Veronesi U, Costa A, Sacchini V, Luini A, Bonanni B, Veronesi P, Rotmensz N, Boyle P
European Institute of Oncology, Milan, Italie.
Contracept Fertil Sex. 1995 Apr;23(4):258-60.
There is currently a large breast cancer chemoprevention trial in Italy. The trial is based on the use of the antioestrogen tamoxifen, which is one of the most successful and most studied anticancer drugs. There is a strong evidence that this drug can prevent the growing of controlateral cancer in women previously operated for breast cancer. The chemoprevention trial using tamoxifen includes healthy women, aged 35 to 70 and hysterectomised. The participants are taking either 20 mg/day of tamoxifen or placebo for 5 years, in double blind; then they are followed-up clinically and instrumentally every 6 months for the further 5 years. The main end-point of the study is to verify the reduction of incidence and mortality from breast cancer. It was decided to recruit only hysterectomised women on the consideration that, according to some studies, tamoxifen could give an additional risk of endometrial cancer: the Italian study was especially designed with the intention of avoiding this unjustified risk.
目前在意大利有一项大型乳腺癌化学预防试验。该试验基于使用抗雌激素药物他莫昔芬，它是最成功且研究最多的抗癌药物之一。有强有力的证据表明，这种药物可以预防曾接受过乳腺癌手术的女性对侧乳腺癌的发生。使用他莫昔芬的化学预防试验纳入了年龄在35至70岁且已接受子宫切除术的健康女性。参与者被随机分为两组，一组每天服用20毫克他莫昔芬，另一组服用安慰剂，为期5年，采用双盲法；在接下来的5年里，每6个月对她们进行一次临床和仪器检查随访。该研究的主要终点是验证乳腺癌发病率和死亡率的降低情况。考虑到根据一些研究，他莫昔芬可能会增加子宫内膜癌的风险，所以决定只招募已接受子宫切除术的女性：意大利的这项研究特意如此设计，目的是避免这种不合理的风险。
