Long-Term Safety and Efficacy of Imatinib in Chronic Myeloid Leukemia: Real-World Evidence from a Single-Center Study

Objective: Imatinib mesylate, a tyrosine kinase inhibitor (TKI), has revolutionized CML treatment, improving patient survival to levels comparable to the general population. This study evaluates treatment response, side effects, and survival rates in CML patients followed at our clinic. Materials and Methods: A retrospective analysis was conducted on 76 CML patients treated with imatinib at ………. University Hospital between August 2000 and April 2022. Treatment responses, side effects, and survival outcomes were assessed. Results: The median age of patients was 49 years, with 93.4% in the chronic phase and 6.6% in the accelerated phase. Patients achieving MMR at the 6th month had significantly longer event-free survival (EFS) (198.09 ± 12.39 months; p<0.0001). The 10-year overall survival (OS) rate was 94.2%, and the 5-year OS rate was 98.5%. A total of 46.05% of patients were switched to second-generation TKIs due to insufficient response or side effects. Cox regression analysis revealed that older age at diagnosis increased the risk of death, and failure to achieve MMR at the 12th month raised event risk by 76-fold. During treatment, 30.3% of patients experienced imatinib-related side effects, with serious side effects observed in 9.2% of patients. Conclusion: Imatinib remains a highly effective and well-tolerated treatment for CML in real-world settings. The outcomes observed in this study aligned similarly with those reported in international clinical trials. Achieving early molecular responses significantly improves long-term survival. These findings underscore the importance of adherence to treatment protocols and regular monitoring.