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Dasatinib discontinuation in patients with chronic-phase chronic myeloid leukemia and stable deep molecular response: the DASFREE study.

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Date

2019-10-24

Authors

Shah, Neil P
Garcia-Gutierrez, Valentin
Jimenez-Velasco, Antonio
Larson, Sarah
Saussele, Susanne
Rea, Delphine
Mahon, François-Xavier
Levy, Moshe Yair
Gomez-Casares, Maria Teresa
Pane, Fabrizio

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Taylor & Francis
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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.

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MeSH Terms

Aged
Dasatinib
Humans
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Chronic-Phase
Protein Kinase Inhibitors
Treatment Outcome

DeCS Terms

Aptitud
Análisis Multivariante
Inhibidores de la Tirosina Proteína Quinasa
Leucemia Mielógena Crónica BCR-ABL Positiva

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Keywords

CML-CP, Dasatinib, Deep molecular response, Imatinib, Major molecular response, Treatment-free remission

Citation

Shah, N. P., García-Gutiérrez, V., Jiménez-Velasco, A., Larson, S., Saussele, S., Rea, D., et al. Dasatinib discontinuation in patients with chronic-phase chronic myeloid leukemia and stable deep molecular response: the DASFREE study. Leukemia & Lymphoma/Leukemia And Lymphoma, 61(3), 650-659