2023
Overall survival analysis from the ADAURA trial of adjuvant osimertinib in patients with resected EGFR-mutated (EGFRm) stage IB–IIIA non-small cell lung cancer (NSCLC).
Herbst R, Tsuboi M, 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, Stachowiak M, Rukazenkov Y, Wu Y. Overall survival analysis from the ADAURA trial of adjuvant osimertinib in patients with resected EGFR-mutated (EGFRm) stage IB–IIIA non-small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2023, 41: lba3-lba3. DOI: 10.1200/jco.2023.41.17_suppl.lba3.Peer-Reviewed Original ResearchNon-small cell lung cancerStage IB-IIIA non-small cell lung cancerAdjuvant osimertinibOverall survival analysisOS HRAdjuvant chemotherapyOS benefitOS ratesII-IIIASurvival analysisDisease-free survival benefitFinal overall survival analysisGlobal phase III studyEGFR T790M resistance mutationII-IIIA diseaseStage IB-IIIAT790M resistance mutationTolerable safety profilePhase III studyCell lung cancerComplete tumor resectionEGFR-TKI sensitizingM resistance mutationExtended treatment durationADAURA study
2022
EP14.01-015 IMforte: A Phase III Study of Lurbinectedin and Atezolizumab Versus Atezolizumab as Maintenance Therapy in ES-SCLC
Paz-Ares L, Reck M, Peters S, Borghaei H, Herbst R, Siddiqui M, Cuchelkar V, Bhatt K, Chakrabarti D, Wang L, Morris S, Liu S. EP14.01-015 IMforte: A Phase III Study of Lurbinectedin and Atezolizumab Versus Atezolizumab as Maintenance Therapy in ES-SCLC. Journal Of Thoracic Oncology 2022, 17: s532-s533. DOI: 10.1016/j.jtho.2022.07.951.Peer-Reviewed Original Research
2020
IMpower110: Clinical safety in a phase III study of atezolizumab (atezo) monotherapy (mono) vs platinum-based chemotherapy (chemo) in first-line non-small cell lung cancer (NSCLC).
Jassem J, Herbst R, de Marinis F, Cadranel J, Csőszi T, Isla D, Chen G, Syrigos K, Cortinovis D, Hida T, Mocci S, Phan S, Enquist I, Patel H, Villalobos M, Wen X, Deng Y, Kuriki H, Spigel D, Giaccone G. IMpower110: Clinical safety in a phase III study of atezolizumab (atezo) monotherapy (mono) vs platinum-based chemotherapy (chemo) in first-line non-small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2020, 38: e21623-e21623. DOI: 10.1200/jco.2020.38.15_suppl.e21623.Peer-Reviewed Original ResearchNon-small cell lung cancerPD-L1 expressionSafety profileFirst‐line non‐small cell lung cancerCarboplatin AUC 6ECOG PS 0NCI CTCAE v4.0Chemo-naive patientsNew safety signalsPhase III studyPlatinum-based chemotherapyFavorable safety profileCell lung cancerAtezolizumab monotherapyAUC 5AUC 6Gemcitabine 1250Endocrine therapySystemic glucocorticoidsCTCAE v4.0Data cutoffIII studyPS 0PD-L1GEM 1000O81 IMpower110: interim overall survival (OS) analysis of a phase III study of atezolizumab (ATEZO) monotherapy vs platinum-based chemotherapy (CHEMO) as first-line (1L) treatment in PD-L1–selected NSCLC
Herbst R, De Marinis F, Giaccone G, Reinmuth N, Vergnenegre A, Barrios C, Morise M, Font E, Andric Z, Geater S, Ozguroglu M, Mocci S, McCleland M, Enquist I, Komatsubara K, Deng Y, Kuriki H, Wen X, Jassem J, Spigel D. O81 IMpower110: interim overall survival (OS) analysis of a phase III study of atezolizumab (ATEZO) monotherapy vs platinum-based chemotherapy (CHEMO) as first-line (1L) treatment in PD-L1–selected NSCLC. Journal For ImmunoTherapy Of Cancer 2020, 8: a1. DOI: 10.1136/lba2019.1.Peer-Reviewed Original ResearchTreatment-related AEsPD-L1 expressionPrimary endpointArm APD-L1Interim overall survival analysisTumor PD-L1 statusPD-L1/PDCarboplatin AUC 6ECOG PS 0Primary efficacy populationUnexpected safety signalsFirst-line treatmentPD-L1 statusPhase III studyPlatinum-based chemotherapyWT populationOverall survival analysisDeclaration of HelsinkiAttractive treatment choiceAtezolizumab monotherapyAUC 5AUC 6CPI monotherapyECOG PS
2019
LBA78 IMpower110: Interim overall survival (OS) analysis of a phase III study of atezolizumab (atezo) vs platinum-based chemotherapy (chemo) as first-line (1L) treatment (tx) in PD-L1–selected NSCLC
