Real World Evidence From 2 Decades of First-Line TKI Therapy in Chronic Myeloid Leukemia (CML): Insights From ACHO's RENEHOC Registry.

Abstract

Background: Chronic myeloid leukemia (CML) treatment has significantly evolved with the introduction of tyrosine kinase inhibitors. However, access to these treatments and outcomes vary globally. This study examines 2 decades of CML management in Colombia using the RENEHOC registry, focusing on TKI efficacy, safety, and healthcare system challenges.

Methods: We performed a descriptive analysis of the sociodemographic and clinical characteristics of 994 CML patients from the RENEHOC cohort in Colombia, who were treated over the past 20 years. Trends in first-line TKI use were assessed, and Kaplan-Meier survival curves were used to estimate EFS and OS. The log-rank test was used to compare survival curves between different first-line TKIs.

Results: The analysis shows trends in the use of first-line TKIs over a 20-year period in Colombia, where, as in other countries, the use of second-generation TKIs in the first-line setting is gradually increasing. Despite the difficulties of the Colombian healthcare system, the results in terms of OS are excellent regardless of the first-line TKI; however, patients treated with imatinib switched lines significantly more often than those treated with second-generation TKIs (imatinib 58.7%, nilotinib 19.5%, dasatinib 29.3%). The median duration of treatment was significantly shorter with imatinib compared to dasatinib and nilotinib (4.08, 12.75 and not reached, respectively). Intolerance was the most common reason for switching in this cohort of patients. The median observation time for OS was 64.89 months (SD 60.15), with survival rates of 99.4% at 1 year, 97.7% at 3 years and 96.6% at 5 years.

Conclusions: The results of this analysis show excellent results in terms of OS for patients with CML treated in Colombia over the last 20 years, despite the difficulties inherent in the health system. Patients treated with first-line imatinib had more frequent line changes. In general, intolerance was the most common reason for switching lines. Despite its retrospective nature, this study allows us to outline how treatment patterns in the country have changed over time. Continued efforts to include more centers and patients in prospective studies are essential to better understand the long-term effects of treatment and to improve adherence to guideline recommendations in clinical practice.