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 researchMulti-stakeholder, intentional outreach for improving representative recruitment in Pragmatica–Lung (SWOG S2302).
Carrizosa D, Miao J, Reckamp K, Dragnev K, Hesketh P, Iams W, Henick B, Czerlanis C, DeSanto F, Sundstrom J, Johnson J, Gansauer L, Groller T, Redman M, Herbst R, Gray J. Multi-stakeholder, intentional outreach for improving representative recruitment in Pragmatica–Lung (SWOG S2302). Journal Of Clinical Oncology 2024, 42: 11019-11019. DOI: 10.1200/jco.2024.42.16_suppl.11019.Peer-Reviewed Original ResearchRecruitment planTrial designClinical trial enrollmentAdvanced/metastatic NSCLCAccrual rateStandard therapyPatient education materialsImprove community awarenessPatient accrual rateSWOGClinical trialsTrial enrollmentVA sitesApproaches to trial designPatient advocatesPatientsDecrease barriersMinority accrualRecruitment strategiesAdvocacy partnersLatinx patientsCommunity awarenessTrialsEducational materialsEnrollment informationA 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 professionalsRepresentativeness of Patients Enrolled in the Lung Cancer Master Protocol (Lung-MAP)
Vaidya R, Unger J, Qian L, Minichiello K, Herbst R, Gandara D, Neal J, Leal T, Patel J, Dragnev K, Waqar S, Edelman M, Sigal E, Adam S, Malik S, Blanke C, LeBlanc M, Kelly K, Gray J, Redman M. Representativeness of Patients Enrolled in the Lung Cancer Master Protocol (Lung-MAP). JCO Precision Oncology 2023, 7: e2300218. PMID: 37677122, PMCID: PMC10581630, DOI: 10.1200/po.23.00218.Peer-Reviewed Original ResearchConceptsCharacteristics of patientsLung-MAPMaster protocolsNSCLC populationCell lung cancer trialsSEER registry dataPatients 65 yearsPrecision medicine clinical trialsPatient exclusion criteriaLung cancer trialsRepresentativeness of patientsMedicine clinical trialsNSCLC trialsOlder patientsMedicaid/More patientsSubgroup analysisCancer trialsClinical trialsVulnerable patientsRegistry dataExclusion criteriaPatientsNSCLC studiesSociodemographic characteristicsNovel 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
2022
Quantitative assessment of Siglec-15 expression in lung, breast, head, and neck squamous cell carcinoma and bladder cancer.
Shafi S, Aung T, Xirou V, Gavrielatou N, Vathiotis I, Fernandez A, Moutafi M, Yaghoobi V, Herbst R, Liu L, Langermann S, Rimm D. Quantitative assessment of Siglec-15 expression in lung, breast, head, and neck squamous cell carcinoma and bladder cancer. Laboratory Investigation 2022, 102: 1143-1149. PMID: 36775354, DOI: 10.1038/s41374-022-00796-6.Peer-Reviewed Original ResearchConceptsSiglec-15 expressionNon-small cell lung cancerNeck squamous cell carcinomaProgression-free survivalSquamous cell carcinomaCancer typesOverall survivalCell carcinomaBladder cancerImmune cellsSiglec-15PD-1/PD-L1 blockadePotential future clinical trialsQuantitative immunofluorescencePD-L1 blockadeStromal immune cellsImmune checkpoint blockadeCell lung cancerFuture clinical trialsNew potential targetsCheckpoint blockadePD-L1Lung cancerClinical trialsIntra-tumoral heterogeneityCirculating Tumor DNA Kinetics Predict Progression-Free and Overall Survival in EGFR TKI–Treated Patients with EGFR-Mutant NSCLC (SWOG S1403)
