2021
Immune adverse events (irAEs) with adjuvant ipilimumab in melanoma, use of immunosuppressants and association with outcome: ECOG-ACRIN E1609 study analysis
Tarhini AA, Kang N, Lee SJ, Hodi FS, Cohen GI, Hamid O, Hutchins LF, Sosman JA, Kluger HM, Eroglu Z, Koon HB, Lawrence DP, Kendra KL, Minor DR, Lee CB, Albertini MR, Flaherty LE, Petrella TM, Streicher H, Sondak VK, Kirkwood JM. Immune adverse events (irAEs) with adjuvant ipilimumab in melanoma, use of immunosuppressants and association with outcome: ECOG-ACRIN E1609 study analysis. Journal For ImmunoTherapy Of Cancer 2021, 9: e002535. PMID: 33963015, PMCID: PMC8108687, DOI: 10.1136/jitc-2021-002535.Peer-Reviewed Original ResearchMeSH KeywordsAdjuvants, ImmunologicAdolescentAdultAgedAged, 80 and overDrug-Related Side Effects and Adverse ReactionsFemaleHumansImmune Checkpoint InhibitorsImmunosuppressive AgentsIpilimumabMaleMelanomaMiddle AgedRisk AssessmentRisk FactorsSkin NeoplasmsTime FactorsTreatment OutcomeYoung AdultConceptsImmune-related adverse eventsRelapse-free survivalUse of immunosuppressantsAdjuvant ipilimumabGrade 3Grade 1Significant associationAdverse eventsPrognostic factorsSpecific immune-related adverse eventsTerms of RFSEndocrine immune-related adverse eventsBetter relapse-free survivalHigh-dose corticosteroidsImmune adverse eventsHigh-risk melanomaIndependent prognostic factorOverall survival outcomesDose corticosteroidsImmunosuppressant useRFS benefitsImproved OSBetter prognosisAdjuvant useSurvival outcomesAdverse events induced by immune checkpoint inhibitors
Perdigoto AL, Kluger H, Herold KC. Adverse events induced by immune checkpoint inhibitors. Current Opinion In Immunology 2021, 69: 29-38. PMID: 33640598, PMCID: PMC8122053, DOI: 10.1016/j.coi.2021.02.002.Peer-Reviewed Original ResearchMeSH KeywordsAnimalsAutoantibodiesAutoantigensAutoimmune DiseasesAutoimmunityCytotoxicity, ImmunologicDrug-Related Side Effects and Adverse ReactionsGene-Environment InteractionGenetic Predisposition to DiseaseHumansImmune Checkpoint InhibitorsImmunotherapyLymphocyte ActivationNeoplasmsT-LymphocytesConceptsImmune checkpoint inhibitorsCheckpoint inhibitorsAdverse eventsT cellsImmune related adverse eventsEmergence of autoantibodiesRelated adverse eventsAnti-tumor responseAutoreactive T cellsActivated T cellsAutoimmune mechanismsTreatment of cancerAutoimmune diseasesInflammatory responsePredictive valueHost factorsToxic effectsInhibitorsDirect effectOngoing investigationAutoantibodiesCellsAutoimmunityPathogenesisCancer
2018
Results of a Phase II Placebo-controlled Randomized Discontinuation Trial of Cabozantinib in Patients with Non–small-cell Lung Carcinoma
Hellerstedt BA, Vogelzang NJ, Kluger HM, Yasenchak CA, Aftab DT, Ramies DA, Gordon MS, Lara P. Results of a Phase II Placebo-controlled Randomized Discontinuation Trial of Cabozantinib in Patients with Non–small-cell Lung Carcinoma. Clinical Lung Cancer 2018, 20: 74-81.e1. PMID: 30528315, DOI: 10.1016/j.cllc.2018.10.006.