Dasatinib discontinuation in patients with chronic-phase chronic myeloid leukemia and stable deep molecular response: the DASFREE study. Issue 3 (23rd February 2020)

• Record Type: Journal Article
• Authors: Shah, Neil P.; García-Gutiérrez, Valentín; Jiménez-Velasco, Antonio; Larson, Sarah; Saussele, Susanne; Rea, Delphine; Mahon, François-Xavier; Levy, Moshe Yair; Gómez-Casares, María Teresa; Pane, Fabrizio; Nicolini, Franck-Emmanuel; Mauro, Michael J.; Sy, Oumar; Martin-Regueira, Patricia; Lipton, Jeffrey H.
• Is Part Of: Leukemia & lymphoma. Volume 61:Issue 3(2020)
• Page Start: 650
• Page End: 659
• Publication Date: 2020-02-23
• Subjects: Dasatinib -- imatinib -- deep molecular response -- treatment-free remission -- major molecular response -- CML-CP; Leukemia -- Periodicals; Lymphomas -- Periodicals; 616.99419
• DOI: 10.1080/10428194.2019.1675879
• Languages: English
• ISSNs: 1042-8194

Abstract

Abstract: Treatment-free remission (TFR) in patients with chronic myeloid leukemia in chronic phase (CML-CP) is considered a feasible option, especially with the ability of second-generation tyrosine kinase inhibitors to induce higher rates of sustained deep molecular response (DMR). DASFREE is an open-label, single-arm, multicenter phase II trial assessing TFR after dasatinib discontinuation in patients with CML-CP ( N = 84). At 2 years, TFR was 46% in all patients. Multivariate analyses revealed statistically significant associations between 2-year TFR and duration of prior dasatinib (≥median; p = .0051), line of therapy (first line; p = .0138), and age (>65 years; p = .0012). No disease transformation occurred, and the most common adverse events experienced off treatment were musculoskeletal (observed in 30 patients); however, dasatinib withdrawal events were reported in nine patients (11%) by the investigator. Overall, these findings support the feasibility of discontinuing dasatinib for patients with CML-CP in sustained DMR in the first line and beyond.