2022
Maximizing the value of phase III trials in immuno-oncology: A checklist from the Society for Immunotherapy of Cancer (SITC)
Atkins MB, Abu-Sbeih H, Ascierto PA, Bishop MR, Chen DS, Dhodapkar M, Emens LA, Ernstoff MS, Ferris RL, Greten TF, Gulley JL, Herbst RS, Humphrey RW, Larkin J, Margolin KA, Mazzarella L, Ramalingam SS, Regan MM, Rini BI, Sznol M. Maximizing the value of phase III trials in immuno-oncology: A checklist from the Society for Immunotherapy of Cancer (SITC). Journal For ImmunoTherapy Of Cancer 2022, 10: e005413. PMID: 36175037, PMCID: PMC9528604, DOI: 10.1136/jitc-2022-005413.Peer-Reviewed Original ResearchConceptsPhase III trialsImmunotherapy of cancerIII trialsCurative responseImmune checkpoint inhibitor monotherapyCell death protein 1Checkpoint inhibitor monotherapyDefinitive predictive biomarkersDurable clinical benefitProgression-free survivalMinority of patientsDeath protein 1Variety of indicationsClinical trial designAnimal tumor modelsLimited Phase IDrug development programsImmunotherapy combinationsInvestigational chemotherapyImmunotherapy fieldInhibitor monotherapyOverall survivalDismal prognosisClinical benefitSurvival outcomes
2018
The biology and management of non-small cell lung cancer
Herbst RS, Morgensztern D, Boshoff C. The biology and management of non-small cell lung cancer. Nature 2018, 553: 446-454. PMID: 29364287, DOI: 10.1038/nature25183.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerCell lung cancerLung cancerSmall molecule tyrosine kinase inhibitorsMolecule tyrosine kinase inhibitorsBroader patient populationTyrosine kinase inhibitorsUnprecedented survival benefitsMetastatic diseaseMultimodal careSurvival benefitClinical benefitCombination therapyOverall curePatient populationSurvival rateTumor progressionEarly detectionKinase inhibitorsNew drugsDisease biologyCancerImmunotherapyPatientsTherapy
2017
OA03.07 KEYNOTE-010: Durable Clinical Benefit in Patients with Previously Treated, PD-L1-Expressing NSCLC Who Completed Pembrolizumab
Herbst R, Garon E, Kim D, Cho B, Gadgeel S, Léna H, Gúrpide A, Han J, Arvis C, Majem M, Forster M, Monnet I, Novello S, Saka H, Szalai Z, Gubens M, Su W, Lubiniecki G, Shentu Y, Ferraro G, Baas P. OA03.07 KEYNOTE-010: Durable Clinical Benefit in Patients with Previously Treated, PD-L1-Expressing NSCLC Who Completed Pembrolizumab. Journal Of Thoracic Oncology 2017, 12: s254-s255. DOI: 10.1016/j.jtho.2016.11.243.Peer-Reviewed Original Research
2016
KDR Amplification Is Associated with VEGF-Induced Activation of the mTOR and Invasion Pathways but does not Predict Clinical Benefit to the VEGFR TKI Vandetanib
Nilsson MB, Giri U, Gudikote J, Tang X, Lu W, Tran H, Fan Y, Koo A, Diao L, Tong P, Wang J, Herbst R, Johnson BE, Ryan A, Webster A, Rowe P, Wistuba II, Heymach JV. KDR Amplification Is Associated with VEGF-Induced Activation of the mTOR and Invasion Pathways but does not Predict Clinical Benefit to the VEGFR TKI Vandetanib. Clinical Cancer Research 2016, 22: 1940-1950. PMID: 26578684, PMCID: PMC4834253, DOI: 10.1158/1078-0432.ccr-15-1994.Peer-Reviewed Original ResearchMeSH KeywordsCarcinoma, Non-Small-Cell LungCell Line, TumorCell MovementCell ProliferationHumansHypoxia-Inducible Factor 1, alpha SubunitLung NeoplasmsP38 Mitogen-Activated Protein KinasesPiperidinesProtein Kinase InhibitorsProto-Oncogene Proteins c-metQuinazolinesSignal TransductionTOR Serine-Threonine KinasesTreatment OutcomeVascular Endothelial Growth Factor AVascular Endothelial Growth Factor Receptor-2ConceptsNon-small cell lung cancerTyrosine kinase inhibitorsVEGFR tyrosine kinase inhibitorsNSCLC cell linesZODIAC studyClinical benefitLung cancerPlatinum-refractory non-small cell lung cancerAdvanced non-small cell lung cancerImproved progression-free survivalDifferent lung cancersObjective response rateProgression-free survivalVEGF pathway inhibitorsCell lung cancerArchival tumor samplesCell linesActivation of mTORVandetanib armOverall survivalNSCLC modelsNSCLC cellsPreclinical studiesPatientsVEGFR inhibition
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
2013
Comprehensive Biomarker Analysis and Final Efficacy Results of Sorafenib in the BATTLE Trial
