Clinical experience and safety of venetoclax in the treatment of patients with chronic lymphocytic leukemia - real-world data from a hemato-oncology center.

Abstract

The treatment of patients with CLL has undergone significant changes in recent years. Standard chemoimmunotherapy is changing to targeted inhibition with modern drugs. The listed drugs have better efficacy and significantly improve the overall survival of patients according to registry clinical studies. In a retrospective analysis, we evaluated 43 patients with CLL who underwent venetoclax treatment at the Hematology Department, University Hospital and Polyclinic F. D. Roosevelt Banská Bystrica, Slovakia (FNsP FDR BB) in 2019-2024. The aim of this work was to evaluate retrospectively the efficacy and safety of venetoclax in the treatment of patients with CLL. The median age of patients at the time of initiation of venetoclax treatment was 58 years, range 41-79 years. The majority of patients, 27 (63%) were men and 16 (37%) were women. Patients were treated with venetoclax in the first and higher line, in combination with obinutuzumab, with rituximab, and in monotherapy. Of these, 16 (37%) patients were after previous treatment with ibrutinib. Treatment indications and response assessment were based on the 2018 international workshop on the Chronic Lymphocytic Leukemia (iwCLL) Criteria. Patients were evaluated after at least 2 months of treatment until disease progression. The effect of treatment was assessed by objective examination of the patient, possibly by imaging examination (USG, CT scan) and evaluation of blood parameters. Adverse effects were assessed based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. In case of disease progression, treatment was interrupted. The results of our work confirmed the efficacy and safety of venetoclax in combination with obinutuzumab, and rituximab, even as monotherapy in patients with CLL. The efficacy of the above regimens in our group of patients is comparable to that in clinical studies, even in patients with high-risk genetic features, such as 17p deletion and unmutated IgVH status. Treatment with venetoclax was also effective and well tolerated in patients after previous treatment with ibrutinib. The limitations of our evaluation are the small patient population and the short median follow-up of patients. In line with the conclusions of clinical trials and retrospective analysis from real-life practice, we can say that venetoclax-based treatment regimens are highly effective in patients with CLL in the first and higher line of treatment, with acceptable and well-manageable toxicity. This treatment is also effective in patients after previous treatment with ibrutinib.