Cancer‐Associated ThrOmboSIs – Patient‐Reported OutcoMes With RivarOxaban (COSIMO) – Baseline characteristics and clinical outcomes

Abstract

Background Patients with cancer‐associated thrombosis (CAT) have a high risk of recurrent venous thromboembolic events, which contribute to significant morbidity and mortality. Direct oral anticoagulants may provide a convenient treatment option for these patients. Objectives To assess clinical characteristics and outcomes of patients with active cancer changing to rivaroxaban after ≥4 weeks of standard therapy for the treatment of venous thromboembolism (VTE) in clinical practice. This analysis focused on secondary outcomes of Cancer‐associated thrOmboSIs – Patient‐reported outcoMes with rivarOxaban (COSIMO). Patients COSIMO was a multinational, prospective, noninterventional, single‐arm cohort study. Overall, 505 patients received at least one dose of rivaroxaban; 96.6% changing from low‐molecular‐weight heparin, 1.6% from a vitamin K antagonist, and 1.8% from fondaparinux. Results Most patients had solid tumors (n = 449; 88.9%) and approximately half of these patients had metastases. The qualifying venous thromboembolic event was deep vein thrombosis (DVT) in 45.3% of patients, pulmonary embolism (PE) in 37.2% of patients, DVT with PE in 9.7% of patients, and catheter‐associated DVT in 7.5% of patients. Approximately 75.1% of patients received rivaroxaban for at least 3 months; 150 (29.7%) patients received concomitant chemotherapy during the study. VTE recurrence, major bleeding, nonmajor bleeding, and major adverse cardiovascular events occurred in 18 (3.6%), 18 (3.6%), 81 (16.0%), and 12 (2.4%) patients, respectively. Conclusions In patients with CAT who changed to rivaroxaban treatment after ≥4 weeks of standard therapy, the observed incidence proportions of recurrent VTE and bleeding events were in keeping with the recognized effectiveness and safety profile of rivaroxaban for the treatment of CAT.

Management of Cancer-Associated Thrombosis in France: A National Survey among Vascular Disease and Supportive Care Specialists

“…In the prospective non-interventional, single-arm cohort COSIMO study [ 20 ], patients receiving standard anticoagulation therapy (LMWH or VKA) for ≥4 weeks who were switched to rivaroxaban at the discretion of the treating physician were included. Interestingly, in line with our results, the median duration of all anticoagulant treatments before switching to rivaroxaban was 100 days (IQR, 47–181 days).…”

Rivaroxaban bei tumorassoziierter venöser Thromboembolie

“…COSIMO untersuchte 505 Patienten mit CAT, die nach mindestens 4-wöchiger Therapie mit NMH, Fondaparinux oder Vitamin-K-Antagonisten (VKAs) auf Rivaroxaban umgestellt worden waren (siehe Supplement-Tabelle 1 ) 12 40 41 42 . Als häufigste Gründe für diese Umstellung wurden neben der Entscheidung der behandelnden Ärzte die Belastung der Patienten durch die parenterale Anwendung bzw.…”

Unanswered questions in cancer‐associated thrombosis

“…Kristen M. Sanfilippo 1,2 | Florian Moik 3,4 | Matteo Candeloro 5 | Cihan Ay 3 | Marcello Di Nisio 6 | Agnes Y. Y. Lee 7,8 with a reduction in the risk of recurrent VTE [risk ratio (RR) 0.58; 95% confidence interval (CI) 0.43-0.77] with no difference in the risks of major or minor bleeding. 9 However, patient preference for oral therapy over injectables, 10,11 coupled with the higher cost of LMWHs and inferior efficacy of VKAs in patients with cancer, created a need for more effective and convenient oral treatment options.…”