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAnilidesAntineoplastic AgentsCarcinoma, Non-Small-Cell LungCohort StudiesDrug-Related Side Effects and Adverse ReactionsFatigueFemaleHumansLung NeoplasmsMaleMiddle AgedPlacebo EffectProtein-Tyrosine KinasesPyridinesSurvival AnalysisTreatment OutcomeConceptsObjective response rateProgression-free survivalMedian progression-free survivalCell lung carcinomaWeek 12Adverse eventsDiscontinuation trialLung carcinomaTreatment-related grade 5 adverse eventsCommon grade 3/4 adverse eventsBioavailable tyrosine kinase inhibitorGrade 3/4 adverse eventsGrade 5 adverse eventsOverall disease control rateSolid Tumors version 1.0Epidermal growth factor receptor (EGFR) mutationsOpen-label leadPhase II PlaceboRandomized discontinuation trialDisease control ratePalmar-plantar erythrodysesthesiaResponse Evaluation CriteriaGrowth factor receptor 2Vascular endothelial growth factor receptor 2Endothelial growth factor receptor 2
2017
Efficacy and Safety of Pembrolizumab in Patients Enrolled in KEYNOTE-030 in the United States
Gangadhar TC, Hwu WJ, Postow MA, Hamid O, Daud A, Dronca R, Joseph R, O’Day S, Hodi FS, Pavlick AC, Kluger H, Oxborough RP, Yang A, Gazdoiu M, Kush DA, Ebbinghaus S, Salama AKS. Efficacy and Safety of Pembrolizumab in Patients Enrolled in KEYNOTE-030 in the United States. Journal Of Immunotherapy 2017, 40: 334-340. PMID: 29028788, PMCID: PMC5647109, DOI: 10.1097/cji.0000000000000186.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic AgentsClinical Trials as TopicDrug Resistance, NeoplasmDrug-Related Side Effects and Adverse ReactionsExanthemaFatigueFemaleHumansMaleMelanomaMiddle AgedNeoplasm MetastasisNeoplasm StagingTreatment OutcomeUnited StatesYoung AdultConceptsTreatment-related adverse eventsAdverse eventsAdvanced melanomaGrade 3/4 treatment-related adverse eventsNational Cancer Institute Common Terminology CriteriaUnresectable stage III/IV melanomaStage III/IV melanomaImmune-related response criteriaDeath-1 antibodySafety of pembrolizumabTreatment-related deathsUse of pembrolizumabCommon Terminology CriteriaObjective response rateSubcutaneous tissue disordersAccess programEvaluable patientsTerminology CriteriaCare therapyComplete responseInvestigator reviewGastrointestinal disordersDisease progressionTissue disordersBRAF inhibitorsSarcoidosis Following Anti-PD-1 and Anti-CTLA-4 Therapy for Metastatic Melanoma
Reddy SB, Possick JD, Kluger HM, Galan A, Han D. Sarcoidosis Following Anti-PD-1 and Anti-CTLA-4 Therapy for Metastatic Melanoma. Journal Of Immunotherapy 2017, 40: 307-311. PMID: 28737620, DOI: 10.1097/cji.0000000000000181.Peer-Reviewed Case Reports and Technical NotesMeSH KeywordsAdrenal Cortex HormonesAntibodies, MonoclonalAntineoplastic Combined Chemotherapy ProtocolsAutoimmunityCTLA-4 AntigenDrug-Related Side Effects and Adverse ReactionsFemaleHumansImmunotherapyIpilimumabLungMelanomaMiddle AgedNivolumabProgrammed Cell Death 1 ReceptorSarcoidosisSkinSkin NeoplasmsTreatment OutcomeConceptsAnti-PD-1 therapyImmune checkpoint inhibitorsStage IV melanomaCheckpoint inhibitorsOncologic responseSevere immune-related adverse effectsImmune checkpoint inhibitor therapyImmune-related adverse effectsAnti PD-1Severe pulmonary manifestationsCheckpoint inhibitor therapyPD-1 inhibitorsDevelopment of sarcoidosisAutoimmune tendencyCorticosteroid treatmentLast dosePulmonary manifestationsCutaneous sarcoidosisRare complicationInhibitor therapyRadiologic findingsPatient's symptomsMetastatic melanomaPotential complicationsSarcoidosis