Dasatinib in imatinib‐resistant or ‐intolerant chronic‐phase,chronic myeloid leukemia patients: 7‐year follow‐up of study CA180‐034 |
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Authors: | Neil P. Shah Philippe Rousselot Charles Schiffer Delphine Rea Jorge E. Cortes Jorge Milone Hesham Mohamed Diane Healey Hagop Kantarjian Andreas Hochhaus Giuseppe Saglio |
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Affiliation: | 1. UCSF School of Medicine, San Francisco, California;2. H?pital André Mignot and Université Versailles Saint‐Quentin‐en‐Yvelines, Versailles, France;3. Wayne State University School of Medicine, Detroit, Michigan;4. Saint Louis Hospital, Paris, France;5. University of Texas M.D. Anderson Cancer Center, Houston, Texas;6. Hospital Italiano De La Plata, La Plata, Argentina;7. Bristol‐Myers Squibb, Princeton, New Jersey;8. Universit?tsklinikum Jena, Jena, Germany;9. University of Turin, Turin, Italy |
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Abstract: | Dasatinib was approved at 100 mg once daily for imatinib‐resistant or ‐intolerant patients with chronic myeloid leukemia (CML) in chronic phase, based on results of the phase 3 CA180‐034 (NCT00123474) study. Here we present the final 7‐year analysis of this pivotal study, the longest follow‐up to date of any second‐generation BCR–ABL1 tyrosine kinase inhibitor (TKI). Patients (n = 670) with imatinib‐resistant or ‐intolerant CML in chronic phase received dasatinib. Nineteen percent of patients continued on study treatment, with a greater proportion in the 100 mg once daily arm remaining on therapy. Seven‐year rates for major molecular response (MMR), progression‐free survival (PFS), and overall survival (OS) were similar across doses; MMR, PFS, and OS results were 46, 42, and 65% at 100 mg once daily, respectively. Improved PFS and OS rates were reported in patients who achieved BCR–ABL1 ≤10% at 3 and 6 months. No new safety signals were identified. The incidence of drug‐related pleural effusion was 28% at 100 mg once daily and 35% at the other three dose groups. Incidence of drug‐related pulmonary hypertension and pulmonary arterial hypertension remained low (≤3% across all doses). Arterial ischemic events occurred in ≤4% of patients across all doses. These data support the long‐term efficacy and well‐established safety profile of dasatinib for patients with imatinib‐resistant or ‐intolerant CML in chronic phase. Am. J. Hematol. 91:869–874, 2016. © 2016 Wiley Periodicals, Inc. |
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