Incidence of venous thromboembolism in advanced lung cancer and efficacy and safety of direct oral anticoagulant: A multicenter, prospective, observational study (Rising-VTE/NEJ037 Study).

Abstract

12021 Background: Venous thromboembolism (VTE) is a well-known kind of cancer-associated thrombosis and a common complication of malignancy. However, little is known about the incidence of VTE and the effectiveness of direct oral anticoagulants (DOACs) associated with lung cancer chemotherapy. Methods: The Rising-VTE/NEJ037 study was a multicenter, prospective, observational study with 40 participating Japanese institutions. A total of 1,021 patients diagnosed with lung cancer that was unsuitable for radical resection or radiation were enrolled and followed up for two years. The diagnosis of VTE was confirmed through a central review by two radiologists. Patients with VTE at the time of lung cancer diagnosis started treatment with edoxaban. The primary endpoint of this trial was the rate of newly diagnosed VTE after enrollment or the recurrence rate 6 months after the start of treatment with edoxaban. Results: Of the 1,021 enrolled patients, data were available for 1,008 patients. The median age was 70 years (range: 30-94 years), and 70.8% were males. Eighty-six percent of patients had non-small cell lung cancer, and 13.6% had small cell lung cancer. Histological types included adenocarcinoma (N = 641, 63.6%), squamous cell carcinoma (N = 187, 18.6%), and others (N = 42, 4.2%). Sixty-two patients (6.2%) had VTE at the time of lung cancer diagnosis, and 42 patients (4.2%) developed VTE during two years follow-up, making a total of 104 patients (10.3%). No cases of VTE recurrence were found 6 months after the start of treatment with edoxaban. Major and minor bleeding occurred in 95 patients (9.4%) and increased to 23% in the edoxaban treatment group. The two-year survival probability was 0.43 in the non-VTE group and 0.48 in the VTE with edoxaban treatment group, showing no difference. Conclusions: This study shows a high cumulative incidence of VTE, suggesting that attention should be paid to VTE during treatment for lung cancer. Treatment with edoxaban was highly effective in preventing recurrence of VTE, and there was no difference in survival with or without VTE, but treatment should be considered more carefully because of the high bleeding rate associated with DOAC. Clinical trial information: jRCTs061180025.