2019
SWOG S1400C (NCT02154490)—A Phase II Study of Palbociclib for Previously Treated Cell Cycle Gene Alteration–Positive Patients with Stage IV Squamous Cell Lung Cancer (Lung-MAP Substudy)
Edelman MJ, Redman MW, Albain KS, McGary EC, Rafique NM, Petro D, Waqar SN, Minichiello K, Miao J, Papadimitrakopoulou VA, Kelly K, Gandara DR, Herbst RS. SWOG S1400C (NCT02154490)—A Phase II Study of Palbociclib for Previously Treated Cell Cycle Gene Alteration–Positive Patients with Stage IV Squamous Cell Lung Cancer (Lung-MAP Substudy). Journal Of Thoracic Oncology 2019, 14: 1853-1859. PMID: 31302234, PMCID: PMC6764876, DOI: 10.1016/j.jtho.2019.06.027.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overAntineoplastic AgentsBiomarkers, TumorBone NeoplasmsCarcinoma, Non-Small-Cell LungCarcinoma, Squamous CellCell Cycle ProteinsFemaleFollow-Up StudiesGene AmplificationHumansLung NeoplasmsMaleMiddle AgedMutationNeoplasm Recurrence, LocalNeoplasm StagingPiperazinesPyridinesSalvage TherapySurvival RateConceptsSquamous NSCLCEligible patientsStage IV squamous cell lung cancerPhase II/III trialsCell cycle gene alterationsCyclin D3 gene amplificationMedian progression-free survivalPrior platinum-based chemotherapySquamous cell lung cancerSingle-arm phase II trialMedian overall survivalPhase II studyPrimary end pointPhase II trialProgression-free survivalPlatinum-based chemotherapyCell lung cancerNormal organ functionCyclin-dependent kinase 4Cyclin-dependent kinase 4 geneKinase 4 geneStable diseaseII trialII studyIII trialsSWOG S1400D (NCT02965378), a Phase II Study of the Fibroblast Growth Factor Receptor Inhibitor AZD4547 in Previously Treated Patients With Fibroblast Growth Factor Pathway–Activated Stage IV Squamous Cell Lung Cancer (Lung-MAP Substudy)
Aggarwal C, Redman MW, Lara PN, Borghaei H, Hoffman P, Bradley JD, Newman AJ, Feldman MJ, Minichiello K, Miao J, Mack PC, Papadimitrakopoulou VA, Herbst RS, Kelly K, Gandara DR. SWOG S1400D (NCT02965378), a Phase II Study of the Fibroblast Growth Factor Receptor Inhibitor AZD4547 in Previously Treated Patients With Fibroblast Growth Factor Pathway–Activated Stage IV Squamous Cell Lung Cancer (Lung-MAP Substudy). Journal Of Thoracic Oncology 2019, 14: 1847-1852. PMID: 31195180, PMCID: PMC6901020, DOI: 10.1016/j.jtho.2019.05.041.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overAntineoplastic AgentsBenzamidesBiomarkers, TumorCarcinoma, Non-Small-Cell LungCarcinoma, Squamous CellFemaleFollow-Up StudiesGene AmplificationHumansLung NeoplasmsMaleMiddle AgedNeoplasm StagingPiperazinesPyrazolesReceptor, Fibroblast Growth Factor, Type 1Receptor, Fibroblast Growth Factor, Type 3Salvage TherapySurvival RateConceptsProgression-free survivalFGFR3 S249CFGFR alterationsOverall survivalPartial responseFGFR1 amplificationLung-MAPGrade 3 adverse eventsMedian progression-free survivalPlatinum-based systemic therapySolid Tumors version 1.1Squamous cell lung cancerMedian age 66 yearsFibroblast growth factor receptor inhibitorGrowth factor receptor inhibitorsFirst phase II trialGrade 4 sepsisResponse-evaluable patientsSquamous cell NSCLCUnconfirmed partial responsePhase II studyAcceptable safety profilePhase II trialResponse Evaluation CriteriaAge 66 years
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
2013
Clinical and Biomarker Outcomes of the Phase II Vandetanib Study from the BATTLE Trial
Tsao AS, Liu S, Lee JJ, Alden CM, Blumenschein GR, Herbst R, Davis SE, Kim E, Lippman S, Heymach J, Tran H, Tang X, Wistuba I, Hong WK. Clinical and Biomarker Outcomes of the Phase II Vandetanib Study from the BATTLE Trial. Journal Of Thoracic Oncology 2013, 8: 658-661. PMID: 23584298, PMCID: PMC5118909, DOI: 10.1097/jto.0b013e31828d08ae.Peer-Reviewed Original ResearchMeSH KeywordsAcute-Phase ProteinsAgedAntineoplastic AgentsBiomarkers, TumorCarcinoma, Non-Small-Cell LungDisease-Free SurvivalFemaleGene AmplificationGenes, erbB-1HumansInterleukin-9Kaplan-Meier EstimateLipocalin-2LipocalinsLung NeoplasmsMaleMiddle AgedMutationPiperidinesProportional Hazards ModelsProto-Oncogene ProteinsProto-Oncogene Proteins p21(ras)QuinazolinesRas ProteinsTNF-Related Apoptosis-Inducing LigandConceptsDisease control rateWorse OSShorter PFSControl rateMutation patientsDual epidermal growth factor receptorVascular endothelial growth factor receptor inhibitionLung Cancer Elimination (BATTLE) trialNeutrophil gelatinase-associated lipocalinCell lung cancer patientsGrowth factor receptor inhibitionPhase II trialGelatinase-associated lipocalinLung cancer patientsTumor core biopsiesSerum biomarker analysisEGFR mutation patientsEpidermal growth factor receptorEGFR gene amplificationApoptosis-inducing ligandGrowth factor receptorMedian PFSOS benefitEpidermal growth factor receptor tyrosine kinaseII trial
2005
Epidermal Growth Factor Receptor Mutations and Gene Amplification in Non–Small-Cell Lung Cancer: Molecular Analysis of the IDEAL/INTACT Gefitinib Trials
Bell DW, Lynch TJ, Haserlat SM, Harris PL, Okimoto RA, Brannigan BW, Sgroi DC, Muir B, Riemenschneider MJ, Iacona RB, Krebs AD, Johnson DH, Giaccone G, Herbst RS, Manegold C, Fukuoka M, Kris MG, Baselga J, Ochs JS, Haber DA. Epidermal Growth Factor Receptor Mutations and Gene Amplification in Non–Small-Cell Lung Cancer: Molecular Analysis of the IDEAL/INTACT Gefitinib Trials. Journal Of Clinical Oncology 2005, 23: 8081-8092. PMID: 16204011, DOI: 10.1200/jco.2005.02.7078.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic AgentsBiomarkers, TumorCarcinoma, Non-Small-Cell LungErbB ReceptorsFemaleGefitinibGene AmplificationGene Expression Regulation, NeoplasticHumansLung NeoplasmsMaleMiddle AgedMutationQuinazolinesReverse Transcriptase Polymerase Chain ReactionSequence Analysis, DNASurvival RateConceptsEpidermal growth factor receptorCell lung cancerEGFR mutationsLung cancerEpidermal growth factor receptor (EGFR) mutationsTrials of gefitinibLarge clinical trialsCombination of gefitinibLung cancer specimensGene amplificationEGFR gene amplificationAdenocarcinoma histologyBiologic subsetsGrowth factor receptorIDEAL trialINTACT trialsSmoking historyClinical featuresEGFR genotypeFemale sexClinical trialsGefitinib responseGefitinib trialsCancer specimensAsian ethnicity