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Annals of Oncology 15:79-87, 2004
© 2004 European Society for Medical Oncology

Original Paper

Epirubicin–cyclophosphamide adjuvant chemotherapy plus tamoxifen administered concurrently versus sequentially: randomized phase III trial in postmenopausal node-positive breast cancer patients. A GEICAM 9401 study

Received 10 April 2003; revised 12 August 2003; accepted 28 August 2003

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/m2 + cyclophosphamide 600 mg/m2 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.

C. Pico1, M. Martin2,*, C. Jara3, A. Barnadas4, A. Pelegri5, A. Balil6, C. Camps7, A. Frau8, A. Rodriguez-Lescure9, J. M. Lopez-Vega10, J. de la Haba11, A. Tres12, I. Alvarez13, E. Alba14, A. Arcusa15, A. Oltra16, N. Batista17, T. Checa18, R. Perez-Carrion19 and J. Curto20

1 Servicio de Oncología Médica, Hospital General Universitario de Alicante, Alicante; 2 Servicio de Oncología Médica, Hospital Clínico Universitario San Carlos, Madrid; 3 Servicio de Oncología Médica, Fundación Hospital de Alcorcón, Alcorcón, Madrid; 4 Servicio de Oncología Médica, Hospital Germans Trias I Pujol, Badalona, Barcelona; 5 Servicio de Oncología Médica, Hospital Universitari Sant Joan de Reus, Reus, Tarragona; 6 Servicio de Oncología Médica, Hospital Universitari Arnau de Vilanova, Lleida; 7 Servicio de Oncología Médica, Hospital General Universitario de Valencia, Valencia; 8 Servicio de Oncología Médica, Hospital Provincial de Castellón, Castellón; 9 Servicio de Oncología Médica, Hospital General Universitario de Elche, Elche, Alicante; 10 Servicio de Oncología Médica, Hospital Universitario Marqués de Valdecilla, Santander; 11 Servicio de Oncología Médica, Hospital Universitario Reina Sofía, Córdoba; 12 Servicio de Oncología Médica, Hospital Clínico Universitario Lozano Blesa, Zaragoza; 13 Servicio de Oncología Médica, Hospital Nuestra Señora de Aránzazu, San Sebastián; 14 Servicio de Oncología Médica, Hospital Clínico Universitario Virgen de la Victoria, Málaga; 15 Servicio de Oncología Médica, Consorci Sanitari de Terrassa, Terrassa, Barcelona; 16 Servicio de Oncología Médica, Hospital Virgen de los Lirios, Alcoy, Alicante; 17 Servicio de Oncología Médica, Hospital Universitario de Canarias, La Laguna, Santa Cruz de Tenerife; 18 Instituto de Oncología Corachán, Barcelona; 19 Servicio de Oncología Médica, Hospital de La Princesa, Madrid; 20 Department of Biostatistics, Pharmacia S.A., Barcelona, Spain

Key words: adjuvant chemotherapy, adjuvant tamoxifen, breast cancer, concomitant, cyclophosphamide, epirubicin, sequential


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