2012
The Microculture-Kinetic (MiCK) Assay: The Role of a Drug-Induced Apoptosis Assay in Drug Development and Clinical Care
Bosserman L, Prendergast F, Herbst R, Fleisher M, Salom E, Strickland S, Raptis A, Hallquist A, Perree M, Rajurkar S, Karimi M, Rogers K, Davidson D, Willis C, Penalver M, Homesley H, Burrell M, Garrett A, Rutledge J, Chernick M, Presant CA. The Microculture-Kinetic (MiCK) Assay: The Role of a Drug-Induced Apoptosis Assay in Drug Development and Clinical Care. Cancer Research 2012, 72: 3901-3905. PMID: 22865459, DOI: 10.1158/0008-5472.can-12-0681.Peer-Reviewed Original ResearchConceptsHigh response rateLonger survivalClinical trialsResponse rateGroup of patientsBlinded clinical trialEpithelial ovarian cancerApoptosis assaysAcute myelocytic leukemiaUnblinded clinical trialDrug developmentGeneric drug useMultiple tumor typesEfficient drug developmentCombination therapyOvarian cancerMyelocytic leukemiaClinical careTumor typesDrug useClinical therapyClinical useMolecular biomarkersDrug approvalHigher apoptosis
2010
A Phase I Safety and Pharmacokinetic Study of the Death Receptor 5 Agonistic Antibody PRO95780 in Patients with Advanced Malignancies
Camidge DR, Herbst RS, Gordon MS, Eckhardt SG, Kurzrock R, Durbin B, Ing J, Tohnya TM, Sager J, Ashkenazi A, Bray G, Mendelson D. A Phase I Safety and Pharmacokinetic Study of the Death Receptor 5 Agonistic Antibody PRO95780 in Patients with Advanced Malignancies. Clinical Cancer Research 2010, 16: 1256-1263. PMID: 20145186, DOI: 10.1158/1078-0432.ccr-09-1267.Peer-Reviewed Original ResearchConceptsAdvanced malignanciesGrade 3 transaminase elevationHuman IgG1 monoclonal antibodyPhase I safetyDose-escalation designDose-dependent increaseDeath receptor 5Different tumor typesIgG1 monoclonal antibodyCohort expansionTransaminase elevationI safetyMost patientsObjective responseTrough concentrationsAdverse eventsEscalation designMultiple dosesMinor responseEfficacious concentrationsOvarian cancerEvidence of activityPharmacokinetic analysisReceptor 5Human studies
2006
A phase I safety and pharmacokinetic (PK) study of recombinant Apo2L/TRAIL, an apoptosis-inducing protein in patients with advanced cancer
Herbst R, Mendolson D, Ebbinghaus S, Gordon M, O’Dwyer P, Lieberman G, Ing J, Kurzrock R, Novotny W, Eckhardt G. A phase I safety and pharmacokinetic (PK) study of recombinant Apo2L/TRAIL, an apoptosis-inducing protein in patients with advanced cancer. Journal Of Clinical Oncology 2006, 24: 3013-3013. DOI: 10.1200/jco.2006.24.18_suppl.3013.Peer-Reviewed Original ResearchAdvanced solid tumorsLiver metastasesSolid tumorsHematologic malignanciesApo2L/TRAILRecombinant human Apo2L/TRAILPost-baseline tumour assessmentPhase I safetyObjective partial responseFurther dose optimizationAttributable toxicityStable diseaseAdult patientsI safetyPartial responseAdvanced cancerCommon diagnosisRandomized trialsStandard treatmentReceptor agonistOvarian cancerPreclinical modelsSafety dataTumor assessmentMost normal cells
2003
Improvements in quality of life and disease-related symptoms in phase I trials of the selective oral epidermal growth factor receptor tyrosine kinase inhibitor ZD1839 in non-small cell lung cancer and other solid tumors.
LoRusso PM, Herbst RS, Rischin D, Ranson M, Calvert H, Raymond E, Kieback D, Kaye S, Gianni L, Harris A, Bjork T, Maddox AM, Rothenberg ML, Small EJ, Rubin EH, Feyereislova A, Heyes A, Averbuch SD, Ochs J, Baselga J. Improvements in quality of life and disease-related symptoms in phase I trials of the selective oral epidermal growth factor receptor tyrosine kinase inhibitor ZD1839 in non-small cell lung cancer and other solid tumors. Clinical Cancer Research 2003, 9: 2040-8. PMID: 12796366.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerPhase I clinical trialCell lung cancerDisease-related symptomsQuality of lifeAdvanced cancerLung cancerClinical changesClinical trialsOvarian cancerEpidermal growth factor receptor tyrosine kinase inhibitor ZD1839Tumor typesEpidermal growth factor receptor tyrosine kinase inhibitorsGrowth factor receptor tyrosine kinase inhibitorsTyrosine kinase inhibitor ZD1839Receptor tyrosine kinase inhibitorsCancer Therapy questionnaireLung Cancer SubscaleMultiple-dose safetyPhase I trialUnited States trialsTyrosine kinase inhibitorsFact QuestionnairePrior therapyTOI scoresErlotinib (Tarceva): An update on the clinical trial program
Herbst RS. Erlotinib (Tarceva): An update on the clinical trial program. Seminars In Oncology 2003, 30: 34-46. PMID: 12840799, DOI: 10.1016/s0093-7754(03)70013-x.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerCell lung cancerLung cancerAdvanced non-small cell lung cancerPhase II monotherapy trialsNeck squamous cell cancerUse of erlotinibAntitumor activitySingle-agent chemotherapyPhase III trialsClinical trial programSquamous cell cancerSimilar patient populationsSubstantial antitumor activityHuman tumor xenograftsMonotherapy trialsEpidermal growth factor receptor tyrosine kinaseIII trialsCell cancerPatient populationPancreatic cancerOvarian cancerPreclinical studiesGrowth factor receptor tyrosine kinaseTumor xenografts
2002
Targeted therapy against human lung cancer in nude mice by high-affinity recombinant antimesothelin single-chain Fv immunotoxin.
Fan D, Yano S, Shinohara H, Solorzano C, Van Arsdall M, Bucana CD, Pathak S, Kruzel E, Herbst RS, Onn A, Roach JS, Onda M, Wang QC, Pastan I, Fidler IJ. Targeted therapy against human lung cancer in nude mice by high-affinity recombinant antimesothelin single-chain Fv immunotoxin. Molecular Cancer Therapeutics 2002, 1: 595-600. PMID: 12479219.Peer-Reviewed Original ResearchMeSH KeywordsADP Ribose TransferasesAnimalsBacterial ToxinsDose-Response Relationship, DrugExotoxinsFlow CytometryHumansImmunoglobulin FragmentsImmunotherapyKineticsLung NeoplasmsMesothelinMiceMice, NudeMicroscopy, FluorescenceMutationNeoplasm TransplantationPseudomonasRecombinant ProteinsTumor Cells, CulturedVirulence FactorsConceptsTargeted therapyNude miceHuman non-small cell lung cancer cellsNon-small cell lung cancer cellsNCI-H226 cellsHuman lung cancer cell linesCell lung cancer cellsSquamous cell carcinomaLung cancer cell linesHuman lung cancerExperimental lung metastasisLung cancer cellsPC14PE6 cellsCancer cell linesLung metastasesCell carcinomaCancer patientsLung cancerOvarian cancerNontoxic doseMesothelinDay 7Recombinant immunotoxinCertain cancersCancer