Association of ALK rearrangement and risk of venous thromboembolism in patients with non-small cell lung cancer: A prospective cohort study.

BACKGROUND: Isolated reports are inconsistent regarding the risk of venous thromboembolism (VTE) in patients with anaplastic lymphoma kinase (ALK) rearranged non-small cell lung cancer (NSCLC). This study examined whether ALK rearrangement could have an influence on VTE in a prospective cohort. METHODS: In a cohort of 836 consecutive patients with NSCLC, patients with epidermal growth factor receptor (EGFR) or kitten rat sarcoma (KRAS) mutations were ruled out for VTE interference. Finally, 341 qualified patients were observed. The median follow up period is 7.5 months (3.1-15.4m). ALK rearrangement was detected by fluorescence in situ hybridization at baseline. RESULTS: Overall VTE events occurred in 37 (10.9%) of 341 patients. In multivariable analysis including age, sex, tumor histology, tumor stage, performance status, and ALK status, ALK rearrangement (sub-distribution hazard radio 2.47, 95% confidence interval 1.04-5.90) was associated with the increased risk of VTE. The cumulative incidence of VTE was 26.9% and 9.2% in the patients with and without ALK rearrangement after 6 months. After 1 year the corresponding cumulative incidence was 26.9% and 9.7% respectively (Gray test P = .005). CONCLUSIONS: The presence of ALK rearrangement is associated with increased risk of VTE in patients with NSCLC.