Dasatinib in the treatment of chronic myeloid leukemia in accelerated phase after imatinib failure: The START a trial

Jane F. Apperley, Jorge E. Cortes, Dong Wook Kim, Lydia Roy, Gail J. Roboz, Gianantonio Rosti, Eduardo O. Bullorsky, Elisabetta Abruzzese, Andreas Hochhaus, Dominik Heim, Carmino A. De Souza, Richard A. Larson, Jeffrey H. Lipton, H. Jean Khoury, Hyeoung Joon Kim, Christian Sillaber, Timothy P. Hughes, Philipp Erben, Jan Van Tornout, Richard M. Stone

Research output: Contribution to journalArticlepeer-review

162 Scopus citations


Purpose: Patients with chronic myelogenous leukemia in accelerated phase (CML-AP) that is resistant or intolerant to imatinib have limited therapeutic options. Dasatinib, a potent inhibitor of BCR-ABL and SRC-family kinases, has efficacy in patients with CML-AP who have experienced treatment failure with imatinib. We now report follow-up data from the full patient cohort of 174 patients enrolled onto a phase II trial to provide a more complete assessment of the efficacy and safety of dasatinib in this population. Patients and Methods: Patients with imatinib-resistant (n = 161) or -intolerant (n = 13) CML-AP received dasatinib 70 mg orally twice daily. Results: At a median follow-up of 14.1 months (treatment duration, 0.1 to 21.7 months), major and complete hematologic responses were attained by 64% and 45% of patients, respectively, and major and complete cytogenetic responses were achieved in 39% and 32% of patients, respectively. Responses were achieved irrespective of imatinib status (resistant or intolerant), prior stem-cell transplantation, or the presence of prior BCR-ABL mutation. The 12-month progression-free survival and overall survival rates were 66% and 82%, respectively. Dasatinib was generally well tolerated; the most frequent nonhematologic severe treatment-related adverse event was diarrhea (52%; grade 3 to 4, 8%). Cytopenias were common, including grade 3 to 4 neutropenia (76%) and thrombocytopenia (82%). Pleural effusion occurred in 27% of patients (grade 3 to 4, 5%). Conclusion: Dasatinib is effective in patients with CML-AP after imatinib treatment failure.

Original languageEnglish (US)
Pages (from-to)3472-3479
Number of pages8
JournalJournal of Clinical Oncology
Issue number21
StatePublished - Jul 20 2009
Externally publishedYes

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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