Originally published as JCO Early Release 10.1200/JCO.2006.07.3916 on November 20 2006

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Sequential Adjuvant Epirubicin-Based and Docetaxel Chemotherapy for Node-Positive Breast Cancer Patients: The FNCLCC PACS 01 Trial

Henri Roché, Pierre Fumoleau, Marc Spielmann, Jean-Luc Canon, Thierry Delozier, Daniel Serin, Michel Symann, Pierre Kerbrat, Patrick Soulié, Françoise Eichler, Patrice Viens, Alain Monnier, Anita Vindevoghel, Mario Campone, Marie-Josèphe Goudier, Jacques Bonneterre, Jean-Marc Ferrero, Anne-Laure Martin, Jean Genève, Bernard Asselain

From the Department of Medical Oncology, Institut Claudius Régaud, Toulouse; Department of Medical Oncology, Centre Georges-François Leclerc, Dijon; Department of Medical Oncology, Institut Gustave Roussy, Villejuif; Department of Medical Oncology, Centre François Baclesse, Caen; Department of Medical Oncology, Institut Sainte-Catherine, Avignon; Department of Medical Oncology, Centre Eugène Marquis, Rennes; Department of Medical Oncology, Centre Paul Papin, Angers; Department of Medical Oncology, Hospices Civils, Strasbourg; Department of Medical Oncology, Institut Paoli-Calmettes, Marseille; Department of Medical Oncology, Centre Hospitalier André Boulloche, Montbéliard; Department of Medical Oncology, Centre René Gauducheau, Nantes Saint-Herblain; Department of Medical Oncology, Centre Hospitalier de Bretagne Sud, Lorient; Department of Medical Oncology, Centre Oscar Lambret, Lille; Department of Medical Oncology, Centre Antoine Lacassagne, Nice; Fédération Nationale des Centres de Lutte Contre le Cancer; Department of Biostatistics, Institut Curie, Paris, France; Department of Medical Oncology, Centre Hospitalier Notre Dame-Reine Fabiola, Charleroi; Department of Medical Oncology, Cliniques Universitaires Saint-Luc, Bruxelles; and the Department of Medical Oncology, Clinique Sainte-Elisabeth, Namur, Belgium

Address reprint requests to Henri Roché, MD, Department of Medical Oncology, Institut Claudius Régaud, 20–24 rue du Pont Saint-Pierre, 31052 Toulouse, France; e-mail: roche.henri{at}claudiusregaud.fr

PURPOSE: The PACS 01 trial compared six cycles of fluorouracil, epirubicin, and cyclophosphamide (FEC) with a sequential regimen of three cycles of FEC followed by three cycles of docetaxel (FEC-D) as adjuvant treatment for women with node-positive early breast cancer.

PATIENTS AND METHODS: Between June 1997 and March 2000, 1,999 patients with operable node-positive breast cancer were randomly assigned to either FEC every 21 days for six cycles, or three cycles of FEC followed by three cycles of docetaxel, both given every 21 days. Hormone-receptor–positive patients received tamoxifen for 5 years after chemotherapy. The primary end point was 5-year disease-free survival (DFS).

RESULTS: Median follow-up was 60 months. Five-year DFS rates were 73.2% with FEC and 78.4% with FEC-D (unadjusted P = .011; adjusted P = .012). Multivariate analysis adjusted for prognostic factors showed an 18% reduction in the relative risk of relapse with FEC-D. Five-year overall survival rates were 86.7% with FEC and 90.7% with FEC-D, demonstrating a 27% reduction in the relative risk of death (unadjusted P = .014; adjusted P = .017). The incidence of grade 3 to 4 neutropenia, the need for hematopoietic growth factor, and incidence of nausea/vomiting were higher with FEC. Docetaxel was associated with more febrile neutropenia in the fourth cycle, stomatitis, edema, and nail disorders. Though rare overall, there were fewer cardiac events after FEC-D (P = .03), attributable mainly to the lower anthracycline cumulative dose.

CONCLUSION: Sequential adjuvant chemotherapy with FEC followed by docetaxel significantly improves disease-free and overall survival in node-positive breast cancer patients and has a favorable safety profile.

published online ahead of print at www.jco.org on November 20, 2006.

Supported in part by the Ligue Nationale Contre le Cancer, sanofi-aventis (France), Pfizer (France), and Amgen (France).

Presented in oral format at the 27th Annual San Antonio Breast Cancer Symposium, San Antonio, TX, December 8-11, 2004.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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Related Correspondence

• PACS 01 Trial: Questions About Patients' Characteristics and Reported Results
  Gaston Demonty and Jan Bogaerts
  JCO 2007 25: 2143 [Full Text]

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