Reduced Thromboembolic Events in Cancer Patients with Antithrombotic Prophylaxis

Strategic Insights -

Clinical trials assessing the efficacy of antithrombotic prophylaxis in cancer patients undergoing chemotherapy are crucial due to their increased risk of thromboembolic events. Scientists in Perugia, Italy, conducted a randomized, double-blind study to evaluate the clinical benefit of nadroparin for preventing thromboembolic events in ambulatory patients with metastatic or locally advanced solid cancer.

Researchers randomly assigned 1,150 patients to receive nadroparin or placebo in a 2:1 ratio. The primary outcome was the composite of symptomatic venous or arterial thromboembolic events. The study found that patients treated with nadroparin had a lower incidence of thromboembolic events, with 2.0% experiencing an event compared to 3.9% in the placebo group. Notably, major bleeding events were not significantly different between the two groups.

Key Takeaways:

  • 769 patients in the nadroparin group and 381 patients in the placebo group were included in the primary efficacy and safety analyses.
  • The incidence of thromboembolic events was significantly lower in the nadroparin group (2.0%) compared to the placebo group (3.9%).
  • Major bleeding events were not significantly different between the two groups, with 0.7% of patients in the nadroparin group experiencing a major bleeding event and no patients in the placebo group.
  • The incidences of minor bleeding were 7.4% (57 of 769) with nadroparin and 7.9% (30 of 381) with placebo.
  • There were 121 (15.7%) serious adverse events in the nadroparin group and 67 (17.6%) serious adverse events in the placebo group.

Statistics:

  • 769 patients in the nadroparin group and 381 patients in the placebo group participated in the study (modified intention-to-treat population).
  • 15 (2.0%) of 769 patients treated with nadroparin and 15 (3.9%) of 381 patients treated with placebo had a thromboembolic event.
  • 57 (7.4%) of 769 patients in the nadroparin group and 30 (7.9%) of 381 patients in the placebo group experienced minor bleeding.
  • 121 (15.7%) serious adverse events were recorded in the nadroparin group and 67 (17.6%) serious adverse events in the placebo group.

Sources:

  • Agnelli, G., et al. Nadroparin for the prevention of thromboembolic events in ambulatory patients with metastatic or locally advanced solid cancer receiving chemotherapy: a randomised, placebo-controlled, double-blind study. Lancet Oncology, 2009;10(10):943-949.
  • ClinicalTrials.gov, NCT 00951574.