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Article: Surrogate End Points For Overall Survival In Loco-regionally Advanced Nasopharyngeal Carcinoma: An Individual Patient Data Meta-analysis

TitleSurrogate End Points For Overall Survival In Loco-regionally Advanced Nasopharyngeal Carcinoma: An Individual Patient Data Meta-analysis
Authors
Issue Date2017
PublisherOxford University Press. The Journal's web site is located at http://jncicancerspectrum.oxfordjournals.org/
Citation
JNCI: Journal of the National Cancer Institute, 2017, v. 109 n. 4, article no. djw239 How to Cite?
AbstractBackground: Our objective was to evaluate progression-free survival (PFS) and distant metastasis–free survival (DMFS) as surrogate end points for overall survival (OS) in randomized trials of chemotherapy in loco-regionally advanced nasopharyngeal carcinomas (NPCs). Methods: Individual patient data were obtained from 19 trials of the updated Meta-Analysis of Chemotherapy in Nasopharyngeal Carcinoma (MAC-NPC) plus one additional trial (total = 5144 patients). Surrogacy was evaluated at the individual level using a rank correlation coefficient ρ and at the trial level using a correlation coefficient R2 between treatment effects on the surrogate end point and OS. A sensitivity analysis was performed with two-year PFS/DMFS and five-year OS. Results: PFS was strongly correlated with OS at the individual level (ρ = 0.93, 95% confidence interval [CI] = 0.93 to 0.94) and at the trial level (R2 = 0.95, 95% CI = 0.47 to 1.00). For DMFS, too, the individual-level correlation with OS was strong (ρ = 0.98, 95% CI = 0.98 to 0.98); at trial level, the correlation was high but the regression adjusted for measurement error could not be computed (unadjusted R2 = 0.96, 95% CI = 0.94 to 0.99). In the sensitivity analysis, two-year PFS was highly correlated with five-year OS at the individual level (ρ = 0.89, 95% CI = 0.88 to 0.90) and at the trial level (R2 = 0.85, 95% CI = 0.46 to 1.00); two-year DMFS was highly correlated with five-year OS at the individual level (ρ = 0.95, 95% CI = 0.94 to 0.95) and at the trial level (R2 = 0.78, 95% CI = 0.33 to 1.00). Conclusions: PFS and DMFS are valid surrogate end points for OS to assess treatment effect of chemotherapy in loco-regionally advanced NPC, while PFS can be measured earlier.
Persistent Identifierhttp://hdl.handle.net/10722/238644
ISSN
2019 Impact Factor: 11.577
2015 SCImago Journal Rankings: 6.192
PubMed Central ID
ISI Accession Number ID

 

DC FieldValueLanguage
dc.contributor.authorRotolo, F-
dc.contributor.authorPignon, JP-
dc.contributor.authorBourhis, J-
dc.contributor.authorMarguet, S-
dc.contributor.authorLeclercq, J-
dc.contributor.authorNg, WT-
dc.contributor.authorMa, J-
dc.contributor.authorChan, ATC-
dc.contributor.authorHuang, PY-
dc.contributor.authorZhu, G-
dc.contributor.authorChua, DTT-
dc.contributor.authorChen, Y-
dc.contributor.authorMai, HQ-
dc.contributor.authorKwong, DLW-
dc.contributor.authorSoong, YL-
dc.contributor.authorMoon, J-
dc.contributor.authorTung, Y-
dc.contributor.authorChi, KH-
dc.contributor.authorFountzilas, G-
dc.contributor.authorZhang, L-
dc.contributor.authorHui, EP-
dc.contributor.authorLee, WMA-
dc.contributor.authorBlanchard, P-
dc.contributor.authorMichiels, S-
dc.date.accessioned2017-02-20T01:24:12Z-
dc.date.available2017-02-20T01:24:12Z-
dc.date.issued2017-
dc.identifier.citationJNCI: Journal of the National Cancer Institute, 2017, v. 109 n. 4, article no. djw239-
dc.identifier.issn0027-8874-
dc.identifier.urihttp://hdl.handle.net/10722/238644-
dc.description.abstractBackground: Our objective was to evaluate progression-free survival (PFS) and distant metastasis–free survival (DMFS) as surrogate end points for overall survival (OS) in randomized trials of chemotherapy in loco-regionally advanced nasopharyngeal carcinomas (NPCs). Methods: Individual patient data were obtained from 19 trials of the updated Meta-Analysis of Chemotherapy in Nasopharyngeal Carcinoma (MAC-NPC) plus one additional trial (total = 5144 patients). Surrogacy was evaluated at the individual level using a rank correlation coefficient ρ and at the trial level using a correlation coefficient R2 between treatment effects on the surrogate end point and OS. A sensitivity analysis was performed with two-year PFS/DMFS and five-year OS. Results: PFS was strongly correlated with OS at the individual level (ρ = 0.93, 95% confidence interval [CI] = 0.93 to 0.94) and at the trial level (R2 = 0.95, 95% CI = 0.47 to 1.00). For DMFS, too, the individual-level correlation with OS was strong (ρ = 0.98, 95% CI = 0.98 to 0.98); at trial level, the correlation was high but the regression adjusted for measurement error could not be computed (unadjusted R2 = 0.96, 95% CI = 0.94 to 0.99). In the sensitivity analysis, two-year PFS was highly correlated with five-year OS at the individual level (ρ = 0.89, 95% CI = 0.88 to 0.90) and at the trial level (R2 = 0.85, 95% CI = 0.46 to 1.00); two-year DMFS was highly correlated with five-year OS at the individual level (ρ = 0.95, 95% CI = 0.94 to 0.95) and at the trial level (R2 = 0.78, 95% CI = 0.33 to 1.00). Conclusions: PFS and DMFS are valid surrogate end points for OS to assess treatment effect of chemotherapy in loco-regionally advanced NPC, while PFS can be measured earlier.-
dc.languageeng-
dc.publisherOxford University Press. The Journal's web site is located at http://jncicancerspectrum.oxfordjournals.org/-
dc.relation.ispartofJNCI: Journal of the National Cancer Institute-
dc.titleSurrogate End Points For Overall Survival In Loco-regionally Advanced Nasopharyngeal Carcinoma: An Individual Patient Data Meta-analysis-
dc.typeArticle-
dc.identifier.emailChua, DTT: dttchua@hkucc.hku.hk-
dc.identifier.emailKwong, DLW: dlwkwong@hku.hk-
dc.identifier.emailLee, WMA: awmlee@hkucc.hku.hk-
dc.identifier.authorityChua, DTT=rp00415-
dc.identifier.authorityKwong, DLW=rp00414-
dc.identifier.authorityLee, WMA=rp02056-
dc.description.naturelink_to_OA_fulltext-
dc.identifier.doi10.1093/jnci/djw239-
dc.identifier.pmid27927756-
dc.identifier.pmcidPMC6059121-
dc.identifier.scopuseid_2-s2.0-85013178428-
dc.identifier.hkuros271119-
dc.identifier.hkuros303053-
dc.identifier.volume109-
dc.identifier.issue4-
dc.identifier.spagearticle no. djw239-
dc.identifier.epagearticle no. djw239-
dc.identifier.isiWOS:000400066800001-
dc.publisher.placeUnited Kingdom-

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