Dasatinib as 2nd line treatment is safe and effective in peruvian CML patients: A multicentric real-world study

Abstract

Abstract Background: The second-generation tyrosine kinase inhibitor Dasatinib (DAS) used as second-line treatment is a valid option in patients with CML after resistance or intolerance to prior Imatinib (IMA). Peru is a developing country where Dasatinib is mostly used as second-line therapy. Methods: We performed a real-life observational retrospective study collecting clinical data of CML patients that received second-line therapy with DAS from 5 hemato-oncology centers in Lima. The patients were treated according to the guidelines and resources of each center and the data was obtained from their respective database in a real-life setting. Results: A total of 258 patients with CML older than 14 years, treated with DAS between 2010 and 2024 were screened from 5 centers. The median age was 43 years. High risk score was observed in 61.8% and 38.2% pts at diagnosis according with Sokal and ELTS score respectively. 82.7% of pts received DAS for IMA failure and 17.3% for IMA intolerance. The initial DAS dose was 100 mg (73.6%), 50 mg (12%), 140 mg (10 %) and 70 mg (4.4%) with a mean DAS dose of 96.7 mg. 62.2 % of pts achieved MMR at any time point. Grade 3-4 hematologic toxicity was observed in 30.2% of pts while pleural effusion was reported in 20.5% (1.9 % G3-4). Due to toxicity, 40.3% required dose modification. At mean follow-up of 45.1 months [0.2-200], 57.1% of patients continue with DAS. We observed an estimated median overall survival of 14.1 years for the entire cohort, with a 10-y OS of 61.2% Conclusion: In this Peruvian real-life cohort we found that DAS as second-line treatment in CML patients is a safe and effective therapy with high RMM rate, low rates of G3-4 pleural effusion and a discontinuation rate similar to other studies, with 57.1% of pts remaining on treatment at the last follow-up. This data will help take actions to improve the outcomes of Peruvian CML patients.