Spigel D, de Marinis F, Giaccone G, Reinmuth N, Vergnenegre A, Barrios C, Morise M, Felip E, Andric Z, Geater S, Özgüroğlu M, Mocci S, McCleland M, Enquist I, Komatsubara K, Deng Y, Kuriki H, Wen X, Jassem J, Herbst R. LBA78 IMpower110: Interim overall survival (OS) analysis of a phase III study of atezolizumab (atezo) vs platinum-based chemotherapy (chemo) as first-line (1L) treatment (tx) in PD-L1–selected NSCLC. Annals Of Oncology 2019, 30: v915. DOI: 10.1093/annonc/mdz293.Peer-Reviewed Original ResearchTreatment-related AEsPD-L1 expressionPD-L1F. Hoffmann-La RocheBristol-Myers SquibbHoffmann-La RocheBoehringer IngelheimArm ACisplatin 75mg/m2Interim overall survival analysisTumor PD-L1 statusTumor-infiltrating immune cellsPD-L1/PDEli LillyCarboplatin AUC 6ECOG PS 0Primary efficacy populationUnexpected safety signalsPD-L1 statusFirst-line treatmentPhase III studyPlatinum-based chemotherapyOverall survival analysisRoche/GenentechBristol-Meyers Squibb
2015
A retrospective analysis of RET translocation, gene copy number gain and expression in NSCLC patients treated with vandetanib in four randomized Phase III studies
Platt A, Morten J, Ji Q, Elvin P, Womack C, Su X, Donald E, Gray N, Read J, Bigley G, Blockley L, Cresswell C, Dale A, Davies A, Zhang T, Fan S, Fu H, Gladwin A, Harrod G, Stevens J, Williams V, Ye Q, Zheng L, de Boer R, Herbst RS, Lee JS, Vasselli J. A retrospective analysis of RET translocation, gene copy number gain and expression in NSCLC patients treated with vandetanib in four randomized Phase III studies. BMC Cancer 2015, 15: 171. PMID: 25881079, PMCID: PMC4412099, DOI: 10.1186/s12885-015-1146-8.Peer-Reviewed Original ResearchConceptsGene copy number gainCopy number gainsRET rearrangementsTumor samplesComparator armVandetanib treatmentNumber gainRandomized phase III studyPhase III clinical trialsCell lung cancer trialsObjective response ratePhase III studyLung cancer trialsRET protein expressionNSCLC subpopulationVandetanib armRadiologic evidenceIII studyNSCLC patientsObjective responseTumor shrinkageComparator drugsCancer trialsClinical trialsRetrospective analysis
2014
EGFR biomarkers predict benefit from vandetanib in combination with docetaxel in a randomized phase III study of second-line treatment of patients with advanced non-small cell lung cancer
Heymach JV, Lockwood SJ, Herbst RS, Johnson BE, Ryan AJ. EGFR biomarkers predict benefit from vandetanib in combination with docetaxel in a randomized phase III study of second-line treatment of patients with advanced non-small cell lung cancer. Annals Of Oncology 2014, 25: 1941-1948. PMID: 25057173, PMCID: PMC4176452, DOI: 10.1093/annonc/mdu269.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerSecond-line treatmentProgression-free survivalAdvanced non-small cell lung cancerRandomized phase III studyPhase III studyCell lung cancerMutation-positive tumorsEGFR mutationsIII studyTumor samplesClinical benefitLung cancerSecond-line non-small cell lung cancerEGFR FISH-positive tumorsEGFR mutation-positive tumorsEpidermal growth factor receptor (EGFR) gene mutationsObjective response rateRelative clinical benefitFirst-line chemotherapyObjective tumor responseProtein expressionOverall study populationGene mutationsPretreatment tumor samples
2010
Comparison of Patient Outcomes According to Histology Among Pemetrexed-Treated Patients With Stage IIIB/IV Non–Small-Cell Lung Cancer in Two Phase II Trials
Zinner RG, Novello S, Peng G, Herbst R, Obasaju C, Scagliotti G. Comparison of Patient Outcomes According to Histology Among Pemetrexed-Treated Patients With Stage IIIB/IV Non–Small-Cell Lung Cancer in Two Phase II Trials. Clinical Lung Cancer 2010, 11: 126-131. PMID: 20199979, DOI: 10.3816/clc.2010.n.017.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCarboplatinCarcinoma, Non-Small-Cell LungCarcinoma, Squamous CellFemaleGlutamatesGuanineHumansLung NeoplasmsMaleMiddle AgedMulticenter Studies as TopicNeoplasm StagingOrganoplatinum CompoundsOxaliplatinPemetrexedRetrospective StudiesSurvival RateTreatment OutcomeConceptsNonsquamous histologyProgression-free survivalSquamous histologyOverall survivalLung cancerStage IIIB/IV non-small cell lung cancerResponse rateStage IIIB/IV NSCLCNon-small cell lung cancerRecent phase III studyPemetrexed-treated patientsChemotherapy-naive patientsPhase II studyPhase II trialPhase III studyCell lung cancerCarboplatin areaNSCLC histologyPlatinum doubletsII trialPrimary endpointII studyIII studyPerformance statusTreatment arms
2007
A phase III study of Æ-941 with induction chemotherapy (IC) and concomitant chemoradiotherapy (CRT) for stage III non- small cell lung cancer (NSCLC) (NCI T99–0046, RTOG 02–70, MDA 99–303)
