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RESEARCH PRODUCT

Progression-free survival as a surrogate for overall survival in advanced/recurrent gastric cancer trials: a meta-analysis.

Markus MoehlerOlivier BouchéMitsuru SasakoPaul J. CatalanoStefan MichielsAtsushi OhtsuPhilippe RougierEric Van CutsemPeter C. Thuss-patienceKohei ShitaraNarikazu BokuArnaud RothDaniel J. SargentYung-jue BangYasuo OhashiKoji ObaNozomu FuseJunichi SakamotoTomasz BurzykowskiMarc BuyseSatoshi MoritaXavier PaolettiHarry Bleiberg

subject

OncologyCancer Researchmedicine.medical_specialtyBioinformaticsBrief CommunicationDisease-Free Survivallaw.inventionRandomized controlled triallawPredictive Value of TestsStomach NeoplasmsInternal medicinemedicineOdds RatioHumansProgression-free survivalRandomized Controlled Trials as Topicddc:616Surrogate endpointbusiness.industryOdds ratioChemotherapy regimenConfidence intervalTreatment OutcomeOncologyPredictive value of testsMeta-analysisNeoplasm Recurrence LocalbusinessBiomarkers

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.

yearjournalcountryeditionlanguage
2013-10-09Journal of the National Cancer Institute
10.1093/jnci/djt269https://pubmed.ncbi.nlm.nih.gov/24108810