Observational studyBMC cancer2026
Efficacy and safety of 50 mg versus 100 mg daily frontline dasatinib therapy in chronic-phase chronic myeloid leukemia: a non-controlled, observational dose-comparative cohort study.
Observational study in BMC cancer, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Authors and funding
6 authors.
Funding
Abstract
backgroundThere is an increasing movement among chronic myeloid leukemia (CML) patients towards optimizing dosages and implementing personalized treatment plans.
methodsWe conducted a non-randomized, non-controlled, observational cohort analysis to evaluate the efficacy and safety of first-line dasatinib treatment for CML, and compare the differences between low-dose dasatinib (50 mg daily) and standard-dose dasatinib (100 mg daily).
resultsNo significant baseline differences in age, sex, Sokal risk, or ELTS scores were observed. The 100 mg group had longer median treatment duration (56.1 vs. 30.3 months, P < 0.001) and lower rates of sustained first-line therapy (61.3% vs. 95.6%, P < 0.001). Both doses achieved comparable 12-month cumulative CCyR (100 mg: 83.5% vs. 50 mg: 93.2%, P = 0.25), MMR (58.3% vs. 59.1%, P = 0.94), MR4 (34.0% vs. 25.0%, P = 0.24), MR4.5 (23.3% vs.13.6%, P = 0.16), and 2-year EFS (86.3% vs. 91.1%; HR = 1.59, 95% CI = 0.69–3.64, P = 0.33). Time to response milestones (CCyR, MR4, DMR) showed no statistical difference. The 50 mg group had significantly lower pleural effusion incidence (2.2% vs. 25.2%, P < 0.001). No differences in hematologic or most non-hematologic AEs were observed. Among 37 patients who reduced from 100 mg to 50 mg, 35/37 (94.6%) maintained or deepened responses. Notably, 13 patients with MMR attained DMR post-reduction.
conclusionDasatinib 50 mg daily demonstrates non-inferior efficacy and superior safety compared to 100 mg, particularly in reducing pleural effusion risk.
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