- •The Hokusai VTE Cancer Study was a randomized controlled trial for cancer patients.
- •It randomized patients to either edoxaban or dalteparin for the treatment of VTE.
- •This analysis provides adjudicated study outcomes for all large cancer groups.
- •In most cancers, the primary outcome was comparable between both regimens.
- •The major bleeding risk in gastrointestinal cancer is higher in edoxaban recipients.
The safety and efficacy of edoxaban and dalteparin is unclear for several cancer groups.
We evaluated the occurrence of the primary outcome in large cancer groups. The primary outcome was the composite of recurrent VTE or major bleeding over 12 months.
In patients with gastrointestinal cancer, the primary outcome occurred in 19.4% patients given edoxaban and in 15.0% given dalteparin (risk difference [RD], 4.4%; 95%-CI, −4.1% to 12.8%). The corresponding rates for edoxaban and dalteparin were 10.4% and 10.7% for lung cancer (RD, −0.3%; 95%-CI, −10.0% to 9.5%), 13.6% and 12.5% for urogenital cancer (RD, 1.1; 95%-CI, −10.1–12.4), 3.1% and 11.7% for breast cancer (RD, −8.6; 95%-CI, −19.3–2.2), 8.9% and 10.9% for hematological malignancies (RD, −2.0; 95%-CI, −13.1–9.1), and 10.4% and 17.4% for gynecological cancer (RD, −7.0; 95%-CI, −19.8–5.7). In the subgroup of gastrointestinal cancer, edoxaban was associated with a 3.5% lower absolute risk of recurrent VTE and a 7.9% higher risk of major bleeding.
Edoxaban has a similar risk-benefit ratio to dalteparin in most cancer groups. In those with gastrointestinal cancer, the lower risk of recurrent VTE and the advantages of oral therapy need to be balanced against the increased risk of major bleeding.
To read this article in full you will need to make a payment
Purchase one-time access:Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
One-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
Subscribe:Subscribe to Thrombosis Research
Already a print subscriber? Claim online access
Already an online subscriber? Sign in
Register: Create an account
Institutional Access: Sign in to ScienceDirect
- Epidemiology of first and recurrent venous thromboembolism in patients with active cancer.Thromb. Haemost. 2016; 117: 57-65https://doi.org/10.1160/TH15-08-0686
- Epidemiology of venous thrombosis.Blood. 2013; 122: 1712-1723https://doi.org/10.1182/blood-2013-04-460121
- Risk of venous thromboembolism in patients with cancer: a systematic review and meta-analysis.PLoS Med. 2012; 9: 1-19https://doi.org/10.1371/journal.pmed.1001275
- Development and validation of a predictive model for chemotherapy-associated thrombosis.Clin. Trials Obs. 2008; 111: 4902-4908https://doi.org/10.1182/blood-2007-10-116327.An
- A modified Khorana risk assessment score for venous thromboembolism in cancer patients receiving chemotherapy: the Protecht score.Intern. Emerg. Med. 2012; 7: 291-292https://doi.org/10.1007/s11739-012-0784-y
- Chemotherapy-associated thromboembolic risk in cancer outpatients and effect of nadroparin thromboprophylaxis: results of a retrospective analysis of the PROTECHT study.J. Transl. Med. 2011; 9: 179https://doi.org/10.1186/1479-5876-9-179
- Value of bevacizumab in treatment of colorectal cancer: a meta-analysis.World J. Gastroenterol. 2015; 21: 5072https://doi.org/10.3748/wjg.v21.i16.5072
- Recurrent venous thromboembolism and bleeding complications during anticoagulant treatment in patients with cancer and venous thrombosis.Blood. 2002; 100: 3484-3488https://doi.org/10.1182/blood-2002-01-0108
- Edoxaban for the treatment of cancer-associated venous thromboembolism.N. Engl. J. Med. 2017; (NEJMoa1711948)https://doi.org/10.1056/NEJMoa1711948
- Edoxaban for treatment of venous thromboembolism in patients with cancer.Thromb. Haemost. 2015; 114: 1268-1276https://doi.org/10.1160/TH15-06-0452
- Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients.J. Thromb. Haemost. 2005; 3: 692-694https://doi.org/10.1111/j.1538-7836.2005.01204.x
- Edoxaban for the treatment of venous thromboembolism in patients with cancer.N. Engl. J. Med. 2018; 378: 673-674https://doi.org/10.1056/NEJMe1800041
- Current practice patterns and patient persistence with anticoagulant treatments for cancer-associated thrombosis.Res. Pract. Thromb. Haemost. 2017; 1: 14-22https://doi.org/10.1002/rth2.12002
- Role of direct oral anticoagulants in the treatment of cancer-associated venous thromboembolism: guidance from the SSC of the ISTH.J. Thromb. Haemost. 2018; 16: 1891-1894https://doi.org/10.1111/jth.14219
- Treatment algorithm in cancer-associated thrombosis: Canadian expert consensus.Curr. Oncol. 2018; 25: 329-337https://doi.org/10.3747/co.25.4266
- Analysis of clinical factors affecting the rates of fatal pulmonary embolism and bleeding in cancer patients with venous thromboembolism.Heliyon. 2017; 3e00229https://doi.org/10.1016/j.heliyon.2016.e00229
Published online: November 09, 2019
Accepted: November 7, 2019
Received in revised form: November 6, 2019
Received: April 2, 2019
© 2019 Published by Elsevier Ltd.