Journal
ENDOCRINE
Volume -, Issue -, Pages -Publisher
SPRINGER
DOI: 10.1007/s12020-023-03507-3
Keywords
Differentiated thyroid cancer; Radioactive iodine refractory; Surrogate endpoint; Progression-free survival; Overall survival
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This study aimed to investigate whether progression-free survival (PFS) could be used as a surrogate endpoint for overall survival (OS) in locally advanced or metastatic differentiated thyroid cancer (DTC) clinical trials. The results showed weak correlation between PFS benefit and OS benefit, and PFS did not meet the statistical criteria for the surrogate endpoint.
PurposePatients with locally advanced or metastatic differentiated thyroid cancer (DTC) have a variable prognosis, and the development of more effective treatment strategies is an important research topic. Overall survival (OS) is the gold standard for research endpoints in randomized controlled trials (RCTs), but observing an OS benefit requires the inclusion of a large number of patients and a long follow-up period. In this study, we aimed to investigate whether progression-free survival (PFS) could be used as a surrogate endpoint for OS in locally advanced or metastatic DTC clinical trials.Materials and methodsWe conducted a search in the PubMed and EMBASE databases to include all RCTs of locally advanced or metastatic DTC and extracted survival data. A weighted linear regression analysis was performed to explore the correlation between PFS benefit and OS benefit by taking the logarithm of the hazard ratios (HRs) of PFS and OS for each trial with a base of 10 and weighted by the number of patients in each RCT.ResultsSeven RCTs, including 1410 patients, were included. At the trial level, PFS benefit was weakly correlated with OS benefit (R2 = 0.210, 95% CI: 0.000-0.811) and did not meet the statistical criteria for the surrogate endpoint.ConclusionThis study does not support PFS as a surrogate endpoint for OS in locally advanced or metastatic DTC clinical trials.Trial registrationPROSPERO Identifier: CRD42022334898
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