2008
Increased EGFR Gene Copy Number Detected by Fluorescent In Situ Hybridization Predicts Outcome in Non–Small-Cell Lung Cancer Patients Treated With Cetuximab and Chemotherapy
Hirsch FR, Herbst RS, Olsen C, Chansky K, Crowley J, Kelly K, Franklin WA, Bunn PA, Varella-Garcia M, Gandara DR. Increased EGFR Gene Copy Number Detected by Fluorescent In Situ Hybridization Predicts Outcome in Non–Small-Cell Lung Cancer Patients Treated With Cetuximab and Chemotherapy. Journal Of Clinical Oncology 2008, 26: 3351-3357. PMID: 18612151, PMCID: PMC3368372, DOI: 10.1200/jco.2007.14.0111.Peer-Reviewed Original ResearchMeSH KeywordsAgedAnalysis of VarianceAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorCarcinoma, Non-Small-Cell LungCetuximabFemaleGene Expression Regulation, NeoplasticGenes, erbB-1HumansIn Situ HybridizationIn Situ Hybridization, FluorescenceLung NeoplasmsMaleMiddle AgedMultivariate AnalysisNeoplasm StagingPatient SelectionPredictive Value of TestsPrognosisProportional Hazards ModelsReference ValuesRisk AssessmentSurvival AnalysisTreatment OutcomeConceptsCell lung cancer patientsLung cancer patientsFISH-negative patientsEGFR FISHNSCLC patientsCancer patientsSurvival timeMedian progression-free survival timeProgression-free survival timeEGFR tyrosine kinase inhibitorsDisease control rateChemotherapy-naive patientsAdvanced-stage NSCLCMedian survival timeEpidermal growth factor receptor (EGFR) gene copy numberFISH-positive patientsAvailable tumor tissueEGFR gene copy numberTyrosine kinase inhibitorsFISH-positive tumorsPhase II selection trialFISH-positive groupConcurrent chemotherapyConcurrent therapyPredictive factors
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
2004
Effects of amifostine on acute toxicity from concurrent chemotherapy and radiotherapy for inoperable non–small-cell lung cancer: report of a randomized comparative trial
Komaki R, Lee JS, Milas L, Lee HK, Fossella FV, Herbst RS, Allen PK, Liao Z, Stevens CW, Lu C, Zinner RG, Papadimitrakopoulou VA, Kies MS, Blumenschein GR, Pisters KM, Glisson BS, Kurie J, Kaplan B, Garza VP, Mooring D, Tucker SL, Cox JD. Effects of amifostine on acute toxicity from concurrent chemotherapy and radiotherapy for inoperable non–small-cell lung cancer: report of a randomized comparative trial. International Journal Of Radiation Oncology • Biology • Physics 2004, 58: 1369-1377. PMID: 15050312, DOI: 10.1016/j.ijrobp.2003.10.005.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAgranulocytosisAmifostineAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Non-Small-Cell LungCisplatinCombined Modality TherapyConfidence IntervalsEtoposideFemaleFollow-Up StudiesHumansLung NeoplasmsMaleMiddle AgedRadiation PneumonitisRadiation-Protective AgentsRadiotherapy DosageSurvival AnalysisTreatment OutcomeConceptsArm 2 patientsCell lung cancerArm 1 patientsLung cancerArm 1Concurrent chemotherapyNational Cancer Institute Common Toxicity CriteriaConcurrent cisplatin-based chemotherapyAbility of amifostineCommon Toxicity CriteriaCisplatin-based chemotherapyTumor-protective effectMedian survival timeEffects of amifostineAcute toxicityEsophageal toxicityNeutropenic feverOral etoposideConcurrent chemoradiotherapyHematologic toxicityMild hypotensionThoracic radiotherapyLiving patientsSevere pneumonitisTumor characteristicsGefitinib 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
2002
The novel and effective nonplatinum, nontaxane combination of gemcitabine and vinorelbine in advanced nonsmall cell lung carcinoma
Herbst RS, Khuri FR, Lu C, Liu DD, Fossella FV, Glisson BS, Pisters KM, Shin DM, Papadimitrakopoulou VA, Kurie JM, Blumenschein G, Kies MS, Zinner R, Jung MS, Lu R, Lee JJ, Munden RF, Hong WK, Lee JS. The novel and effective nonplatinum, nontaxane combination of gemcitabine and vinorelbine in advanced nonsmall cell lung carcinoma. Cancer 2002, 95: 340-353. PMID: 12124835, DOI: 10.1002/cncr.10629.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntimetabolites, AntineoplasticAntineoplastic Agents, PhytogenicAntineoplastic Combined Chemotherapy ProtocolsBiological TherapyCarcinoma, Non-Small-Cell LungCombined Modality TherapyDeoxycytidineDisease ProgressionFemaleGemcitabineHumansLung NeoplasmsMaleMiddle AgedSurvival RateVinblastineVinorelbineConceptsNonsmall cell lung carcinomaYear survival rateAdvanced nonsmall cell lung carcinomaThird-line therapyPhase II trialMedian survival timeCell lung carcinomaGrade 3Survival rateSignificant myelosuppressionStable diseaseII trialLung carcinomaSurvival timeStage IV nonsmall cell lung carcinomaDay 1Day 15Formal phase II trialCurrent phase II trialDose of vinorelbineGemcitabine/vinorelbineGrade 3 granulocytopeniaMedian performance statusMinimal grade 3Prior chemotherapy regimensRandomized 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
1999
Gemcitabine and vinorelbine combinations in the treatment of non-small cell lung cancer.
Herbst RS, Lilenbaum R. Gemcitabine and vinorelbine combinations in the treatment of non-small cell lung cancer. Seminars In Oncology 1999, 26: 67-70; discussion 71-2. PMID: 10585011.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerAdvanced non-small cell lung cancerVinorelbine/gemcitabineCell lung cancerMedian survivalSurvival rateStable diseasePartial responseLung cancerDisease progressionDay 1Treatment of NSCLCStandard platinum-based regimensGemcitabine/vinorelbineChemotherapy-naive patientsPerformance status 0Treatment-naive patientsPhase II studyPlatinum-based regimensCombination of vinorelbineMedian survival timeOverall response rateNonplatinum agentsStatus 0Vinorelbine combination