医学
临床终点
代理终结点
临床试验
肺癌
新辅助治疗
病态的
肿瘤科
癌症
内科学
实体瘤疗效评价标准
免疫疗法
重症监护医学
叙述性评论
化疗
疾病
肺
临床研究阶段
乳腺癌
作者
Shi‐Bin Ren,Anyi Xu,Yilian Lin,D. Ross Camidge,Massimo Di Maïo,Raffaele Califano,Toyoaki Hida,Antonio Rossi,Nicolas Guibert,Chengchu Zhu,Jianfei Shen
出处
期刊:Translational lung cancer research
[AME Publishing Company]
日期:2021-07-01
卷期号:10 (7): 3264-3275
被引量:11
摘要
Objective: This review summarizes the current status of neoadjuvant therapy and discusses the choice of new clinical research endpoints for non-small cell lung cancer.Background: Neoadjuvant chemotherapy is a recognized practice in patients with resectable and locally advanced lung cancer. With the introduction of molecular targeted drugs and immune checkpoint inhibitors (ICIs), the overall survival (OS) of patients with lung cancer has been significantly improved, and the original traditional clinical research endpoints are no longer suitable for existing clinical research. In order to accelerate the process of clinical trials and the development and approval of drugs, it is necessary to find suitable alternative indicators as the main indicators of clinical research.Methods: Therefore, this article focuses on clinical trials using disease-free survival (DFS), progression free survival, and pathological evaluation indicators, pathologic complete response and major pathologic response, as surrogate endpoints. We search related literature through PubMed database and clinical trials through clinicaltrials.gov.Conclusions: Pathologic complete response and major pathologic response are recommended as surrogate endpoints in the era of neoadjuvant immunotherapy, and secondary endpoints are listed for the prediction of pathological results. In addition, the definitions of major pathological response (MPR) and PCR should be standardized, and a new pathological evaluation standard should be developed, which is applicable to all current treatment methods.Keywords: Neoadjuvant therapy; resectable lung cancer; clinical research endpoint; pathological response
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