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.
Publication types
-
Multicenter Study
-
Randomized Controlled Trial
-
Research Support, Non-U.S. Gov't
MeSH terms
-
Aged
-
Antineoplastic Combined Chemotherapy Protocols / therapeutic use
-
Breast Neoplasms / complications*
-
Breast Neoplasms / drug therapy
-
Carcinoma / complications
-
Carcinoma / drug therapy
-
Carcinoma / secondary*
-
Carcinoma, Non-Small-Cell Lung / complications*
-
Carcinoma, Non-Small-Cell Lung / drug therapy
-
Carcinoma, Non-Small-Cell Lung / pathology
-
Double-Blind Method
-
Early Termination of Clinical Trials
-
Female
-
Hemorrhage / chemically induced
-
Heparin, Low-Molecular-Weight / adverse effects
-
Heparin, Low-Molecular-Weight / therapeutic use*
-
Humans
-
Lung Neoplasms / complications*
-
Lung Neoplasms / drug therapy
-
Lung Neoplasms / pathology
-
Male
-
Middle Aged
-
Neoplasm Staging
-
Pulmonary Embolism / etiology
-
Pulmonary Embolism / prevention & control*
-
Thrombocytopenia / chemically induced
-
Thrombophilia / drug therapy*
-
Thrombophilia / etiology
-
Treatment Outcome
-
Venous Thromboembolism / etiology
-
Venous Thromboembolism / prevention & control*
-
Warfarin / adverse effects
-
Warfarin / therapeutic use
Substances
-
Heparin, Low-Molecular-Weight
-
Warfarin
-
certoparin