Annals of Oncology 14:1391-1398, 2003
© 2003 European Society for Medical Oncology
Original Paper |
Mature results of a randomized phase II multicenter study of exemestane versus tamoxifen as first-line hormone therapy for postmenopausal women with metastatic breast cancer
1 Universitair Ziekenhuis, Gasthuisberg, Leuven; 2 Algemeen Ziekenhuis Sint-Augustinus, Wilrijk; 3 IDBBC–EORTC, Brussels, Belgium; 4 Universitair Ziekenhuis, Nijmegen; 5 Leids University Medicine Center, Leiden, The Netherlands; 6 Edinburgh University, Western General Hospital, Edinburgh, UK; 7 Institute of Oncology, Ljubljana, Slovenia; 8 EORTC Data Center, Brussels; 9 Pharmacia, Brussels; 10 Institut Jules Bordet, Brussels, Belgium
Received 15 July 2002; revised 24 January 2003; accepted 11 March 2003
Background:
Women with hormone-responsive metastatic breast cancer (MBC) may respond to or have stable disease with a number of hormone therapies. We explored the efficacy and safety of the steroidal aromatase inactivator exemestane as first-line hormonal therapy in MBC in postmenopausal women.
Patients and methods:
Patients with measurable disease were eligible if they had received no prior hormone therapy for metastatic disease and had hormone receptor positive disease or hormone receptor unknown disease with a long disease-free interval from adjuvant therapy. They were randomized to tamoxifen 20 mg/day or exemestane 25 mg/day in this open-label study.
Results:
Blinded independently reviewed response rates for exemestane and tamoxifen were 41% and 17%, respectively. Fifty-seven per cent of exemestane- and 42% of tamoxifen-treated patients experienced clinical benefit, defined as complete or partial response, or disease stabilization lasting at least 6 months. There was a low incidence of severe flushing, sweating, nausea and edema in women who received exemestane. One exemestane-treated patient had a pulmonary embolism with grade 4 dyspnea.
Conclusions:
Exemestane is well tolerated and active in the first-line treatment of hormone-responsive MBC. An ongoing EORTC phase III trial is comparing the efficacy, measuring time-to-disease progression, of exemestane and tamoxifen.
Key words: aromatase inactivators, hormone therapy, metastatic breast cancer
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