Evaluation of cardiovascular ischemic event rates in dasatinib-treated patients using standardized incidence ratios

Authors

SAGLIO Giuseppe COUTRE Philipp le CORTES Jorge MAYER Jiří ROWLINGS Philip MAHON Francois Xavier KROOG Glenn GOODEN Kyna SUBAR Milayna SHAH Neil P.

Year of publication 2017
Type Article in Periodical
Magazine / Source Annals of hematology
MU Faculty or unit

Faculty of Medicine

Citation
Doi http://dx.doi.org/10.1007/s00277-017-3012-z
Field Oncology and hematology
Keywords Chronic myeloid leukemia; Tyrosine kinase inhibitors; Dasatinib; Cardiovascular; Ischemic
Description 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.

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