Impact of edoxaban-related adverse events in patients with cancer experiencing venous thromboembolism during antineoplastic therapy: Results of the phase IV EDOI study (GOIRC-05–2018)

Background: The oral factor Xa inhibitor, edoxaban, is effective and safe in cancer-associated Venous Thromboembolism (VTE) treatment. The EDOI study aims to evaluate compliance and quality of life (QoL) in patients with cancer-associated VTE treated with edoxaban during antineoplastic care. Material and methods: The EDOI was a multicentre phase IV, single-arm study. Patients received edoxaban for at least 6 months. The primary objective was to evaluate the rate and 90 % Confidence Intervals of edoxaban-related adverse events (AEs) with impact on antineoplastic therapy in terms of delays, reduction, or interruption. Mixed models for repeated measure have been adopted to evaluate the secondary endpoint as the change of QoL scores from enrolment to 6 months. Results: From July 2019 to March 2021, 147 patients were enrolled. Edoxaban-related AEs with impact on antineoplastic therapy were observed in 7 patients (4.76 %; 90 %CI 2.23 %-8.94 %). The cumulative incidence of AEs was 2.7 % at 1 month from enrolment. A statistically significant increase (p < 0.05) was observed for mean changes in PACT-Q2 Convenience (+5 points) and Satisfaction (at least +2.5), and reduction of ACTS Burden (at least +1.7) at 1 month. Overall QoL measured by FACT-G shows a mean increase in the first month (+1.3), while decreases in the subsequent 5 months (-2.5). Conclusion: The results of the EDOI Study demonstrate that edoxaban was well tolerated in patients receiving cancer treatment, showing a low rate of AEs with an impact on antineoplastic therapy, mainly within the first 30 days of administration. Lastly, the edoxaban-related AEs did not result in a lower overall QoL.