Use of direct oral anticoagulants (DOACs) in oncology: A phase IV study on impact of edoxaban treatment in Italian patients with cancer with venous thromboembolism during antineoplastic therapy (EDOI trial, GOIRC 05-2018)

6564 Background: The EDOI Study (EUDRACT 2018-003833-14) was designed to evaluate venous thromboembolism (VTE), a common complication of cancer and cancer therapy. VTE contributes to mortality and morbidity, and may interfere with therapy. When drafting the protocol, the standard treatment for VTE consisted of low-molecular weight heparin followed by vitamin K antagonists. DOACs are as effective as vitamin K antagonists in the treatment of VTE. Edoxaban has been confirmed to be effective and safe in the treatment of VTE. Adverse events (AEs) associated with DOACs can delay or interfere with chemotherapy; to date, data regarding the impact of Edoxaban treatment on cancer treatment AEs are scanty. Methods: In this multicentric, phase IV study, patients receiving an antineoplastic treatment (and candidates for at least 3 additional months of treatment) and diagnosed with VTE, received Edoxaban as per clinical practice. Patients received between 6 and 12 months of Edoxaban and were evaluated at baseline and after 1, 3 and 6 months. Primary endpoint was the impact of Edoxaban-related AEs on antineoplastic therapy, defined as delays/interruptions/reductions due to adverse drug reactions (ADR) related to Edoxaban (bleeding, hepatobiliary toxicity, renal toxicity, anemia, hypersensitivity reactions). As secondary endpoint, we assessed patient-reported outcomes (PROs) during treatment with Edoxaban (health-related quality of life: FACT-G, expectations and satisfaction with anticoagulant treatment: PACT-Q2 and ACTS). For each tool, mean scores at each time point were calculated. Results: One hundred and fifty patients were enrolled, 147 patients were evaluable. The Incidence density rate of antineoplastic therapy delay/interruption/reduction due to ADR related to Edoxaban was 0,8% per person-month (90% CI: [0,4; 1,5%] and 95% CI: [0,4; 1,6%]). For all the patient-reported outcomes, mean scores were maintained at different time points. Conclusions: The results of the study clearly show that the edoxaban treatment is well tolerated and has no relevant impact on the delivery of cancer treatments. Results in terms of quality of life and patients’ satisfaction with anticoagulant treatment are reassuring. Clinical trial information: EUDRACT 2018-003833-14 . [Table: see text]