Adjuvant BEmiparin in Small Cell Lung Carcinoma (ABEL STUDY)
Summary
Main objective: To evaluate whether the subcutaneous administration (sc) of Bemiparin (3,500 UI/day) for 26 weeks, starting on the first day of chemotherapy (CT), delays tumoral spread and increases progression-free survival. Secondary objectives: To evaluate whether the subcutaneous administration (sc) of Bemiparin (3,500 UI/day) for 26 weeks, starting with the onset of chemotherapy, increases global survival, improving the response rates to treatment with CT + RT (radiotherapy) and reduces the incidence of venous thromboembolism (VTE).
Timeline
- Start
- 2005-06
- Primary completion
- 2010-02
- Completion
- 2010-09
Outcome
Met primary endpoint
Stopped (Enrollment): “Sponsor stopped due to difficulties to recruit 130 patients required by protocol”
paper Median progression-free survival was 272 days with chemoradiotherapy alone and 410 days in the bemiparin group; hazard ratio, 2.58 (95% confidence interval [CI], 1.15-5.80); p=0.022. PMID 24491267 ↗
Publications
- Rutjes AW, Porreca E, Candeloro M, Valeriani E, Di Nisio M. Primary prophylaxis for venous thromboembolism in ambulatory cancer patients receiving chemotherapy. Cochrane Database Syst Rev. 2020 Dec 18;12(12):CD008500. doi: 10.1002/14651858.CD008500.pub5.
- Lecumberri R, Lopez Vivanco G, Font A, Gonzalez Billalabeitia E, Gurpide A, Gomez Codina J, Isla D, Galan A, Bover I, Domine M, Vicente V, Rosell R, Rocha E. Adjuvant therapy with bemiparin in patients with limited-stage small cell lung cancer: results from the ABEL study. Thromb Res. 2013;132(6):666-70. doi: 10.1016/j.thromres.2013.09.026. Epub 2013 Sep 27.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bemiparin | Other / unclassified | 3500 iu | Subcutaneous |