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A Retrospective Observational Study of Safety and Effectiveness of Abemaciclib in Chinese Patients with Breast Cancer
Fangyuan Zhao1, Yaxin Liu2, Hanfang Jiang2
1Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Laboratory of Molecular Oncology, Peking University Cancer Hospital & Institute, Beijing, 100142, China.
Introduction:
Abemaciclib is approved in China for treating hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer (ABC) and early breast cancer (EBC). This retrospective, real-world observational study evaluated the safety and effectiveness of abemaciclib among Chinese patients with EBC/ABC.
Methods:
The study included patients from the National Anti-Tumor Drug Surveillance System who initiated abemaciclib between April 2021 and December 2022, with ≥ 1 post-treatment visit by June 2023. Primary objectives were to describe patient characteristics and prevalence of adverse events (AEs) of interest. Real-world progression-free survival (rwPFS) and overall survival (OS) among patients with ABC were exploratory objectives.
Results:
Overall, 3423 patients (EBC 619, ABC 2804) were included (3407 [99.5%] female and 16 [0.5%] male); most initiated abemaciclib at 150 mg twice daily (EBC 79.9%, ABC 68.9%). Among patients with EBC, 92.2% had positive lymph nodes. Among patients with ABC, 45.2%, 25.4%, and 29.3% received abemaciclib as first-line, second-line, and third-or-later-line therapy, respectively. Treatment discontinuation occurred in 5.2% of patients with EBC and 25.1% with ABC, and dose reduction in 21.2% and 20.1%, respectively. AEs of interest occurred in 60.7% of patients with EBC and 57.3% with ABC, mostly grades 1-2 in severity; the most common AE of interest was neutropenia (39.9% and 34.5% in patients with EBC and ABC, respectively). Discontinuation due to AEs occurred in 2.4% of patients with EBC and 4.1% with ABC. Among patients with ABC receiving abemaciclib as first-line, second-line, and third-or-later-line therapy, 12-month rwPFS rates were 80.5%, 72.7%, and 57.3%, and OS rates were 90.5%, 84.3%, and 73.0%, respectively. Effectiveness was consistent across menopausal status and endocrine therapy subgroups.
Conclusions:
In this largest real-world study of abemaciclib in China to date, abemaciclib was well tolerated with no new safety signals, and its effectiveness was consistent with prior trials, confirming its positive benefit-risk profile in real-world settings.