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Background <p>There is an increasing movement among chronic myeloid leukemia (CML) patients towards optimizing dosages and implementing personalized treatment plans.</p> Methods <p>We 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&#xa0;mg daily) and standard-dose dasatinib (100&#xa0;mg daily).</p> Results <p>No significant baseline differences in age, sex, Sokal risk, or ELTS scores were observed. The 100&#xa0;mg group had longer median treatment duration (56.1 vs. 30.3 months, <i>P</i> &lt; 0.001) and lower rates of sustained first-line therapy (61.3% vs. 95.6%, <i>P</i> &lt; 0.001). Both doses achieved comparable 12-month cumulative CCyR (100&#xa0;mg: 83.5% vs. 50&#xa0;mg: 93.2%, <i>P</i> = 0.25), MMR (58.3% vs. 59.1%, <i>P</i> = 0.94), MR4 (34.0% vs. 25.0%, <i>P</i> = 0.24), MR4.5 (23.3% vs.13.6%,<i> P</i> = 0.16), and 2-year EFS (86.3% vs. 91.1%; HR = 1.59, 95% CI = 0.69–3.64, <i>P</i> = 0.33). Time to response milestones (CCyR, MR4, DMR) showed no statistical difference. The 50&#xa0;mg group had significantly lower pleural effusion incidence (2.2% vs. 25.2%, <i>P</i> &lt; 0.001). No differences in hematologic or most non-hematologic AEs were observed. Among 37 patients who reduced from 100&#xa0;mg to 50&#xa0;mg, 35/37 (94.6%) maintained or deepened responses. Notably, 13 patients with MMR attained DMR post-reduction.</p> Conclusion <p>Dasatinib 50&#xa0;mg daily demonstrates non-inferior efficacy and superior safety compared to 100&#xa0;mg, particularly in reducing pleural effusion risk.</p>

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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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年2月11日

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  • Fang Cheng,
  • Fan Wang,
  • Zheng Cui,
  • Qiang Li,
  • Yu Zhu,
  • Weiming Li

摘要

Background

There is an increasing movement among chronic myeloid leukemia (CML) patients towards optimizing dosages and implementing personalized treatment plans.

Methods

We 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).

Results

No 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.

Conclusion

Dasatinib 50 mg daily demonstrates non-inferior efficacy and superior safety compared to 100 mg, particularly in reducing pleural effusion risk.