Real-World Outcomes for 205 Patients with Chronic Lymphocytic Leukemia Treated with Ibrutinib.

Ibrutinib has now been approved for treatment of chronic lymphocytic leukemia (CLL) in both front-line setting and as later-line treatment. However, knowledge about the outcomes and adverse events (AE) among patients at a population-based level are still limited. OBJECTIVES To report outcomes and AEs in a population-based cohort treated with ibrutinib outside clinical trials. METHODS We conducted a multicenter, retrospective cohort study including all patients with CLL treated with ibrutinib. RESULTS In total, 205 patients were included of whom 39 (19%) were treatment-naive. The median follow-up was 21.4 months (IQR, 11.9-32.8), and the estimated overall survival at 12 months was 88.8% (95%CI: 84.3-93.3) and the estimated progression-free survival at 12 months was 86.3% (95% CI: 81.3-91.2%). During follow-up, 200 (97.6%) patients had at least one AE and 100 (48.8%) patients had at least one grade grade ≥3 AE. Eigthy-six patients (42.0%) discontinued ibrutinib, hereof 47 (54.7%) due to AEs and 19 (22.1%) had progression of CLL or Richter transformation. CONCLUSIONS In our study, we find comparable, though slightly inferior, overall and progression-free survival, but discontinuation due to toxicity was higher compared with clinical trials. Patient training and information may improve treatment adherence outside clinical trials.