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A phase I/II investigation of trioxifene mesylate in advanced breast cancer. Clinical and endocrinologic effects

  1. Robert S. Witte MD1,*,
  2. Brian Pruitt MD1,
  3. Douglass C. Tormey MD, PhD1,
  4. Scot Moss MS1,
  5. David P. Rose PhD1,
  6. Paul P. Carbone MD1,
  7. Guillermo Ramirez MD1,
  8. Geoffrey Falkson MD2,
  9. Hendre Falkson MD2,
  10. Florence J. Pretorius MD2

Article first published online: 29 JUN 2006

DOI: 10.1002/1097-0142(19860101)57:1<34::AID-CNCR2820570109>3.0.CO;2-W

Issue

Cancer

Cancer

Volume 57, Issue 1, pages 34–39, 1 January 1986

Additional Information

How to Cite

Witte, R. S., Pruitt, B., Tormey, D. C., Moss, S., Rose, D. P., Carbone, P. P., Ramirez, G., Falkson, G., Falkson, H. and Pretorius, F. J. (1986), A phase I/II investigation of trioxifene mesylate in advanced breast cancer. Clinical and endocrinologic effects. Cancer, 57: 34–39. doi: 10.1002/1097-0142(19860101)57:1<34::AID-CNCR2820570109>3.0.CO;2-W

Author Information

  1. 1

    Department of Human Oncology, University of Wisconsin, Madison, Wisconsin

  2. 2

    Department of Cancer Chemotherapy, University of Pretoria, Pretoria, South Africa

*The Gundersen Clinic, Ltd., 1836 South Avenue, La Crosse, WI 54601

Publication History

  1. Issue published online: 29 JUN 2006
  2. Article first published online: 29 JUN 2006
  3. Manuscript Accepted: 16 APR 1985

Funded by

  • Eli Lilly Company

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Abstract

Tamoxifen and trioxifene are antiestrogens that appear to have different endocrine effects when tested in rats. Whereas tamoxifen has considerable clinical activity, trioxifene is a new antiestrogen with undefined clinical activity. Thirty-six patients were treated with graded doses of trioxifene. The low-dose group (0.5 to 12 mg/m2 twice daily) had a 21% response rate in 24 subjects, and the high-dose group (40 to 100 mg/m2 twice daily) had a 33% response rate in 12 patients (P = 0.13). The time to treatment failure was 67 days and 178 days for the low- and high-dose groups, respectively. Toxicities were non-dose dependent; those of moderate frequency included leukopenia (41%) and nausea (31%). Tamoxifen reduced both prolactin and inducible growth hormone (GH). Trioxifene, although reducing prolactin, differed from tamoxifen in that an increase in inducible GH occurred. Furthermore, a striking dose-dependent decrease in luteinizing hormone and lesser decrease in follicle-stimulating hormone occurred only in the trioxifene-treated patients. This implies an intrinsic estrogenic action of trioxifene in man. Trioxifene is no more efficacious than tamoxifen and has more toxicity.

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