title: 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.affiliation: Institut für Experimentelle Onkologie und Therapieforschung, Technische Universität München, Germany. sylvia.haas@thromboscientific.com
authors.forename: Sylvia K
authors.initials: SK
authors.lastname: Haas
authors.forename: Mathias
authors.initials: M
authors.lastname: Freund
authors.forename: David
authors.initials: D
authors.lastname: Heigener
authors.forename: Lothar
authors.initials: L
authors.lastname: Heilmann
authors.forename: Bettina
authors.initials: B
authors.lastname: Kemkes-Matthes
authors.forename: Georg-Friedrich
authors.initials: GF
authors.lastname: von Tempelhoff
authors.forename: Nima
authors.initials: N
authors.lastname: Melzer
authors.forename: Ajay K
authors.initials: AK
authors.lastname: Kakkar
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000150:complications* / Q000188:drug therapy; D002277:Carcinoma / Q000150:complications / Q000188:drug therapy / Q000556:secondary*; D002289:Carcinoma, Non-Small-Cell Lung / Q000150:complications* / Q000188:drug therapy / Q000473:pathology; D004311:Double-Blind Method; D057239:Early Termination of Clinical Trials; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced; D006495:Heparin, Low-Molecular-Weight / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008175:Lung Neoplasms / Q000150:complications* / Q000188:drug therapy / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011655:Pulmonary Embolism / Q000209:etiology / Q000517:prevention & control*; D013921:Thrombocytopenia / Q000139:chemically induced; D019851:Thrombophilia / Q000188:drug therapy* / Q000209:etiology; D016896:Treatment Outcome; D054556:Venous Thromboembolism / Q000209:etiology / Q000517:prevention & control*; D014859:Warfarin / Q000009:adverse effects / Q000627:therapeutic use
chemical_list: D006495:Heparin, Low-Molecular-Weight; D014859:Warfarin; C403769:certoparin