British Journal of Cancer ( IF 6.4 ) Pub Date : 2020-03-26 , DOI: 10.1038/s41416-020-0805-y Lisa Belin 1 , Aidan Tan 2 , Yann De Rycke 3 , Agnès Dechartres 1
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Background
Progression-free survival (PFS) is a surrogate endpoint widely used for overall survival (OS) in oncology. Validation of PFS as a surrogate must be done for each indication and each intervention. We aimed to identify all studies evaluating the validity of PFS as a surrogate for OS in oncology, and to describe their methodological characteristics.
Methods
We conducted a systematic review by searching MEDLINE via PubMed and the Cochrane Library with no limitation on time, selected relevant studies and extracted data in duplicate on how surrogacy was evaluated (meta-analytic approach, assessment of correlation and level of evaluation).
Results
We identified 91 studies evaluating the validity of PFS as a surrogate for OS in 24 cancer localisations. Although a meta-analytic approach was used in 83 (91%) studies, the methods used to validate PFS as a surrogate of OS were heterogeneous across studies. Of the 47 studies concluding that PFS is a good surrogate for OS, for 15 (32%), there was no quantitative argument for surrogacy.
Conclusions
Although most studies used a meta-analytic approach as recommended, our methodological review highlights heterogeneity in methods and reporting, which stresses the importance of developing and applying clear recommendations in this area.
中文翻译：
无进展生存率是肿瘤学试验中总体生存率的替代指标：系统方法学综述。
背景
无进展生存期（PFS）是广泛用于肿瘤整体生存期（OS）的替代终点。对于每种适应症和每种干预措施，都必须进行PFS的替代验证。我们旨在确定所有评估PFS作为肿瘤OS替代品有效性的研究，并描述其方法学特征。
方法
我们进行了系统的审查，通过PubMed和Cochrane图书馆搜索MEDLINE，没有时间限制，选择了相关研究，并重复提取了关于代孕评估的数据（元分析方法，相关性评估和评估水平）。
结果
我们鉴定了91项研究，评估了PFS在24个癌症地区中作为OS替代品的有效性。尽管在83（91％）个研究中使用了荟萃分析方法，但在整个研究中，用于验证PFS作为OS替代品的方法是异类的。在47项认为PFS是OS的良好替代品的研究中，有15项（32％）没有代孕方面的定量论据。
结论
尽管大多数研究都按照推荐的方法使用了荟萃分析方法，但我们的方法学综述强调了方法和报告的异质性，这强调了在此领域制定和应用明确建议的重要性。
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