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Annals of Oncology Advance Access published online on April 7, 2005
Annals of Oncology, doi:10.1093/annonc/mdi163
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© 2005 European Society for Medical Oncology
Received August 25, 2004
Revised January 3, 2005
Accepted January 7, 2005

Original article

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

M. Colleoni 1*, S. Li 2, R. D. Gelber 2, A. S. Coates 3, M. Castiglione-Gertsch 4, K. N. Price 2, J. Lindtner 5, C.-M. Rudenstam 6, D. Crivellari 7, J. Collins 8, O. Pagani 9, E. Simoncini 10, B. Thürlimann 11, E. Murray 12, J. Forbes 13, D. Erzen 5, S. Holmberg 14, A. Veronesi 7, A. Goldhirsch 15, and 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
15 European Institute of Oncology, Milan, Italy; Oncology Institute of Southern Switzerland Lugano, Switzerland

* To whom correspondence should be addressed.
M. Colleoni, E-mail: marco.colleoni{at}ieo.it


  Abstract

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.

Keywords: breast cancer; chemoendocrine therapy; estrogen receptors; postmenopausal; tamoxifen; timing of chemotherapy.

{dagger}IBCSG trial VII and IX participants and authors are listed in the Appendix.


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