Published by Oxford University Press 2005
Improved disease-free survival with epirubicin-based chemoendocrine adjuvant therapy compared with tamoxifen alone in one to three node-positive, estrogen-receptor-positive, postmenopausal breast cancer patients: results of French Adjuvant Study Group 02 and 07 trials
1 Centre Antoine Lacassagne, Nice; 2 Centre Georges-François Leclerc, Dijon; 3 Institut Claudius Régaud, Toulouse; 4 Centre René Gauducheau, Nantes; 5 Centre Eugène Marquis, Rennes; 6 Centre Hospitalier Jules Courmont, Lyon; 7 Centre Hospitalier André Boulloche, Montbéliard; 8 Centre Alexis Vautrin, Nancy; 9 Clinique St-Vincent, Besançon; 10 Centre Oscar Lambret, Lille, France
* Correspondence to: Prof. M. Namer, Département d'Oncologie Médicale, 33 rue de Valombrose, 06186 Nice Cedex 2, France. Tel: +33-6-12-21-00-01; E-mail: moise.namer{at}wanadoo.fr
Background: The purpose was to compare disease-free survival (DFS) between epirubicin-based chemoendocrine therapy and tamoxifen alone in one to three node-positive (N1–3), estrogen-receptor-positive (ER+), postmenopausal early breast cancer (EBC) patients.
Patients and methods: We analyzed, retrospectively, 457 patients randomized in FASG 02 and 07 trials who received: tamoxifen alone (30 mg/day, 3 years); or FEC50 (fluorouracil 500 mg/m2, epirubicin 50 mg/m2, cyclophosphamide 500 mg/m2, six cycles every 21 days) plus tamoxifen started concurrently. Radiotherapy was delivered after the third cycle in FASG 02 trial, and after the sixth in FASG 07 trial.
Results: The 9-year DFS rates were 72% with tamoxifen and 84% with FEC50-tamoxifen (P = 0.008). The multivariate analysis showed that pathological tumor size >2 cm was an independent prognostic factor (P = 0.002), and treatment effects remained significantly in favor of chemoendocrine therapy (P = 0.0008). The 9-year overall survival rates were 78% and 86%, respectively (P = 0.11). In the multivariate model, there was a trend in favor of chemoendocrine therapy (P = 0.07).
Conclusion: The addition of FEC50 adjuvant chemotherapy to tamoxifen significantly improves long-term DFS in N1–3, ER+ and postmenopausal women. Chemoendocrine therapy seems to be more effective than tamoxifen in terms of long-term survival.
Key words: adjuvant therapy, breast cancer, epirubicin, estrogen-receptor positive, node-positive, tamoxifen
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