1. Dasatinib in imatinib-resistant or -intolerant chronic-phase, chronic myeloid leukemia patients: 7-year follow-up of study CA180-034
- Author
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Jorge Milone, Philippe Rousselot, Andreas Hochhaus, Giuseppe Saglio, Diane Healey, Charles A. Schiffer, Delphine Rea, Hesham Mohamed, Hagop M. Kantarjian, Jorge E. Cortes, and Neil P. Shah
- Subjects
medicine.medical_specialty ,Myeloid ,Pleural effusion ,medicine.drug_class ,business.industry ,Myeloid leukemia ,Hematology ,medicine.disease ,Gastroenterology ,Pulmonary hypertension ,Tyrosine-kinase inhibitor ,Dasatinib ,03 medical and health sciences ,Leukemia ,0302 clinical medicine ,Imatinib mesylate ,medicine.anatomical_structure ,hemic and lymphatic diseases ,030220 oncology & carcinogenesis ,Internal medicine ,Immunology ,medicine ,business ,030215 immunology ,medicine.drug - 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.
- Published
- 2016