Dasatinib Dose Optimization With Weekend Drug Holiday for Improved Tolerability in Chronic Myeloid Leukemia (DasaHIT): A German Chronic Myeloid Leukemia Alliance Randomized Trial.

Authors

Paul La Rosée, Philipp Ernst, Christian Fabisch, Annamaria Brioli, Dominik Wolf, Lino L Teichmann, Ludwig Fischer von Weikersthal, Susanne Saussele, Theresa Früh, Frank Stegelmann, Cornelius F Waller, Bernd Hertenstein, Tim H Brümmendorf, Andreas Burchert, Jenny Rinke, Ali Albeer, Thomas Ernst, Markus Pfirrmann, Andreas Hochhaus, German CML Study Group

Published in

Journal of clinical oncology : official journal of the American Society of Clinical Oncology. Pages JCO2600899. Nov 13, 2026. Epub Nov 13, 2026.

Abstract

To compare standard-dose dasatinib 100 mg once daily with reduced-dose using a weekend drug holiday to improve tolerability for patients with chronic myeloid leukemia (CML).
Patients with chronic phase CML (CP-CML) were randomly assigned to either receive standard-of-care dasatinib 100 mg once daily or an intermittent dasatinib schedule (5 days on, 2 days [weekend] off) in a prospective multicenter phase III trial. Achievement of major molecular remission (MMR) at 24 months and a newly developed cumulative toxicity score were coprimary end points.
Of 289 eligible patients, 147 were assigned to standard-of-care dasatinib and 142 to intermittent dosing. Eighty percent of patients received first-line treatment (n = 232). In the standard arm, 105 of 130 patients (81% [95% CI, 74% to 88%) achieved MMR at 24 months compared with 101 of 130 patients (78% [95% CI, 71% to 85%]) in the experimental arm resulting in noninferiority within the prespecified noninferiority margin of 15% (P = .009). Among second- or later-line patients, MMR at 24 months was 24% lower, failing noninferiority. Comparison of grade 2-4 toxicities revealed no significant difference between the treatment arms. However, a post hoc analysis of toxicities of special interest (pleural effusion/pericardial effusion) showed 21 of 130 patients (16%) in the standard arm versus 10 of 125 (8%) patients in the experimental arm (P = .0464). Consistently, health-related quality of life improved mainly in first-line patients, with more favorable outcomes in the experimental arm.
Intermittent dasatinib dosing with weekend treatment holidays in patients with CP-CML is noninferior to continuous dosing with respect to MMR at 24 months, at least in the first-line setting. The incidence of pleural or pericardial effusion appears to be reduced compared with standard-of-care continuous dosing.

PMID:
43024850
Bibliographic data and abstract were imported from PubMed on 14 Nov 2026.

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