Mack PC, Miao J, Redman MW, Moon J, Goldberg SB, Herbst RS, Melnick MA, Walther Z, Hirsch FR, Politi K, Kelly K, Gandara DR. Circulating Tumor DNA Kinetics Predict Progression-Free and Overall Survival in EGFR TKI–Treated Patients with EGFR-Mutant NSCLC (SWOG S1403). Clinical Cancer Research 2022, 28: 3752-3760. PMID: 35713632, PMCID: PMC9444942, DOI: 10.1158/1078-0432.ccr-22-0741.Peer-Reviewed Original ResearchConceptsProgression-free survivalOverall survivalEGFR mutationsNon-small cell lung cancerCycle 3 day 1Median progression-free survivalMedian overall survivalRisk of progressionCell lung cancerPresence of brainEGFR-mutant NSCLCBaseline ctDNAM1b stageProgression-FreeRECIST responseSerial plasmaLiver metastasesDecreased riskEGFR-TKILung cancerComplete clearanceLong-term benefitsClinical trialsTreatment outcomesPlasma clearanceAdaptive immune resistance at the tumour site: mechanisms and therapeutic opportunities
Kim TK, Vandsemb EN, Herbst RS, Chen L. Adaptive immune resistance at the tumour site: mechanisms and therapeutic opportunities. Nature Reviews Drug Discovery 2022, 21: 529-540. PMID: 35701637, DOI: 10.1038/s41573-022-00493-5.Peer-Reviewed Original ResearchConceptsAdaptive immune resistanceImmune resistanceCell death 1 ligand 1Tumor siteDeath 1 ligand 1Anti-PD therapyBlockade of PDL1Advanced-stage cancerFraction of patientsStrong mechanistic rationaleFuture drug developmentCurrent cancer therapiesImmune attackClinical trialsSolid tumorsTherapeutic opportunitiesTumorsCancer therapySelective inductionAntitumour drugsLigand 1Drug developmentTherapyAdditive effectMechanistic rationaleQuantitative assessment of Siglec-15 expression in lung, breast, head, and neck squamous cell carcinoma and bladder cancer
Shafi S, Aung TN, Xirou V, Gavrielatou N, Vathiotis IA, Fernandez A, Moutafi M, Yaghoobi V, Herbst RS, Liu LN, Langermann S, Rimm DL. Quantitative assessment of Siglec-15 expression in lung, breast, head, and neck squamous cell carcinoma and bladder cancer. Laboratory Investigation 2022, 102: 1143-1149. PMID: 35581307, PMCID: PMC10211373, DOI: 10.1038/s41374-022-00796-6.Peer-Reviewed Original ResearchConceptsSiglec-15 expressionNon-small cell lung cancerNeck squamous cell carcinomaProgression-free survivalSquamous cell carcinomaCancer typesOverall survivalCell carcinomaBladder cancerImmune cellsSiglec-15PD-1/PD-L1 blockadePotential future clinical trialsQuantitative immunofluorescencePD-L1 blockadeStromal immune cellsImmune checkpoint blockadeCell lung cancerFuture clinical trialsNew potential targetsCheckpoint blockadePD-L1Lung cancerClinical trialsIntra-tumoral heterogeneityDevelopment of an immunohistochemical assay for Siglec-15
