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参与第一阶段临床试验的癌症患者的风险和益处趋势.

Thomas G Roberts1, Bernardo H Goulart, Lee Squitieri

  • 1Division of Hematology/Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, Mass 02114, USA. troberts@partners.org

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概括

第1期癌症试验显示患者的风险降低. 从1991年到2002年,毒性死亡率显著下降,这表明癌症药物开发中的安全性有所改善.

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科学领域:

  • 在瘤学瘤学.
  • 临床研究 临床研究
  • 药物开发 药物开发

背景情况:

  • 从历史上看,癌症第一阶段试验存在高风险,对患者的益处有限.
  • 最近的进展包括更有针对性的癌症药物和对临床研究环境的审查.
  • 在第一阶段试验中患者的风险-益处概况的不断变化仍在调查中.

研究的目的:

  • 分析1期癌症试验中与治疗相关的死亡率 (毒性死亡),客观反应率和严重毒性的趋势.
  • 为了确定影响这些临床结果的因素随着时间的推移.

主要方法:

  • 1991-2002年向美国临床瘤学会 (ASCO) 提交的已发表的单剂1期癌症治疗试验的系统审查.
  • 排除涉及已经获得FDA批准的药物或组合疗法的试验.
  • 独立提取关于试验设计,患者群体,药物特征和结果的数据.

主要成果:

  • 在213项研究中,整体毒性死亡率为0.54%,客观反应率为3.8%.
  • 毒性死亡率显著下降,从1.1% (1991-1994) 下降到0.06% (1999-2002) (P<.01). 毒性死亡率从1.1% (1991-1994) 下降到0.06% (1999-2002) (P<.01). 毒性死亡率从1.1% (1991-1994) 下降到0.06% (1999-2002) 下降到0.06% (1999-2002) (P<.01). 毒性死亡率从1.1% (1991-1994) 下降到0.06% (1999-2002) 下降到0.06% (1999-2002) 下降到0.06% (P<.01).
  • 在研究期间,客观反应率下降了大约一半,而毒性死亡率下降了90%以上.

结论:

  • 在1期癌症治疗试验中的患者风险在1991年至2002年间明显改善.
  • 与反应率相比,毒性死亡率的下降速度更快,表明风险与益处的比率有所改善.
  • 这些改进与开发有针对性的,毒性较低的药物以及加强临床试验安全监督有关.