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

Giuseppe Saglio, Philipp le Coutre, Jorge Cortes, Jiří Mayer, Philip Rowlings, François Xavier Mahon, Glenn Kroog, Kyna Gooden, Milayna Subar, Neil P. Shah

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Pages (from-to)1303-1313
Number of pages11
JournalAnnals of Hematology
Volume96
Issue number8
DOIs
StatePublished - Aug 1 2017

Fingerprint

Incidence
docetaxel
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Philadelphia Chromosome
Prednisone
Dasatinib
Protein-Tyrosine Kinases
Prostatic Neoplasms
Atherosclerosis
Leukemia
Survival Rate
History
Placebos
Clinical Trials
Population
Therapeutics

Keywords

  • Cardiovascular
  • Chronic myeloid leukemia
  • Dasatinib
  • Ischemic
  • Tyrosine kinase inhibitors

ASJC Scopus subject areas

  • Hematology

Cite this

Evaluation of cardiovascular ischemic event rates in dasatinib-treated patients using standardized incidence ratios. / Saglio, Giuseppe; le Coutre, Philipp; Cortes, Jorge; Mayer, Jiří; Rowlings, Philip; Mahon, François Xavier; Kroog, Glenn; Gooden, Kyna; Subar, Milayna; Shah, Neil P.

In: Annals of Hematology, Vol. 96, No. 8, 01.08.2017, p. 1303-1313.

Research output: Contribution to journalArticle

Saglio, G, le Coutre, P, Cortes, J, Mayer, J, Rowlings, P, Mahon, FX, Kroog, G, Gooden, K, Subar, M & Shah, NP 2017, 'Evaluation of cardiovascular ischemic event rates in dasatinib-treated patients using standardized incidence ratios', Annals of Hematology, vol. 96, no. 8, pp. 1303-1313. https://doi.org/10.1007/s00277-017-3012-z
Saglio, Giuseppe ; le Coutre, Philipp ; Cortes, Jorge ; Mayer, Jiří ; Rowlings, Philip ; Mahon, François Xavier ; Kroog, Glenn ; Gooden, Kyna ; Subar, Milayna ; Shah, Neil P. / Evaluation of cardiovascular ischemic event rates in dasatinib-treated patients using standardized incidence ratios. In: Annals of Hematology. 2017 ; Vol. 96, No. 8. pp. 1303-1313.
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