Article(id=1236696517688480449, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236696515473895464, articleNumber=null, orderNo=null, doi=null, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=null, receivedDateStr=null, revisedDate=null, revisedDateStr=null, acceptedDate=1652112000000, acceptedDateStr=2022-05-10, onlineDate=1772781026526, onlineDateStr=2026-03-06, pubDate=1673712000000, pubDateStr=2023-01-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1772781026526, onlineIssueDateStr=2026-03-06, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1772781026526, creator=13701087609, updateTime=1772781026526, updator=13701087609, issue=Issue{id=1236696515473895464, tenantId=1146029695717560320, journalId=1235980733773295621, year='2023', volume='32', issue='1', pageStart='1', pageEnd='109', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1772781025999, creator=13701087609, updateTime=1772782685740, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1236703476982542786, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236696515473895464, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1236703476982542787, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236696515473895464, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=93, endPage=102, ext={EN=ArticleExt(id=1236696518007247555, articleId=1236696517688480449, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=A systematic evaluation of meta analyses on the correlation between short-term endpoints and final endpoints in cancer, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

Objective: To summarize the evaluation of meta analyses on the correlation between short-term endpoints (ORR, CR, etc.) and final endpoints (PFS, OS) in cancer, and to explore the correlation between different types of cancer. Methods: Based on Cooper et al. (2020), a systematic search in databases of Medline, Embase, the Cochrane library, Web of Science, and CINAHL were updated from March 2019 to January 2022. Meta analyses assessing the individual-level and trial-level correlation between short-term intermediate endpoints and final endpoints are summarized, and subgroup analyses are conducted in terms of the three most common cancer types. Results: The systematic review includes 77 studies across 20 types of cancer, in which non small cell lung cancer (NSCLC), colorectal cancer (CRC), and breast cancer are the three most common cancer types. The included studies mainly analyzed the correlation between ORR and OS (91%) or PFS (35%), and the correlation was week regardless of individual-level and trial-level. In subgroup analyses, over half studies in NSCLC indicated good or excellent trial-level correlation between ORR and PFS (R²>0.4). Also, most studies in NSCLC and CRC indicated that the trial-level correlation between ORR and PFS >0.3, >0.2) was stronger than that between ORR and OS (>0.1, >0.1). Conclusion: The short-term intermediate endpoints, such as ORR, may not be good surrogates for final endpoints. ORR may be a short-term intermediate indicator worth be noticed by regulators, which could be surrogate for PFS in trial-level in the field of NSCLC and CRC, especially in the field of NSCLC.

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目的：对肿瘤临床试验中短期中间指标［客观缓解率（ORR）、完全缓解（CR）等］与终点指标［无进展生存期（PFS）、总生存期（OS）］相关性研究的Meta分析进行系统评价，以探讨不同肿瘤领域下短期中间指标与终点指标的相关性。方法：在Cooper等（2020）研究基础上，更新检索2019年3月—2022年1月Medline，Embase，Cochrane，Web of science和CINAHL数据库，系统评价短期中间指标与终点指标的个体水平与试验水平相关性分析的Meta分析，并对研究数量最多的3种肿瘤的研究进行亚组分析。结果：共纳入77篇文献，分析了20种不同的肿瘤，其中非小细胞肺癌、结直肠癌和乳腺癌是3种最常见的肿瘤类型。相关性分析结果显示，纳入的研究主要分析了ORR与OS（91%）、ORR与PFS（35%）之间的关系，无论是在个体水平还是试验水平上，ORR等短期中间指标与PFS和OS均无明显的相关性。亚组分析结果显示，在非小细胞肺癌领域，超过一半的研究显示ORR与PFS在试验水平上的相关性R²>0.4，两者具有较好或很好的相关性。且在非小细胞肺癌和结直肠癌领域，多数研究显示ORR与PFS的试验水平相关性（>0.3，>0.2）强于ORR与OS（>0.1，>0.1）。结论：总体而言，ORR等短期中间指标可能不能成为替代终点指标。另外，在非小细胞肺癌和结直肠癌领域，特别是非小细胞肺癌领域，试验水平上ORR可能会成为PFS的替代终点指标，是值得监管部门关注的一个短期中间指标。

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费正洋，男，硕士研究生，研究方向：药物经济学。E-mail: 3220040606@stu.cpu.edu.cn。

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费正洋，男，硕士研究生，研究方向：药物经济学。E-mail: 3220040606@stu.cpu.edu.cn。

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