Largest Trial of VTE (blood clots) Prophylaxis in Cancer Patients on Chemo

Blogger's Note: several articles posted on the same subject, some easier to read (plain english)

Largest Trial of VTE Prophylaxis in Cancer Patients on Chemo:
The new trial adds to previous data showing a benefit, but it is up to individual patients to decide whether or not to use this option, says editorialist.
Medscape Medical News

February 15, 2012 — The largest study to date of thromboprophylaxis in cancer patients on chemotherapy shows that the use of a heparin product significantly reduces the risk for thromboembolic events with no apparent increase in bleeding.
The positive results add to several previous studies showing a benefit from thromboprophylaxis in cancer patients, and reopen an ongoing debate about whether such use should be routine.
The latest study, known as SAVE-ONCO, was conducted in 3212 cancer patients who were beginning chemotherapy and used the hemisynthetic ultra-low-molecular-weight heparin (LMWH) semuloparin (Visamerin, Sanofi; marketed in Europe, but not available in the United States). The study, by Giancarlo Agnelli, MD, from the University of Perugia, Italy, and colleagues, is published in the February 16 issue of the New England Journal of Medicine......

Semuloparin for Thromboprophylaxis in Patients Receiving Chemotherapy for Cancer — NEJM

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Original Article

Semuloparin for Thromboprophylaxis in Patients Receiving Chemotherapy for Cancer

N Engl J Med 2012; 366:601-609February 16, 2012

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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