2022
Randomized Phase 3 LEAP-012 Study: Transarterial Chemoembolization With or Without Lenvatinib Plus Pembrolizumab for Intermediate-Stage Hepatocellular Carcinoma Not Amenable to Curative Treatment
Llovet JM, Vogel A, Madoff DC, Finn RS, Ogasawara S, Ren Z, Mody K, Li JJ, Siegel AB, Dubrovsky L, Kudo M. Randomized Phase 3 LEAP-012 Study: Transarterial Chemoembolization With or Without Lenvatinib Plus Pembrolizumab for Intermediate-Stage Hepatocellular Carcinoma Not Amenable to Curative Treatment. CardioVascular And Interventional Radiology 2022, 45: 405-412. PMID: 35119481, PMCID: PMC8940827, DOI: 10.1007/s00270-021-03031-9.Peer-Reviewed Original ResearchConceptsBlinded independent central reviewIntermediate-stage hepatocellular carcinomaDisease control rateObjective response rateProgression-free survivalDuration of responseHepatocellular carcinomaCurative treatmentRECIST 1.1Primary endpointClinical benefitControl rateEastern Cooperative Oncology Group performance status 0Response rateChild-Pugh class ARandomized phase 3 studyDual primary endpointsOverall survival eventsPerformance status 0Previous systemic treatmentPD-1 inhibitorsPortal vein thrombosisPhase 3 studyResponse Evaluation CriteriaSolid Tumors 1.1
2020
Response criteria for intratumoral immunotherapy in solid tumors: ItRECIST.
Goldmacher G, Khilnani A, Andtbacka R, Luke J, Hodi F, Marabelle A, Harrington K, Perrone A, Tse A, Madoff D, Schwartz L. Response criteria for intratumoral immunotherapy in solid tumors: ItRECIST. Journal Of Clinical Oncology 2020, 38: 3141-3141. DOI: 10.1200/jco.2020.38.15_suppl.3141.Peer-Reviewed Original ResearchLesion responseResponse assessmentIntratumoral immunotherapySolid tumorsTarget lesion responseModification of therapyResponse Evaluation CriteriaRoutine clinical practiceOverall response assessmentUnique treatment strategyInjected lesionsIT drugsRECIST 1.1Immunotherapy trialsNew lesionsTumor burdenMetastatic melanomaTrial protocolClinical trialsInitial progressionTreatment strategiesTherapeutic modalitiesLesion assessmentNadir valuesTreatment evolves