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Comparison of Menopausal Symptoms During the First Year of Adjuvant Therapy With Either Exemestane or Tamoxifen in Early Breast Cancer: Report of a Tamoxifen Exemestane Adjuvant Multicenter Trial Substudy

Stephen E. Jones, James Cantrell, Svetislava Vukelja, John Pippen, Joyce O'Shaughnessy, Joanne L. Blum, Robert Brooks, Nicole L. Hartung, Angel G. Negron, Donald A. Richards, Ragene Rivera, Frankie Ann Holmes, Sreeni Chittoor, Thomas L. Whittaker, James H. Bordelon, Steven J. Ketchel, Jennifer C. Davis, Des Ilegbodu, Jean Kochis, Lina Asmar

From US Oncology Research Inc, Houston, TX

Address reprint requests to Stephen E. Jones, MD, Baylor-Charles A. Sammons Cancer Center, Texas Oncology PA, 3535 Worth St, Suite 600 Collins, Dallas, TX 75246; e-mail: Steve.Jones{at}usoncology.com

Purpose: Hormonal breast cancer treatment increases menopausal symptoms in women. This study investigated differences between the symptoms associated with either adjuvant tamoxifen or exemestane.

Patients and Methods: Ten common symptoms were assessed by self-report questionnaire administered to 1,614 consecutive patients at baseline and every 3 months during the first year of a double-blind, randomized trial of postmenopausal women with early hormone receptor–positive breast cancer. Symptoms were categorized as none, mild, moderate, or severe. A hot flash score was calculated at each time point. Symptoms were analyzed by repeated-measures analysis of variance. Each time period was tested repeatedly against the baseline; an overall P value was assigned for each reported symptom.

Results: Compliance was excellent, with 7,286 questionnaires analyzed. Baseline symptom prevalence ranged from 2% (vaginal bleeding) to 60% to 70% (bone/muscle aches and low energy). There were no significant differences in vaginal bleeding, mood alteration, or low energy. Patients receiving tamoxifen had significantly more vaginal discharge (P < .0001). Exemestane patients reported more bone/muscle aches (P < .0001), vaginal dryness (P = .0004), and difficulty sleeping (P = .03). In both groups, the hot flash score peaked at 3 months and decreased thereafter. At 12 months, patients receiving tamoxifen had a significantly higher mean hot flash score (P = .03), with daily hot flashes increasing from baseline by 33% compared with a 7% increase from baseline with exemestane.

Conclusion: At 12 months, exemestane was associated with fewer hot flashes and less vaginal discharge than tamoxifen, but with more vaginal dryness, bone/muscle aches, and difficulty sleeping. Symptoms were common in both groups.

Supported by Pfizer Inc, New York, NY.

Presented at the San Antonio Breast Cancer Symposium, December 3-6, 2003, and December 8-11, 2005, San Antonio, TX, and the 40th Annual Meeting of the American Society of Clinical Oncology, June 5-8, 2004, New Orleans, LA.

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