Apixaban for the Treatment of Venous Thromboembolism Associated with Cancer.

By G. Agnelli, C. Becattini, G. Meyer, A. Muñoz, M. Huisman, J. Connors, A. Cohen, R. Bauersachs, B. Brenner, A. Torbicki and 7 more. New England Journal of Medicine, 2020

847 citations recorded by the source corpus.

BACKGROUND Recent guidelines recommend consideration of the use of oral edoxaban or rivaroxaban for the treatment of venous thromboembolism in patients with cancer. However, the benefit of these oral agents is limited by the increased risk of bleeding associated with their use. METHODS This was a multinational, randomized, investigator-initiated, open-label, noninferiority trial with blinded central outcome adjudication. We randomly assigned consecutive patients with cancer who had symptomatic or incidental acute proximal deep-vein thrombosis or pulmonary embolism to receive oral apixaban (at a dose of 10 mg twice daily for the first 7 days, followed by 5 mg twice daily) or subcutaneous dalteparin (at a dose of 200 IU per kilogram of body weight once daily for the first month, followed by 150 IU per kilogram once daily). The treatments were administered for 6 months. The primary outcome was objectively confirmed recurrent venous thromboembolism during the trial period. The principal safety outcome was major bleeding. RESULTS Recurrent venous thromboembolism occurred in 32 of 576 patients (5.6%) in the apixaban group and in 46 of 579 patients (7.9%) in the dalteparin group (hazard ratio, 0.63; 95% confidence interval [CI], 0.37 to 1.07; P<0.001 for noninferiority). Major bleeding occurred in 22 patients (3.8%) in the apixaban group and in 23 patients (4.0%) in the dalteparin group (hazard ratio, 0.82; 95% CI, 0.40 to 1.69; P = 0.60). CONCLUSIONS Oral apixaban was noninferior to subcutaneous dalteparin for the treatment of cancer-associated venous thromboembolism without an increased risk of major bleeding. (Funded by the Bristol-Myers Squibb-Pfizer Alliance; Caravaggio ClinicalTrials.gov number, NCT03045406.).

Subfields: Hematology, Internal Medicine, Surgery

View Paper: https://www.semanticscholar.org/paper/4e41152014741c5f1ff2b4e08b299c380ed234ed

How researchers see this paper

The researchers whose trusted networks rank it highest, strongest advocate first. Every researcher gets a different order.

G. Lyman
C. Ay
M. Carrier
A. Khorana
B. Schneider
Agnes Y. Y. Lee
M. Di Nisio
L. Hicks

Citations in the corpus

Management of Immune-Related Adverse Events in Patients Treated With Immune Checkpoint Inhibitor Therapy: ASCO Guideline Update (2021, background): “For longterm anticoagulation, LMWH, edoxaban, rivaroxaban, or apixaban for at least 6 months are preferred over VKAs because of improved efficacy.(31,32) • IV heparin is an acceptable alternative for initial use and oral anticoagulants are acceptable for the long term.”
American Society of Hematology 2021 guidelines for management of venous thromboembolism: prevention and treatment in patients with cancer. (2021, methodology): “From these reviews, we identified 4 eligible RCTs that fulfilled our inclusion criteria and measured outcomes relevant to this question.(300-302,333) All 4 RCTs reported on recurrent VTE and major bleeding.”