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无进展生存期作为实体瘤的一个终点——来自临床试验和临床实践的观点

Progression-free survival as an end-point in solid tumours--perspectives from clinical trials and clinical practice.

作者信息

Robinson Andrew G, Booth Christopher M, Eisenhauer Elizabeth A

机构信息

Department of Oncology, Queens University and Kingston General Hospital, Kingston, Canada.

Department of Oncology, Queens University and Kingston General Hospital, Kingston, Canada.

出版信息

Eur J Cancer. 2014 Sep;50(13):2303-8. doi: 10.1016/j.ejca.2014.05.024. Epub 2014 Jun 25.

DOI:10.1016/j.ejca.2014.05.024
PMID:24974171
Abstract

Progression-free survival (PFS) is an end-point in an increasing number of cancer clinical trials, informing both regulatory bodies and clinical practice. PFS is utilised both as a surrogate end-point for overall survival and as a primary trial end-point in itself. Understanding the history of clinical trial definitions of progression provides some context for how PFS may be applied to clinical practice as well as some of its limitations that need to be considered in patient care decisions. This commentary reviews recent drug approval for anti-cancer agents in solid tumours, reviews various concepts of progression in clinical trials and outlines some future directions for patient care and clinical trial research using progression free survival.

摘要

无进展生存期(PFS)在越来越多的癌症临床试验中作为一个终点指标,为监管机构和临床实践提供依据。PFS既被用作总生存期的替代终点指标,也本身作为主要的试验终点指标。了解临床试验中进展定义的历史,能为PFS如何应用于临床实践提供一些背景信息,以及在患者护理决策中需要考虑的一些局限性。本评论回顾了近期实体瘤抗癌药物的获批情况,回顾了临床试验中进展的各种概念,并概述了使用无进展生存期进行患者护理和临床试验研究的一些未来方向。

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