Shafi S, Aung TN, Robbins C, Zugazagoitia J, Vathiotis I, Gavrielatou N, Yaghoobi V, Fernandez A, Niu S, Liu LN, Cusumano ZT, Leelatian N, Cole K, Wang H, Homer R, Herbst RS, Langermann S, Rimm DL. Development of an immunohistochemical assay for Siglec-15. Laboratory Investigation 2022, 102: 771-778. PMID: 35459795, PMCID: PMC9253057, DOI: 10.1038/s41374-022-00785-9.Peer-Reviewed Original ResearchConceptsSiglec-15IHC assaysPD-L1PD-1/PD-L1 inhibitionPD-L1 blockadePD-L1 inhibitionHigh expressionFuture clinical trialsImmunoglobulin-type lectinsSiglec-15 expressionCompanion diagnostic assayPromising new targetTumor histologyImmunotherapeutic targetLung cancerImmune cellsClinical trialsNovel recombinant antibodiesCancer histologyImmunohistochemical assaysMyeloid cellsTumor typesScoring systemNew targetsHigh concordance
2021
Nivolumab Plus Ipilimumab vs Nivolumab for Previously Treated Patients With Stage IV Squamous Cell Lung Cancer
Gettinger SN, Redman MW, Bazhenova L, Hirsch FR, Mack PC, Schwartz LH, Bradley JD, Stinchcombe TE, Leighl NB, Ramalingam SS, Tavernier SS, Yu H, Unger JM, Minichiello K, Highleyman L, Papadimitrakopoulou VA, Kelly K, Gandara DR, Herbst RS. Nivolumab Plus Ipilimumab vs Nivolumab for Previously Treated Patients With Stage IV Squamous Cell Lung Cancer. JAMA Oncology 2021, 7: 1368-1377. PMID: 34264316, PMCID: PMC8283667, DOI: 10.1001/jamaoncol.2021.2209.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerInvestigator-assessed progression-free survivalNivolumab/ipilimumabPlatinum-based chemotherapyCell lung cancerOverall survivalIpilimumab groupLung cancerClinical trialsDisease progressionStage IV squamous cell lung cancerAdvanced non-small cell lung cancerHigher treatment-related adverse eventsTreatment-related adverse eventsSquamous cell lung cancerNational Clinical Trials NetworkStandard platinum-based chemotherapyEnd pointAddition of ipilimumabIntolerable toxic effectsNivolumab Plus IpilimumabMedian response durationPrimary end pointSecondary end pointsProgression-free survivalPatient Knowledge and Expectations About Return of Genomic Results in a Biomarker-Driven Master Protocol Trial (SWOG S1400GEN)
Roth JA, Trivedi MS, Gray SW, Patrick DL, Delaney DM, Watabayashi K, Litwin P, Shah P, Crew KD, Yee M, Redman MW, Unger JM, Papadimitrakopoulou V, Johnson J, Kelly K, Gandara D, Herbst RS, Hershman DL, Ramsey SD. Patient Knowledge and Expectations About Return of Genomic Results in a Biomarker-Driven Master Protocol Trial (SWOG S1400GEN). JCO Oncology Practice 2021, 17: e1821-e1829. PMID: 33797955, PMCID: PMC9810137, DOI: 10.1200/op.20.00770.Peer-Reviewed Original ResearchConceptsMaster protocolsPatient knowledgeCell lung cancerOncology clinical trialsMost participantsMaster protocol trialsMedian ageEligible participantsLung cancerLung-MAPClinical trialsOdds ratioGenomic resultsCancer riskProtocol trialSociodemographic factorsCancer treatmentPilot studyCancer diagnosisTelephone surveyRiskCorrect responsesDemographic factorsCancerDescriptive statistics
2020
Increased tumor purity and improved biomarker detection using precision needle punch enrichment of pathology specimen paraffin blocks: Method validation and implementation in a prospective clinical trial.
