2024
Pragmaticism in Cancer Clinical Trials.
Sankar K, Redman M, Dragnev K, Henick B, Iams W, Blanke C, Herbst R, Gray J, Reckamp K. Pragmaticism in Cancer Clinical Trials. American Society Of Clinical Oncology Educational Book 2024, 44: e100040. PMID: 38771997, DOI: 10.1200/edbk_100040.Peer-Reviewed Original ResearchConceptsCancer clinical trialsTraditional explanatory trialsCancer mortality ratesPatient care scenariosGoal of improving patient outcomesPragmatic trial designTrial designRepresentative patient populationPragmatic trialIntervention effectsIntervention efficacyCare scenariosExplanatory trialsTrial generalizabilityPragmatic designPatient outcomesClinical trialsReal-world practiceOncologyEscalating costsCancer clinical trial designPatient populationMortality rateDuration of trialsOncology researchA process to reanalyze clinical DNA sequencing data for biomarker matching in the Lung-MAP Master Protocol
Neal J, Minichiello K, Brennick R, Huang R, Hiemenz M, Amler C, Patel J, Herbst R, Reckamp K, Borghaei H, Highleyman L, Redman M, Pasquina L, Kozono D. A process to reanalyze clinical DNA sequencing data for biomarker matching in the Lung-MAP Master Protocol. The Oncologist 2024, 29: e843-e847. PMID: 38597608, PMCID: PMC11144964, DOI: 10.1093/oncolo/oyae062.Peer-Reviewed Original ResearchLung mappingClinical trialsStandard-of-care testingTumor genomic profilingClinical trial assayMaster protocolDNA sequence dataRaw genomic dataMedian timeBioinformatics pipelineSequence dataGenomic dataBiomarker testingGenomic profilingCancer clinical trialsMolecular resultsTissue samplesPatientsSubstudy
2023
Understanding health-related quality of life measures used in early-stage non-small cell lung cancer clinical trials: A review
Majem M, Basch E, Cella D, Garon E, Herbst R, Leighl N. Understanding health-related quality of life measures used in early-stage non-small cell lung cancer clinical trials: A review. Lung Cancer 2023, 187: 107419. PMID: 38070301, DOI: 10.1016/j.lungcan.2023.107419.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerEarly-stage diseaseHealth-related qualityClinical trialsEarly-stage non-small cell lung cancerTreatment-related adverse effectsAppropriate HRQoL instrumentNSCLC clinical trialsCell lung cancerLong-term treatmentLung cancer clinical trialsCancer clinical researchCancer clinical trialsAdjuvant treatmentAdvanced diseaseHRQOL assessmentTreatment landscapeDisease recurrenceHRQoL instrumentsLung cancerDisease progressionLife measuresHRQoLNarrative reviewHealthcare professionals
2012
Tobacco Assessment in Actively Accruing National Cancer Institute Cooperative Group Program Clinical Trials
Peters EN, Torres E, Toll BA, Cummings KM, Gritz ER, Hyland A, Herbst RS, Marshall JR, Warren GW. Tobacco Assessment in Actively Accruing National Cancer Institute Cooperative Group Program Clinical Trials. Journal Of Clinical Oncology 2012, 30: 2869-2875. PMID: 22689794, PMCID: PMC3410402, DOI: 10.1200/jco.2011.40.8815.Peer-Reviewed Original ResearchConceptsCooperative group clinical trialsGroup clinical trialTobacco use assessmentClinical trialsTobacco useCancer treatment outcomesTreatment outcomesTobacco assessmentEvidence-based cessation supportPhase III trialsSecondhand smoke exposureClinical oncology practiceCooperative Group ProgramCancer clinical trialsCurrent cigarette useIII trialsSmoke exposureCessation supportNeck trialsOncology practiceNicotine dependenceRoutine assessmentCigarette useTrialsGroup program
2011
