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Rivaroxaban for Thromboprophylaxis in High-Risk Ambulatory Patients with Cancer
Alok A Khorana1, Gerald A Soff1, Ajay K Kakkar1
1From the Department of Hematology and Medical Oncology, Taussig Cancer Institute and Case Comprehensive Cancer Center, Cleveland Clinic, Cleveland (A.A.K.); the Department of Medicine, Memorial Sloan Kettering Cancer Center (G.A.S., E.M.O.), and Weill Cornell Medical College (G.A.S., E.M.O.), New York; the Thrombosis Research Institute and University College London, London (A.K.K.); University of Texas M.D. Anderson Cancer Center, Houston (S.V.-R.), and U.S. Oncology Research-Texas Oncology, Tyler (H.A.Y.) - both in Texas; the Department of Medicine, Charité Universitätsmedizin Berlin, Berlin (H.R.); the Division of Hematology-Oncology, University of California Davis School of Medicine, Sacramento (T.W.), and the Keck School of Medicine, University of Southern California, Los Angeles (H.A.L.); the Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (M.B.S.); the University of Washington School of Medicine (D.A.G., N.M.K., G.H.L.), Advanced Cancer Research Group (N.M.K.), and Fred Hutchinson Cancer Research Center (G.H.L.), Seattle; Penn State Cancer Institute, Milton S. Hershey Medical Center, Hershey, PA (C.P.B.); the Department of Cancer Pharmacology, Levine Cancer Institute, Atrium Health, Charlotte, NC (J.N.P.); Janssen Scientific Affairs, Titusville (P.W., P.B., S.K.), and Janssen Research and Development, Raritan (U.V.) - both in New Jersey; the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.E.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (R.M.); and the Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Boston (K.A.B.).
Background:
Ambulatory patients receiving systemic cancer therapy are at varying risk for venous thromboembolism. However, the benefit of thromboprophylaxis in these patients is uncertain.
Methods:
In this double-blind, randomized trial involving high-risk ambulatory patients with cancer (Khorana score of ≥2, on a scale from 0 to 6, with higher scores indicating a higher risk of venous thromboembolism), we randomly assigned patients without deep-vein thrombosis at screening to receive rivaroxaban (at a dose of 10 mg) or placebo daily for up to 180 days, with screening every 8 weeks. The primary efficacy end point was a composite of objectively confirmed proximal deep-vein thrombosis in a lower limb, pulmonary embolism, symptomatic deep-vein thrombosis in an upper limb or distal deep-vein thrombosis in a lower limb, and death from venous thromboembolism and was assessed up to day 180. In a prespecified supportive analysis involving the same population, the same end point was assessed during the intervention period (first receipt of trial agent to last dose plus 2 days). The primary safety end point was major bleeding.
Results:
Of 1080 enrolled patients, 49 (4.5%) had thrombosis at screening and did not undergo randomization. Of the 841 patients who underwent randomization, the primary end point occurred in 25 of 420 patients (6.0%) in the rivaroxaban group and in 37 of 421 (8.8%) in the placebo group (hazard ratio, 0.66; 95% confidence interval [CI], 0.40 to 1.09; P = 0.10) in the period up to day 180. In the prespecified intervention-period analysis, the primary end point occurred in 11 patients (2.6%) in the rivaroxaban group and in 27 (6.4%) in the placebo group (hazard ratio, 0.40; 95% CI, 0.20 to 0.80). Major bleeding occurred in 8 of 405 patients (2.0%) in the rivaroxaban group and in 4 of 404 (1.0%) in the placebo group (hazard ratio, 1.96; 95% CI, 0.59 to 6.49).
Conclusions:
In high-risk ambulatory patients with cancer, treatment with rivaroxaban did not result in a significantly lower incidence of venous thromboembolism or death due to venous thromboembolism in the 180-day trial period. During the intervention period, rivaroxaban led to a substantially lower incidence of such events, with a low incidence of major bleeding. (Funded by Janssen and others; CASSINI ClinicalTrials.gov number, NCT02555878.).
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