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Conclusion:Low-molecular-weight heparin does not provide survival benefit in patients with advanced cancer.Summary: It has been suggested that patients with cancer who develop venous thromboembolism (VTE) and are treated with low-molecularweight heparin have a survival advantage over those treated with unfractionated heparin (Am J Med 1996;100:269-277 and Ann Intern Med 1999; 130:800-809). The authors therefore sought to assess whether lowmolecular-weight heparin might provide a survival advantage in patients with advanced cancer.This was a randomized clinical trial conducted between December 1998 and June 2001. Patients with advanced cancer were randomized to receive low-molecular-weight heparin or placebo. The study began as a double-blinded placebo-controlled trial with patients receiving injections daily of saline or 5000 U of low-molecular-weight heparin. Recruitment for the trial was low; therefore, the placebo arm was eliminated midway through the study. At this point, the study became open labeled, and patients received low-molecular-weight heparin injections and standard clinical care, or standard clinical care alone. The primary study end point was overall survival.There were 138 patients analyzed. Median survival for the combined standard-care and placebo groups was 10.5 months (95% confidence interval [CI], 7.6 to 12.2 months). Median survival for the low-molecular-weight heparin arms of the trial was 7.3 months (95% CI, 4.8 to 12.2). This was not significantly different from the placebo group (P ϭ .46). Median survival times for unblinded and blinded low-molecular-weight heparin groups were 9.0 months and 6.2 months, respectively. Median survival time was 10.5 months in the standard-care group and 10.3 months in the placebo-blinded group. There was a 6% rate of significant VTE in the low-molecular-weight heparin arms and a 7% rate in the control arms. Major bleeding was 7% in the control arms and 3% in the low-molecular-weight heparin arms.Comment: It has been suggested for a number of years that lowmolecular-weight heparin may confer a survival advantage over unfractionated heparin in patients with VTE and cancer. A pleiotropic effect of low-molecular-weight heparin was postulated. This study argues against such an effect. Weaknesses of the study include changing its design in mid-course and inclusion of four different groups of cancer patients, perhaps masking a treatment effect in one group vs another. The trial did demonstrate safety of low-molecular-weight heparin in patients with advanced cancer.

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