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- Title
Evaluation of cardiovascular ischemic event rates in dasatinib-treated patients using standardized incidence ratios.
- Authors
Saglio, Giuseppe; Coutre, Philipp; Cortes, Jorge; Mayer, Jiří; Rowlings, Philip; Mahon, François-Xavier; Kroog, Glenn; Gooden, Kyna; Subar, Milayna; Shah, Neil; le Coutre, Philipp; Mayer, Jiří; Mahon, François-Xavier; Shah, Neil P
- Abstract
With high survival rates for chronic myeloid leukemia (CML) patients treated with BCR-ABL1 tyrosine kinase inhibitors (TKIs), emerging consequences, such as arterial ischemic events, require consideration when evaluating treatment options. Cardiovascular ischemic event incidence in clinical trials was evaluated in 2712 dasatinib-treated patients with Philadelphia chromosome-positive (Ph+) leukemias from 11 first- and second-line trials (pooled), newly diagnosed CML patients treated with dasatinib or imatinib (DASISION), and prostate cancer patients treated with dasatinib or placebo plus docetaxel/prednisone (READY). Overall, 2-4% of dasatinib-treated patients had cardiovascular ischemic events. Most dasatinib-treated patients with an event had a history of and/or risk factor for atherosclerosis (pooled 77 with history/risk and event/96 with events; DASISION 8/10; READY 15/18). Most cardiovascular ischemic events occurred within 1 year of initiating dasatinib (pooled 69/96; DASISION 7/10; READY 16/18). Comparison of observed and expected event rates through standardized incidence ratios indicates that dasatinib does not increase risk for cardiovascular ischemic events compared with external reference populations.
- Subjects
MYELOID leukemia; LEUKEMIA treatment; TYROSINE; DASATINIB; IMATINIB; ANTINEOPLASTIC agents; THERAPEUTICS
- Publication
Annals of Hematology, 2017, Vol 96, Issue 8, p1303
- ISSN
0939-5555
- Publication type
journal article
- DOI
10.1007/s00277-017-3012-z