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JCO Early Release, published online ahead of print Nov 16 2009
Received March 16, 2009 Trastuzumab for Patients With Axillary-Node–Positive Breast Cancer: Results of the FNCLCC-PACS 04 Trial
From the Department of Medicine, Institut Gustave Roussy, Villejuif; Department of Medicine, Institut Claudius Régaud, Toulouse; Department of Medicine, Centre François Baclesse, Caen; Department of Medicines and Biostatistics, Centre Val d'Aurelle, Montpellier; Department of Medicine, Centre Hospitalo-Universitaire, Poitiers; Department of Medicine, Institut Curie; Fédération Nationale des Centres de Lutte Contre le Cancer, Paris, France; Department of Medicine, Institut Sainte-Catherine, Avignon; Department of Medicine, Centre Eugène Marquis, Rennes; Department of Medicine, Centre Paul Papin, Angers; Department of Medicine, Centre Hospitalier, Bourg-en-Bresse; Department of Medicine, Centre René Gauducheau, Nantes; Department of Medicine, Clinique Armoricaine de Radiologie, Saint-Brieuc; Department of Medicine, Centre Georges-François Leclerc, Dijon; Department of Medicine, Centre-Médico Chirurgical les Ormeaux, Le Havre; Department of Pathology, Centre Jean Perrin, Clermont-Ferrand, France; Department of Medicine, Grand Hôpital de Charleroi, Charleroi; Department of Medicine, Hôpital Saint Luc, Brussels; and the Department of Medicine, Clinique Saint-Pierre, Ottignies, Belgium. * To whom correspondence should be addressed. E-mail: marc.spielmann{at}igr.fr
Purpose: To evaluate the efficacy of trastuzumab in patients with node-positive breast cancer treated with surgery, adjuvant chemotherapy, radiotherapy, and hormone therapy if applicable. Patients and Methods: Three thousand ten patients with operable node-positive breast cancer were randomly assigned to receive adjuvant anthracycline-based chemotherapy with or without docetaxel. Patients who presented human epidermal growth factor receptor 2 (HER2) -overexpressing tumors were secondary randomly assigned to either a sequential regimen of trastuzumab (6 mg/kg every 3 weeks) for 1 year or observation. The primary end point was disease-free survival (DFS). Results: Overall 528 patients were randomly assigned between trastuzumab (n = 260) and observation (n = 268) arm. Of the 234 patients (90%) who received at least one administration of trastuzumab, 196 (84%) received at least 6 months of treatment, and 41 (18%) discontinued treatment due to cardiac events (any grade). At the date of analysis (October 2007), 129 DFS events were recorded. Random assignment to the trastuzumab arm was associated with a nonsignificant 14% reduction in the risk of relapse (hazard ratio, 0.86; 95% CI, 0.61 to 1.22; P = .41, log-rank stratified on pathologic node involvement). Three-year DFS rates were 78% (95% CI, 72.3 to 82.5) and 81% (95% CI, 75.3 to 85.4) in the observation and trastuzumab arms, respectively. Conclusion: After a 47-month median follow-up, 1 year of trastuzumab given sequentially after adjuvant chemotherapy was not associated with a statistically significant decrease in the risk of relapse.
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Copyright © 2009 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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