Edoxaban for treatment of venous thromboembolism in patients with cancer

Nick van Es; Marcello Di Nisio; Suzanne M. Bleker; Annelise Segers; Michele F. Mercuri; Lee Schwocho; Ajay Kakkar; Jeffrey I. Weitz; Jan Beyer-Westendorf; Zoltan Boda; Marc Carrier; Jaromir Chlumsky; Hervé Décousus; David Garcia; Harry Gibbs; Pieter W. Kamphuisen; Manuel Monreal; Paul Ockelford; Ingrid Pabinger; Peter Verhamme; Michael A. Grosso; Harry R. Büller; Gary E. Raskob

doi:10.1160/TH15-06-0452

Thrombosis and Haemostasis, Inhaltsverzeichnis

Thromb Haemost 2015; 114(06): 1268-1276
DOI: 10.1160/TH15-06-0452

Stroke, Systemic or Venous Thromboembolism

Schattauer GmbH

Edoxaban for treatment of venous thromboembolism in patients with cancer

Rationale and design of the Hokusai VTE-cancer study

Nick van Es

¹Department of Vascular Medicine, Academic Medical Center, Amsterdam, The Netherlands

,

Marcello Di Nisio

²Department of Medical, Oral and Biotechnological Sciences, G. D’Annunzio University, Chieti, Italy

,

Suzanne M. Bleker

¹Department of Vascular Medicine, Academic Medical Center, Amsterdam, The Netherlands

,

Annelise Segers

³ITREAS, Amsterdam, The Netherlands

,

Michele F. Mercuri

⁴Clinical Development, Daiichi Sankyo Pharma Development, Edison, New Jersey, USA

,

Lee Schwocho

⁴Clinical Development, Daiichi Sankyo Pharma Development, Edison, New Jersey, USA

,

Ajay Kakkar

⁵Thrombosis Research Institute, London and University College London, UK

,

Jeffrey I. Weitz

⁶Thrombosis & Atherosclerosis Research Institute and McMaster University, Hamilton, Ontario, Canada

,

Jan Beyer-Westendorf

⁷University Hospital “Carl-Gustav Carus”, Department of Vascular Medicine, Technische Universität Dresden, Germany

,

Zoltan Boda

⁸Department of Medicine, University of Debrecen, Debrecen, Hungary

,

Marc Carrier

⁹Department of Medicine, The Ottawa Hospital Research Institute, University of Ottawa, Ontario, Canada

,

Jaromir Chlumsky

¹⁰Department of Medicine, 2^nd Faculty Hospital, Charles University, Prague, Czech Republic

,

Hervé Décousus

¹¹Service Médecine Vasculaire et Thérapeutique, Centre Hospitalier Universitaire de Saint-Etienne, Hôpital Nord, Saint-Etienne, France

,

David Garcia

¹²Division of Hematology, University of Washington, Seattle, Washington, USA

,

Harry Gibbs

¹³Department of General Medicine, The Alfred Hospital, Prahran, Victoria, Australia

,

Pieter W. Kamphuisen

¹⁴Department of Vascular Medicine, University Medical Center Groningen, Groningen, The Netherlands

,

Manuel Monreal

¹⁵Department of Internal Medicine, Hospital Universitari Germans Trias i Pujol, Carretera del Canyet, Badalona, Spain

,

Paul Ockelford

¹⁶Department of Haematology, Auckland City Hospital, Auckland, New Zealand

,

Ingrid Pabinger

¹⁷Clinical Division of Haematology and Haemostaseology, Department of Medicine I, Medical University of Vienna, Vienna, Austria

,

Peter Verhamme

¹⁸Department of Vascular Medicine and Hemostasis, University of Leuven, Leuven, Belgium

,

Michael A. Grosso

⁴Clinical Development, Daiichi Sankyo Pharma Development, Edison, New Jersey, USA

,

Harry R. Büller

¹Department of Vascular Medicine, Academic Medical Center, Amsterdam, The Netherlands

,

Gary E. Raskob

¹⁹College of Public Health, University of Oklahoma Health Sciences Centre, Oklahoma City, Oklahoma, USA

› Institutsangaben

Abstract

Summary

Direct oral anticoagulants may be effective and safe for treatment of venous thromboembolism (VTE) in cancer patients, but they have not been compared with low-molecular-weight heparin (LMWH), the current recommended treatment for these patients. The Hokusai VTE-cancer study is a randomised, open-label, clinical trial to evaluate whether edoxaban, an oral factor Xa inhibitor, is non-inferior to LMWH for treatment of VTE in patients with cancer. We present the rationale and some design features of the study. One such feature is the composite primary outcome of recurrent VTE and major bleeding during a 12-month study period. These two complications occur frequently in cancer patients receiving anticoagulant treatment and have a significant impact. The evaluation beyond six months will fill the current gap in the evidence base for the long-term treatment of these patients. Based on the observation that the risk of recurrent VTE in patients with active cancer is similar to that in those with a history of cancer, the Hokusai VTE-cancer study will enrol patients if whose cancer was diagnosed within the past two years. In addition, patients with incidental VTE are eligible because their risk of recurrent VTE is similar to that in patients with symptomatic disease. The unique design features of the Hokusai VTE-cancer study should lead to enrolment of a broad spectrum of cancer patients with VTE who could benefit from oral anticoagulant treatment.

Keywords

Anticoagulant drugs - clinical trial - edoxaban - cancer - venous thromboembolism

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Referenzen

References
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