病理完整反应和乳腺癌的长期临床益处:CTNeoBC综合分析
Patricia Cortazar1, Lijun Zhang1, Michael Untch2
1US Food and Drug Administration, Silver Spring, MD, USA.
Lancet (London, England)
|February 18, 2014
概括
病理完整反应,特别是乳腺和淋巴结中的瘤根除,预测乳腺癌患者的生存率有所改善. 然而,它不能在本分析中被验证为替代终点.
科学领域:
- 在瘤学瘤学.
- 临床试验 临床试验
- 生物统计学 生物统计学
背景情况:
- 病理完整反应 (pCR) 被研究为预测乳腺癌的长期临床益处的替代终点.
- 关键目标包括建立PCR与无事件生存 (EFS) 和总生存 (OS) 之间的关联,定义最佳PCR标准,确定预测亚型,并评估PCR的替代潜力.
研究的目的:
- 评估乳腺癌患者病理完整反应 (pCR) 和长期结果 (EFS和OS) 之间的关联.
- 为了确定pCR的最有效的定义来预测长期存活率.
- 识别乳腺癌亚型,其中pCR与结果的相关性最强.
- 评估增加的pCR率是否预测了改善的EFS和OS.
主要方法:
- 在PubMed,Embase和Medline进行了系统的搜索,寻找符合条件的新辅助乳腺癌试验.
- 纳入标准:≥200名患者,手术前化疗,可用的PCR,EFS和OS数据,中位数随访时间≥3年.
- 响应者分析比较了三个pCR定义 (ypT0 ypN0, ypT0/is ypN0, ypT0/is);试验级分析评估了pCR作为替代终点.
主要成果:
- 分析了12项试验和11,955名患者的数据.
- 从乳腺和淋巴结中消除瘤 (ypT0 ypN0或ypT0/is ypN0) 与仅乳腺的消除 (ypT0/is) 相比,与改善EFS和OS的相关性更强.
- 在三阴性乳腺癌和 HER2 阳性,荷尔蒙受体阴性瘤中观察到最强的关联,这些瘤接受了 trastuzumab 治疗. 试验层面的分析显示,增加的pCR频率与改善的EFS/OS之间存在有限的关联.
结论:
- 病理完整反应,定义为ypT0 ypN0或ypT0/is ypN0,与乳腺癌患者的生存率改善有关.
- 在侵袭性瘤亚型中,pCR的预后值最为显著.
- 聚合分析没有验证病理完整反应作为改善EFS和OS的可靠代用终点.
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