Surrogate End Points for Overall Survival in Loco-Regionally Advanced Nasopharyngeal Carcinoma: An Individual Patient Data Meta-analysis.

Details

Serval ID
serval:BIB_01129E815553
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Surrogate End Points for Overall Survival in Loco-Regionally Advanced Nasopharyngeal Carcinoma: An Individual Patient Data Meta-analysis.
Journal
Journal of the National Cancer Institute
Author(s)
Rotolo F., Pignon J.P., Bourhis J., Marguet S., Leclercq J., Tong Ng W., Ma J., Chan A.T., Huang P.Y., Zhu G., Chua D.T., Chen Y., Mai H.Q., Kwong D.L., Soong Y.L., Moon J., Tung Y., Chi K.H., Fountzilas G., Zhang L., Hui E.P., Lee A.W., Blanchard P., Michiels S.
Working group(s)
MAC-NPC Collaborative Group
Contributor(s)
Al-Sarraf M., Baujat B., Blanchard P., Benhamou E., Bourhis J., Chan A.T., Chan L.K., Cheah S.L., Chen L., Chen Q.Y., Chen Y., Chi K.H., Chappell R.J., Chua D.T., Fountzilas G., Gourgioti G., Hareyama M., Hong M.H., Huang P.Y., Hui E.P., Kam M., Kwong D.L., Lam K.O., Leclercq J., Lee A., Lee H.F., Lu T.X., Lueza B., Ma B., Ma J., Mai H.Q., Marguet S., Michiels S., Mo F., Moon J., Ng W.T., Ngan R., O'Sullivan B., Pignon J.P., Sham J., Soong Y.L., Tung Y., Wee J., Wu X., Xu T., Zhang L., Zhu G.
ISSN
1460-2105 (Electronic)
ISSN-L
0027-8874
Publication state
Published
Issued date
04/2017
Peer-reviewed
Oui
Volume
109
Number
4
Pages
1-9
Language
english
Notes
Publication types: Journal Article ; Meta-Analysis
Publication Status: ppublish
Abstract
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).
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 R(2) between treatment effects on the surrogate end point and OS. A sensitivity analysis was performed with two-year PFS/DMFS and five-year OS.
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 (R(2) = 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 R(2) = 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 (R(2) = 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 (R(2) = 0.78, 95% CI = 0.33 to 1.00).
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.

Keywords
Biomarkers, Tumor, Carcinoma/drug therapy, Carcinoma/secondary, Disease-Free Survival, Humans, Nasopharyngeal Neoplasms/drug therapy, Nasopharyngeal Neoplasms/pathology, Neoplasm Metastasis, Randomized Controlled Trials as Topic, Survival Rate
Pubmed
Web of science
Open Access
Yes
Create date
22/12/2016 14:39
Last modification date
20/08/2019 12:23
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