Progression‐free survival assessed per immune‐related or conventional response criteria, which is the better surrogate endpoint for overall survival in trials of immune‐checkpoint inhibitors in lung cancer: A systematic review and meta‐analysis

Abstract Progression‐free survival (PFS) has been used as a surrogate endpoint for overall survival (OS) in lung cancer trials. The pattern of response to immune‐checkpoint inhibitors (ICIs) differs from that to conventional chemotherapy, so immune‐related response evaluation criteria were proposed....

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Autores principales: Guang‐Li Zhu, Kai‐Bin Yang, Si‐Qi Tang, Liang Peng
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Publicado: Wiley 2021
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spelling oai:doaj.org-article:453ad8aa9af1416885e7badeae00b7962021-12-01T04:49:14ZProgression‐free survival assessed per immune‐related or conventional response criteria, which is the better surrogate endpoint for overall survival in trials of immune‐checkpoint inhibitors in lung cancer: A systematic review and meta‐analysis2045-763410.1002/cam4.4347https://doaj.org/article/453ad8aa9af1416885e7badeae00b7962021-12-01T00:00:00Zhttps://doi.org/10.1002/cam4.4347https://doaj.org/toc/2045-7634Abstract Progression‐free survival (PFS) has been used as a surrogate endpoint for overall survival (OS) in lung cancer trials. The pattern of response to immune‐checkpoint inhibitors (ICIs) differs from that to conventional chemotherapy, so immune‐related response evaluation criteria were proposed. This study aims at determining which PFS measure, PFS assessed per immune‐related response evaluation criteria (iPFS), or conventional criteria (cPFS), is the better surrogate endpoint for OS in trials of ICIs in lung cancer. We selected clinical trials in lung cancer that administered ICIs to at least one arm and reported both median OS and median PFS from PubMed, Embase, and The Cochrane Library. We compared the correlation between treatment effect (hazard ratio) on OS and cPFS or iPFS and the correlation between median OS and median cPFS or iPFS using weighted linear regression at trial level. We analyzed 78 ICI arms (13,438 patients) from 54 studies, including 66 arms with cPFS, seven arms with iPFS, and five arms with both kinds of PFS. We demonstrated an excellent correlation between treatment effect (hazard ratio) on OS and iPFS (RWLS2 = 0.91), while the correlation was moderate for cPFS (RWLS2 = 0.38). Similarly, the correlation between median OS and median iPFS was also strong (RWLS2 ranging from 0.86 to 0.96) across different phases of trials and different types of lung cancer, ICI, and treatment modalities, while it was much weaker for median cPFS (RWLS2 ranging from 0.28 to 0.88). In conclusion, iPFS provides better trial‐level surrogacy for OS than cPFS in trials of ICIs in lung cancer.Guang‐Li ZhuKai‐Bin YangSi‐Qi TangLiang PengWileyarticleimmune‐checkpoint inhibitorslung cancerprogression‐free survivalsurrogate endpointsNeoplasms. Tumors. Oncology. Including cancer and carcinogensRC254-282ENCancer Medicine, Vol 10, Iss 23, Pp 8272-8287 (2021)
institution DOAJ
collection DOAJ
language EN
topic immune‐checkpoint inhibitors
lung cancer
progression‐free survival
surrogate endpoints
Neoplasms. Tumors. Oncology. Including cancer and carcinogens
RC254-282
spellingShingle immune‐checkpoint inhibitors
lung cancer
progression‐free survival
surrogate endpoints
Neoplasms. Tumors. Oncology. Including cancer and carcinogens
RC254-282
Guang‐Li Zhu
Kai‐Bin Yang
Si‐Qi Tang
Liang Peng
Progression‐free survival assessed per immune‐related or conventional response criteria, which is the better surrogate endpoint for overall survival in trials of immune‐checkpoint inhibitors in lung cancer: A systematic review and meta‐analysis
description Abstract Progression‐free survival (PFS) has been used as a surrogate endpoint for overall survival (OS) in lung cancer trials. The pattern of response to immune‐checkpoint inhibitors (ICIs) differs from that to conventional chemotherapy, so immune‐related response evaluation criteria were proposed. This study aims at determining which PFS measure, PFS assessed per immune‐related response evaluation criteria (iPFS), or conventional criteria (cPFS), is the better surrogate endpoint for OS in trials of ICIs in lung cancer. We selected clinical trials in lung cancer that administered ICIs to at least one arm and reported both median OS and median PFS from PubMed, Embase, and The Cochrane Library. We compared the correlation between treatment effect (hazard ratio) on OS and cPFS or iPFS and the correlation between median OS and median cPFS or iPFS using weighted linear regression at trial level. We analyzed 78 ICI arms (13,438 patients) from 54 studies, including 66 arms with cPFS, seven arms with iPFS, and five arms with both kinds of PFS. We demonstrated an excellent correlation between treatment effect (hazard ratio) on OS and iPFS (RWLS2 = 0.91), while the correlation was moderate for cPFS (RWLS2 = 0.38). Similarly, the correlation between median OS and median iPFS was also strong (RWLS2 ranging from 0.86 to 0.96) across different phases of trials and different types of lung cancer, ICI, and treatment modalities, while it was much weaker for median cPFS (RWLS2 ranging from 0.28 to 0.88). In conclusion, iPFS provides better trial‐level surrogacy for OS than cPFS in trials of ICIs in lung cancer.
format article
author Guang‐Li Zhu
Kai‐Bin Yang
Si‐Qi Tang
Liang Peng
author_facet Guang‐Li Zhu
Kai‐Bin Yang
Si‐Qi Tang
Liang Peng
author_sort Guang‐Li Zhu
title Progression‐free survival assessed per immune‐related or conventional response criteria, which is the better surrogate endpoint for overall survival in trials of immune‐checkpoint inhibitors in lung cancer: A systematic review and meta‐analysis
title_short Progression‐free survival assessed per immune‐related or conventional response criteria, which is the better surrogate endpoint for overall survival in trials of immune‐checkpoint inhibitors in lung cancer: A systematic review and meta‐analysis
title_full Progression‐free survival assessed per immune‐related or conventional response criteria, which is the better surrogate endpoint for overall survival in trials of immune‐checkpoint inhibitors in lung cancer: A systematic review and meta‐analysis
title_fullStr Progression‐free survival assessed per immune‐related or conventional response criteria, which is the better surrogate endpoint for overall survival in trials of immune‐checkpoint inhibitors in lung cancer: A systematic review and meta‐analysis
title_full_unstemmed Progression‐free survival assessed per immune‐related or conventional response criteria, which is the better surrogate endpoint for overall survival in trials of immune‐checkpoint inhibitors in lung cancer: A systematic review and meta‐analysis
title_sort progression‐free survival assessed per immune‐related or conventional response criteria, which is the better surrogate endpoint for overall survival in trials of immune‐checkpoint inhibitors in lung cancer: a systematic review and meta‐analysis
publisher Wiley
publishDate 2021
url https://doaj.org/article/453ad8aa9af1416885e7badeae00b796
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