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How is overall survival assessed in randomised clinical trials in cancer and are subsequent treatment lines considered? A systematic review
BACKGROUND: Overall survival is the “gold standard” endpoint in cancer clinical trials. It plays a key role in determining the clinical- and cost-effectiveness of a new intervention and whether it is recommended for use in standard of care. The assessment of overall survival usually requires trial p...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10626781/ https://www.ncbi.nlm.nih.gov/pubmed/37926806 http://dx.doi.org/10.1186/s13063-023-07730-1 |
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author | Royle, Kara-Louise Meads, David Visser-Rogers, Jennifer K. White, Ian R. Cairns, David A. |
author_facet | Royle, Kara-Louise Meads, David Visser-Rogers, Jennifer K. White, Ian R. Cairns, David A. |
author_sort | Royle, Kara-Louise |
collection | PubMed |
description | BACKGROUND: Overall survival is the “gold standard” endpoint in cancer clinical trials. It plays a key role in determining the clinical- and cost-effectiveness of a new intervention and whether it is recommended for use in standard of care. The assessment of overall survival usually requires trial participants to be followed up for a long period of time. In this time, they may stop receiving the trial intervention and receive subsequent anti-cancer treatments, which also aim to extend survival, during trial follow-up. This can potentially change the interpretation of overall survival in the context of the clinical trial. This review aimed to determine how overall survival has been assessed in cancer clinical trials and whether subsequent anti-cancer treatments are considered. METHODS: Two searches were conducted using MEDLINE within OVID© on the 9th of November 2021. The first sought to identify papers publishing overall survival results from randomised controlled trials in eight reputable journals and the second to identify papers mentioning or considering subsequent treatments. Papers published since 2010 were included if presenting or discussing overall survival in the context of treating cancer. RESULTS: One hundred and thirty-four papers were included. The majority of these were presenting clinical trial results (98, 73%). Of these, 45 (46%) reported overall survival as a (co-) primary endpoint. A lower proportion of papers including overall survival as a (co-) primary endpoint compared to a secondary endpoint were published in recent years. The primary analysis of overall survival varied across the papers. Fifty-nine (60%) mentioned subsequent treatments. Seven papers performed additional analysis, primarily when patients in the control arm received the experimental treatment during trial follow-up (treatment switching). DISCUSSION: Overall survival has steadily moved from being the primary to a secondary endpoint. However, it is still of interest with papers presenting overall survival results with the caveat of subsequent treatments, but little or no investigation into their effect. This review shows that there is a methodological gap for what researchers should do when trial participants receive anti-cancer treatment during trial follow-up. Future research will identify the stakeholder opinions, on how this methodological gap should be addressed. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-023-07730-1. |
format | Online Article Text |
id | pubmed-10626781 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-106267812023-11-07 How is overall survival assessed in randomised clinical trials in cancer and are subsequent treatment lines considered? A systematic review Royle, Kara-Louise Meads, David Visser-Rogers, Jennifer K. White, Ian R. Cairns, David A. Trials Review BACKGROUND: Overall survival is the “gold standard” endpoint in cancer clinical trials. It plays a key role in determining the clinical- and cost-effectiveness of a new intervention and whether it is recommended for use in standard of care. The assessment of overall survival usually requires trial participants to be followed up for a long period of time. In this time, they may stop receiving the trial intervention and receive subsequent anti-cancer treatments, which also aim to extend survival, during trial follow-up. This can potentially change the interpretation of overall survival in the context of the clinical trial. This review aimed to determine how overall survival has been assessed in cancer clinical trials and whether subsequent anti-cancer treatments are considered. METHODS: Two searches were conducted using MEDLINE within OVID© on the 9th of November 2021. The first sought to identify papers publishing overall survival results from randomised controlled trials in eight reputable journals and the second to identify papers mentioning or considering subsequent treatments. Papers published since 2010 were included if presenting or discussing overall survival in the context of treating cancer. RESULTS: One hundred and thirty-four papers were included. The majority of these were presenting clinical trial results (98, 73%). Of these, 45 (46%) reported overall survival as a (co-) primary endpoint. A lower proportion of papers including overall survival as a (co-) primary endpoint compared to a secondary endpoint were published in recent years. The primary analysis of overall survival varied across the papers. Fifty-nine (60%) mentioned subsequent treatments. Seven papers performed additional analysis, primarily when patients in the control arm received the experimental treatment during trial follow-up (treatment switching). DISCUSSION: Overall survival has steadily moved from being the primary to a secondary endpoint. However, it is still of interest with papers presenting overall survival results with the caveat of subsequent treatments, but little or no investigation into their effect. This review shows that there is a methodological gap for what researchers should do when trial participants receive anti-cancer treatment during trial follow-up. Future research will identify the stakeholder opinions, on how this methodological gap should be addressed. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-023-07730-1. BioMed Central 2023-11-06 /pmc/articles/PMC10626781/ /pubmed/37926806 http://dx.doi.org/10.1186/s13063-023-07730-1 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Review Royle, Kara-Louise Meads, David Visser-Rogers, Jennifer K. White, Ian R. Cairns, David A. How is overall survival assessed in randomised clinical trials in cancer and are subsequent treatment lines considered? A systematic review |
title | How is overall survival assessed in randomised clinical trials in cancer and are subsequent treatment lines considered? A systematic review |
title_full | How is overall survival assessed in randomised clinical trials in cancer and are subsequent treatment lines considered? A systematic review |
title_fullStr | How is overall survival assessed in randomised clinical trials in cancer and are subsequent treatment lines considered? A systematic review |
title_full_unstemmed | How is overall survival assessed in randomised clinical trials in cancer and are subsequent treatment lines considered? A systematic review |
title_short | How is overall survival assessed in randomised clinical trials in cancer and are subsequent treatment lines considered? A systematic review |
title_sort | how is overall survival assessed in randomised clinical trials in cancer and are subsequent treatment lines considered? a systematic review |
topic | Review |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10626781/ https://www.ncbi.nlm.nih.gov/pubmed/37926806 http://dx.doi.org/10.1186/s13063-023-07730-1 |
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