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Annals of Oncology Advance Access originally published online on April 7, 2005
Annals of Oncology 2005 16(5):716-725; doi:10.1093/annonc/mdi163
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© 2005 European Society for Medical Oncology

Timing of CMF chemotherapy in combination with tamoxifen in postmenopausal women with breast cancer: role of endocrine responsiveness of the tumor

M. Colleoni1,*, S. Li2, R. D. Gelber2, A. S. Coates3, M. Castiglione-Gertsch4, K. N. Price2, J. Lindtner5, C.-M. Rudenstam6, D. Crivellari7, J. Collins8, O. Pagani9, E. Simoncini10, B. Thürlimann11, E. Murray12, J. Forbes13, D. Erzen5, S. Holmberg14, A. Veronesi7, A. Goldhirsch1,9 On behalf of the International Breast Cancer Study Group (IBCSG){dagger}

1 European Institute of Oncology, Milan, Italy; 2 IBCSG Statistical Center, Dana-Farber Cancer Institute and Frontier Science and Technology Research Foundation, Boston, MA, USA; 3 The Cancer Council Australia and University of Sydney, Sydney, Australia; 4 IBCSG Coordinating Center, Bern, Switzerland; 5 Institute of Oncology, Ljubljana, Slovenia; 6 West Swedish Breast Cancer Study Group, Sahlgrenska University Hospital, Göteborg, Sweden; 7 Centro di Riferimento Oncologico, Aviano, Italy; 8 Department of Surgery, The Royal Melbourne Hospital, Melbourne, Australia; 9 Oncology Institute of Southern Switzerland Lugano, Switzerland; 10 Oncologia Medica-Spedali Civili, Brescia, Italy; 11 Kantonsspital, St Gallen, Switzerland; 12 Groote Schuur Hospital and University of Cape Town, Cape Town, South Africa; 13 Australian New Zealand Breast Cancer Trials Group, Newcastle, Australia; 14 Department of Surgery, SU/Moelndal's Hospital, Moelndal, Sweden

*Correspondence to: Dr M. Colleoni, Division of Medical Oncology, European Institute of Oncology, Via Ripamonti 435, 20141, Milan, Italy. Tel: +39-02-57489439; Fax: +39-02-7489212; Email: marco.colleoni{at}ieo.it

Background:: Controversy persists about whether chemotherapy benefits all breast cancer patients.

Patients and methods:: In the International Breast Cancer Study Group (IBCSG) trial VII, 1212 postmenopausal patients with node-positive disease were randomized to receive tamoxifen for 5 years or tamoxifen plus three concurrent courses of cyclophosphamide, methotrexate and 5-fluorouracil (‘classical’ CMF) chemotherapy, either early, delayed or both. In IBCSG trial IX, 1669 postmenopausal patients with node-negative disease were randomized to receive either tamoxifen alone or three courses of adjuvant classical CMF prior to tamoxifen. Results were assessed according to estrogen receptor (ER) content of the primary tumor.

Results:: For patients with node-positive, ER-positive disease, adding CMF either early, delayed or both reduced the risk of relapse by 21% (P=0.06), 26% (P=0.02) and 25% (P=0.02), respectively, compared with tamoxifen alone. There was no difference in disease-free survival when CMF was given prior to tamoxifen in patients with node-negative, ER-positive tumors.

Conclusions:: CMF given concurrently (early, delayed or both) with tamoxifen was more effective than tamoxifen alone for patients with node-positive, endocrine-responsive breast cancer, supporting late administration of chemotherapy even after commencement of tamoxifen. In contrast, sequential CMF and tamoxifen for patients with node-negative, endocrine-responsive disease was ineffective.

Key words: breast cancer, chemoendocrine therapy, estrogen receptors, postmenopausal, tamoxifen, timing of chemotherapy


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