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BACKGROUND:A prospective randomized clinical trial was implemented to assess whether the concomitant or the sequential addition of tamoxifen to chemotherapy provides improved clinical benefit in the adjuvant treatment of breast cancer in postmenopausal patients. PATIENTS AND METHODS:Four-hundred and eighty-five patients with node-positive operable disease were randomized to receive tamoxifen (20 mg/day) concomitantly (CON) or sequentially (SEQ) to EC chemotherapy (epirubicin 75 mg/m(2) + cyclophosphamide 600 mg/m(2) on day 1, every 21 days for four cycles). RESULTS:In the 474 fully evaluable patients there were 96 events; eight being second neoplasms and 88 being related to the breast cancer. Of these, 48 of 88 occurred in the CON arm and 40 of 88 in the SEQ arm. The Kaplan-Meier estimation of disease-free survival (DFS) at 5 years was 70% in the CON and 75% in the SEQ group (log-rank test, P = 0.43). Adjusted hazard ratio for treatment was 1.11 (95% confidence interval 0.71-1.73; P = 0.64). CONCLUSION:This study fails to show an advantage of one treatment arm over the other, but a trend, albeit non-significant, appears to favor the sequential addition of tamoxifen to epirubicin + cyclophosphamide and, as such, warrants further investigation.

Original publication

DOI

10.1093/annonc/mdh016

Type

Journal article

Journal

Annals of oncology : official journal of the European Society for Medical Oncology

Publication Date

01/2004

Volume

15

Pages

79 - 87

Addresses

Servicio de Oncología Médica, Hospital General Universitario de Alicante, Alicante, Spain.

Keywords

GEICAM Group, Humans, Breast Neoplasms, Neoplasm Metastasis, Tamoxifen, Cyclophosphamide, Epirubicin, Antibiotics, Antineoplastic, Antineoplastic Agents, Alkylating, Antineoplastic Agents, Hormonal, Antineoplastic Combined Chemotherapy Protocols, Disease-Free Survival, Chemotherapy, Adjuvant, Postmenopause, Drug Interactions, Aged, Middle Aged, Female