2023
Novel Approaches for Dynamic Visualization of Adverse Event Data in Oncology Clinical Trials: A Case Study Using Immunotherapy Trial S1400-I (SWOG)
Lee S, Fan W, Wang A, Vaidya R, Redman M, Gettinger S, Bazhenova L, Herbst R, Hershman D, Unger J. Novel Approaches for Dynamic Visualization of Adverse Event Data in Oncology Clinical Trials: A Case Study Using Immunotherapy Trial S1400-I (SWOG). JCO Clinical Cancer Informatics 2023, 7: e2200165. PMID: 37084329, PMCID: PMC10281446, DOI: 10.1200/cci.22.00165.Peer-Reviewed Original ResearchConceptsSystem organ classAdverse event dataRandomized phase III trialPhase III trialsCell lung cancerOncology clinical trialsOverall toxicity profileIII trialsNeurologic toxicityTreatment armsCardiac toxicityLung cancerClinical trialsGrade 3High prevalenceOrgan classToxicity profileNivolumabTreatment groupsStage IVEndocrine toxicityType of AEToxicity typesAE termsIpilimumab
2019
Immune Checkpoint Inhibitor–Associated Pericarditis
Altan M, Toki MI, Gettinger SN, Carvajal-Hausdorf DE, Zugazagoitia J, Sinard JH, Herbst RS, Rimm DL. Immune Checkpoint Inhibitor–Associated Pericarditis. Journal Of Thoracic Oncology 2019, 14: 1102-1108. PMID: 30851443, PMCID: PMC6617516, DOI: 10.1016/j.jtho.2019.02.026.Peer-Reviewed Original ResearchConceptsAdverse eventsCTLA-4 inhibitorsImmune checkpoint inhibitorsDeath-1/Pericardial window procedureCheckpoint inhibitorsThird patientClinical presentationCardiac toxicityHistopathologic findingsSide effectsPericarditisPatientsDeath ligandsPotential mechanismsWindow procedureInhibitorsImmunotherapyNSCLCCardiotoxicityAutopsiesTherapy
2007
Efficacy and Safety of Single-Agent Pertuzumab, a Human Epidermal Receptor Dimerization Inhibitor, in Patients with Non–Small Cell Lung Cancer
Herbst RS, Davies AM, Natale RB, Dang TP, Schiller JH, Garland LL, Miller VA, Mendelson D, Van den Abbeele AD, Melenevsky Y, de Vries DJ, Eberhard DA, Lyons B, Lutzker SG, Johnson BE. Efficacy and Safety of Single-Agent Pertuzumab, a Human Epidermal Receptor Dimerization Inhibitor, in Patients with Non–Small Cell Lung Cancer. Clinical Cancer Research 2007, 13: 6175-6181. PMID: 17947484, DOI: 10.1158/1078-0432.ccr-07-0460.Peer-Reviewed Original ResearchMeSH KeywordsAdultAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsBiopsyCarcinoma, Non-Small-Cell LungDimerizationErbB ReceptorsFemaleFluorodeoxyglucose F18HumansLung NeoplasmsMaleMiddle AgedMutationPositron-Emission TomographyProtein Structure, TertiaryReceptor, ErbB-2Time FactorsTreatment OutcomeConceptsNon-small cell lung cancerProgression-free survival ratesCell lung cancerPositron emission tomographyLung cancerRecurrent non-small cell lung cancerHumanized monoclonal anti-HER2 antibodyGrade 4 adverse eventsGrade 4 cardiac toxicityPrimary efficacy end pointEmission tomographyEfficacy end pointPhase II trialResponse Evaluation CriteriaMonoclonal anti-HER2 antibodyOverall response rateMetabolic responseTumor glucose metabolismAnti-HER2 antibodyStable diseaseII trialAdverse eventsCardiac toxicityPharmacodynamic markersCore biopsy