A phase-III prevention trial of low-dose tamoxifen in postmenopausal hormone replacement therapy users: The HOT study

A. DeCensi, B. Bonanni, P. Maisonneuve, D. Serrano, U. Omodei, C. Varricchio, M. Cazzaniga, M. Lazzeroni, N. Rotmensz, B. Santillo, M. Sideri, E. Cassano, C. Belloni, M. Muraca, N. Segnan, P. Masullo, A. Costa, N. Monti, A. Vella, L. BisantiG. D'Aiuto, U. Veronesi

Research output: Contribution to journalArticle

Abstract

Background: Postmenopausal hormone replacement therapy (HRT) relieves menopausal symptoms and may decrease mortality in recently postmenopausal women, but increases breast cancer risk. Low-dose tamoxifen has shown retained activity in phase-II studies. Methods: We conducted a phase-III trial in 1884 recently postmenopausal women on HRT who were randomly assigned to either tamoxifen, 5 mg/day, or placebo for 5 years. The primary end point was breast cancer incidence. Results: After 6.2 ± 1.9 years mean follow-up, there were 24 breast cancers on placebo and 19 on tamoxifen (risk ratio, RR, 0.80; 95% CI 0.44-1.46). Tamoxifen showed favorable trends in luminal-A tumors (RR, 0.32; 95% CI 0.12-0.86), in HRT users

Original languageEnglish
Article numbermdt244
Pages (from-to)2753-2760
Number of pages8
JournalAnnals of Oncology
Volume24
Issue number11
DOIs
Publication statusPublished - Nov 2013

Keywords

  • Breast cancer
  • Chemoprevention
  • Hormone replacement therapy and low dose
  • Tamoxifen

ASJC Scopus subject areas

  • Oncology
  • Hematology

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    DeCensi, A., Bonanni, B., Maisonneuve, P., Serrano, D., Omodei, U., Varricchio, C., Cazzaniga, M., Lazzeroni, M., Rotmensz, N., Santillo, B., Sideri, M., Cassano, E., Belloni, C., Muraca, M., Segnan, N., Masullo, P., Costa, A., Monti, N., Vella, A., ... Veronesi, U. (2013). A phase-III prevention trial of low-dose tamoxifen in postmenopausal hormone replacement therapy users: The HOT study. Annals of Oncology, 24(11), 2753-2760. [mdt244]. https://doi.org/10.1093/annonc/mdt244