Low-molecular-weight heparin versus placebo for the prevention of venous thromboembolism in metastatic breast cancer or stage III/IV lung cancer.

Abstract

In 2 double-blind studies, ambulatory patients with objectively proven, disseminated metastatic breast carcinoma (TOPIC-1) or stage III/IV non-small-cell lung carcinoma (TOPIC-2) were randomized to certoparin 3000 IU or placebo subcutaneously once daily, for 6 months. Primary efficacy outcome was objectively confirmed symptomatic or asymptomatic venous thromboembolism (VTE). Safety outcomes included bleeding (major and minor), and thrombocytopenia. TOPIC-1 was halted after an interim analysis. Venous thromboembolism occurrence was not different between treatment groups in TOPIC-1 (4% treated with certoparin, 7 of 174 vs 4% receiving placebo, 7 of 177, odds ratio [OR] 1.02; 95% confidence interval [CI] 0.30-3.48) and in TOPIC-2 (4.5%, 12 of 268) vs 8.3%, 22 of 264, respectively, OR 0.52; CI 0.23-1.12). Mortality was not different between groups. A post hoc analysis showed certoparin significantly reduced VTE in stage IV lung carcinoma (3.5% vs 10.2%; P = .032) without increased bleeding. In conclusion, thrombosis risk and prophylactic benefit was highest in stage IV lung carcinoma patients.

• Authors: Sylvia K Haas, Mathias Freund, David Heigener, Lothar Heilmann, Bettina Kemkes-Matthes, Georg-Friedrich von Tempelhoff, Nima Melzer, Ajay K Kakkar, TOPIC Investigators
• Journal: Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis (Clin Appl Thromb Hemost) 2012 Mar-Apr Vol. 18 Issue 2 Pg. 159-65 ISSN: 1938-2723 [Electronic] United States
• PMID: 22275397 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Heparin, Low-Molecular-Weight
• Warfarin
• certoparin

Topics

• Aged
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Breast Neoplasms (complications, drug therapy)
• Carcinoma (complications, drug therapy, secondary)
• Carcinoma, Non-Small-Cell Lung (complications, drug therapy, pathology)
• Double-Blind Method
• Early Termination of Clinical Trials
• Female
• Hemorrhage (chemically induced)
• Heparin, Low-Molecular-Weight (adverse effects, therapeutic use)
• Humans
• Lung Neoplasms (complications, drug therapy, pathology)
• Male
• Middle Aged
• Neoplasm Staging
• Pulmonary Embolism (etiology, prevention & control)
• Thrombocytopenia (chemically induced)
• Thrombophilia (drug therapy, etiology)
• Treatment Outcome
• Venous Thromboembolism (etiology, prevention & control)
• Warfarin (adverse effects, therapeutic use)