Tamoxifen for the prevention of breast cancer: Late results of the Italian randomized tamoxifen prevention trial among women with hysterectomy Journal Article


Authors: Veronesi, U.; Maisonneuve, P.; Rotmensz, N.; Bonanni, B.; Boyle, P.; Viale, G.; Costa, A.; Sacchini, V.; Travaglini, R.; D'Aiuto, G.; Oliviero, P.; Lovison, F.; Gucciardo, G.; del Turco, M. R.; Muraca, M. G.; Pizzichetta, M. A.; Conforti, S.; Decensi, A.
Article Title: Tamoxifen for the prevention of breast cancer: Late results of the Italian randomized tamoxifen prevention trial among women with hysterectomy
Abstract: Background: Initial findings of the Italian Randomized Tamoxifen Prevention Trial found no reduction in risk of breast cancer with tamoxifen use, whereas the National Surgical Adjuvant Breast and Bowel Project Breast Cancer Prevention Trial showed that tamoxifen treatment reduces risk of estrogen receptor-positive breast cancer. Here we present an extended follow-up of the Italian trial. Methods: From October 1, 1992, to December 31, 1997, 5408 otherwise healthy women who had undergone hysterectomy were randomly assigned in a double-blind manner to tamoxifen (20 mg daily) or placebo for 5 years. Rates of breast cancer and other events in the two groups were compared by the use of risk ratios (RRs) and 95% confidence intervals (CIs). Results: After 11 years of follow-up, 136 women (74 placebo, 62 tamoxifen) developed breast cancer (RR = 0.84, 95% CI = 0.60 to 1.17; annual rates were 2.48 and 2.07 per 1000 women-years, respectively). The rates of breast cancer in the two study groups were similar among women who had had bilateral oophorectomy and among women at low risk for hormone receptor-positive (HR+) disease but were much lower in the tamoxifen group among women at high risk (placebo, 6.26 per 1000 women-years, tamoxifen, 1.50 per 1000 women-years; RR = 0.24, 95% CI = 0.10 to 0.59). During the treatment period, women in the tamoxifen group reported more hot flashes (RR = 1.78, 95% CI = 1.57 to 2.00), vaginal discharge (RR = 3.44, 95% CI = 2.90 to 4.09), and urinary disturbances (RR = 1.52, 95% CI = 1.23 to 1.89) but fewer headaches (RR = 0.68, 95% CI = 0.50 to 0.94) than women in the placebo group. Hypertriglyceridemia (RR = 4.33, 95% CI = 1.96 to 9.53), thromboembolic events (RR = 1.63, 95% CI = 1.02 to 2.62), and cardiac arrhythmia or atrial fibrillation (RR = 1.73, 95% CI = 1.01 to 2.98) were also more frequent in the tamoxifen group than in the placebo group. Conclusions: Appropriate selection of women at high risk for HR+ disease may improve the risk-benefit ratio of tamoxifen intervention. © The Author 2007. Published by Oxford University Press.
Keywords: adult; controlled study; human tissue; aged; middle aged; major clinical study; clinical trial; placebo; cancer risk; diarrhea; drug efficacy; drug withdrawal; hypertension; patient selection; risk benefit analysis; side effect; treatment duration; follow up; follow-up studies; cancer incidence; hysterectomy; endometrium cancer; cancer prevention; controlled clinical trial; breast cancer; nausea; randomized controlled trial; vomiting; ovariectomy; incidence; female sexual dysfunction; estrogen; estrogen therapy; vaginal dryness; deep vein thrombosis; pathology; breast neoplasms; high risk patient; time; time factors; risk assessment; lung embolism; confidence interval; drug fatality; drug induced headache; urine incontinence; cardiovascular disease; cerebrovascular disease; multicenter study; stroke; thromboembolism; breast tumor; transient ischemic attack; tamoxifen; skin disease; anxiety; hot flush; eye disease; antineoplastic agents, hormonal; heart arrhythmia; cystitis; hormone receptor; double blind procedure; heart atrium fibrillation; antineoplastic hormone agonists and antagonists; hypertriglyceridemia; placebos; fluid retention; phlebitis; vasomotor disorder; venous thromboembolism; weight gain; italy; retina vein occlusion; angina pectoris; stomach disease; urinary tract disease; vagina discharge
Journal Title: JNCI: Journal of the National Cancer Institute
Volume: 99
Issue: 9
ISSN: 0027-8874
Publisher: Oxford University Press  
Date Published: 2007-05-02
Start Page: 727
End Page: 737
Language: English
DOI: 10.1093/jnci/djk154
PUBMED: 17470740
PROVIDER: scopus
DOI/URL:
Notes: --- - "Cited By (since 1996): 49" - "Export Date: 17 November 2011" - "CODEN: JNCIA" - "Source: Scopus"
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  1. Virgilio Sacchini
    104 Sacchini