Reference : Extended Benefit from Sequential Administration of Docetaxel after Standard Fluoroura...
Scientific journals : Article
Human health sciences : Oncology
Extended Benefit from Sequential Administration of Docetaxel after Standard Fluorouracil, Epirubicin, and Cyclophosphamide Regimen for Node-Positive Breast Cancer: The 8-Year Follow-Up Results of the UNICANCER-PACS01 Trial.
Coudert, Bruno [> >]
Asselain, Bernard [> >]
Campone, Mario [> >]
Spielmann, Marc [> >]
Machiels, Jean-Pascal [> >]
Penault-Llorca, Frederique [> >]
Serin, Daniel [> >]
Levy, Christelle [> >]
Romieu, Gilles [> >]
Canon, Jean-Luc [> >]
Orfeuvre, Hubert [> >]
Piot, Gilles [> >]
Petit, Thierry [> >]
JERUSALEM, Guy mailto [Centre Hospitalier Universitaire de Liège - CHU > > Oncologie médicale >]
Audhuy, Bruno [> >]
Veyret, Corinne [> >]
Beauduin, Marc [> >]
Eymard, Jean-Christophe [> >]
Martin, Anne-Laure [> >]
Roche, Henri [> >]
Yes (verified by ORBi)
[en] breast cancer ; adjuvant treatment ; Epirubicin ; Docetaxel ; Sequential treatment ; randomized trial ; oncology
[en] Purpose. The initial report from the Programme Action Concertee Sein (PACS) PACS01 trial demonstrated a benefit at 5 years for disease-free survival (DFS) and overall survival (OS) rates with the sequential administration of docetaxel after FEC100 (fluorouracil 500 mg/m(2), epirubicin 100 mg/m(2), and cyclophosphamide 500 mg/m(2)) for patients with node-positive, operable breast cancer. We evaluate here the impact of this regimen at 8 years. Patients and Methods. Between June 1997 and March 2000, a total of 1,999 patients (age <65) with localized, resectable, non-pretreated, unilateral breast cancer were randomly assigned to receive either standard FEC100 for 6 cycles or 3 cycles of FEC100 followed by 3 cycles of 100 mg/m(2) docetaxel (FEC-D), both given every 21 days. Radiotherapy was mandatory after conservative surgery and tamoxifen was given for 5 years to hormone receptor (HR)-positive patients. Five-year DFS was the trial's main endpoint. Updated 8-year survival data are presented. Results. With a median follow-up of 92.8 months, 639 patients experienced at least one event. A total number of 383 deaths were registered. Eight-year DFS rates were 65.8% with FEC alone and 70.2% with FEC-D. OS rates at 8 years were 78% with FEC alone and 83.2% with FEC-D. Cox regression analysis adjusted for age and number of positive nodes showed a 15% reduction in the relative risk of relapse and a 25% reduction in the relative risk of death in favor of FEC-D. Significant relative risk reductions were observed in the HR-positive, HER2-positive, and Ki67 >/=20% subpopulations. Conclusion. Benefits for DFS and OS rates with the sequential FEC-D regimen are fully confirmed at 8 years.

File(s) associated to this reference

Fulltext file(s):

Restricted access
Extended benefit from sequential administration of Docetaxel.pdfPublisher postprint1.31 MBRequest copy

Bookmark and Share SFX Query

All documents in ORBi are protected by a user license.