Lu C, Lee J, Komaki R, Herbst R, Evans W, Choy H, Desjardins P, Esparaz B, Truong M, Fisch M. A phase III study of Æ-941 with induction chemotherapy (IC) and concomitant chemoradiotherapy (CRT) for stage III non- small cell lung cancer (NSCLC) (NCI T99–0046, RTOG 02–70, MDA 99–303). Journal Of Clinical Oncology 2007, 25: 7527-7527. DOI: 10.1200/jco.2007.25.18_suppl.7527.Peer-Reviewed Original ResearchNon-small cell lung cancerStage III non-small cell lung cancerUnresectable stage III non-small cell lung cancerMedian survival timeConcomitant chemoradiotherapyInduction chemotherapyOverall survivalPerformance statusMedian age 63 yearsExperienced grade 3Site of enrollmentHigher adverse eventsPlacebo-controlled trialPhase III studyType of chemotherapyAge 63 yearsCell lung cancerShark cartilage extractMaintenance therapyMedian followPrimary endpointStage IIIBStudy drugAdverse eventsEligible subjects
2005
A phase III study of Æ-941 with induction chemotherapy (IC) and concomitant chemoradiotherapy (CRT) for stage III non-small cell Lung cancer (NSCLC) (NCI T99–0046, RTOG 02–70, MDA 99–303): An interim report of toxicity and response
Lu C, Komaki R, Herbst R, Evans W, Lee J, Truong M, Moore C, Choy H, Bleyer A, Fisch M. A phase III study of Æ-941 with induction chemotherapy (IC) and concomitant chemoradiotherapy (CRT) for stage III non-small cell Lung cancer (NSCLC) (NCI T99–0046, RTOG 02–70, MDA 99–303): An interim report of toxicity and response. Journal Of Clinical Oncology 2005, 23: 7144-7144. DOI: 10.1200/jco.2005.23.16_suppl.7144.Peer-Reviewed Original Research
2004
Anti-Vascular Endothelial Growth Factor Monoclonals in Non-Small Cell Lung Cancer
Sandler AB, Johnson DH, Herbst RS. Anti-Vascular Endothelial Growth Factor Monoclonals in Non-Small Cell Lung Cancer. Clinical Cancer Research 2004, 10: 4258s-4262s. PMID: 15217970, DOI: 10.1158/1078-0432.ccr-040023.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerMetastatic non-small cell lung cancerCarboplatin/paclitaxel chemotherapyCell lung cancerVascular endothelial growth factorEndothelial growth factorPaclitaxel chemotherapyLung cancerAdvanced metastatic non-small cell lung cancerStandard carboplatin/paclitaxel chemotherapyPhase I/II studyRecent phase II trialGrowth factorCurrent chemotherapy regimensEastern Cooperative GroupNeo-adjuvant studyNon-squamous histologyRole of bevacizumabNausea/vomitingAddition of bevacizumabPhase II trialPhase III studyTyrosine kinase inhibitor agentsSquamous cell histologySubset of patients
2003
O-311 A phase III study of Æ-941 (Neovastat®) with induction chemotherapy (IC) and conconmitant chemoradiotherapy (CRT) for stage III non-small cell lung cancer (NSCLC) (NCI T99-0046, RTOG 02-70, MDA 99-303): An interim analysis of toxicity and response
Lu C, Komaki R, Herbst R, Evans W, Smith T, Moore C, Kolbye S, Choi N, Choy H, Bleyer A. O-311 A phase III study of Æ-941 (Neovastat®) with induction chemotherapy (IC) and conconmitant chemoradiotherapy (CRT) for stage III non-small cell lung cancer (NSCLC) (NCI T99-0046, RTOG 02-70, MDA 99-303): An interim analysis of toxicity and response. Lung Cancer 2003, 41: s90. DOI: 10.1016/s0169-5002(03)91969-6.Peer-Reviewed Original Research
2002
Randomized phase III study of chemoradiation with or without amifostine for patients with favorable performance status inoperable stage II-III non-small cell lung cancer: Preliminary results
Komaki R, Lee J, Kaplan B, Allen P, Kelly J, Liao Z, Stevens C, Fossella F, Zinner R, Papadimitrakopoulou V, Khuri F, Glisson B, Pisters K, Kurie J, Herbst R, Milas L, Ro J, Thames H, Hong W, Cox J. Randomized phase III study of chemoradiation with or without amifostine for patients with favorable performance status inoperable stage II-III non-small cell lung cancer: Preliminary results. Seminars In Radiation Oncology 2002, 12: 46-49. PMID: 11917284, DOI: 10.1053/srao.2002.31363.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerThoracic radiation therapyInoperable stage IICell lung cancerSevere esophagitisArm 2Arm 1Lung cancerDay 1Randomized phase III studyStage IIPhase III studyGy/fractionMedian survival timeLong-term efficacyOral etoposideAcute pneumonitisConcurrent chemoradiotherapyIII studyTumor characteristicsPulmonary toxicityStudy groupRadiation therapyDay 29Survival time