Edoxaban for treatment of venous thromboembolism in patients with cancer. Rationale and design of the Hokusai VTE-cancer study.
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.
Nick van Es, MD, Department of Vascular Medicine, Academic Medical Center, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands, Tel.: +31 20 56 65973, Fax: +31 20 56 69343, E-mail: n.vanes@amc.nl.
Nick
N
van Es
Marcello
M
Di Nisio
Suzanne M
SM
Bleker
Annelise
A
Segers
Michele F
MF
Mercuri
Lee
L
Schwocho
Ajay
A
Kakkar
Jeffrey I
JI
Weitz
Jan
J
Beyer-Westendorf
Zoltan
Z
Boda
Marc
M
Carrier
Jaromir
J
Chlumsky
Hervé
H
Décousus
David
D
Garcia
Harry
H
Gibbs
Pieter W
PW
Kamphuisen
Manuel
M
Monreal
Paul
P
Ockelford
Ingrid
I
Pabinger
Peter
P
Verhamme
Michael A
MA
Grosso
Harry R
HR
Büller
Gary E
GE
Raskob
D000328:Adult; D000925:Anticoagulants / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D017985:Dalteparin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D004311:Double-Blind Method; D065427:Factor Xa Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D009369:Neoplasms / Q000097:blood / Q000150:complications*; D011446:Prospective Studies; D011655:Pulmonary Embolism / Q000188:drug therapy* / Q000453:epidemiology / Q000209:etiology; D011725:Pyridines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012008:Recurrence; D012107:Research Design; D018401:Sample Size; D013844:Thiazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome; D020246:Venous Thrombosis / Q000188:drug therapy* / Q000453:epidemiology / Q000209:etiology
D000925:Anticoagulants; D065427:Factor Xa Inhibitors; D011725:Pyridines; D013844:Thiazoles; C552171:edoxaban; D017985:Dalteparin
Anticoagulant drugs; cancer; clinical trial; edoxaban; venous thromboembolism