The BATTLE Trial: Personalizing Therapy for Lung Cancer
Kim ES, Herbst RS, Wistuba II, Lee JJ, Blumenschein GR, Tsao A, Stewart DJ, Hicks ME, Erasmus J, Gupta S, Alden CM, Liu S, Tang X, Khuri FR, Tran HT, Johnson BE, Heymach JV, Mao L, Fossella F, Kies MS, Papadimitrakopoulou V, Davis SE, Lippman SM, Hong WK. The BATTLE Trial: Personalizing Therapy for Lung Cancer. Cancer Discovery 2011, 1: 44-53. PMID: 22586319, PMCID: PMC4211116, DOI: 10.1158/2159-8274.cd-10-0010.Peer-Reviewed Original ResearchConceptsLung cancer patientsCancer patientsNon-small cell lung cancer patientsLung Cancer Elimination (BATTLE) trialCell lung cancer patientsDisease control rateCore needle biopsy specimensLung cancer clinical trialsSpecific patient populationsLung cancer therapyNeedle biopsy specimensCancer clinical trialsRelevant molecular biomarkersKRAS patientsNSCLC patientsPatient populationRandomization periodControl rateLaboratory findingsLung cancerBiopsy specimensClinical trialsTargeted therapyBATTLE TrialIndividualized treatment
2009
The changing face of Phase 1 cancer clinical trials
Craft BS, Kurzrock R, Lei X, Herbst R, Lippman S, Fu S, Karp DD. The changing face of Phase 1 cancer clinical trials. Cancer 2009, 115: 1592-1597. PMID: 19165808, PMCID: PMC2668727, DOI: 10.1002/cncr.24171.Peer-Reviewed Original ResearchConceptsPhase 2 trialEarly phase clinical trialsPhase 1 studyPhase 1 trialClinical trialsVital sign determinationsCancer clinical trialsPhysical examinationEarly phase cancer clinical trialsWeeks of protocolPhase 2 studyPhase 1 cancer clinical trialsNew drug studyStudy requirementsPhase 1Pharmacokinetic samplingMore patientsMedical oncologyOncology communityLaboratory testsSuch trialsDrug studiesTrialsPhase 1 programElectrocardiogram
2007
The changing face of phase I protocols: A closer look at study requirements
Craft B, Kurzrock R, Herbst R, Culotta K, Stewart C, Dorsey V, Lippman S, Gingher D, Bekele N, Karp D. The changing face of phase I protocols: A closer look at study requirements. Journal Of Clinical Oncology 2007, 25: 3061-3061. DOI: 10.1200/jco.2007.25.18_suppl.3061.Peer-Reviewed Original ResearchClinical Translational Research CenterPhase II trialPhase I clinical trialPhase I trialII trialClinical trialsPhase II trialMedical oncologyTranslational Research CenterCancer clinical trialsCurrent phase ILate-phase studiesPhase I programSame time periodTherapeutic requirementsECG monitoringTrialsSignificant financial relationshipElectrocardiographyStudy requirementsOncologyStudy complexityI programMore PK
2002
Non-small cell lung cancer clinical trials with trastuzumab: their foundation and preliminary results
Zinner RG, Kim J, Herbst RS. Non-small cell lung cancer clinical trials with trastuzumab: their foundation and preliminary results. Lung Cancer 2002, 37: 17-27. PMID: 12057863, DOI: 10.1016/s0169-5002(02)00035-1.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerHER2 overexpressionClinical trialsHER2-overexpressing metastatic breast cancerAntibody-dependent cell-mediated cytotoxicityMetastatic breast cancer trialsRandomized phase II trialRecombinant humanized monoclonal antibodyActivity of trastuzumabNSCLC clinical specimensPhase II studyPhase II trialEfficacy of trastuzumabMetastatic breast cancerBreast cancer trialsCell lung cancerCell-mediated cytotoxicityPoor clinical outcomeTreatment of patientsLung cancer clinical trialsHumanized monoclonal antibodyCombination of chemotherapyOverexpression of HER2Cancer clinical trialsDownregulation of HER2