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Annals of Oncology Advance Access originally published online on March 5, 2008
Annals of Oncology 2008 19(7):1231-1241; doi:10.1093/annonc/mdn037
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© The Author 2008. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oxfordjournals.org

breast cancer

Premenopausal endocrine-responsive early breast cancer: who receives chemotherapy?

M. M. Regan1,*, O. Pagani2,3, B. Walley4, R. Torrisi5, E. A. Perez6, P. Francis7, G. F. Fleming8, K. N. Price9, B. Thürlimann3,10, R. Maibach11, M. Castiglione-Gertsch11, A. S. Coates12,13, A. Goldhirsch14, R. D. Gelber15 and for the SOFT/TEXT/PERCHE Steering Committee and the International Breast Cancer Study Group

1 IBCSG Statistical Center, Dana-Farber Cancer Institute, Harvard School of Public Health, Boston, MA, USA
2 Oncology Institute of Southern Switzerland, Ospedale Italiano, Viganello, Lugano
3 Swiss Group for Clinical Cancer Research, Bern, Switzerland
4 Tom Baker Cancer Centre, Calgary, Alberta, Canada
5 European Institute of Oncology, Milan, Italy
6 Mayo Clinic Jacksonville, Jacksonville, FL, USA
7 Peter MacCallum Cancer Centre, Melbourne, Australia
8 University of Chicago Medical Center, Chicago, IL, USA
9 IBCSG Statistical Center, Frontier Science and Technology Research Foundation, Boston, MA, USA
10 Senology Center of Eastern Switzerland, Kantonsspital, St Gallen, Switzerland
11 IBCSG Coordinating Center, Bern, Switzerland
12 International Breast Cancer Study Group, Bern, Switzerland
13 University of Sydney, Sydney, Australia
14 Oncology Institute of Southern Switzerland, Bellinzona, Switzerland
15 IBCSG Statistical Center, Dana-Farber Cancer Institute, Frontier Science and Technology Research Foundation, Harvard School of Public Health, Boston, MA, USA

* Correspondence to: Dr M. M. Regan, IBCSG Coordinating Center, Effingerstrasse 40, CH-3008 Bern, Switzerland. Tel: +41 31 389 93 91; Fax: +41 31 389 93 92; E-mail: mregan{at}jimmy.harvard.edu

Background: The role of chemotherapy in addition to combined endocrine therapy for premenopausal women with endocrine-responsive early breast cancer remains an open question, yet trials designed to answer it have repeatedly failed to adequately accrue. The International Breast Cancer Study Group initiated two concurrent trials in this population: in Premenopausal Endocrine Responsive Chemotherapy (PERCHE), chemotherapy use is determined by randomization and in Tamoxifen and Exemestane Trial (TEXT) by physician choice. PERCHE closed with inadequate accrual; TEXT accrued rapidly.

Methods: From 2003 to 2006, 1317 patients (890 with baseline data) were randomly assigned to receive ovarian function suppression (OFS) plus tamoxifen or OFS plus exemestane for 5 years in TEXT. We explore patient-related factors according to whether or not chemotherapy was given using descriptive statistics and classification and regression trees.

Results: Adjuvant chemotherapy was chosen for 64% of patients. Lymph node status was the predominant determinant of chemotherapy use (88% of node positive treated versus 46% of node negative). Geography, patient age, tumor size and grade were also determinants, but degree of receptor positivity and human epidermal growth factor receptor 2 status were not.

Conclusions: The perceived estimation of increased risk of relapse is the primary determinant for using chemotherapy despite uncertainties regarding the degree of benefit it offers when added to combined endocrine therapy in this population.

Key words: chemotherapy, estrogen receptor, exemestane, ovarian ablation, premenopausal, tamoxifen

Received for publication October 29, 2007. Accepted for publication January 23, 2008.


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