Real-world data on the efficacy and safety of ibrutinib and venetoclax in patients with chronic lymphocytic leukemia, a single-center experience

Abstract

Introduction: treatment of chronic lymphocytic leukemia (CLL) continues to undergo a very dynamic development. Chemoimmunotherapy, which has been the mainstay of treatment, has been largely replaced by target molecules that are more effective and safer. Objective: retrospective analysis of our data to evaluate the results of CLL patients treated with innovative non-chemotherapeutic treatment „chemo-free". Material and methods: in the period from January 2016 to September 2021, we included 83 patients with chronic lymphocytic leukemia who were treated in our institute. A total of 63 patients received ibrutinib (15.8% in the first line) and 20 patients received venetoclax +/- rituximab (84% in monotherapy and 5% in the first line). The median age was 64 years (range 39-81 years). Each group had a median of the two previous therapies (range 1 to 6). The median follow-up was 31 months for ibrutinib and 23 months for venetoclax. Results: the majority of patients responded to treatment with an overall response rate (ORR) of 92% for ibrutinib and 90% for venetoclax. The rate of complete remission was higher with venetoclax (relative risk - RR = 2,02. 95% CI: 1,16 - 3.5, p = 0,012). The 3-year progression-free survival (PFS) and overall survival (OS) were 82% and 83% for ibrutinib, 80% and 80% for venetoclax respectively. Patients treated in the first line had better outcome (OS). The side effects were mostly mild or moderate. Conclusion: in our study, we demonstrated that the new molecules ibrutinib and venetoclax provide comparable results in patients with CLL treated outside of the clinical trial.

Key words: chronic lymphocytic leukemia, ibrutinib, venetoclax, efficacy and safety.