2023
Interplay of Immunosuppression and Immunotherapy Among Patients With Cancer and COVID-19
Bakouny Z, Labaki C, Grover P, Awosika J, Gulati S, Hsu C, Alimohamed S, Bashir B, Berg S, Bilen M, Bowles D, Castellano C, Desai A, Elkrief A, Eton O, Fecher L, Flora D, Galsky M, Gatti-Mays M, Gesenhues A, Glover M, Gopalakrishnan D, Gupta S, Halfdanarson T, Hayes-Lattin B, Hendawi M, Hsu E, Hwang C, Jandarov R, Jani C, Johnson D, Joshi M, Khan H, Khan S, Knox N, Koshkin V, Kulkarni A, Kwon D, Matar S, McKay R, Mishra S, Moria F, Nizam A, Nock N, Nonato T, Panasci J, Pomerantz L, Portuguese A, Provenzano D, Puc M, Rao Y, Rhodes T, Riely G, Ripp J, Rivera A, Ruiz-Garcia E, Schmidt A, Schoenfeld A, Schwartz G, Shah S, Shaya J, Subbiah S, Tachiki L, Tucker M, Valdez-Reyes M, Weissmann L, Wotman M, Wulff-Burchfield E, Xie Z, Yang Y, Thompson M, Shah D, Warner J, Shyr Y, Choueiri T, Wise-Draper T, Fromowitz A, Gandhi R, Gartrell B, Goel S, Halmos B, Makower D, O' Sullivan D, Ohri N, Portes M, Shapiro L, Shastri A, Sica R, Verma A, Butt O, Campian J, Fiala M, Henderson J, Monahan R, Stockerl-Goldstein K, Zhou A, Bitran J, Hallmeyer S, Mundt D, Pandravada S, Papaioannou P, Patel M, Streckfuss M, Tadesse E, Gatson N, Kundranda M, Lammers P, Loree J, Yu I, Bindal P, Lam B, Peters M, Piper-Vallillo A, Egan P, Farmakiotis D, Arvanitis P, Klein E, Olszewski A, Vieira K, Angevine A, Bar M, Del Prete S, Fiebach M, Gulati A, Hatton E, Houston K, Rose S, Steve Lo K, Stratton J, Weinstein P, Garcia J, Routy B, Hoyo-Ulloa I, Dawsey S, Lemmon C, Pennell N, Sharifi N, Painter C, Granada C, Hoppenot C, Li A, Bitterman D, Connors J, Demetri G, Florez (Duma) N, Freeman D, Giordano A, Morgans A, Nohria A, Saliby R, Tolaney S, Van Allen E, Xu W, Zon R, Halabi S, Zhang T, Dzimitrowicz H, Leighton J, Graber J, Grivas P, Hawley J, Loggers E, Lyman G, Lynch R, Nakasone E, Schweizer M, Vinayak S, Wagner M, Yeh A, Dansoa Y, Makary M, Manikowski J, Vadakara J, Yossef K, Beckerman J, Goyal S, Messing I, Rosenstein L, Steffes D, Alsamarai S, Clement J, Cosin J, Daher A, Dailey M, Elias R, Fein J, Hosmer W, Jayaraj A, Mather J, Menendez A, Nadkarni R, Serrano O, Yu P, Balanchivadze N, Gadgeel S, Accordino M, Bhutani D, Bodin B, Hershman D, Masson C, Alexander M, Mushtaq S, Reuben D, Bernicker E, Deeken J, Jeffords K, Shafer D, Cárdenas A, Cuervo Campos R, De-la-Rosa-Martinez D, Ramirez A, Vilar-Compte D, Gill D, Lewis M, Low C, Jones M, Mansoor A, Mashru S, Werner M, Cohen A, McWeeney S, Nemecek E, Williamson S, Peters S, Smith S, Lewis G, Zaren H, Akhtari M, Castillo D, Cortez K, Lau E, Nagaraj G, Park K, Reeves M, O'Connor T, Altman J, Gurley M, Mulcahy M, Wehbe F, Durbin E, Nelson H, Ramesh V, Sachs Z, Wilson G, Bardia A, Boland G, Gainor J, Peppercorn J, Reynolds K, Rosovsky R, Zubiri L, Bekaii-Saab T, Joyner M, Riaz I, Senefeld J, Shah S, Ayre S, Bonnen M, Mahadevan D, McKeown C, Mesa R, Ramirez A, Salazar M, Shah P, Wang C, Bouganim N, Papenburg J, Sabbah A, Tagalakis V, Vinh D, Nanchal