Progression-free survival as a surrogate for overall survival in advanced/recurrent gastric cancer trials: a meta-analysis
The traditional endpoint for assessing efficacy of chemotherapies for advanced/recurrent gastric cancer is overall survival (OS), but OS requires prolonged follow-up. We investigated whether progression-free survival (PFS) is a valid surrogate for OS. Using individual patient data from the GASTRIC m...
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creator | Paoletti, Xavier Oba, Koji Bang, Yung-Jue Bleiberg, Harry Boku, Narikazu Bouché, Olivier Catalano, Paul Fuse, Nozomu Michiels, Stefan Moehler, Markus Morita, Satoshi Ohashi, Yasuo Ohtsu, Atsushi Roth, Arnaud Rougier, Philippe Sakamoto, Junichi Sargent, Daniel Sasako, Mitsuru Shitara, Kohei Thuss-Patience, Peter Van Cutsem, Eric Burzykowski, Tomasz Buyse, Marc |
description | The traditional endpoint for assessing efficacy of chemotherapies for advanced/recurrent gastric cancer is overall survival (OS), but OS requires prolonged follow-up. We investigated whether progression-free survival (PFS) is a valid surrogate for OS. Using individual patient data from the GASTRIC meta-analysis, surrogacy of PFS was assessed through the correlation between the endpoints and through the correlation between the treatment effects on the endpoints. External validation of the prediction based on PFS was also evaluated. Individual data from 4069 patients in 20 randomized trials were analyzed. The rank correlation coefficient between PFS and OS was 0.853 (95% confidence interval [CI] = 0.852 to 0.854). The R (2) between treatment effects on PFS and on OS was 0.61 (95% CI = 0.04 to 1.00). Treatment effects on PFS and on OS were only moderately correlated, and we could not confirm the validity of PFS as a surrogate endpoint for OS in advanced/recurrent gastric cancer. |
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We investigated whether progression-free survival (PFS) is a valid surrogate for OS. Using individual patient data from the GASTRIC meta-analysis, surrogacy of PFS was assessed through the correlation between the endpoints and through the correlation between the treatment effects on the endpoints. External validation of the prediction based on PFS was also evaluated. Individual data from 4069 patients in 20 randomized trials were analyzed. The rank correlation coefficient between PFS and OS was 0.853 (95% confidence interval [CI] = 0.852 to 0.854). The R (2) between treatment effects on PFS and on OS was 0.61 (95% CI = 0.04 to 1.00). Treatment effects on PFS and on OS were only moderately correlated, and we could not confirm the validity of PFS as a surrogate endpoint for OS in advanced/recurrent gastric cancer.</description><identifier>ISSN: 0027-8874</identifier><identifier>EISSN: 1460-2105</identifier><identifier>DOI: 10.1093/jnci/djt269</identifier><identifier>PMID: 24108811</identifier><language>eng</language><publisher>United States: Oxford University Press</publisher><subject>Biomarkers ; Brief Communication ; Disease-Free Survival ; Humans ; Neoplasm Recurrence, Local - mortality ; Neoplasm Recurrence, Local - therapy ; Odds Ratio ; Predictive Value of Tests ; Randomized Controlled Trials as Topic ; Stomach Neoplasms - mortality ; Stomach Neoplasms - pathology ; Stomach Neoplasms - therapy ; Treatment Outcome</subject><ispartof>JNCI : Journal of the National Cancer Institute, 2013-11, Vol.105 (21), p.1667-1670</ispartof><rights>The Author 2013. Published by Oxford University Press. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com. 2013</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c447t-a7f9e8f6e4f69f31cba253483b14a0a6044f2b921265dac20eca29f0f499be2e3</citedby><cites>FETCH-LOGICAL-c447t-a7f9e8f6e4f69f31cba253483b14a0a6044f2b921265dac20eca29f0f499be2e3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,780,784,885,27923,27924</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/24108811$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Paoletti, Xavier</creatorcontrib><creatorcontrib>Oba, Koji</creatorcontrib><creatorcontrib>Bang, Yung-Jue</creatorcontrib><creatorcontrib>Bleiberg, Harry</creatorcontrib><creatorcontrib>Boku, Narikazu</creatorcontrib><creatorcontrib>Bouché, Olivier</creatorcontrib><creatorcontrib>Catalano, Paul</creatorcontrib><creatorcontrib>Fuse, Nozomu</creatorcontrib><creatorcontrib>Michiels, Stefan</creatorcontrib><creatorcontrib>Moehler, Markus</creatorcontrib><creatorcontrib>Morita, Satoshi</creatorcontrib><creatorcontrib>Ohashi, Yasuo</creatorcontrib><creatorcontrib>Ohtsu, Atsushi</creatorcontrib><creatorcontrib>Roth, Arnaud</creatorcontrib><creatorcontrib>Rougier, Philippe</creatorcontrib><creatorcontrib>Sakamoto, Junichi</creatorcontrib><creatorcontrib>Sargent, Daniel</creatorcontrib><creatorcontrib>Sasako, Mitsuru</creatorcontrib><creatorcontrib>Shitara, Kohei</creatorcontrib><creatorcontrib>Thuss-Patience, Peter</creatorcontrib><creatorcontrib>Van