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January 23, 2012Clinical and Applied Thrombosis/Hemostasis

Low-Molecular-Weight Heparin Versus Placebo for the Prevention of Venous Thromboembolism in Metastatic Breast Cancer or Stage III/IV Lung Cancer

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Why the study?

Does certoparin reduce venous thromboembolism in ambulatory patients with metastatic breast cancer or stage III/IV lung cancer?

Population

883 ambulatory patients with objectively proven, disseminated metastatic breast carcinoma or stage III/IV…

Comparison

Certoparin 3000 IU subcutaneously once daily for… vs Placebo subcutaneously once daily for 6 months

Design

RCT, randomized, double-blind

Follow-up

6 months

Authors

SHSylvia HaasVascular MedicineMFMathias FreundUniversitätsmedizin RostockDHDavid F. HeigenerBerlin Institute of Health at Charité - Universitätsmedizin Berlin

Discussion

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Overview

Certoparin does not support routine VTE prophylaxis in these cohorts; challenges broad LMWH use while leaving open targeted benefit in stage IV lung cancer.

Structured PICO

Does certoparin reduce venous thromboembolism in ambulatory patients with metastatic breast cancer or stage III/IV lung cancer?

P
Population
883 ambulatory patients with objectively proven, disseminated metastatic breast carcinoma (TOPIC-1, n=351) or stage III/IV non-small-cell lung carcinoma (TOPIC-2, n=532)
I
Intervention
Certoparin 3000 IU subcutaneously once daily for 6 months
C
Comparator
Placebo subcutaneously once daily for 6 months
O
Outcome
Objectively confirmed symptomatic or asymptomatic venous thromboembolism (VTE)hard clinical

Prophylactic certoparin did not significantly reduce VTE in the overall cohorts of metastatic breast or stage III/IV lung cancer, but may offer benefit in stage IV lung cancer.

Limitations

  • TOPIC-1 was halted after an interim analysis
  • Significant finding was based on a post hoc analysis

Cite This Study

Haas et al. (2012) studied this question.

synapsesocial.com/papers/6a702bf66c240de38cdbb3d2https://doi.org/10.1177/1076029611433769
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