在胃或胃食道结腺癌中进行随机对照试验,经过二十年的全身治疗
Bin-Bin Xu1, Jun Lu1, Hua-Long Zheng1
1Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Department of General Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Key Laboratory of Ministry of Education of Gastrointestinal Cancer, Fujian Medical University, Fuzhou, China; Fujian Key Laboratory of Tumor Microbiology, Fujian Medical University, Fuzhou, China; Fujian Province Minimally Invasive Medical Center, Fuzhou, China.
尽管胃癌随机对照试验 (RCT) 的增加,但全身治疗没有显著改善存活率. 很少有试验达到临床益处值,这表明需要在未来的研究中优先考虑患者的结果.
科学领域:
- 在瘤学瘤学.
- 临床试验 临床试验
- 胃肠癌的治疗方法 胃肠癌的治疗方法
背景情况:
- 胃或胃食道结腺癌 (GA) 系统治疗的随机对照试验 (RCT) 的数量正在增加.
- 了解20多年来这些试验的演变和临床益处对于推进GA治疗至关重要.
研究的目的:
- 描述过去20年 (2001-2020年) 的 GA-RCTs 的趋势.
- 通过使用欧洲医学瘤学会临床益处量表 (ESMO-MCBS) 评估在GA-RCT中研究的全身治疗的临床益处.
主要方法:
- 从2001年到2020年,在八个主要期刊上发表的GA-RCT在PubMed上的系统搜索.
- 提取研究特征和结果,通过ESMO-MCBS评估临床益处.
主要成果:
- 分析了93个涉及38365名患者的RCT,显示出外部资金增加和向治疗/免疫治疗试验的增加.
- 尽管试验活动增加,但总体生存率中位数没有改善,只有36.4%的研究达到ESMO-MCBS值.
- 随着时间的推移,没有观察到符合ESMO-MCBS研究设计或结果门的RCT的显著增加.
结论:
- GA-RCTs越来越多地包含向治疗和免疫疗法,并获得更多的外部资金.
- 然而,在过去的二十年中,GA系统治疗的临床益处和效果大小并没有显著改善.
- 未来的GA-RCT必须优先考虑可证明的临床益处,以优化治疗策略和改革临床实践.
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