Originally published as JCO Early Release 10.1200/JCO.2004.02.145 on October 25 2004

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Disease-Free Survival Advantage of Weekly Epirubicin Plus Tamoxifen Versus Tamoxifen Alone As Adjuvant Treatment of Operable, Node-Positive, Elderly Breast Cancer Patients: 6-Year Follow-Up Results of the French Adjuvant Study Group 08 Trial

From the Centre Georges-François Leclerc, Dijon; Cetre Oscar Lambret, Lille; Institut Claudius Régaud, Toulouse; Clinique Catherine de Sienne; Centre René Gauducheau, Nantes; Centre Jean Perrin, Clermont-Ferrand; Centre Hospitalier André Boulloche, Montbéliard; Centre Antoine Lacassagne, Nice; Centre Paul Strauss, Strasbourg; Centre Hospitalier Louis Pasteur, Colmar; Centre Léon Bérard, Lyon; and Centre Hospitalier de Bretagne Sud, Lorient, France. Dr Chapelle-Marcillac is a consultant in Chatenay-Malabry, France

Address reprint requests to Pierre Fargeot, MD, Département d'Oncologie Médicale, Centre Georges-François Leclerc, 1 rue du Professeur Marion, BP 77980, 21079 Dijon Cedex, France; e-mail: pfargeot{at}dijon.fnclcc.fr

PURPOSE: To assess whether an epirubicin (EPI) -based chemotherapy plus hormonal regimen improves disease-free (DFS) in women older than 65 years, with node-positive, operable breast cancer (BC), relative to tamoxifen (TAM) alone.

PATIENTS AND METHODS: A total of 338 patients were randomly assigned after surgery to receive TAM 30 mg/d for 3 years (TAM, n = 164), or EPI 30 mg on days 1, 8, and 15 every 28 days for six cycles plus TAM 30 mg/d for 3 years (EPI-TAM, n = 174). In both arms, patients received radiotherapy, delivered after chemotherapy (CT) in the EPI-TAM group.

RESULTS: The 6-year DFS rates were 69.3% with TAM and 72.6% with EPI-TAM (P = .14). The multivariate analysis shows a relative risk of relapse of 1.93 (95% CI, 1.70 to 2.17) with TAM compared with EPI-TAM (P = .005). The 6-year OS, related to disease progression, was 79.1% and 79.8%, respectively (P = .41). Compliance with CT was good: 96.9% of patients received six cycles. The acute toxicity per patient was mild: grade 2 neutropenia in 5.9%, grade 2 anemia in 2.0%, grade 3 nausea or vomiting in 4.6%, and grade 3 alopecia in 7.2%. Five cases (in five patients) of decreased left ventricular ejection fraction occurred after CT: three after adjuvant CT, and two after anthracycline-based CT for relapse. One patient died as a result of dysrhythmia related to carcinomatous lymphangitis. No secondary leukemia occurred.

CONCLUSION: This study conducted in node-positive elderly patients demonstrates a significant contribution of a weekly EPI regimen in terms of DFS. Moreover, this regimen is safe for hematologic, nonhematologic, and cardiac toxicities.

Supported by grants from Pfizer, France.

Presented as abstract 145 (oral presentation) at the 38th Annual Meeting of the American Society of Clinical Oncology, Orlando, FL, May 18-21, 2002.

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

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  Anne Schott and Daniel F. Hayes
  JCO 2004 22: 4660-4662 [Full Text]

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