Clinical lymphoma, myeloma & leukemia · 2026
Outcomes of Patients Treated With Dasatinib 50 mg/d: A Pooled Analysis.
СтатьяКлиническое исследование II фазыНазвание и аннотация: Перевод в очереди
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Haddad Fadi G, Jabbour Elias, Sasaki Koji, Black Samuel, Savoy Jonathan Michael, Alvarado Yesid, Borthakur Gautam, Pemmaraju Naveen, Yilmaz Musa, Delasalla Sara, Issa Ghayas C, Kantarjian Hagop
Аннотация
BACKGROUND: Dasatinib is approved at 100 mg/d for newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP). We report outcomes with frontline dasatinib 50 mg/d in a large cohort of patients with CML-CP.
METHODS: In a phase II clinical trial, patients with newly diagnosed CML-CP received dasatinib 50 mg/d alone (n = 83) or in combination with venetoclax (n = 66). We evaluated the molecular response rates, incidence of adverse events, event-free survival (EFS), and overall survival (OS).
RESULTS: One hundred forty-nine patients were included; the median age at diagnosis was 46.7 years (range, 19.9-84.3); Sokal risk was high-risk in 7 patients (4.7%). By 60 months of dasatinib therapy, the cumulative rates of major molecular response, MR4, and MR4.5 were 95%, 87%, and 86%, respectively. With a median follow-up of 73 months, the 5-year EFS and OS rates were 96% and 98%, respectively. Adverse events were observed in 72 patients (48%), including pleural effusion in 19 (12.7%), of which 3 (2%) of Grade 3. Eighteen patients (12%) discontinued dasatinib due to adverse events.
CONCLUSION: The long-term follow-up confirms the safety and efficacy of dasatinib 50 mg/d in patients with newly diagnosed CML-CP.
METHODS: In a phase II clinical trial, patients with newly diagnosed CML-CP received dasatinib 50 mg/d alone (n = 83) or in combination with venetoclax (n = 66). We evaluated the molecular response rates, incidence of adverse events, event-free survival (EFS), and overall survival (OS).
RESULTS: One hundred forty-nine patients were included; the median age at diagnosis was 46.7 years (range, 19.9-84.3); Sokal risk was high-risk in 7 patients (4.7%). By 60 months of dasatinib therapy, the cumulative rates of major molecular response, MR4, and MR4.5 were 95%, 87%, and 86%, respectively. With a median follow-up of 73 months, the 5-year EFS and OS rates were 96% and 98%, respectively. Adverse events were observed in 72 patients (48%), including pleural effusion in 19 (12.7%), of which 3 (2%) of Grade 3. Eighteen patients (12%) discontinued dasatinib due to adverse events.
CONCLUSION: The long-term follow-up confirms the safety and efficacy of dasatinib 50 mg/d in patients with newly diagnosed CML-CP.