Tamoxifen for the prevention of breast cancer: Late results of the Italian randomized tamoxifen prevention trial among women with hysterectomy
Tamoxifen for the prevention of breast cancer: Late results of the Italian randomized tamoxifen prevention trial among women with hysterectomy
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DOI：
10.1093/jnci/djk154
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发表时间：
2007-05-02
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影响因子：
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通讯作者：
Decensi, Andrea
中科院分区：
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作者：
Veronesi, Umberto;Maisonneuve, Patrick;Decensi, Andrea
意大利随机三苯氧胺预防试验的初步结果发现，使用三苯氧胺不会降低乳腺癌的风险，而国家外科辅助乳腺和肠道项目乳腺癌预防试验表明，三苯氧胺治疗可降低雌激素受体阳性乳腺癌的风险。在这里，我们提出了一个扩展的后续意大利trial.Methods从1992年10月1日，1997年12月31日，5408，否则健康的妇女谁经历了子宫切除术被随机分配在一个双盲的方式，他莫昔芬（20毫克，每天）或安慰剂5年。通过使用风险比（RR）和95%置信区间（CI）比较两组中乳腺癌和其他事件的发生率。（74例安慰剂组，62例他莫昔芬组）发生乳腺癌（RR = 0.84，95%CI = 0.60 - 1.17;年发生率分别为2.48和2.07/1000女性-年）。在两个研究组中，接受双侧卵巢切除术的妇女和激素受体阳性（HR+）疾病低风险妇女的乳腺癌发病率相似，但在高危妇女中，三苯氧胺组的乳腺癌发病率要低得多（安慰剂，6.26/1000女性-年，他莫昔芬，1.50/1000女性-年; RR = 0.24，95% CI = 0.10至0.59）。在治疗期间，他莫昔芬组的女性报告更多的潮热（RR = 1.78，95%CI = 1.57 ~ 2.00），阴道分泌物（RR = 3.44，95%CI = 2.90 - 4.09），以及泌尿系统紊乱（RR = 1.52，95% CI = 1.23至1.89），但头痛（RR 0.68，95% CI = 0.50至0.94）少于安慰剂组。高甘油三酯（RR = 4.33，95% CI 1.96 - 9.53），血栓栓塞事件（RR = 1.63，95%CI = 1.02 ~ 2.62），心律失常或房颤（资源1.73，95%CI = 1.01 ~ 2.98）在他莫昔芬组也比安慰剂组更常见。疾病可能会提高他莫昔芬干预的风险效益比。
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% Cl = 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% Cl = 0.10 to 0.59). During the treatment period, women in the tamoxifen group reported more hot flashes (RR = 1.78, 95% Cl = 1.57 to 2.00), vaginal discharge (RR = 3.44, 95% Cl = 2.90 to 4.09), and urinary disturbances (RR = 1.52, 95% Cl = 1.23 to 1.89) but fewer headaches (RR 0.68, 95% Cl = 0.50 to 0.94) than women in the placebo group. Hypertriglyceridemia (RR = 4.33, 95% Cl 1.96 to 9.53), thromboembolic events (RR = 1.63, 95% Cl = 1.02 to 2.62), and cardiac arrhythmia or atrial fibrillation (RR 1.73, 95% Cl = 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.