Exemestane shows high tumor response rate in first-line treatment of advanced bre...( BRUSSELS BELGIUM (September 19 2003) ...),Health

BRUSSELS, BELGIUM (September 19, 2003) - A study published in the September 2003 issue of Annals of Oncology (vol. 14, issue 9) indicated that exemestane demonstrates a high response rate for first-line treatment of advanced breast cancer in postmenopausal women. Response rate is a measurement of how effective the treatments are in shrinking the tumor.

In this phase II clinical study, 122 patients were randomized to either exemestane (25 mg/day) or tamoxifen (20 mg/day). The results indicate that exemestane was well-tolerated. Women treated with exemestane experienced the following grade 2/3 side-effects compared with those treated with tamoxifen: dyspnea (10 % vs. 8 %), edema or swelling (2 % vs. 11 %), grade 2/3 fatigue (13 % vs. 13 %), hot flashes (3 % vs. 14 %) and bone pain (10 % vs. 15 %). No patients were withdrawn from treatment due to toxicity. Moreover, patients treated with exemestane had three times the response rate (complete plus partial responses) in shrinking tumors (41 % vs. 17 %) relative to tamoxifen-treated patients.

"Although a formal statistical comparison between the two study arms is not allowed in the setting of this phase II clinical trial, the results were found very promising," said Robert J. Paridaens, M.D., Ph.D., professor and head of the medical oncology clinic, University Hospital Gasthuisberg, Catholic University Leuven, Leuven, Belgium, and lead investigator for the EORTC Breast Group. "The results lead to the European Organization for Research and Treatment of Cancer (EORTC), the organization that conducted the clinical trial, decision to extend the study in a phase III trial, for which the accrual of 342 patients was recently completed. The final results with statistical comparison of efficacy of both arms (exemestane versus tamoxifen) will be available by end of this year."

Exemestane currently is indicated for the treatment of advanced breast cancer in postmenopausal women whose tumors have stoppe
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Contact: Todd Ringler
todd.ringler@edelman.com
212-704-4572
Edelman Public Relations
19-Sep-2003

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