2023
Novel 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
2020
Long-Term Outcomes and Retreatment Among Patients With Previously Treated, Programmed Death-Ligand 1‒Positive, Advanced Non‒Small-Cell Lung Cancer in the KEYNOTE-010 Study.
Herbst RS, Garon EB, Kim DW, Cho BC, Perez-Gracia JL, Han JY, Arvis CD, Majem M, Forster MD, Monnet I, Novello S, Szalai Z, Gubens MA, Su WC, Ceresoli GL, Samkari A, Jensen EH, Lubiniecki GM, Baas P. Long-Term Outcomes and Retreatment Among Patients With Previously Treated, Programmed Death-Ligand 1‒Positive, Advanced Non‒Small-Cell Lung Cancer in the KEYNOTE-010 Study. Journal Of Clinical Oncology 2020, 38: 1580-1590. PMID: 32078391, DOI: 10.1200/jco.19.02446.Peer-Reviewed Original ResearchConceptsTumor proportion scoreTreatment-related adverse eventsSecond-course treatmentOverall survivalAdverse eventsLung cancerGrade 3Advanced non-small cell lung cancerPD-L1 tumor proportion scoreNon-small cell lung cancerLong-term OS benefitPembrolizumab improved overall survivalProgression-free survival ratesProgrammed Death Ligand 1Improved overall survivalDeath ligand 1Cell lung cancerLong-term outcomesYears of treatmentOS benefitPembrolizumab dosesStable diseaseAdvanced NSCLCEligible patientsDurable responses
2015
Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial
Herbst RS, Baas P, Kim DW, Felip E, Pérez-Gracia JL, Han JY, Molina J, Kim JH, Arvis CD, Ahn MJ, Majem M, Fidler MJ, de Castro G, Garrido M, Lubiniecki GM, Shentu Y, Im E, Dolled-Filhart M, Garon EB. Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial. The Lancet 2015, 387: 1540-1550. PMID: 26712084, DOI: 10.1016/s0140-6736(15)01281-7.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic AgentsB7-H1 AntigenCarcinoma, Non-Small-Cell LungDisease-Free SurvivalDocetaxelDrug Administration ScheduleFemaleGene Expression Regulation, NeoplasticHumansKaplan-Meier EstimateLung NeoplasmsMaleMiddle AgedMolecular Targeted TherapyPatient SelectionTaxoidsTreatment OutcomeConceptsCell lung cancerProgression-free survivalPD-L1 expressionOverall survivalLung cancerPD-L1Tumor cellsMedian progression-free survivalTreatment-related adverse eventsEfficacy of pembrolizumabMedian overall survivalProlongs overall survivalNew treatment optionsAcademic medical centerPrimary endpointAdverse eventsProgressive diseasePatient populationTotal populationTreatment optionsPembrolizumabGrade 3Medical CenterEffective treatmentInteractive voice response system
2012
Clinical Outcomes and Biomarker Profiles of Elderly Pretreated NSCLC Patients from the BATTLE Trial
Tsao AS, Liu S, Lee JJ, Alden C, Blumenschein G, Herbst R, Davis SE, Kim E, Lippman S, Stewart D, Tang XM, Wistuba I, Hong WK. Clinical Outcomes and Biomarker Profiles of Elderly Pretreated NSCLC Patients from the BATTLE Trial. Journal Of Thoracic Oncology 2012, 7: 1645-1652. PMID: 23059780, PMCID: PMC5161038, DOI: 10.1097/jto.0b013e31826910ff.Peer-Reviewed Original ResearchMeSH KeywordsAdenocarcinomaAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBexaroteneBiomarkers, TumorCarcinoma, Non-Small-Cell LungCarcinoma, Squamous CellDrug Resistance, NeoplasmErlotinib HydrochlorideFemaleFollow-Up StudiesHumansLung NeoplasmsMaleMiddle AgedNeoplasm StagingNiacinamidePhenylurea CompoundsPiperidinesPrognosisQuinazolinesRetrospective StudiesSalvage TherapySorafenibSurvival RateTetrahydronaphthalenesConceptsProgression-free survivalDisease control rateNSCLC patientsOverall survivalElderly menGrade 3Older womenOlder menBetter median progression-free survivalHigher disease control rateLung Cancer Elimination (BATTLE) trialMedian progression-free survivalAge groupsBetter progression-free survivalCell lung cancer patientsBiomarker-Integrated ApproachesBiopsy-related pneumothoraxElderly NSCLC patientsMore grade 3Treatment-related deathsTumor tissue biomarkersRetrospective subgroup analysisSubset of patientsHigher overall survivalLung cancer patients
2010
Phase II Study of Vinorelbine and Docetaxel in the Treatment of Advanced Non–Small-Cell Lung Cancer as Frontline and Second-Line Therapy
William WN, Khuri FR, Fossella FV, Glisson BS, Zinner RG, Lee JJ, Herbst RS, Lippman SM, Kim ES. Phase II Study of Vinorelbine and Docetaxel in the Treatment of Advanced Non–Small-Cell Lung Cancer as Frontline and Second-Line Therapy. American Journal Of Clinical Oncology 2010, 33: 148-152. PMID: 19687727, PMCID: PMC5118944, DOI: 10.1097/coc.0b013e318199fb99.Peer-Reviewed Original ResearchMeSH KeywordsAdenocarcinomaAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBone NeoplasmsCarcinoma, Non-Small-Cell LungCarcinoma, Squamous CellDocetaxelFemaleFollow-Up StudiesHumansLung NeoplasmsMaleMiddle AgedNeoplasm StagingSalvage TherapySurvival RateTaxoidsTreatment OutcomeVinblastineVinorelbineConceptsCell lung cancerLung cancerGrade 3Advanced non-small cell lung cancerNon-small cell lung cancerCommon grade 3Experienced febrile neutropeniaFirst-line settingMedian overall survivalNausea/vomitingSecond-line patientsSecond-line settingSecond-line therapyPhase 2 studyPhase II studySingle-agent chemotherapyUse of docetaxelCombination of docetaxelFrontline treatment optionFilgrastim supportNonplatinum agentsFebrile neutropeniaNonhematologic toxicitySalvage therapyII study
