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Influence of Hormone Replacement Therapy on Tamoxifen-Induced Vasomotor Symptoms

Ivana Sestak, Roseann Kealy, Robert Edwards, John Forbes, Jack Cuzick

From Cancer Research UK, Centre for Epidemiology, Mathematics and Statistics, Wolfson Institute of Preventive Medicine, London; and the Department of Surgical Oncology, Newcastle Mater Hospital, University of Newcastle, Newcastle, United Kingdom

Address reprint requests to Jack Cuzick, PhD, Cancer Research UK, Department for Epidemiology, Mathematics and Statistics, Wolfson Institute of Preventive Medicine, Charterhouse Square, London EC1M 6BQ, United Kingdom; e-mail: jack.cuzick{at}cancer.org.uk

PURPOSE: Tamoxifen is an effective drug, but its role in prevention is limited by its adverse effect profile. Non–life-threatening adverse effects, such as vasomotor symptoms, have an important influence in its use for prevention. Vasomotor symptoms were evaluated according to follow-up time, severity, and use of hormone replacement therapy (HRT) in a retrospective analysis.

PATIENTS AND METHODS: In the International Breast Cancer Intervention Study-I study, 7,154 women at increased risk of breast cancer were randomly assigned to either tamoxifen 20 mg/d or placebo for 5 years. Women gave detailed information on any vasomotor symptoms at each 6-month follow-up visit.

RESULTS: Hot flushes were reported more often in the tamoxifen group than in the placebo group (70.6% v 57.1%, respectively; odds ratio, 1.80; 95% CI, 1.63 to 1.99). Severe hot flushes were more strongly related to tamoxifen. In the tamoxifen arm, more women taking HRT at entry experienced hot flushes in the first 6 months than those who did not take HRT (60.8% v 49.2%, respectively; P = .09). In contrast, women on placebo taking HRT at entry experienced fewer hot flushes than women who stopped HRT (22.9% v 34.3%, respectively; P = .03). Furthermore, for women who first began HRT in the first 6 months of the trial compared with women who did not begin HRT, HRT seemed to be much more effective in controlling hot flushes in months 6 to 12 in the placebo arm (47.9% v 20.4%, respectively) than in the tamoxifen arm (51.4% v 39.0%, respectively).

CONCLUSION: HRT use at entry or during the trial was not effective in alleviating hot flushes for women in the tamoxifen arm. Our retrospective study suggests that estrogen-based HRT has limited effectiveness among women receiving tamoxifen.

Supported by Cancer Research UK, Oncosuisse Switzerland, and by National Health and Medical Research Council Grants No. 920876, 950319, 980381, 209811, and 401200 (J.F.).

Presented at the British Breast Group Meeting, July 1, 2005, London, United Kingdom; and the 9th International Nottingham Breast Cancer Conference, September 13-16, 2005, Nottingham, United Kingdom.

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

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