在瘤学临床试验中的性别结果差异
Ashwin V Kammula1, Alejandro A Schäffer2, Padma Sheila Rajagopal1,3
1Cancer Data Science Laboratory, Center for Cancer Research, National Cancer Institute, Bethesda, MD, 20892, USA.
Nature communications
|March 24, 2024
概括
很少有瘤学临床试验报告性别差异,但分析显示男性和女性之间治疗结果和毒性存在显著差异. 进一步报告对于个性化癌症护理至关重要.
科学领域:
- 在瘤学瘤学.
- 临床试验 临床试验
- 性差异研究 研究 研究 研究
背景情况:
- 国家卫生研究院要求在瘤学临床试验中确定性别差异.
- 目前报告的基于性别的结果和试验中毒性比较是最小的.
研究的目的:
- 分析Trialtrove数据库,查看瘤学临床试验中性别比较的流行情况.
- 为了确定在癌症治疗中男性和女性之间报告的结果和毒性差异.
主要方法:
- 对瘤学临床试验的Trialtrove数据库的分析.
- 检查报告治疗后性别比较生存,反应和毒性的试验.
主要成果:
- 只有0.5%的瘤学试验 (472/89,221) 包含精选的性别比较.
- 在42%的比较试验中,女性在统计学上显著地显示出更好的生存结果,而男性则为16%.
- 在治疗肺癌的EGFR抑制剂和治疗非霍奇金淋巴瘤的Rituximab试验中,发现了有利于女性的显著差异.
- 更多的试验报告说,男性的副作用显著较小 (22),而不是女性 (13).
结论:
- 尽管报告很少,但在瘤学试验结果和毒性方面存在显著的基于性别的差异.
- 这些发现强调了临床试验数据中更彻底地报告性别差异的必要性.
- 解决这些差异对于推进个性化癌症医学和改善患者护理至关重要.
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