Clinical experience and satisfaction in patients with advanced breast cancer participating in the abemaciclib patient...

To evaluate the impact of a patient support program (PSP) on the management of abemaciclib-related diarrhea in patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer (MBC) and its influence on adherence and patient-reported outcomes in routine clinical practice.

This is a multicenter, prospective, observational Spanish study in patients with locally advanced or MBC receiving abemaciclib and enrolled in the PSP, assessed over 6 months. The primary endpoint was the proportion of patients reducing or discontinuing abemaciclib due to diarrhea. The secondary endpoints included diarrhea-related temporary interruptions, diarrhea management, adherence, HRQoL, and satisfaction with the PSP. Descriptive statistics were applied and treatment modification endpoints were analyzed using Kaplan-Meier.

The study included 39 patients (median age: 58 years), with a median time since diagnosis of MBC of 2 months. Diarrhea occurred in 89.7% of patients, with grade 3 events in 7.7% and no grade ≥ 4 events. Nine patients (23.1%) experienced treatment modifications due to diarrhea; however, no permanent treatment discontinuations were reported. Loperamide (over 75% of patients) and dietary modifications were the most used self-care strategies. At week 24, results from the ad hoc questionnaires showed that over 70% of the patients reported high satisfaction with all PSP aspects, and 80% were classified as treatment adherent.

Episodes of diarrhea were mostly graded 1-2 and no patients discontinued abemaciclib due to diarrhea. Patients reported high satisfaction with abemaciclib PSP, good adherence, and favorable quality of life, supporting the use of PSP in clinical practice.