Abstract

Background: Tyrosine kinase inhibitors revolutionized the treatment of chronic myeloid leukemia. The present study aimed to review the efficacy and tolerance of Imatinib in a group of patients who are treated outside the clinical trial.
Methodology: CML patients presenting to King Abdulla Medical (KAMC), Mecca, Saudi Arabia, during the period between June 2010 and December 2019 were included in this study. All started Imatinib as the first line. Evaluation of response was done according to ELN 2020 recommendation.
Results: 141 patients were included in this study with a male to female ratio of 1.1 and a median age of 42. The majority of patients were considered to be at low risk (70.2%) as by EUTOS risk score. For the whole group, the median follow up was 47.7 months. At 36 m, the OS was 94.8%, which continued as there was no death afterward. Mean event-free survival was 65 m (95% CI 55.6-72.5) with a median of 56.5m. It was significantly longer in those with a low-risk score (p = 0.0001), patients with favorable molecular responses at 3,6,12 m, and compliant patients. Favorable molecular responses were obtained in 67%,53%,51% at 3,6,12 months respectively. Factors that affected molecular responses were higher Hemoglobin, higher platelets, lower blasts, basophils, low-risk score, and better compliance.
Conclusion: In a real-life setting, the efficacy of Imatinib in CML patients was found high coupled with a safe toxicity profile.

Key words: CML, Imatinib, Saudi Arabia, real world.