Journal of Clinical Oncology, 2004 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 22, No 14S (July 15 Supplement), 2004: 516
© 2004 American Society of Clinical Oncology

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Abstract

A planned comparison of menopausal symptoms during the first year in 1,000 patients receiving either exemestane or tamoxifen in a double-blind adjuvant hormonal study

US Oncology Research, Inc, Houston, TX

516

Background: We assessed 10 menopausal symptoms at baseline and every 3 months during the first year of an ongoing randomized Phase III trial comparing relapse-free survival of postmenopausal women with receptor positive, early breast cancer treated with exemestane (an aromatase inactivator) or tamoxifen for 5 years. Methods: Symptoms were assessed by each patient as none, mild, moderate, or severe with more detail used to establish a "hot flash score". The median age of 997 evaluable pts was 65 years (range, 40–90). The symptoms were examined statistically by analysis of variance with repeated measurement design. Results: Vaginal dryness (p=0.0021) and bone/muscle aches (p<0.001) were worse in pts receiving exemestane while vaginal discharge was more common (p<0.001) in pts receiving tamoxifen. Most symptoms were mild or moderate and many pts recorded symptoms prior to the start of treatment (e.g. only 27% of pts recorded "none" for "low energy"). Based on the current sample size of 997 pts, there are no significant differences between the 2 treatments with respect to vaginal bleeding, mood alteration, impaired word finding, low energy, and hot flashes. Conclusion: This analysis is based on review of 3740 forms and by the time of the ASCO meeting, an analysis based on >4500 forms will be presented. Supported by Pfizer, New York, NY, USA

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Abstract presentation from the 2004 ASCO Annual Meeting