2009
A phase 2 study of cetuximab in combination with docetaxel in chemotherapy‐refractory/resistant patients with advanced nonsmall cell lung cancer
Kim ES, Mauer AM, William WN, Tran HT, Liu D, Lee JJ, Windt P, Hong WK, Vokes EE, Herbst RS. A phase 2 study of cetuximab in combination with docetaxel in chemotherapy‐refractory/resistant patients with advanced nonsmall cell lung cancer. Cancer 2009, 115: 1713-1722. PMID: 19208430, PMCID: PMC5142442, DOI: 10.1002/cncr.24148.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Non-Small-Cell LungCetuximabDisease ProgressionDocetaxelDrug Administration ScheduleErbB ReceptorsFemaleHumansLung NeoplasmsMaleMiddle AgedNeoplasm Recurrence, LocalTaxoidsConceptsNonsmall cell lung cancerAdvanced nonsmall cell lung cancerResponse rateOverall survivalResistant patientsLung cancerEpidermal growth factor receptor expressionCommon grade 3Growth factor receptor expressionMedian overall survivalSecond-line settingPhase 2 studyCell lung cancerTarget sample sizeFactor receptor expressionStable diseaseAdverse eventsPartial responseComplete responseDisease recurrenceMedian timeDisease progressionReceptor expressionAllergic reactionsGrade 3
2007
Phase II study of the efficacy and safety of intravenous (IV) AVE0005 (VEGF Trap) given every 2 weeks in patients (Pts) with platinum- and erlotinib- resistant adenocarcinoma of the lung (NSCLA)
Massarelli E, Miller V, Leighl N, Rosen P, Albain K, Hart L, Melnyk O, Sternas L, Ackerman J, Herbst R. Phase II study of the efficacy and safety of intravenous (IV) AVE0005 (VEGF Trap) given every 2 weeks in patients (Pts) with platinum- and erlotinib- resistant adenocarcinoma of the lung (NSCLA). Journal Of Clinical Oncology 2007, 25: 7627-7627. DOI: 10.1200/jco.2007.25.18_suppl.7627.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsPartial responsePerformance statusGrade 3Prior treatmentSquamous cell lung cancerEmergent adverse eventsSignificant bleeding diathesisECOG performance statusObjective response ratePhase II studyProgression-free survivalSingle-agent activityDuration of responseMulti-center trialMost common reasonsInterim futility analysisVEGF receptor inhibitorQuality of lifeBone painEvaluable ptsFebrile neutropeniaMeasurable diseaseBrain metastasesAdverse events
2006
Managing cutaneous side effects associated with erlotinib in head and neck cancer (HNC) and non-small cell lung cancer (NSCLC) patients (pts)
Oishi K, Garey J, Burke B, Herbst R, Kim E. Managing cutaneous side effects associated with erlotinib in head and neck cancer (HNC) and non-small cell lung cancer (NSCLC) patients (pts). Journal Of Clinical Oncology 2006, 24: 18538-18538. DOI: 10.1200/jco.2006.24.18_suppl.18538.Peer-Reviewed Original ResearchGrade 1 rashPartial responseGrade 2Epidermal growth factor receptorGrade 3NSCLC ptsDose modificationComplete responseTreatment algorithmTreatment responseSide effectsNon-small cell lung cancer patientsGrade 1Cell lung cancer patientsPrior chemotherapy regimenPhase II studyCutaneous side effectsLung cancer patientsGrade 4Acneiform rashChemotherapy regimenDose delaysGrowth factor receptorII studyCutaneous toxicity
2003
Induction docetaxel and carboplatin followed by weekly docetaxel and carboplatin with concurrent radiotherapy, then surgery in stage III non-small cell lung cancer: a Phase I study.
Wirth LJ, Lucca J, Ostler P, Fidias P, Lynch C, Jänne PA, Herbst RS, Johnson BE, Sugarbaker DJ, Mathisen DJ, Lukanich JM, Choi NC, Berman SM, Skarin AT. Induction docetaxel and carboplatin followed by weekly docetaxel and carboplatin with concurrent radiotherapy, then surgery in stage III non-small cell lung cancer: a Phase I study. Clinical Cancer Research 2003, 9: 1698-704. PMID: 12738723.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerStage III non-small cell lung cancerCT/RTMaximum-tolerated doseCell lung cancerConcurrent radiotherapyLung cancerDose levelsConcurrent weekly carboplatinGrade 3 toxicityPathologic complete responsePhase II studyInduction docetaxelTrimodality treatmentWeekly carboplatinWeekly docetaxelII studyOverall survivalStage IIIAComplete responseSurgical patientsSubsequent radiotherapyNew regimenInduction CTGrade 3
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 regimens