Extended anticoagulation supported for cancer patients with isolated distal DVTs

medwireNews: Among people with cancer and isolated distal deep vein thrombosis (DVT), the risk for symptomatic recurrent venous thromboembolism (VTE) and associated mortality is significantly lower with 12 versus 3 months of edoxaban treatment, shows the ONCO DVT trial. Yugo Yamashita (Kyoto University, Japan) – who presented the findings at the ESC Congress 2023 in Amsterdam, the Netherlands – said in a press release that “[t]his 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.” He continued: “We expect that the results will change practice and clinical guidelines in the cardio-oncology field.” In the trial, 604 patients from 60 institutions in Japan, all of whom had active cancer and a new ultrasonography-confirmed diagnosis of isolated distal DVT, were randomly assigned to receive edoxaban 60 mg/day for 12 or 3 months; a lower dose of 30 mg/day was allowed for individuals with a creatinine clearance of 30–50 mL/min, a bodyweight of 60 kg or less, or those receiving concomitant treatment with a P-glycoprotein inhibitor. Participants were aged an average of 70.8 years and nearly three-quarters (72%) were women. Cancer types included ovarian, uterine, lung, colon, and pancreatic. At the 12-month timepoint, the primary endpoint of symptomatic recurrent VTE or VTE-related death occurred in 1.2% of patients in the 12-month group and 8.5% of those in the 3-month group, a significant difference equating to an odds ratio in favor of the longer duration of 0.13. The presenter highlighted that the cumulative incidence of events was “quite low” and essentially identical in both arms up to the 3-month mark, after which it rose gradually in the 3-month edoxaban group. The major secondary endpoint of major bleeding occurred in a numerically higher proportion of patients treated with edoxaban for 12 versus 3 months, at a cumulative incidence at 12 months of 10.2% and 7.6%, respectively, but the between-group difference was not statistically significant. Yamashita outlined several limitations of the study, such as the open-label design, albeit with blinded adjudication of endpoints, lower than expected event rates of the primary endpoint, and a possible lack of generalizability of the results owing to the differences in races and inclusion of a variety of cancer types. The discussant, Teresa Lopez Fernandez (La Paz University Hospital, Madrid, Spain), said that “this study supports the need for extended anticoagulation” in people with active cancer and isolated distal DVTs. “But we need to be cautious and to try to really understand what are the bleeding risk of these patients, particularly because it’s not always easy to transfer the results from Asian populations to other populations,” she continued. And Lopez Fernandez concluded: “We need to really understand if these results are similar in clinical practice, with other [novel oral anticoagulants], other doses, and in specific patients with high risk of bleeding.” The study findings are published simultaneously in Circulation. medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2023 Springer Healthcare Ltd, part of the Springer Nature Group ESC Congress 2023; Amsterdam, the Netherlands: 25–28 August Circulation 2023; doi:10.1161/CIRCULATIONAHA.123.066360

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Extended anticoagulation supported for cancer patients with isolated distal DVTs

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