Adjuvant abemaciclib in early-stage breast cancer: hypothesis-generating safety observations from a real-world cohort study

Abstract

Background: Invasive disease-free survival in adjuvant treatment of HR+/HER2– early-stage breast cancer is improved by the use of CDK4/6 inhibitors. However, to date, minimal data are available on their safety and effectiveness in older patients (≥70 years old). Methods: A retrospective, multi-centre cohort study was conducted in two oncology centres in Pavia, Italy. Patients had to have received at least 3 months of therapy with adjuvant abemaciclib (a CDK4/6 inhibitor). Data on demographics, toxicity, dose reductions and clinical outcomes were analysed. Analyses were descriptive, with continuous variables reported as median (IQR) and categorical variables as counts and percentages. Results: Fifty-four patient records were reviewed (median age 55; six patients ≥70 years (older-age subgroup). Adverse events of any grade were reported in 53/54 patients (98.1%), most commonly haematological and gastrointestinal. Dose reductions occurred more frequently and earlier in the older-age subgroup (66.7% versus 45.8%; median 4.2 versus 8.3 months). Toxicities were generally of low–moderate grade and manageable. Conclusion: During adjuvant abemaciclib, low–moderate- grade toxicities were common, particularly haematological and gastrointestinal events. Older patients showed a numerically higher rate of dose reductions, suggesting a potential need for personalized dosing and early monitoring in this subgroup. These findings should be considered hypothesis-generating and warrant confirmation in larger prospective studies.

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