High dose toremifene for estrogen and progesterone receptor negative metastatic breast cancer: A phase II trial of the Cancer and Leukemia Group B (CALGB) |
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Authors: | James J. Perry Donald A. Berry Raymond B. Weiss Daniel M. Hayes David B. Duggan I. Craig Henderson |
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Affiliation: | (1) Section of Hematology-Oncology, Comprehensive Cancer Center of Wake Forest University, 03927, CA, USA;(2) CALGB Statistical Office, 33601, CA, USA;(3) Section of Medical Oncology, Walter Reed Army Medical Center, 26806, CA, USA;(4) Dana-Farber Cancer Institute, 32291, CA, USA;(5) SUNY Health Science Center at Syracuse, 21060, CA, USA;(6) University of California, 60138 San Francisco, CA, USA;(7) Comprehensive Cancer Center of Wake Forest University, Medical Center Blvd., 27157-1082 Winston-Salem, NC, USA |
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Abstract: | Summary In pre-clinical and limited clinical studies, high doses ( 200 mg/day) of the triphenylethylene derivative toremifene showed activity in estrogen receptor (ER) negative and ER-unknown metastatic breast cancer after progression on tamoxifen, and a mechanism of action independent of hormone receptor binding was speculated. The CALGB conducted a Phase II trial (CALGB 8945) to test the efficacy of high dose toremifene in a population of patients who had hormone receptor-negative, metastatic breast cancer with limited prior chemotherapy exposure, good performance status, and measurable disease. Twenty eligible patients received toremifene at a dose of 400 mg/day orally for 8 weeks. Toxicity was minimal. Nausea was reported by 20% of the patients, lightheadedness by 20%, weight loss by 20%, and hot flashes by 15%. There was no grade 3–4 toxicity. No objective responses were observed, and 5 of 6 patients with stable disease at 8 weeks developed progressive disease at 11 to 33 weeks. High dose toremifene (400 mg/day) is well-tolerated but imparts no detectable activity in hormone receptor-negative, metastatic breast cancer. |
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Keywords: | anti-estrogens toremifene hormonal therapy breast cancer |
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