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• W4232237852 abstract "1503 Background: Tamoxifen (T) and fenretinide (F) are active in preventing premenopausal breast cancer and work synergistically in preclinical models. We assessed the activity of their combination in a 2x2 biomarker trial. Methods: We randomly assigned 235 premenopausal women with intraepithelial neoplasia (IEN) or Gail risk>1.3% to either T, 5 mg/day, or F, 200 mg/day, or T+F, or placebo for 2 years. Here we report data after a median of 5.5 years on plasma IGF-I, IGF-I/IGFBP-3, mammographic %density, endometrial thickness and breast cancer events. Results: T induced a 20% reduction of IGF-I and IGF-I/BP-3 in the IEN strata (n=181) versus a 9% reduction in the Gail strata (n=54), whereas F only slightly lowered IGFs levels. T lowered mammographic density by 21% (95% CI, 16–26%) at 24 months, compared with 11% (3–20%) on placebo (p=0.026), whereas F did not affect mammographic density. T increased endometrial thickness and uterine volume in women becoming postmenopausal during the trial, whereas F significantly reduced endometrial thickness and uterine volume. As of Nov 2007, 51 women developed breast cancer, mostly in the IEN strata, with an annual %rate (±SD) of 3.5±1.1, 2.7±0.9, 5.1±1.3 and 5.2±1.3 on T, F, T+F and placebo, respectively. Cox analysis in table shows some evidence of an antagonistic interaction between T and F (p=0.046 vs placebo). Adjusting for baseline ER, PgR or HER-2 status of the IEN strata had no influence on the interaction estimate. Plasma IGF-I had a strong predictive trend on breast neoplasms (p=0.008). Conclusions: Low-dose T and F given alone show promising activity in premenopausal breast cancer prevention, but their combination may be adverse. T lowers IGF-I more profoundly in women with prior IEN than in unaffected women and decreases mammographic density like the standard dose, whereas F has antiestrogenic effects at uterine level. Our clinical data support the role of circulating IGF-I as a risk biomarker for premenopausal breast cancer. Multivariate Cox regression analysis of breast cancer incidence Variable HR 95% CI p Disease status at baseline (Gail vs IEN) 5.94 1.43-24.64 0.014 T 0.65 0.29-1.44 0.280 F 0.48 0.21-1.09 0.081 T+F 3.23 1.02-10.20 0.046 IGF-I quartile 0.008 lowest 1.00 - middle low 0.98 0.42-2.29 middle high 1.11 0.48-2.58 top 1.50 0.67-3.34 No significant financial relationships to disclose." @default.
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• W4232237852 date "2008-05-20" @default.
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• W4232237852 title "A randomized double-blind 2x2 trial of low-dose tamoxifen and fenretinide for breast cancer prevention of high-risk premenopausal women" @default.
• W4232237852 doi "https://doi.org/10.1200/jco.2008.26.15_suppl.1503" @default.
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