Abstract
Introduction Few data exist on the use of edoxaban in cancer-associated venous thromboembolism (VTE) outside of clinical trials. Aim of this study was to evaluate the characteristics and outcomes of these patients in a real world clinical setting. Methods We retrospectively analyzed the characteristics of patients with cancer-associated VTE who were prescribed edoxaban. Follow-up at 3, 6, and 12 months was performed: VTE recurrences, bleedings, mortality, cancer progression and treatment, edoxaban interruption and its reason were assessed. Results Fifty-four patients, 38 females (70.4%), mean age 71 ± 14 years, were enrolled. In 38 patients (70.4%), the episode of VTE was the first one, in 28 (51.8%) it was an isolated deep vein thrombosis (DVT), in 13 (24.1%) a pulmonary embolism (PE) associated with DVT, in 13 (24.1%) an isolated PE. Median time between cancer and VTE diagnosis was 6 (interquartile range [IQR] 2–47) months. Median time between VTE diagnosis and edoxaban prescription was 36 (IQR 7–117) days. At 3, 6, and 12 months the incidence of all-cause mortality was 16.6, 22.2, and 38.8%, that of VTE recurrence 1.8, 1.8, and 3.7%, and that of major bleeding 7.4, 9.2, and 12.9%, respectively. No bleeding was fatal. Of the 33 patients alive at 12 months, 32 (96.9%) were still on edoxaban therapy, in seven (21.2%) cancer was in progression. Conclusion Our study, conducted on a real world population of patients with cancer-associated VTE, confirms the results of randomized controlled clinical trials, and supports the use of edoxaban as effective and safe treatment in this context.
Highlights
Few data exist on the use of edoxaban in cancer-associated venous thromboembolism (VTE) outside of clinical trials
The episode of VTE was an isolated deep vein thrombosis (DVT) in 28 patients (51.8%), a pulmonary embolism (PE) associated with DVT or superficial vein thrombosis (SVT) in 13 cases (24.1%), an isolated PE in 13 (24.1%)
DVT involved the upper limbs in five patients (12.2%), was bilateral in six cases (14.6%), and proximal in 33 (80.5%)
Summary
Few data exist on the use of edoxaban in cancer-associated venous thromboembolism (VTE) outside of clinical trials. In recent years direct oral anticoagulants (DOACs) have shown similar efficacy and better safety profile compared with vitamin K antagonists, becoming the standard of care for the treatment of venous thromboembolism (VTE) in the general population. In the main phase III randomized clinical trials on DOACs for VTE treatment, a small percentage of patients, around 5 to 6%, were affected by cancer.[1] received November 30, 2021 accepted after revision February 1, 2022. The phase III randomized controlled clinical trials HOKUSAI-VTE CANCER,[3,4] SELECT-D,5 and the more recent ADAM-VTE6 and CARAVAGGIO7 confirmed the efficacy and safety of DOACs in patients with cancer-associated VTE. Few data exist on the use of DOACs in patients with cancer-associated VTE in the real world as well as on 12-month follow-up.[13] Based on the results of these trials, since 2018 international guidelines recommend the use of DOACs as treatment of choice for such patients together with LMWH.[8–12] few data exist on the use of DOACs in patients with cancer-associated VTE in the real world as well as on 12-month follow-up.[13]
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