耐火性结直肠癌早期临床试验的有效性和安全性:一个元分析
Lidwien P Smabers1, Maarten A Huismans2, Niels van Nieuwenhuijzen3
1Department of Medical Oncology, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands; Laboratory of Translational Oncology, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.
概括
从2010年到2021年,转移性结直肠癌的1/2期试验的疗效略有改善. 这一进展与在更年轻,更健康和分子选择患者群体中测试新型免疫疗法和向治疗相关.
科学领域:
- 在瘤学瘤学.
- 临床试验 临床试验
- 癌症治疗方法 癌症治疗方法
背景情况:
- 对于转移性结直肠癌 (mCRC) 的1/2期试验的患者结局和风险-益处概况存在有限的综合分析.
- 最近mCRC的治疗创新需要对临床试验数据进行全面评估.
研究的目的:
- 在第一期和第二期mCRC试验中对疗效,安全性和时间趋势进行元分析.
- 评估临床益处率 (CBR),整体反应率 (ORR) 和不良事件 (AE).
主要方法:
- 遵守PRISMA系统审查指南.
- 在PubMed和Embase搜索了2010-2021年间发表的1/2期mCRC试验.
- 包括报告治疗耐药mCRC的新疗法的试验.
主要成果:
- 分析了258篇出版物,代表了277个独特的治疗手臂.
- 整体ORR为6%;第一阶段CBR为27%,第二阶段CBR为36%.
- CBR从23% (2010-2012) 增加到42% (2019-2021),转向免疫调节剂,分子预选种群和年轻患者.
结论:
- 在1/2期mCRC试验中,治疗疗效在2010-2021年间略有改善.
- 改善的结果与向疗法,免疫疗法和患者选择有关.
- 试验越来越多地集中在年轻,更健康和分子定义的患者队列上.
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