R, Singh H, Bahadur N, Bao T, Belenkaya R, Nambiar P, O’Cearbhaill R, Papadopoulos E, Philip J, Robson M, Rosenberg J, Wilkins C, Tamimi R, Cerrone K, Dill J, Faller B, Alomar M, Chandrasekhar S, Hume E, Islam J, Ajmera A, Brouha S, Cabal A, Choi S, Hsiao A, Jiang J, Kligerman S, Park J, Razavi P, Reid E, Bhatt P, Mariano M, Thomson C, Glace M, Knoble J, Rink C, Zacks R, Blau S, Brown C, Cantrell A, Namburi S, Polimera H, Rovito M, Edwin N, Herz K, Kennecke H, Monfared A, Sautter R, Cronin T, Elshoury A, Fleissner B, Griffiths E, Hernandez-Ilizaliturri F, Jain P, Kariapper A, Levine E, Moffitt M, O'Connor T, Smith L, Wicher C, Zsiros E, Jabbour S, Misdary C, Shah M, Batist G, Cook E, Ferrario C, Lau S, Miller W, Rudski L, Santos Dutra M, Wilchesky M, Mahmood S, McNair C, Mico V, Dixon B, Kloecker G, Logan B, Mandapakala C, Cabebe E, Jha A, Khaki A, Nagpal S, Schapira L, Wu J, Whaley D, Lopes G, de Cardenas K, Russell K, Stith B, Taylor S, Klamerus J, Revankar S, Addison D, Chen J, Haynam M, Jhawar S, Karivedu V, Palmer J, Pillainayagam C, Stover D, Wall S, Williams N, Abbasi S, Annis S, Balmaceda N, Greenland S, Kasi A, Rock C, Luders M, Smits M, Weiss M, Chism D, Owenby S, Ang C, Doroshow D, Metzger M, Berenberg J, Uyehara C, Fazio A, Huber K, Lashley L, Sueyoshi M, Patel K, Riess J, Borno H, Small E, Zhang S, Andermann T, Jensen C, Rubinstein S, Wood W, Ahmad S, Brownfield L, Heilman H, Kharofa J, Latif T, Marcum M, Shaikh H, Sohal D, Abidi M, Geiger C, Markham M, Russ A, Saker H, Acoba J, Choi H, Rho Y, Feldman L, Gantt G, Hoskins K, Khan M, Liu L, Nguyen R, Pasquinelli M, Schwartz C, Venepalli N, Vikas P, Zakharia Y, Friese C, Boldt A, Gonzalez C, Su C, Su C, Yoon J, Bijjula R, Mavromatis B, Seletyn M, Wood B, Zaman Q, Kaklamani V, Beeghly A, Brown A, Charles L, Cheng A, Crispens M, Croessmann S, Davis E, Ding T, Duda S, Enriquez K, French B, Gillaspie E, Hausrath D, Hennessy C, Lewis J, Li X, Prescott L, Reid S, Saif S, Slosky D, Solorzano C, Sun T, Vega-Luna K, Wang L, Aboulafia D, Carducci T, Goldsmith K, Van Loon S, Topaloglu U, Moore J, Rice R, Cabalona W, Cyr S, Barrow McCollough B, Peddi P, Rosen L, Ravindranathan D, Hafez N, Herbst R, LoRusso P, Lustberg M, Masters T, Stratton C. Interplay of Immunosuppression and Immunotherapy Among Patients With Cancer and COVID-19. JAMA Oncology 2023, 9: 128-134. PMID: 36326731, PMCID: PMC9634600, DOI: 10.1001/jamaoncol.2022.5357.Peer-Reviewed Original ResearchConceptsCOVID-19 severitySystemic anticancer therapyWorse COVID-19 severityCytokine stormBaseline immunosuppressionCohort studyAnticancer therapyCOVID-19Registry-based retrospective cohort studyIntensive care unit admissionCare unit admissionRetrospective cohort studyMulti-institutional registryLaboratory-confirmed infectionSevere clinical outcomesImmune system activationSARS-CoV-2Non-Hispanic whitesCOVID-19 diagnosisIO therapyPrevious cancerUnit admissionSecondary outcomesMedian agePrimary outcome
2022
