Spotlight on advances in VTE management: CALLISTO and EINSTEIN CHOICE

Bach, Miriam; Bauersachs, Rupert

doi:10.1160/th16-06-0486

Cited by 22 publications

(25 citation statements)

References 44 publications

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“…The COSIMO study aims to collect real-world data in consecutive patients with cancer switching from SOC therapy (LMWH or VKA) to rivaroxaban in circumstances where SOC therapy cannot be continued [44]. The study began recruiting patients in October 2016.…”

Section: Discussionmentioning

confidence: 99%

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

et al. 2018

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BackgroundAround 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.MethodsCOSIMO 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.ConclusionsCOSIMO 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 registrationNCT02742623. Registered 19 April 2016.Electronic supplementary materialThe online version of this article (10.1186/s12959-018-0176-2) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 99%

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

et al. 2018

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“…Table 5 summarizes the key characteristics and data from AVERT and CASSINI. AVERT and CASSINI were the first phase III randomized trials assessing the efficacy and safety of DOAC thromboprophylaxis in higher‐risk outpatients with cancer, and provide the first data on the use of long‐term oral anticoagulation for the primary prevention of VTE in this setting …”

Section: Evidence Base For the Use Of Rivaroxaban In Catmentioning

confidence: 99%

“…This review details the rationale, study designs, and results (where applicable) of completed and ongoing investigations of DOACs in CAT, with a focus on rivaroxaban and the studies in the CALLISTO (Cancer Associated thrombosis—expLoring soLutions for patients through Treatment and Prevention with RivarOxaban) program (Tables 1 and 2). The aim is to provide an update to a previously published review of the CALLISTO program.…”

Section: Introductionmentioning

confidence: 99%

Cancer‐associated venous thromboembolism: Treatment and prevention with rivaroxaban

Bauersachs¹,

Khorana

Lee

et al. 2020

Research and Practice in Thrombosis and Haemostasis

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Cancer‐associated venous thromboembolism (VTE) is a frequent, potentially life‐threatening event that complicates cancer management. Anticoagulants are the cornerstone of therapy for the treatment and prevention of cancer‐associated thrombosis (CAT); factor Xa–inhibiting direct oral anticoagulants (DOACs; apixaban, edoxaban, and rivaroxaban), which have long been recommended for the treatment of VTE in patients without cancer, have been investigated in this setting. The first randomized comparisons of DOACs against low‐molecular‐weight heparin for the treatment of CAT indicated that DOACs are efficacious in this setting, with findings reflected in recent updates to published guidance on CAT treatment. However, the higher risk of bleeding events (particularly in the gastrointestinal tract) with DOACs highlights the need for appropriate patient selection. Further insights will be gained from additional studies that are ongoing or awaiting publication. The efficacy and safety of DOAC thromboprophylaxis in ambulatory patients with cancer at a high risk of VTE have also been assessed in placebo‐controlled randomized controlled trials of apixaban and rivaroxaban. Both studies showed efficacy benefits with DOACs, but both studies also showed a nonsignificant increase in major bleeding events while on treatment. This review summarizes the evidence base for rivaroxaban use in CAT, the patient profile potentially most suited to DOAC use, and ongoing controversies under investigation. We also describe ongoing studies from the CALLISTO (Cancer Associated thrombosis—expLoring soLutions for patients through Treatment and Prevention with RivarOxaban) program, which comprises several randomized clinical trials and real‐world evidence studies, including investigator‐initiated research.

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“…gov: NCT02583191; CONKO_011/ AIO-SUP-0115/Ass and ISRCTN Registry: 86712308; Select-D). [59][60][61] These studies should provide clarity about the role of DOACs in the treatment of cancer-associated VTE.…”

Section: Perioperative Thromboprophylaxismentioning

confidence: 99%

Antithrombotic therapy for prophylaxis and treatment of venous thromboembolism in patients with cancer: review of the literature on current practice and emerging options

Kamphuisen

Agnelli

2017

ESMO Open

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The treatment of cancer-associated venous thromboembolism (VTE) is difficult because cancer patients with VTE on anticoagulation are at an increased risk of bleeding compared with patients without VTE. This review summarises the evidence supporting the current standard of care and emerging treatment options. In difficult-to-treat subpopulations, where clinical data are often lacking, this review also provides the best clinical practice strategies based on the available data. The use of therapeutic doses of parenteral anticoagulants in patients with cancer-associated VTE for at least 3 to 6 months is supported by the current clinical data. After major cancer surgery, extended thromboprophylaxis for approximately 1 month following hospital discharge is also supported. In select populations of ambulatory cancer patients with solid tumours, or in patients with myeloma receiving immunomodulatory agents in combination with chemotherapy and/or corticosteroids, pharmacological prophylaxis could be considered. Although parenteral anticoagulants may not be tolerated by some patients, the data pertaining to the use of direct oral anticoagulants (DOACs) in cancer patients with VTE at this point can only be considered hypothesis generating. Clarity of the use of DOACs is awaiting the results of head-to-head trials between DOACs and parenteral anticoagulants. In addition, because of the lack of clinical trials, there are still unanswered questions on the optimal treatment regimens in subpopulations at increased risk of bleeding, including cancer patients with thrombocytopenia and those with brain metastases. For clinicians to balance the risk of recurrent thrombosis with the chance of bleeding, they need to assess the relevant clinical data. Current data support the use of parenteral anticoagulants in cancer patients with VTE, but many unanswered questions pertaining to the optimal regimens in special subpopulations and regarding the efficacy and safety of DOACs remain. To address this need, there are currently several clinical trials under way.

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Spotlight on advances in VTE management: CALLISTO and EINSTEIN CHOICE

Cited by 22 publications

References 44 publications

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

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

Cancer‐associated venous thromboembolism: Treatment and prevention with rivaroxaban

Antithrombotic therapy for prophylaxis and treatment of venous thromboembolism in patients with cancer: review of the literature on current practice and emerging options

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