COSIMO - patients with active cancer changing to rivaroxaban for the treatment and prevention of recurrent venous thromboembolism: a non-interventional study

Alexander T Cohen, Anthony Maraveyas, Jan Beyer-Westendorf, Agnes Y Y Lee, Lorenzo G Mantovani, Miriam Bach, COSIMO Investigators, Hayley Dawson, Alexander T Cohen, Anthony Maraveyas, Jan Beyer-Westendorf, Agnes Y Y Lee, Lorenzo G Mantovani, Miriam Bach, COSIMO Investigators, Hayley Dawson

Abstract

Background: Around 20% of venous thromboembolism (VTE) cases occur in patients with cancer. Current guidelines recommend low molecular weight heparin (LMWH) as the preferred anticoagulant for VTE treatment. However, some guidelines state that vitamin K antagonists (VKAs) and direct oral anticoagulants (DOACs) are acceptable alternatives for long-term therapy in some patients if LMWHs are not available. LMWHs and VKAs have a number of drawbacks that can increase the burden on patients. DOACs, such as rivaroxaban, can ameliorate some burdens and may offer an opportunity to increase patient satisfaction and health-related quality of life (HRQoL). The Cancer-associated thrOmboSIs - patient-reported outcoMes with rivarOxaban (COSIMO) study is designed to provide real-world information on treatment satisfaction in patients with active cancer who switch from LMWH or VKA to rivaroxaban for the treatment of acute VTE or to prevent recurrent VTE.

Methods: COSIMO is a prospective, non-interventional, single-arm cohort study that aims to recruit 500 patients in Europe, Canada and Australia. Adults with active cancer who are switching to rivaroxaban having received LMWH/VKA for the treatment and secondary prevention of recurrent VTE for at least the previous 4 weeks are eligible. Patients will be followed for 6 months. The primary outcome is treatment satisfaction assessed as change in the Anti-Clot Treatment Scale (ACTS) Burdens score at week 4 after enrolment compared with baseline. Secondary outcomes include treatment preferences, measured using a discrete choice experiment, change in ACTS Burdens score at months 3 and 6, and change in HRQoL (assessed using the Functional Assessment of Chronic Illness Therapy - Fatigue questionnaire). COSIMO will collect data on patients' medical history, patterns of anticoagulant use and incidence of bleeding and thromboembolic events. Study recruitment started in autumn 2016.

Conclusions: COSIMO will provide information on outcomes associated with switching from LMWH or VKA therapy to rivaroxaban for the treatment or secondary prevention of cancer-associated thrombosis in a real-life setting. The key goal is to assess whether there is a change in patient-reported treatment satisfaction. In addition, COSIMO will facilitate the evaluation of the safety and effectiveness of rivaroxaban in preventing recurrent VTE in this patient population.

Trial registration: NCT02742623. Registered 19 April 2016.

Keywords: Active cancer; Health-related quality of life; Low molecular weight heparin; Patient preference; Recurrent venous thromboembolism; Rivaroxaban; Vitamin K antagonist.

Conflict of interest statement

Documented approval from appropriate independent ethics committees/institutional review boards will be obtained for all participating centres prior to study start. Patients will be asked to provide signed informed consent forms before joining the study. Few patients have yet completed the study, and so no data are available to share.Not applicable.ATC reports grants and personal fees from Bayer during the conduct of the study; personal fees from Boehringer Ingelheim, grants and personal fees from Bristol-Myers Squibb, grants and personal fees from Daiichi Sankyo Europe, personal fees from Johnson & Johnson, grants and personal fees from Pfizer, personal fees from Portola, personal fees from Sanofi, personal fees from XO1, personal fees from Janssen, personal fees from ONO Pharmaceuticals, outside the submitted work; AM reports personal fees and non-financial support from Bayer, during the conduct of the study; personal fees and non-financial support from Bayer, grants from Bristol-Myers Squibb, other from Pfizer, outside the submitted work; JB-W reports grants and personal fees from Bayer, grants and personal fees from Boehringer Ingelheim, grants and personal fees from Daiichi Sankyo, grants and personal fees from Pfizer, outside the submitted work; AYYL reports other from Bayer, during the conduct of the study; LGM reports personal fees from Bayer, during the conduct of the study; grants and personal fees from Boehringer Ingelheim, personal fees from Pfizer, grants from Daiichi Sankyo, outside the submitted work; MB is an employee of Bayer AG.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Initial and long-term anticoagulant therapy in patients with cancerb and a first episode of VTE – data from the RIETE registry [22]. aIncludes unfractionated heparin and thrombolytic agents. bDefined as newly diagnosed cancer, metastatic cancer or cancer undergoing treatment. LMWH, low molecular weight heparin; PE, pulmonary embolism; VKA, vitamin K antagonist; VTE, venous thromboembolism
Fig. 2
Fig. 2
COSIMO – study design and data collection. aDCE per telephone interview 4–12 weeks after starting rivaroxaban treatment. bPatients treated for at least 4 weeks of SOC anticoagulation therapy with LMWH or VKA therapy. cFor previous anticoagulation therapy. dFor rivaroxaban treatment. eIncluding anti-cancer medication. fHaemoglobin, haematocrit, white blood cells, platelets, electrolytes, C-reactive protein, serum creatinine, CrCl, liver enzymes and haemoccult test. ACTS, Anti-Clot Treatment Scale; CrCl, creatinine clearance; DCE, discrete choice experiment; DVT, deep vein thrombosis; FACIT, Functional Assessment of Chronic Illness Therapy – Fatigue questionnaire; LMWH, low molecular weight heparin; PE, pulmonary embolism; SOC, standard of care; VKA, vitamin K antagonist

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