Assessment of Regional Variability in COVID-19 Outcomes Among Patients With Cancer in the United States
Hawley J, Sun T, Chism D, Duma N, Fu J, Gatson N, Mishra S, Nguyen R, Reid S, Serrano O, Singh S, Venepalli N, Bakouny Z, Bashir B, Bilen M, Caimi P, Choueiri T, Dawsey S, Fecher L, Flora D, Friese C, Glover M, Gonzalez C, Goyal S, Halfdanarson T, Hershman D, Khan H, Labaki C, Lewis M, McKay R, Messing I, Pennell N, Puc M, Ravindranathan D, Rhodes T, Rivera A, Roller J, Schwartz G, Shah S, Shaya J, Streckfuss M, Thompson M, Wulff-Burchfield E, Xie Z, Yu P, Warner J, Shah D, French B, Hwang C, Halmos B, Verma A, Gartrell B, Goel S, Ohri N, Sica R, Thakkar A, Stockerl-Goldstein K, Butt O, Campian J, Fiala M, Henderson J, Monahan R, Zhou A, Thompson M, Bohachek P, Mundt D, Streckfuss M, Tadesse E, Lammers P, Panagiotou O, Egan P, Farmakiotis D, Khan H, Olszewski A, Loaiza-Bonilla A, Del Prete S, Bar M, Gulati A, Steve Lo K, Rose S, Stratton J, Weinstein P, Caimi P, Barnholtz-Sloan J, Garcia J, Nakayama J, Gupta S, Pennell N, Ahluwalia M, Dawsey S, Lemmon C, Nizam A, Hoppenot C, Li A, Choueiri T, Bakouny Z, Bouchard G, Busser F, Connors J, Curran C, Demetri G, Giordano A, Kelleher K, Nohria A, Schmidt A, Shaw G, Van Allen E, Nuzzo P, Xu V, Zon R, Zhang T, Halabi S, Leighton J, Lyman G, Graber J, Grivas P, Khaki A, Loggers E, Lynch R, Nakasone E, Schweizer M, Tachiki L, Vinayak S, Wagner M, Yeh A, Gatson N, Goyal S, Huynh-Le M, Rosenstein L, Yu P, Clement J, Daher A, Dailey M, Elias R, Jayaraj A, Hsu E, Menendez A, Rathmann J, Serrano O, Hwang C, Gadgeel S, Singh S, Hawley J, Hershman D, Accordino M, Bhutani D, Schwartz G, Reuben D, Alexander M, Mushtaq S, Bernicker E, Deeken J, Shafer D, Lewis M, Rhodes T, Gill D, Low C, Mashru S, Mansoor A, Zaren H, Smith S, Nagaraj G, Akhtari M, Lau E, Reeves M, Berg S, Elms D, Morgans A, Wehbe F, Altman J, Gurley M, Mulcahy M, Durbin E, Kulkarni A, Nelson H, Sachs Z, Shah S, Rosovsky R, Reynolds K, Bardia A, Boland G, Gainor J, Zubiri L, Halfdanarson T, Bekaii-Saab T, Desai A, Xie Z, Mesa R, Bonnen M, Mahadevan D, Ramirez A, Salazar M, Shah D, Shah P, Faller B, McKay R, Ajmera A, Brouha S, Cabal A, Hsiao A, Kligerman S, Shaya J, Weissmann L, Jani C, Thomson C, Knoble J, Glace M, Rink C, Stauffer K, Zacks R, Blau S, Joshi M, Menon H, Rovito M, Griffiths E, Elshoury A, Jabbour S, Misdary C, Shah M, Bashir B, McNair C, Mahmood S, Mico V, Rivera A, Flora D, Logan B, Kloecker G, Mandapakala C, Shah S, Cabebe E, Glover M, Jha A, Schapira L, Wu J, Subbiah S, Lopes G, Revankar S, Stover D, Addison D, Chen J, Gatti-Mays M, Jhawar S, Karivedu V, Lustberg M, Palmer J, Wall S, Williams N, Wulff-Burchfield E, Kasi A, Edwin N, Smits M, Chism D, Owenby S, Doroshow D, Galsky M, Wotman M, Zhu H, Fu J, Fazio A, Sueyoshi M, Huber K, Riess J, Patel K, Rubinstein S, Wood W, Jensen C, Kumar V, Wise-Draper T, Ahmad S, Grover P, Gulati S, Kharofa J, Latif T, Marcum M, Park C, Shaikh H, Bowles D, Geiger C, Markham M, Bishnoi R, Russ A, Shah C, Acoba J, Rho Y, Feldman L, Hoskins