Frontiers in pharmacology · 2026
Low-dose dasatinib in second-line therapy or beyond for the treatment of chronic-phase chronic myeloid leukemia: a real-world cohort study.
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Chen Yilin, Wang Hongxiang, Cheng Fang, Li Weiming
Аннотация
BACKGROUND: Dasatinib is a favorable option for patients with chronic-phase chronic myeloid leukemia (CML-CP) who have an inadequate response, treatment intolerance, or are attempting treatment-free remission (TFR). Dasatinib dose reduction is a strategy to improve tolerability while maintaining efficacy in first-line settings or patients with a stable molecular response. However, whether low-dose dasatinib is safe and effective in second-line or later setting for patients with CML-CP remains unclear.
METHODS: We conducted a retrospective analysis of 53 patients with CML-CP who switched to low-dose dasatinib due to inadequate molecular response (n = 37), treatment intolerance (n = 13), or to re-induce a deeper molecular response (n = 3).
RESULTS: Among the 37 patients who had not achieved major molecular response (MMR) before switching, 10 patients (27.0%) attained MMR, 12 patients (32.4%) achieved deep molecular response (DMR/MR4), and 11 patients (29.7%) reached molecular response 4.5 (MR4.5) following low-dose dasatinib therapy. Notably, 81.8% of patients with only baseline MMR improved to MR4 or MR4.5 after switching to low-dose dasatinib. One patient lost MR4 while receiving dasatinib at 50 mg/day and subsequently switched to nilotinib. All three patients who were switched to re-induce deeper molecular responses successfully re-attained MR4.5 after switching to low-dose dasatinib. Adverse events resolved in all 13 patients who switched due to prior TKI intolerance, and no worsening grade 2 or more adverse events were observed.
CONCLUSION: Our findings suggest that low-dose dasatinib for selected patients with CML-CP in second-line therapy or beyond may be safe and effective under close monitoring. Nevertheless, multicenter prospective clinical trials are needed to validate the efficacy and safety of low-dose dasatinib therapy in second-line treatment settings or beyond in CML.
METHODS: We conducted a retrospective analysis of 53 patients with CML-CP who switched to low-dose dasatinib due to inadequate molecular response (n = 37), treatment intolerance (n = 13), or to re-induce a deeper molecular response (n = 3).
RESULTS: Among the 37 patients who had not achieved major molecular response (MMR) before switching, 10 patients (27.0%) attained MMR, 12 patients (32.4%) achieved deep molecular response (DMR/MR4), and 11 patients (29.7%) reached molecular response 4.5 (MR4.5) following low-dose dasatinib therapy. Notably, 81.8% of patients with only baseline MMR improved to MR4 or MR4.5 after switching to low-dose dasatinib. One patient lost MR4 while receiving dasatinib at 50 mg/day and subsequently switched to nilotinib. All three patients who were switched to re-induce deeper molecular responses successfully re-attained MR4.5 after switching to low-dose dasatinib. Adverse events resolved in all 13 patients who switched due to prior TKI intolerance, and no worsening grade 2 or more adverse events were observed.
CONCLUSION: Our findings suggest that low-dose dasatinib for selected patients with CML-CP in second-line therapy or beyond may be safe and effective under close monitoring. Nevertheless, multicenter prospective clinical trials are needed to validate the efficacy and safety of low-dose dasatinib therapy in second-line treatment settings or beyond in CML.