Dasatinib in imatinib‐resistant or ‐intolerant chronic‐phase, chronic myeloid leukemia patients: 7‐year follow‐up of study CA180‐034. Issue 9 (20th June 2016)

• Record Type: Journal Article
• Authors: Shah, Neil P.; Rousselot, Philippe; Schiffer, Charles; Rea, Delphine; Cortes, Jorge E.; Milone, Jorge; Mohamed, Hesham; Healey, Diane; Kantarjian, Hagop; Hochhaus, Andreas; Saglio, Giuseppe
• Is Part Of: American journal of hematology. Volume 91:Issue 9(2016:Sep.)
• Page Start: 869
• Page End: 874
• Publication Date: 2016-06-20
• Subjects: Hematology -- Periodicals; 616.15
• DOI: 10.1002/ajh.24423
• Languages: English
• ISSNs: 0361-8609

Abstract

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.