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Extended edoxaban, dalteparin equally effective among patients with cancer, venous thromboembolism
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Extended treatment with oral edoxaban appeared comparable to subcutaneous dalteparin in safety and effectiveness for prevention of recurrent venous thromboembolism and major bleeding among patients with active cancer, according to results of a post-hoc analysis published in Journal of Thrombosis and Haemostasis.
“VTE is associated with significant morbidity and mortality. Hence, it is important to initiate anticoagulant therapy immediately and to continue it for as long as the patient remains at high risk for recurrent events,” Marcello Di Nisio, MD, associate professor in department of medicine and aging sciences at G. D’Annunzio University of Chieti-Pescara in Chieti, Italy, and colleagues wrote. “However, anticoagulant therapy is problematic in [patients with cancer] because they are at higher risk for both recurrent VTE and major bleeding than patients without cancer. [These] complications can interfere with cancer treatment.”
Di Nisio and colleagues sought to provide guidance for clinicians on extended treatment for cancer-associated VTE by conducting a post-hoc analysis of the Hokusai VTE Cancer trial, results of which appeared in The New England Journal of Medicine. Researchers in the trial randomly assigned 1,046 patients with active cancer to edoxaban (Savaysa, Daiichi Sankyo; n = 522) or dalteparin (Fragmin, Pfizer; n = 524) and found that edoxaban was noninferior to dalteparin with respect to the composite outcome of recurrent VTE or major bleeding.
The post-hoc analysis examined the follow-up period from 6 to 12 months. It included patients who received more than 6 months of treatment with edoxaban (n = 294; median duration, 318 days) or dalteparin (n = 273; median duration, 211 days).
A composite of adjudicated first recurrent VTE or major bleeding served as the primary endpoint. Recurrent VTE, major bleeding and clinically relevant bleeding served as secondary endpoints.
Results showed that seven patients (2.4%; 95% CI, 0.6-4.1) in the edoxaban group and six patients (2.2%; 95% CI, 0.5-3.9) in the dalteparin group experienced the composite outcome of recurrent VTE or major bleeding between 6 and 12 months (HR = 1.05; 95% CI, 0.36-3.05).
One patient in each group experienced a pulmonary embolism, and one in each group experienced deep vein thrombosis.
During the extended treatment period, five patients (1.7%; 95% CI, 0.2-3.2) in the edoxaban group and three patients (1.1%; 95% CI, 0-2.3) in the dalteparin group experienced major bleeding (HR = 1.47; 95% CI, 0.36-5.99). This included severe major bleeding in one patient in the edoxaban group and three patients in the dalteparin group.
One patient in each group died as a result of VTE after the first 6 months.
The relatively small number of patients in the analysis served as the study’s primary limitation.
“Extended treatment with oral edoxaban appears as effective and safe as dalteparin, rendering oral edoxaban a more convenient alternative to subcutaneous low-molecular-weight heparin for most patients with cancer who require extended treatment for prevention of recurrent VTE.” – by John DeRosier
Additional reference:
Raskob GE, et al. N Engl J Med. 2019;doi:10.1056/NEJMoa1711948.
Disclosures: Di Nisio reports personal fees from Aspen, Bayer, Daiichi Sankyo, Leo Pharma and Pfizer. Please see the study for all other authors’ relevant financial disclosures.
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