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Recent Results Cancer Res. 2003;163:104-11; discussion 264-6.

HRT opposed to low-dose tamoxifen (HOT study): rationale and design.

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1
European Institute of Oncology, Via Ripamonti 435, 20141 Milan, Italy.

Abstract

The rationale for the HOT study is mainly based on the findings of the Italian Tamoxifen Prevention Study, where 5,408 healthy hysterectomized women aged 35-70 years were randomized to 20 mg/day of tamoxifen or placebo for 5 years. After 81.2 months median follow-up, 79 breast cancers occurred (34 on tamoxifen versus 45 on placebo, p=0.215). In the subgroup of 1,580 women who used estrogen replacement therapy (ERT) at some point during the study, 23 breast cancers were observed: 17 on placebo and 6 on tamoxifen (hazard ratio=0.35, 95% CI, 0.14-0.89). Pharmacokinetic and pharmacodynamic (surrogate endpoint biomarkers) studies showed that a lower dose of tamoxifen (such as 5 mg/day) does not affect the drug's activity on several biomarkers of both cardiovascular and breast cancer risk. We therefore propose a multicenter placebo-controlled phase III trial in postmenopausal healthy women on hormone replacement therapy (HRT) to assess whether the combination of HRT and low-dose tamoxifen retains the benefits while reducing the risks of either.

PMID:
12903847
DOI:
10.1007/978-3-642-55647-0_10
[Indexed for MEDLINE]

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