In patients with cancer-associated thrombosis (CAT) who switched to rivaroxaban treatment after at least 4 weeks of standard anticoagulation therapy, the observed incidence proportions of recurrent venous thromboembolism (VTE) and bleeding events were in line with the recognized effectiveness and safety profile of rivaroxaban for the treatment of CAT, according to the results of a study published in Research and Practice in Thrombosis and Haemostasis.
The findings are from the analysis of secondary outcomes of COSIMO (Cancer-associated thrombosis patient – reported outcoMes with rivaroxaban; ClinicalTrails.gov Identifier: NCT02742623), a multinational, prospective, non-interventional, single-arm cohort study of patients with CAT who switched to rivaroxaban following ≥4 weeks of standard anticoagulation. The investigators aimed to determine the clinical characteristics, including patterns of anticoagulation therapy, and outcomes.
“The [COSIMO] study builds upon the existing evidence for the use of [direct oral anticoagulants] for the treatment of CAT by providing insights into the patient-reported treatment satisfaction and clinical outcomes with rivaroxaban for the treatment of VTE in patients with active cancer,” the authors wrote.
A total of 505 patients received at least 1 dose of rivaroxaban. Patients had a mean age of 64.0 ± 11.7 years, and most had an ECOG performance status of 0 (32.1%) or 1 (54.7%). The cohort was 66.4% female. Most patients had solid tumors (88.9%), and of these patients, 54.6% had metastases. Overall, 96.6% of patients had switched to rivaroxaban from low-molecular-weight heparin, while the remaining patients switched from a vitamin K antagonist (1.6%) or fondaparinux (1.8%).
Among the study patients, the index diagnosis was deep vein thrombosis (DVT) in 45.3%, pulmonary embolism (PE) in 37.2%, DVT with PE in 9.7%, and catheter-associated DVT in 7.5%. Most patients received rivaroxaban for ≥3 months (75.1%), and 29.7% of patients received concomitant chemotherapy. VTE recurrence was reported in 3.6% of the cohort; major bleeding, non-major bleeding, and major adverse cardiovascular events occurred in 3.6%, 16.0%, and 2.4% of the patients, respectively.
Limitations of the study included the single-arm design, the possibility of bias due to the limitation of the study to patients switching to rivaroxaban, the limited geographic distribution for the patterns of anticoagulant use, and the possibility of bias by indication and of selection bias for lower-risk patients.
“The incidence of recurrent VTE, rivaroxaban-related AEs, and bleeding events during the study was relatively low in this population of patients with previous anticoagulation therapy, suggesting that with appropriate patient selection, clinical benefit can be achieved with [direct oral anticoagulant] treatment in patients with CAT,” the authors concluded.
Disclosure: This research was supported by Bayer AG and Janssen Pharmaceuticals. Please see the original reference for a full list of disclosures.
Maraveyas A, Beyer-Westendorf J, Lee AY, et al. Cancer-associated thrOmboSIs – patient-reported outcoMes with rivarOxaban (COSIMO) – baseline characteristics and clinical outcomes. Res Pract Thromb Haemost. 2021;5(8):e12604. doi:10.1002/rth2.12604