Ibrutinib in Elderly Patients with Chronic Lymphocytic Leukemia: Adverse Event Incidence, Management, and Outcomes in a Canadian Real-World Setting.

BACKGROUND

Long-term clinical trials and real-world data have established a comprehensive risk-benefit profile for ibrutinib, informing adverse event (AE) management strategies to optimize safety and efficacy.

METHODS

We retrospectively assessed the incidence of AEs of special interest and management strategies in all patients treated with ibrutinib for chronic lymphocytic leukemia (CLL) in Saskatchewan, Canada, since 2014.

RESULTS

Among 187 patients (median age 75.7 years, 63% male), the median time from ibrutinib treatment initiation to data cutoff was 3.1 years. Approximately two-thirds of patients received ibrutinib for relapsed CLL (33.7% second-line and 32.6% third-line and beyond), with 33.7% receiving it first-line. All patients initiated ibrutinib as monotherapy at 420 mg. AEs of interest were observed in 81.3% of patients, with 42.8% experiencing ≥2 AEs. No grade 5 AEs were reported. Among the 284 first-onset AEs observed in 152 patients, 90.8% were successfully managed, allowing treatment continuation. The median time to successful management ranged from 27.0 days (range: 12.5-73.0) for infections to 84.0 days (range: 55.0-141.0) for hypertension. Both AE and discontinuation rates were comparable or favourable to previous reports.

CONCLUSION

This real-world analysis suggests that ibrutinib may be safely used in the majority of CLL patients encountered in routine practice.