Blumenschein GR, Saintigny P, Liu S, Kim ES, Tsao AS, Herbst RS, Alden C, Lee JJ, Tang X, Stewart DJ, Kies MS, Fossella FV, Tran HT, Mao L, Hicks ME, Erasmus J, Gupta S, Girard L, Peyton M, Diao L, Wang J, Davis SE, Minna JD, Wistuba I, Hong WK, Heymach JV, Lippman SM. Comprehensive Biomarker Analysis and Final Efficacy Results of Sorafenib in the BATTLE Trial. Clinical Cancer Research 2013, 19: 6967-6975. PMID: 24166906, PMCID: PMC3905243, DOI: 10.1158/1078-0432.ccr-12-1818.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerDisease control rateProgression-free survivalWild-type EGFROverall survivalClinical benefitEGFR gene copy number gainMedian progression-free survivalWild-type EGFR tumorsImproved progression-free survivalComprehensive biomarker analysisCell lung cancerGene copy number gainEGFR gene copy numberNSCLC cell linesGrowth factor-1Patient tumor biopsiesFibroblast growth factor 1Unacceptable toxicityEGFR tumorsClinical efficacyFuture trialsControl rateLung cancerEGFR mutations
2010
Future directions in multimodality therapy for NSCLC
Tsao AS, Roth JA, Herbst RS. Future directions in multimodality therapy for NSCLC. Nature Reviews Clinical Oncology 2010, 7: 10-12. PMID: 20029443, DOI: 10.1038/nrclinonc.2009.174.Peer-Reviewed Original Research
2009
Antitumor activity of cediranib in patients with metastatic or recurrent head and neck cancer (HNC) or recurrent non-small cell lung cancer (NSCLC): An open-label exploratory study
Saura C, Baselga J, Herbst R, del Campo J, Marotti M, Tessier J, Collins B, Heymach J. Antitumor activity of cediranib in patients with metastatic or recurrent head and neck cancer (HNC) or recurrent non-small cell lung cancer (NSCLC): An open-label exploratory study. Journal Of Clinical Oncology 2009, 27: 6023-6023. DOI: 10.1200/jco.2009.27.15_suppl.6023.Peer-Reviewed Original ResearchNon-small cell lung cancerFDG-PETTumor sizeCediranib monotherapyDay 22Manageable adverse event profileOpen-label exploratory studyEffects of cediranibRECIST response rateAntitumor activityCommon adverse eventsPre-treated patientsAdverse event profileCell lung cancerTumor metabolic activityPost-baseline measurementEvidence of responseEvaluable patientsRecurrent HNCUnacceptable toxicityAdverse eventsRecurrent headFDG uptakeClinical benefitEvent profile
2008
Baseline VEGF as a potential predictive biomarker of vandetanib clinical benefit in patients with advanced NSCLC
Heymach J, Hanrahan E, Mann H, Langmuir P, Natale R, Johnson B, Herbst R, Ryan A. Baseline VEGF as a potential predictive biomarker of vandetanib clinical benefit in patients with advanced NSCLC. Journal Of Clinical Oncology 2008, 26: 8009-8009. DOI: 10.1200/jco.2008.26.15_suppl.8009.Peer-Reviewed Original Research
2006
Multicenter Open-label Extension Trial of Long-term Treatment with Gefitinib (IRESSA®)
Nakagawa K, Ranson M, Yano S, Tamura T, Saka H, Imamura F, Yokoyama A, Matsui K, Jiang H, Herbst R. Multicenter Open-label Extension Trial of Long-term Treatment with Gefitinib (IRESSA®). Haigan 2006, 46: 345. DOI: 10.2482/haigan.46.345.Peer-Reviewed Original ResearchProgression-free survivalLong-term treatmentNew safety issuesExtension trialOpen-label extension trialSkin-related adverse eventsMedian overall survivalMajority of patientsLong-term safetyGefitinib monotherapyAdvanced NSCLCAdverse eventsOverall survivalParent trialClinical benefitGefitinib treatmentSafety profileClinical trialsClinical studiesPatientsGefitinibIdeal 1TrialsSafety issuesSurvival
2002
Angiogenesis inhibitors in lung cancer
Kim ES, Herbst RS. Angiogenesis inhibitors in lung cancer. Current Oncology Reports 2002, 4: 325-333. PMID: 12044242, DOI: 10.1007/s11912-002-0008-0.Peer-Reviewed Original ResearchMeSH KeywordsAngiogenesis InhibitorsAngiostatinsCarcinoma, Non-Small-Cell LungCollagenCyclohexanesEndostatinsHumansLung NeoplasmsO-(Chloroacetylcarbamoyl)fumagillolPeptide FragmentsPlasminogenReceptor Protein-Tyrosine KinasesReceptors, Growth FactorReceptors, Vascular Endothelial Growth FactorSesquiterpenesSurvival RateThalidomideConceptsLung cancerAngiogenesis inhibitorsSurvival rateMajor public health problemVascular endothelial growth factor receptorOngoing randomized studiesCell lung cancerEndothelial growth factor receptorTraditional cytotoxic therapiesCancer-related deathImproved survival ratesPublic health problemSevere side effectsInhibitors of angiogenesisEndogenous angiogenesis inhibitorGrowth factor receptorMetastatic diseaseRandomized studyChemotherapy dosesClinical benefitCytotoxic therapyCyclooxygenase inhibitorRadiation therapySide effectsHealth problems