Results of dasatinib therapy in patients with early chronic-phase chronic myeloid leukemia

Jorge E. Cortes, Dan Jones, Susan O'Brien, Elias Jabbour, Farhad Ravandi, Charles Koller, Gautam Borthakur, Brenda Walker, Weiqiang Zhao, Jianqin Shan, Hagop Kantarjian

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181 Scopus citations

Abstract

Purpose: Dasatinib is effective therapy for chronic myeloid leukemia (CML) after imatinib failure. In this study, we investigate the efficacy of dasatinib as initial therapy for patients with CML in early chronic phase. Patients and Methods: Patients with newly diagnosed CML in early chronic phase were randomly assigned to receive dasatinib 100 mg once daily or 50 mg twice daily as initial therapy. Results: Among 50 patients observed for at least 3 months, 49 patients (98%) achieved a complete cytogenetic response (CCyR), and 41 patients (82%) achieved a major molecular response (MMR). Responses occurred rapidly, with 94% of patients achieving CCyR by 6 months. There was no difference in response rate by treatment arm. The projected event-free survival rate at 24 months is 88%, and all patients are alive after a median follow-up time of 24 months. Grade ≥ 3 neutropenia and thrombocytopenia occurred in 21% and 10% of patients, respectively. Nonhematologic toxicity was usually grade 1 to 2. There was no significant difference in toxicity between the two arms, and the actual median dose at 12 months was 100 mg (range, 20 to 100 mg). Conclusion: Dasatinib is an effective agent for the initial management of CML in early chronic phase, producing high rates of CCyR and MMR.

Original languageEnglish (US)
Pages (from-to)389-404
Number of pages16
JournalJournal of Clinical Oncology
Volume28
Issue number3
DOIs
StatePublished - Jan 20 2010
Externally publishedYes

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ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Cortes, J. E., Jones, D., O'Brien, S., Jabbour, E., Ravandi, F., Koller, C., Borthakur, G., Walker, B., Zhao, W., Shan, J., & Kantarjian, H. (2010). Results of dasatinib therapy in patients with early chronic-phase chronic myeloid leukemia. Journal of Clinical Oncology, 28(3), 389-404. https://doi.org/10.1200/JCO.2009.25.4920