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Patients with cancer and distal deep vein thrombosis (DVT) who are treated with the anticoagulant edoxaban for 12 months have a reduced risk of thrombotic events compared to those who are take edoxaban for just three months, according to the results of a clinical trial.
Principal investigator Dr. Yugo Yamashita of Kyoto University, Japan said he expects the results will “change practice and clinical guidelines in the cardio-oncology field.”
- Further reading: ESC Congress 2023 conference report
ONCO DVT was the first randomised trial to compare two different treatment durations of edoxaban for isolated distal DVT in patients with cancer.
Patients with active cancer and minor blood clots enrolled in trial
The trial enrolled patients with active cancer and newly diagnosed isolated distal DVT and compared 12 months of treatment with edoxaban to three months of treatment with edoxaban. The most frequent site of cancer was the ovaries (14%), followed by the uterus (13%), lung (11%), colon (9%) and pancreas (8%). The remaining cancer types included stomach (5%), blood (5%) and breast (5%).
Patients were randomised in a 1:1 fashion to 12 months of edoxaban or 3 months of edoxaban. Patients were typically administered an oral fixed dose of 60 mg of edoxaban once daily. However, patients with a creatinine clearance of 30 to 50 mL/minute, or a body weight of 60 kg or less, or receiving concomitant treatment with a P-glycoprotein inhibitor were administered a lower dose of 30 mg once daily.
In total, 604 patients with an average age of 70.8 years were included in the trial. The primary endpoint was symptomatic recurrent venous thromboembolism (VTE) or VTE-related death event at 12 months. The secondary endpoint was a major bleeding event at 12 months.
Extended edoxaban treatment improved outcomes
The primary endpoint occurred in three of 296 patients (1.0%) in the 12-month edoxaban group and in 22 of 305 patients (7.2%) in the 3-month edoxaban group.
Major bleeding occurred in 28 of 296 patients (9.5%) in the 12-month edoxaban group and in 22 of 305 patients (7.2%) in the 3-month edoxaban group.
Dr. Yamashita said: “In cancer patients with isolated distal DVT, 12 months of edoxaban treatment was superior to 3 months with respect to the composite outcome of symptomatic recurrent VTE or VTE-related death with no difference in the rate of major bleeding.
“This is the first and only randomised trial to show the superiority of longer duration over shorter duration of anticoagulation therapy for reducing thrombotic events in cancer patients with isolated distal DVT.”