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Annals of Oncology Advance Access originally published online on May 26, 2006
Annals of Oncology 2006 17(8):1221-1227; doi:10.1093/annonc/mdl107
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© 2006 European Society for Medical Oncology

Complete hormonal blockade versus epirubicin-based chemotherapy in premenopausal, one to three node-positive, and hormone-receptor positive, early breast cancer patients: 7-year follow-up results of French Adjuvant Study Group 06 randomised trial

H. Roché1,*, P. Kerbrat2, J. Bonneterre3, P. Fargeot4, P. Fumoleau4, A. Monnier5, P. Clavère6, M.-J. Goudier7, P. Chollet8, J.-P. Guastalla9, D. Serin10 On behalf of the French Adjuvant Study Group

1 Institut Claudius Régaud, Toulouse; 2 Centre Eugène Marquis, Rennes; 3 Centre Oscar Lambret, Lille; 4 Centre Georges-François Leclerc, Dijon; 5 Centre Hospitalier André Boulloche, Montbéliard; 6 Centre Hospitalier Universitaire Dupuytren, Limoges; 7 Centre Hospitalier de Bretagne Sud, Lorient; 8 Centre Jean Perrin, Clermont-Ferrand; 9 Centre Léon Bérard, Lyon; 10 Institut Sainte-Catherine, Avignon, France

* Correspondence to: Prof. H. Roché, Département d'Oncologie Médicale, Institut Claudius Régaud, 20–24 rue du Pont Saint-Pierre, 31052 Toulouse Cedex, France. Tel: +33-5-61-42-41-29; Fax: +33-5-61-42-46-23; E-mail: roche{at}icr.fnclcc.fr

Background: The purpose of this study was to determine optimal adjuvant therapy between complete hormonal blockade in premenopausal patients with hormone receptor positive breast cancer and one to three positive nodes.

Patients and methods: We randomised 333 patients to receive either LHRH agonist (triptorelin 3.75 mg i.m., monthly) plus tamoxifen 30 mg/day for 3 years (TAM-LHRHa, n = 164), or fluorouracil 500 mg/m2, epirubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 every 21 days for six cycles, without any hormonal treatment (FEC50, n = 169).

Results: The 7-year disease-free survival (DFS) was 76% with TAM-LHRHa, and 72% with FEC50 (P = 0.13). The 7-year overall survival (OS) was 91% and 88%, respectively (P = 0.20). The multivariate analysis confirmed that both treatments were not different for DFS and OS (P = 0.83 and P = 0.41, respectively). Amenorrhoea occurred in 64% of patients treated with FEC50; it was temporary in 58% of cases after hormonotherapy and in 31% after chemotherapy.

Conclusion: In intermediate-risk breast cancer, complete hormonal blockade and chemotherapy provided similar outcomes. Hormonal treatment is an alternative to chemotherapy in hormone-sensitive patients, considering the preference of patients in terms of quality of life.

Key words: breast cancer, epirubicin, hormonal blockade, hormone-receptor positive, node-positive, premenopausal


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Comments on "Complete Hormonal Blockade ..." by H. Roché et. al.
Orhan Sencan, et al.
Annals of Oncology, 11 Aug 2006 [Full text]
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