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Low-molecular-weight heparin and the survival of patients with advanced malignancy.

8018 Background: Studies on the treatment of venous tromboembolism (VTE) have found a better survival in cancer patients treated with low-molecular-weight heparin (LMWH) when compared to unfractionated heparin.


METHODS
In a double-blind randomized controlled study we investigated the effect of LMWH on the survival of patients with advanced solid cancer without VTE. Patients received a weight-adjusted therapeutic dose of LMWH for two weeks and half this dose for another six weeks. Primary study outcome was cumulative mortality of all causes. Primary safety endpoint was major hemorrhage during study treatment. All analyses were on an intention-to-treat basis.


RESULTS
A total of 302 patients was included. 148 were randomized to LMWH and 154 to placebo. The overall hazard ratio was 0.75 (95% confidence interval 0.59-0.96) in favor of LMWH. Median survival was 8.0 and 6.6 months in the LMWH and placebogroup, respectively. A statistically significant treatment effect remained even after adjustment for potential confounders. Five of the LMWH-treated patients (3%) versus one of the placebo-recipients (1%) had a major hemorrhage during study treatement (p=0.12). An a priori defined subgroup analysis of patients with a life expectancy of 6 months or more at enrollment found a hazard ratio of 0.64 (95% CI 0.45-0.90) in favor of LMWH with a median survival of 15.4 months versus 9.4 months in the placebo group. In patients with a life expectancy of less than 6 months, the hazard ratio was 0.88 (NS).


CONCLUSIONS
LMWH appears to increase the median survival of patients with an advanced solid malignancy and further clinical evaluation seems warranted. [Table: see text].