li Zhihua, Ji Xuening, Liu Lina, Wang Mopei, Zou Liqun, Xu Ling, Yang Suisheng, Zhu Zhenxin, Yang Liu, Li Jinnan, Liu Qiang
Аннотация
BACKGROUND: Abemaciclib is approved for hormone-receptor positive (HR+), human epidermal growth factor receptor-2 negative (HER2-) locally advanced/metastatic breast cancer (ABC) and high-risk early BC (EBC) in China. This prospective observational study describes real-world abemaciclib safety and effectiveness among Chinese patients with HR+/HER2- EBC/ABC.
METHODS: Adults with HR+/HER2- EBC/ABC who received abemaciclib between Mar-2022 and Jan-2024 across 32 Chinese centers were enrolled. Primary objective was to evaluate treatment-emergent adverse event (TEAE) and serious AE (SAE) incidence within 24 weeks of treatment. Secondary objective was to describe Week 24 event-free survival (EFS).
RESULTS: Among 387 patients with EBC and 539 with ABC (median age: 50.0 and 55.0 years, respectively), 89.1% and 82.4% received 150 mg twice daily initially. Abemaciclib was combined with aromatase inhibitors in 95.6% (EBC) and 60.5% (ABC) patients, and fulvestrant in 38.0% (ABC). TEAEs occurred in 85.5% (EBC) and 81.8% (ABC) patients (commonly diarrhea, neutrophil count decreased, and white blood cell count decreased), and SAEs in 3.9% and 7.4%. AEs led to discontinuation in 4.4% (EBC) and 7.2% (ABC) patients. Diarrhea was the most common AE leading to discontinuation (2.1% [EBC] and 1.7% [ABC]). Most patients who discontinued treatment due to AEs had no dose modification, while most with dose reduction/interruption remained on abemaciclib. Week 24 EFS rates (95% CI) were 99.7% (97.6-100.0; EBC) and 85.1% (81.3-88.2; ABC).
CONCLUSIONS: Real-world safety, tolerability, and effectiveness of abemaciclib in Chinese patients with HR+/HER2- EBC and ABC were consistent with clinical trials, with no new safety signals, supporting its positive real-world benefit-risk profile.
METHODS: Adults with HR+/HER2- EBC/ABC who received abemaciclib between Mar-2022 and Jan-2024 across 32 Chinese centers were enrolled. Primary objective was to evaluate treatment-emergent adverse event (TEAE) and serious AE (SAE) incidence within 24 weeks of treatment. Secondary objective was to describe Week 24 event-free survival (EFS).
RESULTS: Among 387 patients with EBC and 539 with ABC (median age: 50.0 and 55.0 years, respectively), 89.1% and 82.4% received 150 mg twice daily initially. Abemaciclib was combined with aromatase inhibitors in 95.6% (EBC) and 60.5% (ABC) patients, and fulvestrant in 38.0% (ABC). TEAEs occurred in 85.5% (EBC) and 81.8% (ABC) patients (commonly diarrhea, neutrophil count decreased, and white blood cell count decreased), and SAEs in 3.9% and 7.4%. AEs led to discontinuation in 4.4% (EBC) and 7.2% (ABC) patients. Diarrhea was the most common AE leading to discontinuation (2.1% [EBC] and 1.7% [ABC]). Most patients who discontinued treatment due to AEs had no dose modification, while most with dose reduction/interruption remained on abemaciclib. Week 24 EFS rates (95% CI) were 99.7% (97.6-100.0; EBC) and 85.1% (81.3-88.2; ABC).
CONCLUSIONS: Real-world safety, tolerability, and effectiveness of abemaciclib in Chinese patients with HR+/HER2- EBC and ABC were consistent with clinical trials, with no new safety signals, supporting its positive real-world benefit-risk profile.