Cutsem, Eric</creatorcontrib><creatorcontrib>Burzykowski, Tomasz</creatorcontrib><creatorcontrib>Buyse, Marc</creatorcontrib><creatorcontrib>GASTRIC group</creatorcontrib><title>Progression-free survival as a surrogate for overall survival in advanced/recurrent gastric cancer trials: a meta-analysis</title><title>JNCI : Journal of the National Cancer Institute</title><addtitle>J Natl Cancer Inst</addtitle><description>The traditional endpoint for assessing efficacy of chemotherapies for advanced/recurrent gastric cancer is overall survival (OS), but OS requires prolonged follow-up. 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Treatment effects on PFS and on OS were only moderately correlated, and we could not confirm the validity of PFS as a surrogate endpoint for OS in advanced/recurrent gastric cancer.</description><subject>Biomarkers</subject><subject>Brief Communication</subject><subject>Disease-Free Survival</subject><subject>Humans</subject><subject>Neoplasm Recurrence, Local - mortality</subject><subject>Neoplasm Recurrence, Local - therapy</subject><subject>Odds Ratio</subject><subject>Predictive Value of Tests</subject><subject>Randomized Controlled Trials as Topic</subject><subject>Stomach Neoplasms - mortality</subject><subject>Stomach Neoplasms - pathology</subject><subject>Stomach Neoplasms - therapy</subject><subject>Treatment Outcome</subject><issn>0027-8874</issn><issn>1460-2105</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpVkctLxDAQh4Mo7vo4eZccBambpNm28SCI-AJBD3oO03SyZuk2mnQL-tebZXXVXPKYj28m_Ag54uyMM5VP5p1xk2bei0JtkTGXBcsEZ9NtMmZMlFlVlXJE9mKcs7SUkLtkJCRnVcX5mHw-BT8LGKPzXWYDIo3LMLgBWgqRwuqWAOiRWh-oHzBA2_4yrqPQDNAZbCYBTYKx6-kMYh-coWZVCDSdoY3nybbAHjLooP2ILh6QHZve8fB73ycvN9fPV3fZw-Pt_dXlQ2akLPsMSquwsgVKWyibc1ODmOayymsugUHBpLSiVoKLYtqAEQwNCGWZlUrVKDDfJxdr79uyXmBj0oTpE_otuAWED-3B6f-Vzr3qmR90EkglqiQ4-RYE_77E2OuFiwbbFjr0y6i5TFhZ8ool9HSNmuBjDGg3bTjTq7T0Ki29TivRx38n27A_8eRf5h6WGA</recordid><startdate>20131106</startdate><enddate>20131106</enddate><creator>Paoletti, Xavier</creator><creator>Oba, Koji</creator><creator>Bang, Yung-Jue</creator><creator>Bleiberg, Harry</creator><creator>Boku, Narikazu</creator><creator>Bouché, Olivier</creator><creator>Catalano, Paul</creator><creator>Fuse, Nozomu</creator><creator>Michiels, Stefan</creator><creator>Moehler, Markus</creator><creator>Morita, Satoshi</creator><creator>Ohashi, Yasuo</creator><creator>Ohtsu, Atsushi</creator><creator>Roth, Arnaud</creator><creator>Rougier, Philippe</creator><creator>Sakamoto, Junichi</creator><creator>Sargent, Daniel</creator><creator>Sasako, Mitsuru</creator><creator>Shitara, Kohei</creator><creator>Thuss-Patience, Peter</creator><creator>Van Cutsem, Eric</creator><creator>Burzykowski, Tomasz</creator><creator>Buyse, Marc</creator><general>Oxford University Press</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20131106</creationdate><title>Progression-free survival as a surrogate for overall survival in advanced/recurrent gastric cancer trials: a meta-analysis</title><author>Paoletti, Xavier ; 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We investigated whether progression-free survival (PFS) is a valid surrogate for OS. Using individual patient data from the GASTRIC meta-analysis, surrogacy of PFS was assessed through the correlation between the endpoints and through the correlation between the treatment effects on the endpoints. External validation of the prediction based on PFS was also evaluated. Individual data from 4069 patients in 20 randomized trials were analyzed. The rank correlation coefficient between PFS and OS was 0.853 (95% confidence interval [CI] = 0.852 to 0.854). The R (2) between treatment effects on PFS and on OS was 0.61 (95% CI = 0.04 to 1.00). Treatment effects on PFS and on OS were only moderately correlated, and we could not confirm the validity of PFS as a surrogate endpoint for OS in advanced/recurrent gastric cancer.</abstract><cop>United States</cop><pub>Oxford University Press</pub><pmid>24108811</pmid><doi>10.1093/jnci/djt269</doi><tpages>4</tpages><oa>free_for_read</oa></addata></record> |
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subjects | Biomarkers Brief Communication Disease-Free Survival Humans Neoplasm Recurrence, Local - mortality Neoplasm Recurrence, Local - therapy Odds Ratio Predictive Value of Tests Randomized Controlled Trials as Topic Stomach Neoplasms - mortality Stomach Neoplasms - pathology Stomach Neoplasms - therapy Treatment Outcome |
title | Progression-free survival as a surrogate for overall survival in advanced/recurrent gastric cancer trials: a meta-analysis |
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