在胃食道腺癌的新辅助性临床试验中,病理完整反应是整体生存的替代品吗?
Luís Felipe Leite1, Mariana Macambira Noronha2, Samuel Menezes3
1Department of Medical Sciences, Universidade Federal Fluminense, RJ, Brazil.
European journal of cancer (Oxford, England : 1990)
|February 27, 2026
概括
在新辅助性胃食道腺癌 (GEA) 试验中,病理完整反应 (pCR) 不是整体生存 (OS) 的可靠预测指标. 它的预测价值因癌症类型和治疗而异,需要谨慎解释和对未来疗法的重新评估.
科学领域:
- 在瘤学瘤学.
- 临床试验 临床试验
- 胃肠道癌症 胃肠道癌症
背景情况:
- 病理完整反应 (pCR) 是胃食道腺癌 (GEA) 的新辅助疗法试验中常见的代用终点.
- 在预测GEA的整体存活期 (OS) 中,pCR的可靠性仍然不确定.
- 目前的证据不足以完全验证pCR在这个患者群体中作为OS的替代品.
研究的目的:
- 系统地评估pCR作为OS的替代终点在GEA新辅助疗法的随机对照试验 (RCT) 中的有效性.
- 在个人和试验水平上评估治疗对pCR和OS的影响之间的相关性.
- 在GEA治疗试验中确定影响pCR代孕的因素.
主要方法:
- 按照PRISMA和ReSEEM指南进行系统审查和元分析.
- 包括可切除的远端食道,胃食道结 (GEJ) 或胃腺癌的RCT,其中报告了PCR和OS.
- 通过将pCR率与中位数生存期相关联来评估个人级别的代孕;通过将治疗对pCR的影响 (odds比率) 与治疗对生存期的影响 (危险比率) 相关联来评估试验级别的代孕.
主要成果:
- 对26项涉及7452名患者的RCT进行分析.
- 总的来说,pCR在个人水平 (R2 = 0.006) 或试验水平 (R2 = 0.060) 上没有与OS显著相关.
- 代孕在食道腺癌 (R2 = 0.886) 中很强,在胃癌 (R2 = 0.386) 中很温和,但在GEJ试验中没有. 用放射治疗的试验显示出强烈的代孕,与仅使用化疗的试验不同.
结论:
- 在GEA试验中解释pCR需要谨慎,因为它对OS的预测价值有限.
- 在不同的GEA亚型和治疗方式中,pCR的代孕有很大差异.
- 重新评估PCR代孕非常重要,特别是随着免疫疗法等新疗法的出现.
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