Killian J, Wright C, Chan L, Danziger N, Elvin J, Vergilio J, Lin D, Williams E, Ramkissoon S, Severson E, Hemmerich A, Duncan D, Edgerly C, Tse J, McGregor K, Schrock A, Alexander B, Ross J, Redman M, Herbst R. Increased tumor purity and improved biomarker detection using precision needle punch enrichment of pathology specimen paraffin blocks: Method validation and implementation in a prospective clinical trial. Journal Of Clinical Oncology 2020, 38: 3622-3622. DOI: 10.1200/jco.2020.38.15_suppl.3622.Peer-Reviewed Original ResearchProspective clinical trialsClinical trialsTumor purityTissue blocksClinical trial enrollmentHomologous recombination deficiency scoresValidation studyTrial enrollmentTrial armsHigh tumor purityPathology specimensShort variantDeficiency scoresParaffin blocksPatient matchingTumor cellsBiomarker resultsStatistical differenceComplex biomarkersPass/fail rateSequencing assaysTrialsGenomic lossScoresGroup
2019
LBA1 Clinical efficacy of atezolizumab (atezo) in biomarker subgroups by SP142, SP263 and 22C3 PD-L1 immunohistochemistry (IHC) assays and by blood tumour mutational burden (bTMB): Results from the IMpower110 study
Herbst R, de Marinis F, Giaccone G, Reinmuth N, Vergnenegre A, Barrios C, Morise M, Felip E, Andric Z, Geater S, Ozguroglu M, Mocci S, McCleland M, Zou W, Enquist I, Komatsubara K, Deng Y, Kuriki H, Spigel D, Jassem J. LBA1 Clinical efficacy of atezolizumab (atezo) in biomarker subgroups by SP142, SP263 and 22C3 PD-L1 immunohistochemistry (IHC) assays and by blood tumour mutational burden (bTMB): Results from the IMpower110 study. Annals Of Oncology 2019, 30: xi62-xi63. DOI: 10.1093/annonc/mdz453.Peer-Reviewed Original ResearchBlood tumor mutational burdenBiomarker-evaluable populationTumor proportion scorePD-L1Bristol-Myers SquibbClinical trialsF. Hoffmann-La RocheLecture feesAstra ZenecaBoehringer IngelheimHoffmann-La RocheOS HRBiomarker subgroupsPD-L1 IHC assaysPD-L1 immunohistochemistry assaysIHC assaysEli LillyPrincipal investigatorECOG PS 0Genentech/RochePD-L1 cutoffsSignificant OS improvementStage IV NSCLCAstellas PharmaTumor mutational burden
2018
Concomitant targeting of the mTOR/MAPK pathways: novel therapeutic strategy in subsets of RICTOR/KRAS-altered non-small cell lung cancer
Ruder D, Papadimitrakopoulou V, Shien K, Behrens C, Kalhor N, Chen H, Shen L, Lee JJ, Hong WK, Tang X, Girard L, Minna JD, Diao L, Wang J, Mino B, Villalobos P, Rodriguez-Canales J, Hanson NE, Sun J, Miller V, Greenbowe J, Frampton G, Herbst RS, Baladandayuthapani V, Wistuba II, Izzo JG. Concomitant targeting of the mTOR/MAPK pathways: novel therapeutic strategy in subsets of RICTOR/KRAS-altered non-small cell lung cancer. Oncotarget 2018, 9: 33995-34008. PMID: 30338041, PMCID: PMC6188056, DOI: 10.18632/oncotarget.26129.Peer-Reviewed Original ResearchLung cancerAdvanced non-small cell lung cancer (NSCLC) patientsNon-small cell lung cancer patientsNon-small cell lung cancerCell lung cancer patientsSubset of NSCLCWorse overall survivalCell lung cancerLung cancer patientsAnti-tumor effectsNovel therapeutic strategiesNSCLC cell linesTherapeutic paradigm shiftMAPK pathwayUnique therapeutic vulnerabilitiesOverall survivalCancer patientsClinical trialsLung adenocarcinomaKRAS/Therapeutic strategiesPharmacologic inhibitionTherapeutic vulnerabilitiesTherapeutic opportunitiesConcomitant targetingClinical and Molecular Characteristics Associated With Survival Among Patients Treated With Checkpoint Inhibitors for Advanced Non–Small Cell Lung Carcinoma: A Systematic Review and Meta-analysis
