用于预防乳腺癌的阿纳斯托 (IBIS-II):随机对照试验的长期结果
Jack Cuzick1, Ivana Sestak1, John F Forbes2
1Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University London, London, UK.
Lancet (London, England)
|December 17, 2019
概括
在高风险妇女中,阿纳斯托显著降低了乳腺癌的发展,即使在治疗结束后也显示了持续的效果. 长期跟踪没有发现新的安全问题,表明阿纳斯特
科学领域:
- 癌症学
- 临床试验
- 药理学
背景情况:
- 两项主要试验表明,芳酶抑制剂可以降低高风险女性的乳腺癌.
- 国际乳腺癌干预研究II (IBIS-II) 试验研究了阿纳斯特罗的长期疗效.
- 专注于对乳腺癌的治疗后效果.
研究的目的:
- 评估阿纳斯特在治疗后预防乳腺癌的长期疗效.
- 评估侵袭性乳腺癌和直管癌 (DCIS) 的发生率.
- 监测主要不良事件,包括心血管问题和骨折.
主要方法:
- 随机,双盲,安慰剂对照试验 (IBIS-II).
- 3864名高风险的绝经后妇女接受了阿纳斯托 (每天1毫克) 或安慰剂治疗5年.
- 随访包括每年对乳腺癌发病率,死亡率和不良事件的评估.
主要成果:
- 在平均131个月的随访期内,阿纳斯托的乳腺癌发病率降低了49% (HR0. 51, p< 0. 0001).
- 在最初的5年治疗期和治疗后阶段均观察到显著的减少.
- 侵袭性雌激素受体阳性乳腺癌 (54%) 和DCIS (59%) 的减少;死亡或重大不良事件的增加没有.
结论:
- 在治疗后,阿纳斯特可显著持续减少乳腺癌发病率.
- 这种药物表现出良好的安全性,没有新的晚期副作用.
- 需要进一步的随访,以确定对乳腺癌死亡率的影响.
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