6533b873fe1ef96bd12d4f68

RESEARCH PRODUCT

Progression-Free Survival Early Assessment Is a Robust Surrogate Endpoint of Overall Survival in Immunotherapy Trials of Hepatocellular Carcinoma

Domenica MatrangaAntonio CraxìA. BusaccaCalogero CammàMaria ReigGiacomo Emanuele Maria RizzoMassimo AttanasioCiro CelsaGiuseppe CabibboSalvatore BattagliaMarco Enea

subject

OncologyCancer Researchmedicine.medical_specialtymedicine.medical_treatmentoverall survivallcsh:RC254-282ArticleSettore MED/01 - Statistica Medica03 medical and health sciences0302 clinical medicineInternal medicinesurrogate endpointmedicineOverall survival030212 general & internal medicineProgression-free survivalneoplasmsSettore MED/12 - Gastroenterologiabusiness.industrySurrogate endpointImmunotherapyhepatocellular carcinomamedicine.diseaselcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogensConfidence intervalClinical trialOncologyQuartile030220 oncology & carcinogenesisHepatocellular carcinomasurrogate endpointsimmunotherapySettore SECS-S/01 - Statisticabusinessprogression-free survival

description

Background: Radiology-based outcomes, such as progression-free survival (PFS) and objective response rate (ORR), are used as surrogate endpoints in oncology trials. We aimed to assess the surrogacy relationship of PFS with overall survival (OS) in clinical trials of systemic therapies targeting advanced hepatocellular carcinoma (HCC) by novel meta-regression methods. Methods: A search of databases (PubMed, American Society of Clinical Oncology (ASCO), and European Society for Medical Oncology (ESMO) Meeting Libraries, Clinicaltrials.gov) for trials of systemic therapies for advanced HCC reporting both OS and PFS was performed. Individual patient data were extracted from PFS and OS Kaplan&ndash

10.3390/cancers13010090http://europepmc.org/articles/PMC7796103