Similar Outcomes With Tinzaparin vs Warfarin in Treatment of Acute Venous Thromboembolism in Patients With Active Cancer
In the phase III CATCH trial reported in JAMA, Lee et al found that the low–molecular-weight heparin tinzaparin (Innohep) did not significantly reduce the risk of recurrent venous thromboembolism vs warfarin in the treatment of acute symptomatic venous thromboembolism in patients with active cancer.
Study Details
In the open-label trial, 900 patients from 164 sites in Asia; Africa; Europe; and North, Central, and South America were randomly assigned between August 2010 and November 2013 to receive tinzaparin 175 IU/kg once daily for 6 months (n = 449) vs conventional therapy with tinzaparin 175 IU/kg once daily for 5 to 10 days followed by warfarin at a dose adjusted to maintain the international normalied ratio within the therapeutic range (2.0–3.0) for 6 months (n = 451).
Patients had to have a diagnosis of cancer and be receiving anticancer therapy or had to have been diagnosed with cancer or received anticancer therapy within the previous 6 months and had to have objectively documented proximal deep-vein thrombosis or pulmonary embolism. The primary outcome was composite recurrent venous thromboembolism consisting of symptomatic deep-vein thrombosis, symptomatic nonfatal pulmonary embolism, fatal pulmonary embolism, and incidental proximal deep-vein thrombosis.
Recurrent Venous Thromboembolism
The 6-month cumulative incidence of recurrent venous thromboembolism was 7.2% in the tinzaparin group vs 10.5% in the warfarin group (hazard ratio [HR] = 0.65, P = .07). Rates were 2.7% vs 5.3% (HR = 0.48, P = .04) for symptomatic deep-vein thrombosis, 0.7% vs 0.4% for symptomatic nonfatal pulmonary embolism, 3.8% vs 3.8% for fatal pulmonary embolism (HR = 0.96, P = .89), and 0% vs 0.2% for incidental proximal deep-vein thrombosis.
Bleeding, Mortality
There were no differences between groups in major bleeding (2.7% vs 2.4%, HR = 0.89, P = .77) or overall mortality (33.4% vs 30.6%, HR = 1.08, P = .54). Tinzaparin treatment was associated with a significant reduction in clinically relevant nonmajor bleeding (10.9% vs 15.3%, HR = 0.58, P = .004).
The investigators concluded: “Among patients with active cancer and acute symptomatic [venous thromboembolism], the use of full-dose tinzaparin (175 IU/kg) daily compared with warfarin for 6 months did not significantly reduce the composite measure of recurrent [venous thromboembolism] and was not associated with reductions in overall mortality or major bleeding but was associated with a lower rate of clinically relevant nonmajor bleeding. Further studies are needed to assess whether efficacy outcomes would be different in patients at higher risk of recurrent [venous thromboembolism].”
The study was sponsored and funded by Leo Pharma and had research support from the Sondra and Stephen Hardis Endowed Chair in Oncology Research and Scott Hamilton CARES Initiative. For full disclosures of the study authors, visit jama.jamanetwork.com.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
