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| |  Benefits of Docetaxel After FEC Regimen Sustained for 8 Years in Node-Positive Breast Cancer: Presented at SABCS By Jennifer Reising SAN ANTONIO, Tex -- December 15, 2009 -- Eight-year follow-up data from the Fédération Nationale des Centres de Lutte Contre le Cancer (FNCLCC) PACS 01 study confirm the long-term benefits of the sequential delivery of docetaxel after a standard regimen of 5-fluorouracil (5-FU), epirubicin, and cyclophosphamide for node-positive breast cancer. “The study shows that a sequential administration of docetaxel improves survival after 8 years by 25%,” said Bruno Coudert, MD, Roche H. Centre Georges-Francois Leclerc, Dijon, France, during a presentation here December 11 at the 32nd Annual San Antonio Breast Cancer Symposium (SABCS). “There was also less cardiac toxicity with this regimen.” Between June 1997 and March 2000, a total of 1,999 patients with localised, resectable, non-pretreated, unilateral breast cancer were enrolled in the study. Patients were randomised to receive either 6 cycles of 5-FU 500 mg/m2, epirubicin 100 mg/m2, and cyclophosphamide 500 mg/m2 (FEC) every 3 weeks (arm A) or 3 cycles of FEC followed by 3 cycles of docetaxel 100 mg/m2 every 3 weeks (arm B). The first chemotherapy cycle started no more than 42 days after surgery. Radiation therapy was administered after conservative surgery and hormone therapy was given for 5 years if tumours were positive for at least 1 hormone receptor. The main endpoint of the prospective, non-blinded, randomised, multicentre phase 3 study was disease-free survival (DFS) at 5 years. The initial report at 5 years showed a benefit in DFS and overall survival (OS) with sequential administration of FEC plus docetaxel. Since this first published analysis, survival data have been updated with a median long-term follow-up of 92.8 months. Findings show that the 8-year DFS rate was 65.8% for arm A and 70.2% for arm B. Results also showed a 25% reduction in the relative risk of death with the FEC/docetaxel regimen (P = .006). The 8-year OS rate was 78% with FEC alone and 83.2% with FEC plus docetaxel. There was also a 15% reduction in the relative risk of relapse in combination arm B (P = .03). Researchers confirmed from the updated analysis that substituting 3 cycles of docetaxel for 3 cycles of FEC, following 3 cycles of FEC, significantly improves DFS and OS in patients with node-positive breast cancer. The sequential regimen also shows significantly fewer long-term cardiac events. A subset analysis found that this benefit is more significant for patients aged older than 50 years than for younger patients and for 1 to 3 positive nodes than for 4 or over. Funding for this study was provided by the Ligue Nationale Contre Le Cancer, The French Health Ministry (PHRC), Sanofi-aventis France, Pfizer, and Amgen France. [Presentation title: Benefit of the Sequential Administration of Docetaxel After Standard FEC Regimen for Node-Positive Breast Cancer: Long-Term Follow-Up Results of the FNCLCC-PACS 01 Trial. Abstract 603]
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