Originally published as JCO Early Release 10.1200/JCO.2007.14.4659 on September 15 2008

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Phase III Study Comparing Exemestane With Tamoxifen As First-Line Hormonal Treatment of Metastatic Breast Cancer in Postmenopausal Women: The European Organisation for Research and Treatment of Cancer Breast Cancer Cooperative Group

Robert J. Paridaens, Luc Y. Dirix, Louk V. Beex, Marianne Nooij, David A. Cameron, Tanja Cufer, Martine J. Piccart, Jan Bogaerts, Patrick Therasse

From the Universitair Ziekenhuis Gasthuisberg, Leuven; Algemeen Ziekenhuis Sint Augustinus, Antwerp; Institut Jules Bordet, Université Libre de Bruxelles; European Organisation for Research and Treatment of Cancer Data Centre, Brussels, Belgium; Radboud University Nijmegen Medical Centre, Nijmegen; Leiden University Medical Centre, Leiden, the Netherlands; University of Edinburgh & Western General Hospital, Edinburgh, United Kingdom; and The Institute of Oncology, Ljubljana, Slovenia

Corresponding author: Robert J. Paridaens, MD, PhD, University Hospital Gasthuisberg Katholieke Universiteit Leuven, B-3000 Leuven, Belgium; e-mail: robert.paridaens{at}uz.kuleuven.ac.be

Purpose This phase III randomized open-label clinical trial was designed to evaluate the efficacy and safety of the steroidal aromatase inactivator exemestane versus the antiestrogen tamoxifen as first-line treatment for metastatic breast cancer (MBC) in postmenopausal women.

Patients and Methods The study was conducted at 81 centers and enrolled postmenopausal patients with measurable hormone-sensitive metastatic or locally advanced breast cancer. Prior adjuvant chemotherapy and/or tamoxifen were allowed. One previous chemotherapy regimen and no prior hormone therapy for advanced disease were permitted. Patients were randomly assigned to receive exemestane 25 mg or tamoxifen 20 mg orally once daily until disease progression or unacceptable toxicity occurred.

Results A total of 371 patients enrolled at 79 sites (182 exemestane, 189 tamoxifen) were included in the analysis. Both treatments were generally well tolerated without major toxicity. Overall response rate was greater for exemestane than for tamoxifen treatment (46% v 31%; odds ratio = 1.85; 95% CI, 1.21 to 2.82; P = .005). Median progression-free survival (PFS) was longer with exemestane (9.9 months; 95% CI, 8.7 to 11.8 months) than with tamoxifen (5.8 months; 95% CI, 5.3 to 8.1 months). However, these early differences (Wilcoxon P = .028) did not translate to a longer-term benefit in PFS, the primary study end point (log-rank P = .121). There was also no difference in survival between both study arms.

Conclusion Exemestane is an effective and well-tolerated first-line hormonal treatment for postmenopausal women with MBC and offers significant early improvement in time to tumor progression when compared with tamoxifen.

published online ahead of print at www.jco.org on September 15, 2008

Supported in part by a grant from Pfizer Inc and Grant No. 2U10 CA11488-25 5U10 CA11488-34 from the National Cancer Institute (Bethesda, MD).

Presented in part at the 40th Annual Meeting of the American Society of Clinical Oncology, New Orleans, LA, June 5-8, 2004.

The contents of this article are solely the responsibility of the authors and do not necessarily represent the official views of the National Cancer Institute.

Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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