0195: Identification of patients (pts) with chronic myeloid leukemia (CML) at high risk of artery occlusive events (AOE) during treatment with the 2nd generation tyrosine kinase inhibitor (TKI) nilotinib

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Nilotinib is approved for use in pts with CML after failure of imatinib and in newly diagnosed CP-CML. However, several studies report a nilotinib-associated risk of AOE (arterial occlusive event), especially in pts with preexisting risk factors for CVD. In this study, we aimed at determining whether CVD risk estimation using the 2012 ESC classification could be useful to identify patients at high risk of AOE during nilotinib therapy. Pts (n=75) treated with nilotinib upfront or after failure of prior TKI at our institution were included provided that baseline CVD status could be retrospectively collected. Patients were categorized into 2 groups according to ESC 2012 classification: low/moderate (L/M) and high/very high (H/VH) CVD risk. At nilotinib initiation, median age was 51 years (19-76), 41 pts (54.7%) were males. At baseline, medical history revealed H/VH risk category in 15 pts (20%) including established CVD in 6 pts (8%) (all diagnosed before CML), DM (diabete melitus) in 10 pts (13.3%), severe AH (arterial hypertension) in 1 pt (1.3%), familial dyslipidemia in 1 pt (1.3%) and a SCORE ≥5% in 2 pts (2.6%). AOE occurred in 12 pts with myocardial infarction (MI) or coronary heart disease (CHD) (n=3), cerebrovascular events (CeVD) (n=3) and peripheral artery disease (PAD) (n=6). Cumulative incidence of AOE by 48 months was 72.22% (95% CI: 47.46-100) in the H/VH group and only 12.13% (95% CI: 4.32-34.08) in the L/M group. Log Rank comparison of Kaplan Meier analysis of 48-month survival without AOE showed a significant difference between the 2 groups (27.78% (95% CI: 0-58.9) versus 84.38% (95% CI: 67.04-100) p=0.0001). Sensitivity of the ESC classification in nilotinib-treated patients was 67% and specificity 89%. In our retrospective study, CVD risk estimation according to the 2012 ESC classification reveals that pts who belong to the H/VH risk group at baseline are at very high risk of AOE during nilotinib therapy. In this context, CVD risk should be reassessed throughout therapy and risk factors should be tightly controlled according to current guidelines.