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Purpose Venous thromboembolism (VTE) is common in patients with cancer. Long-term daily subcutaneous low molecular weight heparin has been standard treatment for such patients. The purpose of this study was to assess if an oral factor Xa inhibitor, rivaroxaban, would offer an alternative treatment for VTE in patients with cancer. Patient and Methods In this multicenter, randomized, open-label, pilot trial in the United Kingdom, patients with active cancer who had symptomatic pulmonary embolism (PE), incidental PE, or symptomatic lower-extremity proximal deep vein thrombosis (DVT) were recruited. Allocation was to dalteparin (200 IU/kg daily during month 1, then 150 IU/kg daily for months 2-6) or rivaroxaban (15 mg twice daily for 3 weeks, then 20 mg once daily for a total of 6 months). The primary outcome was VTE recurrence over 6 months. Safety was assessed by major bleeding and clinically relevant nonmajor bleeding (CRNMB). A sample size of 400 patients would provide estimates of VTE recurrence to within ± 4.5%, assuming a VTE recurrence rate at 6 months of 10%. Results A total of 203 patients were randomly assigned to each group, 58% of whom had metastases. Twenty-six patients experienced recurrent VTE (dalteparin, n = 18; rivaroxaban, n = 8). The 6-month cumulative VTE recurrence rate was 11% (95% CI, 7% to 16%) with dalteparin and 4% (95% CI, 2% to 9%) with rivaroxaban (hazard ratio [HR], 0.43; 95% CI, 0.19 to 0.99). The 6-month cumulative rate of major bleeding was 4% (95% CI, 2% to 8%) for dalteparin and 6% (95% CI, 3% to 11%) for rivaroxaban (HR, 1.83; 95% CI, 0.68 to 4.96). Corresponding rates of CRNMB were 4% (95% CI, 2% to 9%) and 13% (95% CI, 9% to 19%), respectively (HR, 3.76; 95% CI, 1.63 to 8.69). Conclusion Rivaroxaban was associated with relatively low VTE recurrence but higher CRNMB compared with dalteparin.

Original publication

DOI

10.1200/jco.2018.78.8034

Type

Journal article

Journal

Journal of clinical oncology : official journal of the american society of clinical oncology

Publication Date

10/05/2018

Pages

JCO2018788034 - JCO2018788034

Addresses

Annie M. Young, Andrea Marshall, Jenny Thirlwall, Catherine Hill, Danielle Hale, Janet A. Dunn, and Stavros Petrou, Warwick Clinical Trials Unit, University of Warwick; Oliver Chapman and Christopher J. Poole, University Hospitals Coventry and Warwickshire; Charles Hutchinson and Jeremy Dale, Warwick Medical School, University of Warwick, Coventry; Anand Lokare, Heart of England National Health Service Foundation Trust, Birmingham; Peter MacCallum, Queen Mary University of London; Ajay Kakkar, Thrombosis Research Institute, London; F.D. Richard Hobbs, University of Oxford, Oxford; Anthony Maraveyas, Hull York Medical School, Hull, United Kingdom; Gary H. Lyman, Fred Hutchinson Cancer Research Center, Seattle, WA; and Mark Levine, McMaster University, Hamilton, Ontario, Canada.