TY - JOUR
T1 - Dasatinib in imatinib-resistant or -intolerant chronic-phase, chronic myeloid leukemia patients
T2 - 7-year follow-up of study CA180-034
AU - Shah, Neil P.
AU - Rousselot, Philippe
AU - Schiffer, Charles
AU - Rea, Delphine
AU - Cortes, Jorge E.
AU - Milone, Jorge
AU - Mohamed, Hesham
AU - Healey, Diane
AU - Kantarjian, Hagop
AU - Hochhaus, Andreas
AU - Saglio, Giuseppe
N1 - Publisher Copyright:
© 2016 The Authors. American Journal of Hematology Published by Wiley Periodicals, Inc.
PY - 2016/9/1
Y1 - 2016/9/1
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=84983070734&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84983070734&partnerID=8YFLogxK
U2 - 10.1002/ajh.24423
DO - 10.1002/ajh.24423
M3 - Article
C2 - 27192969
AN - SCOPUS:84983070734
SN - 0361-8609
VL - 91
SP - 869
EP - 874
JO - American Journal of Hematology
JF - American Journal of Hematology
IS - 9
ER -