Prolonged Edoxaban in Patients With Low Body Weight and Cancer-Associated Isolated Distal Deep Vein Thrombosis

BACKGROUND: The ONCO DVT study revealed that 12-month edoxaban treatment for cancer-associated isolated distal deep vein thrombosis (IDDVT) was superior to 3-month edoxaban treatment. However, the influence of body weight on efficacy and safety remains unknown. OBJECTIVES: We compared 12-month and 3-month edoxaban treatments in patients with low body weight and cancer-associated IDDVT. METHODS: In this prespecified subgroup analysis of the ONCO DVT study, we divided patients by body weight with a 60 kg cutoff. The primary endpoint was symptomatic recurrent venous thromboembolism or venous thromboembolism-related death at 12 months. RESULTS: Of the 601 participants, 426 had low body weight, 99% receiving a reduced dose of edoxaban. The 1-year primary endpoint rate was significantly lower in the 12-month edoxaban group than in the 3-month group in both the low body weight (1.0% vs 6.2%, P = 0.003; OR: 0.15; 95% CI: 0.02-0.55) and the non-low body weight (1.0% vs 10.0%, P = 0.005; OR: 0.10; 95% CI: 0.01-0.54) subgroups. The 1-year major bleeding rate was not different between the 12-month and 3-month groups in the low body weight subgroup (7.0% vs 8.4%, P = 0.57), whereas in the non-low body weight subgroup, it was significantly higher in the 12-month edoxaban group than in the 3-month edoxaban group (14.7% vs 3.8%, P = 0.01). CONCLUSIONS: Twelve-month edoxaban treatment in cancer-associated IDDVT was superior to 3-month edoxaban treatment in terms of thrombotic events without increased bleeding risk among patients with low body weight but with increased bleeding risk among patients with non-low body weight.