Factors affecting hemorrhagic events in patients with advanced lung cancer: from the Rising-VTE/NEJ037 study

Background: Despite the occurrence of various hemorrhagic events during the treatment of advanced lung cancer, few studies have reported on their risk factors. In addition, the development of cancer-related thromboembolism indicates the use of anticoagulants. However, adverse events such as bleeding should be monitored. This study aimed to identify the factors that influence the onset of hemorrhagic events in patients with advanced lung cancer. Methods: The Rising-VTE/NEJ037 study was a multicenter, prospective, observational study. A total of 1008patients with lung cancer who were unsuitable for radical resection or radiation were enrolled and followed up for 2 years. Multivariate analysis using a Cox proportional hazard model was performed to compare the outcomes of the time to the onset of hemorrhagic events for 2 years after registration. Results: Hemorrhagic events occurred in 115 patients (11.4%), of which 35 (30.4%) had major bleeding events. The factors that significantly increased the risk of hemorrhagic events were venous thromboembolism (VTE) and an Eastern Cooperative Oncology Performance Status score of 1. The factors that significantly reduced the risk of hemorrhagic events were female sex and M1a status. Conclusion: VTE is a risk factor for hemorrhagic events in patients with advanced lung cancer, and risks associated with anticoagulant therapy should be considered.