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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.


ABSTRACT:

Purpose

The initial report from the Programme Action Concertée 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.

SUBMITTER: Coudert B 

PROVIDER: S-EPMC3399644 | biostudies-literature | 2012

REPOSITORIES: biostudies-literature

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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 B   Asselain Bernard B   Campone Mario M   Spielmann Marc M   Machiels Jean-Pascal JP   Pénault-Llorca Frédérique F   Serin Daniel D   Lévy Christelle C   Romieu Gilles G   Canon Jean-Luc JL   Orfeuvre Hubert H   Piot Gilles G   Petit Thierry T   Jerusalem Guy G   Audhuy Bruno B   Veyret Corinne C   Beauduin Marc M   Eymard Jean-Christophe JC   Martin Anne-Laure AL   Roché Henri H  

The oncologist 20120518 7


<h4>Purpose</h4>The initial report from the Programme Action Concertée 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.<h4>Patients and methods</h4>Between June 1997 a  ...[more]

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