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Randomized Controlled Trial
. 2006 Jan;17(1):65-73.
doi: 10.1093/annonc/mdj022.

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

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Randomized Controlled Trial

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

M Namer et al. Ann Oncol. .

Abstract

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.

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