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Quality of Life in the Intergroup Exemestane Study: A Randomized Trial of Exemestane Versus Continued Tamoxifen After 2 to 3 Years of Tamoxifen in Postmenopausal Women With Primary Breast Cancer

From the Cancer Research UK Psychosocial Oncology Group, Brighton & Sussex Medical School, Falmer; Institute of Cancer Research Clinical Trials and Statistics Unit, Sutton; International Collaborative Cancer Group Data Centre, Imperial College, London, United Kingdom; and US Oncology Research, Houston, TX

Address reprint requests to Lesley J. Fallowfield, BSc, D Phil, Cancer Research UK Psychosocial Oncology Group, Brighton & Sussex Medical School, University of Sussex, Falmer, United Kingdom BN1 9QG; e-mail: l.j.fallowfield{at}sussex.ac.uk

PURPOSE: To compare and describe the quality of life (QOL) of women allocated to tamoxifen or exemestane within the Intergroup Exemestane Study (IES).

PATIENTS AND METHODS: Postmenopausal women with primary breast cancer who were disease free after 2 to 3 years were randomly assigned to switch from tamoxifen to exemestane or continue with tamoxifen until 5 years of treatment were completed. A subset of IES centers participated in a QOL substudy. The Functional Assessment of Cancer Therapy–Breast (FACT-B) and endocrine subscale (ES) were administered before random assignment and at predefined follow-up times. The primary end point was the FACT-B composite Trial Outcome Index (TOI). Secondary end points included total FACT-B+ES score, total ES score, and severity of individual endocrine symptoms. This analysis reports QOL up to 24 months.

RESULTS: Five hundred eighty-two patients from eight countries were enrolled onto the substudy. Completion and return of questionnaires was excellent, with 85% available for analysis. QOL was generally good and stable over 2 years, with no clinically meaningful differences found between groups in TOI or ES. Prevalence of severe endocrine symptoms at trial entry was high for vasomotor complaints and sexual problems, which persisted for both groups during the study. No significant differences between groups were seen for any endocrine symptoms apart from vaginal discharge, which was more pronounced with tamoxifen (P < .001).

CONCLUSION: The switch from tamoxifen to exemestane neither increased nor decreased endocrine symptoms present after 2 to 3 years of tamoxifen; the switch also did not initiate significant reports of new symptoms. Results indicate that the clinical benefits of exemestane over tamoxifen are achieved without significant detrimental effect on QOL.

Supported by Pfizer. The coordinating units at Brighton & Sussex Medical School, Imperial College, and the Institute of Cancer Research also received funding support from Cancer Research UK.

Presented in part at the 27th Annual San Antonio Breast Cancer Symposium, San Antonio, TX, December 8-11, 2004.

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

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