Background
Patients receiving chemotherapy for cancer are at increased risk for venous thromboembolism. Limited data support the clinical benefit of antithrombotic prophylaxis.
Methods
In this double-blind, multicenter trial, we evaluated the efficacy and safety of the ultra-low-molecular-weight heparin semuloparin for prevention of venous thromboembolism (blood clots) in patients receiving chemotherapy for cancer. Patients with metastatic or locally advanced solid tumors who were beginning to receive a course of chemotherapy were randomly assigned to receive subcutaneous semuloparin, 20 mg once daily, or placebo until there was a change of chemotherapy regimen. The primary efficacy outcome was the composite of any symptomatic deep-vein thrombosis, any nonfatal pulmonary embolism, and death related to venous thromboembolism. Clinically relevant bleeding (major and nonmajor) was the main safety outcome.
Results
The median treatment duration was 3.5 months. Venous thromboembolism occurred in 20 of 1608 patients (1.2%) receiving semuloparin, as compared with 55 of 1604 (3.4%) receiving placebo (hazard ratio, 0.36; 95% confidence interval [CI], 0.21 to 0.60; P<0.001), with consistent efficacy among subgroups defined according to the origin and stage of cancer and the baseline risk of venous thromboembolism. The incidence of clinically relevant bleeding was 2.8% and 2.0% in the semuloparin and placebo groups, respectively (hazard ratio, 1.40; 95% CI, 0.89 to 2.21). Major bleeding occurred in 19 of 1589 patients (1.2%) receiving semuloparin and 18 of 1583 (1.1%) receiving placebo (hazard ratio, 1.05; 95% CI, 0.55 to 1.99). Incidences of all other adverse events were similar in the two study groups.
Conclusions
Semuloparin reduces the incidence of thromboembolic events in patients receiving chemotherapy for cancer, with no apparent increase in major bleeding. (
Funded by Sanofi; ClinicalTrials.gov number, NCT00694382.)
Additional members of the SAVE-ONCO Study Group are listed in the
Supplementary Appendix, available at NEJM.org.
Source Information
From the Division of Internal and Cardiovascular Medicine and Stroke Unit, Department of Internal Medicine, University of Perugia, Perugia, Italy (G.A.); Duke University Medical Center, Durham, NC (D.J.G.); the Thrombosis Research Institute and University College London, London (A.K.K.); the Department of Orthopedic Surgery, McGill University Health Center, Montreal (W.F.); Spine Center Copenhagen, Copenhagen University Hospital Glostrup, Glostrup, Denmark (M.R.L.); the Clinical Pharmacology Unit, University Jean Monnet, Saint-Etienne, France (P.M.); Klinikum Frankfurt, Höchst, Germany (P.M.); Sanofi, Bridgewater, NJ (U.C., F.L.); and McMaster University, Hamilton, ON, Canada (A.G.G.T.).
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