Highlights
- •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.
Abstract
Background
The safety and efficacy of edoxaban and dalteparin is unclear for several cancer groups.
Methods
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.
Results
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.
Conclusion
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.
Keywords
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Article info
Publication history
Published online: November 09, 2019
Accepted:
November 7,
2019
Received in revised form:
November 6,
2019
Received:
April 2,
2019
Identification
Copyright
© 2019 Published by Elsevier Ltd.
