Featured Publications
Overall Survival with Osimertinib in Resected EGFR-Mutated NSCLC
Tsuboi M, Herbst R, John T, Kato T, Majem M, Grohé C, Wang J, Goldman J, Lu S, Su W, de Marinis F, Shepherd F, Lee K, Le N, Dechaphunkul A, Kowalski D, Poole L, Bolanos A, Rukazenkov Y, Wu Y. Overall Survival with Osimertinib in Resected EGFR-Mutated NSCLC. New England Journal Of Medicine 2023, 389: 137-147. PMID: 37272535, DOI: 10.1056/nejmoa2304594.Peer-Reviewed Original ResearchConceptsDisease-free survivalOverall survivalIIIA diseaseStage IBAdjuvant osimertinibPlacebo groupOsimertinib groupNew serious adverse eventsSignificant overall survival benefitStage IILonger disease-free survivalEnd pointData cutoff datePrevious adjuvant chemotherapyDouble-blind trialOverall survival benefitPrimary end pointSecondary end pointsSerious adverse eventsCell lung cancerCoronavirus disease 2019Epidermal growth factor receptorADAURA trialAdjuvant chemotherapyEligible patients
2024
Summary of Research: Overall Survival with Osimertinib in Resected EGFR-Mutated NSCLC
Tsuboi M, Herbst R, John T, Kato T, Majem M, Grohé C, Wang J, Goldman J, Lu S, de Marinis F, Shepherd F, Lee K, Le N, Dechaphunkul A, Kowalski D, Bonanno L, Dómine M, Poole L, Bolanos A, Rukazenkov Y, Wu Y. Summary of Research: Overall Survival with Osimertinib in Resected EGFR-Mutated NSCLC. Targeted Oncology 2024, 19: 131-134. PMID: 38466534, PMCID: PMC10963460, DOI: 10.1007/s11523-024-01034-3.Peer-Reviewed Original ResearchNon-small cell lung cancerEGFR-mutant non-small cell lung cancerResected EGFR-mutant non-small cell lung cancerEpidermal growth factor receptorOverall survivalEGFR-mutantStage IB-IIIA non-small cell lung cancerPatients treated with osimertinibDisease-free survivalStage II-IIIAEffects of osimertinibCell lung cancerGrowth factor receptorCancer cell deathRisk of deathADAURA studyLength of time patientsOsimertinib groupTumor shrinkagePlacebo groupCancer-freeOsimertinibLung cancerFactor receptorCancer cells
2020
Osimertinib in Resected EGFR-Mutated Non–Small-Cell Lung Cancer
Wu YL, Tsuboi M, He J, John T, Grohe C, Majem M, Goldman JW, Laktionov K, Kim SW, Kato T, Vu HV, Lu S, Lee KY, Akewanlop C, Yu CJ, de Marinis F, Bonanno L, Domine M, Shepherd FA, Zeng L, Hodge R, Atasoy A, Rukazenkov Y, Herbst RS. Osimertinib in Resected EGFR-Mutated Non–Small-Cell Lung Cancer. New England Journal Of Medicine 2020, 383: 1711-1723. PMID: 32955177, DOI: 10.1056/nejmoa2027071.Peer-Reviewed Original ResearchMeSH KeywordsAcrylamidesAdultAgedAged, 80 and overAniline CompoundsAntineoplastic AgentsCarcinoma, Non-Small-Cell LungChemotherapy, AdjuvantDisease-Free SurvivalDouble-Blind MethodErbB ReceptorsFemaleHumansLung NeoplasmsLymphatic MetastasisMaleMiddle AgedMutationNeoplasm Recurrence, LocalNeoplasm StagingPneumonectomyProtein Kinase InhibitorsConceptsDisease-free survivalMutation-positive NSCLCIIIA diseasePlacebo groupOsimertinib groupStage IBLung cancerUntreated epidermal growth factor receptorNon-small cell lung cancerOverall populationStage IIEnd pointCentral nervous system diseaseSafety of osimertinibPrimary end pointSecondary end pointsPhase 3 trialOverall survival dataCell lung cancerNew safety concernsNervous system diseasesEpidermal growth factor receptorGrowth factor receptorAdjuvant therapyOverall survival
2010
Vandetanib plus docetaxel versus docetaxel as second-line treatment for patients with advanced non-small-cell lung cancer (ZODIAC): a double-blind, randomised, phase 3 trial
Herbst RS, Sun Y, Eberhardt W, Germonpré P, Saijo N, Zhou C, Wang J, Li L, Kabbinavar F, Ichinose Y, Qin S, Zhang L, Biesma B, Heymach JV, Langmuir P, Kennedy SJ, Tada H, Johnson BE. Vandetanib plus docetaxel versus docetaxel as second-line treatment for patients with advanced non-small-cell lung cancer (ZODIAC): a double-blind, randomised, phase 3 trial. The Lancet Oncology 2010, 11: 619-626. PMID: 20570559, PMCID: PMC3225192, DOI: 10.1016/s1470-2045(10)70132-7.Peer-Reviewed Original ResearchConceptsProgression-free survivalMedian progression-free survivalVascular endothelial growth factor receptorCell lung cancerEpidermal growth factor receptorVandetanib groupFebrile neutropeniaGrowth factor receptorPlacebo groupAdverse eventsLung cancerCommon serious adverse eventsDefinitive phase 3 trialLonger progression-free survivalComparison of PFSDaily oral inhibitorHigher adverse eventsSecond-line treatmentFirst-line chemotherapyFirst-line therapyPhase 2 studyPhase 3 trialSerious adverse eventsFactor receptorEndothelial growth factor receptorChemoradiotherapy With or Without AE-941 in Stage III Non–Small Cell Lung Cancer: A Randomized Phase III Trial
