Work

Rapid clinical improvement of peripheral artery occlusive disease symptoms after nilotinib discontinuation despite persisting vascular occlusion

Year: 2014

Type: article

Abstract: Peripheral artery occlusive disease (PAOD) is an emerging adverse event in chronic myelogenous leukemia (CML) patients treated with nilotinib. 1 , 2 , 3 , 4 The largest published cohort of CML patients treated with nilotinib comes from the phase III ENESTnd trial (Evaluating Nilotinib Efficacy and Safety in Clinical Trials - newly diagnosed patients), which compared nilotinib (300 or 400 mg BID) to standard therapy with imatinib (400 mg). From the 3-year follow-up analysis published in 2012, 8 patients out of 556 (1.4%) in the nilotinib arm were identified as having PAOD. 5 This figure does not take into account three patients reported in the 2-year analysis as having PAOD, but who were removed from the 3-year analysis as a result of changes in the AE search algorithm. 6 When these three patients are included, 11 patients out of 556 (2.0%) can be considered as having PAOD compared to no cases among the 280 patients treated in the imatinib arm.

Source: Blood Cancer Journal

DOI: 10.1038/bcj.2014.66