Dasatinib induces durable cytogenetic responses in patients with chronic myelogenous leukemia in chronic phase with resistance or intolerance to imatinib

A. Hochhaus, M. Baccarani, M. Deininger, J. F. Apperley, J. H. Lipton, S. L. Goldberg, S. Corm, N. P. Shah, F. Cervantes, R. T. Silver, D. Niederwieser, R. M. Stone, H. Dombret, R. A. Larson, L. Roy, T. Hughes, M. C. Müller, R. Ezzeddine, A. M. Countouriotis, H. M. Kantarjian

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Abstract

Dasatinib, a potent inhibitor of BCR-ABL in vitro, is effective for patients with chronic myelogenous leukemia (CML) resistant or intolerant to imatinib. To provide a more definitive assessment of dasatinib in chronic-phase (CP)-CML, we report extended follow-up of a phase II trial, presenting data for the entire patient cohort (N=387). Dasatinib (70mg) twice daily was administered to patients with imatinib-resistant or -intolerant CP-CML. With median follow-up of 15.2 months (treatment duration, <1-18.4 months), a complete hematologic response was attained or maintained in 91% of patients. A major cytogenetic response (MCyR) was attained or maintained by 59% (52% imatinib resistant and 80% imatinib intolerant); this was complete in 49% of patients (40% imatinib resistant and 75% imatinib intolerant). Of 230 patients achieving an MCyR, 7 experienced disease progression. Fifteen-month progression-free survival was 90% while overall survival was 96%. Grade 3/4 thrombocytopenia and neutropenia were reported in 48 and 49% of patients, respectively. Non-hematologic toxicity (any grade) consisted primarily of diarrhea (37%), headache (32%), fatigue (31%), dyspnea (30%) and pleural effusion (27%). Pleural effusions were classified as grade 3 in 6% of reported events, with no incidence of grade 4. Dasatinib is associated with high response rates in patients with imatinib-resistant or -intolerant CP-CML.

Original languageEnglish
Pages (from-to)1200-1206
Number of pages7
JournalLeukemia
Volume22
Issue number6
DOIs
Publication statusPublished - Jun 2008

ASJC Scopus subject areas

  • Hematology
  • Oncology
  • Cancer Research

Cite this

Hochhaus, A., Baccarani, M., Deininger, M., Apperley, J. F., Lipton, J. H., Goldberg, S. L., ... Kantarjian, H. M. (2008). Dasatinib induces durable cytogenetic responses in patients with chronic myelogenous leukemia in chronic phase with resistance or intolerance to imatinib. Leukemia, 22(6), 1200-1206. https://doi.org/10.1038/leu.2008.84