Lee CK, Man J, Lord S, Cooper W, Links M, Gebski V, Herbst RS, Gralla RJ, Mok T, Yang JC. Clinical and Molecular Characteristics Associated With Survival Among Patients Treated With Checkpoint Inhibitors for Advanced Non–Small Cell Lung Carcinoma: A Systematic Review and Meta-analysis. JAMA Oncology 2018, 4: 210-216. PMID: 29270615, PMCID: PMC5838598, DOI: 10.1001/jamaoncol.2017.4427.Peer-Reviewed Original ResearchConceptsNon-small cell lung carcinomaAdvanced non-small cell lung carcinomaSecond-line therapyCheckpoint inhibitorsOverall survivalCell lung carcinomaWild-type subgroupClinicopathological characteristicsHazard ratioClinical trialsLung carcinomaMutant subgroupSystematic reviewKRAS wild-type subgroupStandard second-line therapyKRAS mutant subgroupRelative treatment benefitOverall survival benefitCochrane Central RegisterType of chemotherapyProlonged overall survivalProlongs overall survivalEGFR-mutant tumorsPatients' clinicopathological characteristicsRandomized clinical trialsChapter 6 Management of Advanced Non–Small Cell Lung Cancer Noncurative Intent Treatment
Xia B, Herbst R. Chapter 6 Management of Advanced Non–Small Cell Lung Cancer Noncurative Intent Treatment. 2018, 99-115. DOI: 10.1016/b978-0-323-48565-4.00006-0.Peer-Reviewed Original ResearchNon-small cell lung cancerPD-L1 expressionPlatinum-based chemotherapyTreatment optionsLung cancerFirst-line systemic treatment optionMolecular alterationsSecond-line settingSystemic treatment optionsTime of diagnosisMain treatment optionCell lung cancerCancer-related mortalityBiomarkers of responseEfficacy of treatmentAbstract Lung cancerAdenocarcinoma histologyIntent treatmentMetastatic diseaseMost patientsClinical outcomesNoninvasive testingClinical trialsNovel therapiesTreatment strategies60 How to Promote and Organize Clinical Research in Lung Cancer
Barlesi F, Mazieres J, Zhou Y, Herbst R, Zalcman G. 60 How to Promote and Organize Clinical Research in Lung Cancer. 2018, 628-634.e2. DOI: 10.1016/b978-0-323-52357-8.00060-3.Peer-Reviewed Original ResearchLung cancerClinical trialsNew clinical trial designsClinical trial designPotential therapeutic drugBasic science dataClinical researchersAppropriate trialsPreclinical dataPreventative optionsCertain therapiesTrial designNew treatmentsClinical researchPreclinical conceptsTherapeutic drugsCancerTrialsPatientsPersonalized medicineTherapyBiomarkers
2017
Enhancing Insights into Pulmonary Vascular Disease through a Precision Medicine Approach. A Joint NHLBI–Cardiovascular Medical Research and Education Fund Workshop Report
Newman JH, Rich S, Abman SH, Alexander JH, Barnard J, Beck GJ, Benza RL, Bull TM, Chan SY, Chun HJ, Doogan D, Dupuis J, Erzurum SC, Frantz RP, Geraci M, Gillies H, Gladwin M, Gray MP, Hemnes AR, Herbst RS, Hernandez AF, Hill NS, Horn EM, Hunter K, Jing ZC, Johns R, Kaul S, Kawut SM, Lahm T, Leopold JA, Lewis GD, Mathai SC, McLaughlin VV, Michelakis ED, Nathan SD, Nichols W, Page G, Rabinovitch M, Rich J, Rischard F, Rounds S, Shah SJ, Tapson VF, Lowy N, Stockbridge N, Weinmann G, Xiao L. Enhancing Insights into Pulmonary Vascular Disease through a Precision Medicine Approach. A Joint NHLBI–Cardiovascular Medical Research and Education Fund Workshop Report. American Journal Of Respiratory And Critical Care Medicine 2017, 195: 1661-1670. PMID: 28430547, PMCID: PMC5476915, DOI: 10.1164/rccm.201701-0150ws.Peer-Reviewed Original ResearchConceptsPulmonary vascular diseaseClinical trialsPulmonary hypertensionVascular diseaseNational Biological SamplePrecision medicine principlesVascular disease phenotypesNational Precision Medicine InitiativeSmall clinical trialsFuture clinical trialsPrecision medicine approachInnovative statistical designLung diseasePatient populationPatient advocacy organizationsPrecision Medicine InitiativeTherapeutic interventionsClinical investigatorsMedicine approachMedicine principlesMetabolic testsTrialsDiseaseBreakthrough InitiativePharmaceutical industry experts