CML-296: First-Line Treatment Outcomes of CML Patients in a Real-World Data Setting in Lebanon

Abstract

Context: BCR–ABL-targeting tyrosine kinase inhibitors (TKIs) constitute the cornerstone of treatment for CML, leading to a life expectancy that is currently very close to that of age-matched individuals in the general population. Objective: To describe aspects of CML in a real-world data setting in Lebanon, including responses to first-line treatment with the first-generation TKI imatinib compared to those with the second-generation TKIs dasatinib and nilotinib. To evaluate the proportion of patients eligible for an attempt to stop TKI treatment. Design: Medical charts of patients diagnosed with CML between 2003 and 2019 were reviewed and updated in January 2020. Settings: Lebanese patients from two university medical centers in Beirut, Mount Lebanon Hospital and Hotel-Dieu de France Hospital, were included. Patients: The registry covered 70 patients, of which 54 patients were included. Inclusion criteria were patients older than 18 years, confirmed diagnosis with CML based on BCR-ABL PCR, and available follow-up data in the clinical chart for at least 2 years. Outcomes: Major and deep molecular responses were based on BCR-ABL1 levels; time of attaining these responses and duration of sustained responses were measured. The reason for switching to another TKI was noted (‘treatment failure’ or ‘intolerance’). Eligibility criteria for an attempt to stop TKI were based on the EURO-SKI trial. Modality of Treatment: Imatinib was given at a dose of 400 mg once daily, nilotinib 300 mg twice daily, and dasatinib 100 mg once daily. Results: 70% of patients were treated with imatinib and 30% with a second-generation TKI. 14% of patients discontinued their first-line treatment, mainly due to intolerance (10%) or treatment failure (5%). At 24 months, deep molecular response (MR4.0 and MR4.5) was achieved, at 15.3% and 40.3%, respectively, for imatinib, and 22% and 33.5%, respectively, for second-generation (p=1). The 5-year cumulative incidence of eligibility for TKI cessation attempt was 37%. Conclusion: We report the experience in CML from two health care institutions in Beirut, Lebanon. There was no statistically significant difference in response between the first- and second-generation TKIs. The criteria for an attempt to stop TKI therapy were met by one-third of patients.