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Conference Paper: Evaluation of disease-free survival as surrogate endpoint for overall survival using two individual patient data meta-analyses of adjuvant chemotherapy in operable non-small cell lung cancer

TitleEvaluation of disease-free survival as surrogate endpoint for overall survival using two individual patient data meta-analyses of adjuvant chemotherapy in operable non-small cell lung cancer
Authors
Issue Date2011
PublisherLippincott Williams & Wilkins.
Citation
The 2011 Annual Meeting of the American Society of Clinical Oncology (ASCO), Chicago, IL., 3-7 June 2011. In Journal of Clinical Oncology, 2011, v. 29 n. 15 suppl., abstract no. 7004 How to Cite?
AbstractBACKGROUND: The gold standard endpoint in clinical trials of adjuvant chemotherapy (CT) in lung cancer is overall survival (OS), which while a reliant and simple-to-measure outcome, takes a long time to observe in this setting. This study aimed to evaluate disease-free survival (DFS) as a potential surrogate endpoint for OS in adjuvant CT trials, which could lead to more rapid conclusion of trials. METHODS: This analysis was based on individual patient data of 7,626 patients (pts) and 25 randomized trials from two large meta-analyses of adjuvant CT: surgery alone versus surgery + CT and surgery + radiotherapy (RT) versus surgery + RT + CT. DFS was defined as the time from randomization to the first event (local or distant recurrence or death from any cause). A correlation approach was used to assess individual and trial level surrogacy: at the individual level, to estimate association between distributions of DFS and OS ( ), and at trial level, to estimate association between treatment effects on DFS and OS (R). Values of and R closer to 1.0 would indicate strong surrogacy. RESULTS: Analysis 1 (without RT) included 18 trials (5,379 pts, 2,525 DFS events and 2,163 deaths); analysis 2 (with RT) included 7 trials (2,247 pts, 1,673 DFS events and 1,566 deaths). 79% and 84% of DFS events, respectively, occurred in the first three years. Correlations between DFS and OS were very strong, both at the individual ( =0.91 in trials without RT and 0.93 in trials with RT) and trial level (R=0.96, 95% confidence interval [0.92-1.00] and 0.99 [0.98-1.00], respectively). Considering only events occurring in the first three years and deaths in the first five years, trial-level correlation remained strong (R=0.94 [0.88-1.00] and 0.98 [0.95-1.01] respectively). CONCLUSIONS: Our large database provides good evidence that disease-free survival is a valid surrogate endpoint for overall survival in operable non-small cell lung cancer in the adjuvant CT setting. Supported by French Cancer League, PHRC and British Medical Research Council.
DescriptionThis journal suppl. entitled: ASCO Meeting Abstracts Part 1
Persistent Identifierhttp://hdl.handle.net/10722/195782
ISSN
2015 Impact Factor: 20.982
2015 SCImago Journal Rankings: 9.204

 

DC FieldValueLanguage
dc.contributor.authorMichiels, Sen_US
dc.contributor.authorMauguen, Aen_US
dc.contributor.authorFisher, Den_US
dc.contributor.authorBurdett, Sen_US
dc.contributor.authorPaulus, R-
dc.contributor.authorMandrekar, SJ-
dc.contributor.authorBelani, CP-
dc.contributor.authorShepherd, FA-
dc.contributor.authorEisen, T-
dc.contributor.authorPang, HMH-
dc.contributor.authorCollette, L-
dc.contributor.authorLe Pechoux, C-
dc.contributor.authorPignon, J-
dc.contributor.authorSurrogate Lung Project Collaborative Group-
dc.date.accessioned2014-03-10T04:52:57Z-
dc.date.available2014-03-10T04:52:57Z-
dc.date.issued2011en_US
dc.identifier.citationThe 2011 Annual Meeting of the American Society of Clinical Oncology (ASCO), Chicago, IL., 3-7 June 2011. In Journal of Clinical Oncology, 2011, v. 29 n. 15 suppl., abstract no. 7004en_US
dc.identifier.issn0732-183X-
dc.identifier.urihttp://hdl.handle.net/10722/195782-
dc.descriptionThis journal suppl. entitled: ASCO Meeting Abstracts Part 1-
dc.description.abstractBACKGROUND: The gold standard endpoint in clinical trials of adjuvant chemotherapy (CT) in lung cancer is overall survival (OS), which while a reliant and simple-to-measure outcome, takes a long time to observe in this setting. This study aimed to evaluate disease-free survival (DFS) as a potential surrogate endpoint for OS in adjuvant CT trials, which could lead to more rapid conclusion of trials. METHODS: This analysis was based on individual patient data of 7,626 patients (pts) and 25 randomized trials from two large meta-analyses of adjuvant CT: surgery alone versus surgery + CT and surgery + radiotherapy (RT) versus surgery + RT + CT. DFS was defined as the time from randomization to the first event (local or distant recurrence or death from any cause). A correlation approach was used to assess individual and trial level surrogacy: at the individual level, to estimate association between distributions of DFS and OS ( ), and at trial level, to estimate association between treatment effects on DFS and OS (R). Values of and R closer to 1.0 would indicate strong surrogacy. RESULTS: Analysis 1 (without RT) included 18 trials (5,379 pts, 2,525 DFS events and 2,163 deaths); analysis 2 (with RT) included 7 trials (2,247 pts, 1,673 DFS events and 1,566 deaths). 79% and 84% of DFS events, respectively, occurred in the first three years. Correlations between DFS and OS were very strong, both at the individual ( =0.91 in trials without RT and 0.93 in trials with RT) and trial level (R=0.96, 95% confidence interval [0.92-1.00] and 0.99 [0.98-1.00], respectively). Considering only events occurring in the first three years and deaths in the first five years, trial-level correlation remained strong (R=0.94 [0.88-1.00] and 0.98 [0.95-1.01] respectively). CONCLUSIONS: Our large database provides good evidence that disease-free survival is a valid surrogate endpoint for overall survival in operable non-small cell lung cancer in the adjuvant CT setting. Supported by French Cancer League, PHRC and British Medical Research Council.-
dc.languageengen_US
dc.publisherLippincott Williams & Wilkins.-
dc.relation.ispartofJournal of Clinical Oncologyen_US
dc.titleEvaluation of disease-free survival as surrogate endpoint for overall survival using two individual patient data meta-analyses of adjuvant chemotherapy in operable non-small cell lung canceren_US
dc.typeConference_Paperen_US
dc.identifier.emailPang, HMH: herbpang@hku.hken_US
dc.identifier.authorityPang, HMH=rp01857en_US
dc.identifier.volume29en_US
dc.identifier.issue15_suppl. (May 20 Supplement)-
dc.publisher.placeUnited States-

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