TY - JOUR
T1 - Low-Dose Dasatinib (50 mg Daily) Frontline Therapy in Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia
T2 - 5-Year Follow-Up Results
AU - Gener-Ricos, Georgina
AU - Haddad, Fadi G.
AU - Sasaki, Koji
AU - Issa, Ghayas C.
AU - Skinner, Jeffrey
AU - Masarova, Lucia
AU - Borthakur, Gautam
AU - Alvarado, Yesid
AU - Garcia-Manero, Guillermo
AU - Jabbour, Elias
AU - Kantarjian, Hagop
N1 - Publisher Copyright:
© 2023 Elsevier Inc.
PY - 2023/10
Y1 - 2023/10
N2 - Background: Dasatinib is a BCR::ABL1 tyrosine kinase inhibitor approved as frontline therapy at a 100 mg daily for chronic myeloid leukemia in chronic phase (CML-CP). The use of a lower dose of dasatinib (50 mg daily) has demonstrated better tolerance and improved outcomes compared with the standard dose. Here, we report the updated results in a large cohort with a 5-year follow-up. Patients and Methods: Patients with newly diagnosed CML-CP were eligible. Entry and response-outcome criteria were standard. Dasatinib was given as 50 mg orally daily. Results: Eighty-three patients were included. At 3 months, 78 (96%) patients achieved BCR::ABL1 transcripts (IS) ≤10%, and at 12 months, 65 (81%) patients achieved BCR::ABL1 transcript (IS) ≤0.1%. The cumulative incidence of complete cytogenetic, major molecular, and deep molecular responses at 5 years were 98%, 95%, and 82%, respectively. Rates of failures due to resistance (n = 4; 5%) and toxicity (n = 4; 5%) were low. The 5-year overall survival was 96% and event-free survival 90%. No transformations to accelerated or blastic phase were observed. Grade 3 to 4 pleural effusions developed in 2% of patients. Conclusion: Dasatinib 50 mg daily is an effective and safe treatment for newly diagnosed CML-CP.
AB - Background: Dasatinib is a BCR::ABL1 tyrosine kinase inhibitor approved as frontline therapy at a 100 mg daily for chronic myeloid leukemia in chronic phase (CML-CP). The use of a lower dose of dasatinib (50 mg daily) has demonstrated better tolerance and improved outcomes compared with the standard dose. Here, we report the updated results in a large cohort with a 5-year follow-up. Patients and Methods: Patients with newly diagnosed CML-CP were eligible. Entry and response-outcome criteria were standard. Dasatinib was given as 50 mg orally daily. Results: Eighty-three patients were included. At 3 months, 78 (96%) patients achieved BCR::ABL1 transcripts (IS) ≤10%, and at 12 months, 65 (81%) patients achieved BCR::ABL1 transcript (IS) ≤0.1%. The cumulative incidence of complete cytogenetic, major molecular, and deep molecular responses at 5 years were 98%, 95%, and 82%, respectively. Rates of failures due to resistance (n = 4; 5%) and toxicity (n = 4; 5%) were low. The 5-year overall survival was 96% and event-free survival 90%. No transformations to accelerated or blastic phase were observed. Grade 3 to 4 pleural effusions developed in 2% of patients. Conclusion: Dasatinib 50 mg daily is an effective and safe treatment for newly diagnosed CML-CP.
KW - Complete cytogenetic response
KW - Major molecular response
KW - Outcome
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U2 - 10.1016/j.clml.2023.05.009
DO - 10.1016/j.clml.2023.05.009
M3 - Article
C2 - 37308342
AN - SCOPUS:85163404063
SN - 2152-2650
VL - 23
SP - 742
EP - 748
JO - Clinical Lymphoma, Myeloma and Leukemia
JF - Clinical Lymphoma, Myeloma and Leukemia
IS - 10
ER -