Lu C, Lee JJ, Komaki R, Herbst RS, Feng L, Evans WK, Choy H, Desjardins P, Esparaz BT, Truong MT, Saxman S, Kelaghan J, Bleyer A, Fisch MJ. Chemoradiotherapy With or Without AE-941 in Stage III Non–Small Cell Lung Cancer: A Randomized Phase III Trial. Journal Of The National Cancer Institute 2010, 102: 859-865. PMID: 20505152, PMCID: PMC2902826, DOI: 10.1093/jnci/djq179.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAngiogenesis InhibitorsAntineoplastic Combined Chemotherapy ProtocolsBiological ProductsCarcinoma, Non-Small-Cell LungCartilageChemotherapy, AdjuvantDisease-Free SurvivalDouble-Blind MethodFemaleHumansKaplan-Meier EstimateLung NeoplasmsMaleMiddle AgedMultivariate AnalysisNeoplasm StagingRadiotherapy, AdjuvantTissue ExtractsTreatment OutcomeConceptsNon-small cell lung cancerStage III non-small cell lung cancerUnresectable stage III non-small cell lung cancerProgression-free survivalTumor response rateCell lung cancerOverall survivalAE-941Lung cancerPlacebo groupClinical trialsUnresectable stage III NSCLC patientsResponse rateStage III NSCLC patientsPhase III clinical trialsAcademic oncology centerCommon grade 3Kaplan-Meier methodPhase III trialsShark cartilage extractTarget sample sizeToxic effectsChest radiotherapyConcurrent chemotherapyEligible patientsPharmacokinetic study of the phase III, randomized, double-blind, multicenter trial (TRIBUTE) of paclitaxel and carboplatin combined with erlotinib or placebo in patients with advanced Non-small Cell Lung Cancer (NSCLC)
Tran HT, Zinner RG, Blumenschein GR, Oh YW, Papadimitrakopoulou VA, Kim ES, Lu C, Malik M, Lum BL, Herbst RS. Pharmacokinetic study of the phase III, randomized, double-blind, multicenter trial (TRIBUTE) of paclitaxel and carboplatin combined with erlotinib or placebo in patients with advanced Non-small Cell Lung Cancer (NSCLC). Investigational New Drugs 2010, 29: 499-505. PMID: 20094773, DOI: 10.1007/s10637-009-9380-z.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerAdvanced non-small cell lung cancerDrug-drug interactionsErlotinib groupPlacebo groupPotential drug-drug interactionsErlotinib treatment groupPlacebo-treated patientsPossible drug-drug interactionsStandard chemotherapy regimenPhase III trialsCell lung cancerAddition of erlotinibPharmacokinetics of erlotinibMetabolite OSI-420Non-compartmental modelingAUC 6Erlotinib 150Paclitaxel 200Resultant paclitaxelChemotherapy regimenIII trialsUntreated patientsConcomitant administrationMulticenter trial
2004
Gefitinib in Combination With Gemcitabine and Cisplatin in Advanced Non–Small-Cell Lung Cancer: A Phase III Trial—INTACT 1
Giaccone G, Herbst RS, Manegold C, Scagliotti G, Rosell R, Miller V, Natale RB, Schiller JH, von Pawel J, Pluzanska A, Gatzemeier U, Grous J, Ochs JS, Averbuch SD, Wolf MK, Rennie P, Fandi A, Johnson DH. Gefitinib in Combination With Gemcitabine and Cisplatin in Advanced Non–Small-Cell Lung Cancer: A Phase III Trial—INTACT 1. Journal Of Clinical Oncology 2004, 22: 777-784. PMID: 14990632, DOI: 10.1200/jco.2004.08.001.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Non-Small-Cell LungCisplatinDeoxycytidineDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleFemaleGefitinibGemcitabineHumansLung NeoplasmsMaleMaximum Tolerated DoseMiddle AgedMultivariate AnalysisNeoplasm InvasivenessNeoplasm StagingProbabilityPrognosisQuinazolinesReference ValuesSurvival AnalysisTreatment OutcomeConceptsChemotherapy-naive patientsAdvanced NSCLCLung cancerAdvanced non-small cell lung cancerResponse rateNon-small cell lung cancerEpidermal growth factor receptor tyrosine kinase inhibitor gefitinibEnd pointUnresectable stage IIICycles of chemotherapyEfficacy end pointPhase II trialFirst-line gemcitabineTyrosine kinase inhibitor gefitinibPhase I trialCell lung cancerUnexpected adverse eventsMedian survival timeKinase inhibitor gefitinibFurther preclinical testingDaily gefitinibFavorable tolerabilityII trialPlacebo groupAdverse events