K, Gantt G, Liu L, Khan M, Nguyen R, Pasquinelli M, Schwartz C, Venepalli N, Vikas P, Friese C, Fecher L, Mavromatis B, Bijjula R, Zaman Q, Warner J, Cheng A, Davis E, Duda S, Enriquez K, French B, Gillaspie E, Hennessy C, Hausrath D, Hsu C, Johnson D, Li X, Mishra S, Reid S, Rini B, Slosky D, Shyr Y, Solorzano C, Sun T, Tucker M, Vega-Luna K, Wang L, Kennecke H, Aboulafia D, Schroeder B, Puc M, Carducci T, Goldsmith K, Van Loon S, Topaloglu U, Alimohamed S, Rice R, Cabalona W, Pilar C, Peddi P, Rosen L, McCollough B, Bilen M, Ravindranathan D, Hafez N, Herbst R, LoRusso P, Masters T, Stratton C. Assessment of Regional Variability in COVID-19 Outcomes Among Patients With Cancer in the United States. JAMA Network Open 2022, 5: e2142046. PMID: 34982158, PMCID: PMC8728628, DOI: 10.1001/jamanetworkopen.2021.42046.Peer-Reviewed Original ResearchMeSH KeywordsAgedCause of DeathCensusesCOVID-19FemaleHealth FacilitiesHumansIntensive Care UnitsMaleMiddle AgedNeoplasmsOdds RatioPandemicsRegistriesRespiration, ArtificialRetrospective StudiesRisk FactorsRural PopulationSARS-CoV-2Severity of Illness IndexSocial VulnerabilitySpatial AnalysisUnited StatesUrban PopulationConceptsCOVID-19 outcomesRural-Urban Continuum CodesCohort studyLaboratory-confirmed SARS-CoV-2 infectionMortality rateUS census divisionsRegistry-based retrospective cohort studyIntensive care unit admissionRegistry-based cohort studySARS-CoV-2 infectionPatient-level risk factorsSecondary composite outcomeCare unit admissionRetrospective cohort studyCare of patientsCensus divisionsInvasive malignant neoplasmCOVID-19Significant differencesCOVID-19 diagnosisCause deathUnit admissionCause mortalityComposite outcomePatient characteristics
2021
EGFR High Copy Number Together With High EGFR Protein Expression Predicts Improved Outcome for Cetuximab-based Therapy in Squamous Cell Lung Cancer: Analysis From SWOG S0819, a Phase III Trial of Chemotherapy With or Without Cetuximab in Advanced NSCLC
Hirsch FR, Redman MW, Moon J, Agustoni F, Herbst RS, Semrad TJ, Varella-Garcia M, Rivard CJ, Kelly K, Gandara DR, Mack PC. EGFR High Copy Number Together With High EGFR Protein Expression Predicts Improved Outcome for Cetuximab-based Therapy in Squamous Cell Lung Cancer: Analysis From SWOG S0819, a Phase III Trial of Chemotherapy With or Without Cetuximab in Advanced NSCLC. Clinical Lung Cancer 2021, 23: 60-71. PMID: 34753703, PMCID: PMC8766941, DOI: 10.1016/j.cllc.2021.10.002.Peer-Reviewed Original ResearchConceptsSquamous cell carcinomaKRAS mutation statusAddition of cetuximabEGFR IHCMutation statusEGFR FISHAdvanced NSCLCSquamous cell lung cancerCetuximab-based therapyFirst-line chemotherapyPhase III trialsEGFR antibody therapyCell lung cancerImproved OSNon-SCCEGFR FISH statusEligible patientsOS benefitSCC patientsIII trialsKRAS statusCell carcinomaLung cancerSubgroup analysisExpression predictsPhase II study of durvalumab plus tremelimumab as therapy for patients with previously treated anti-PD-1/PD-L1 resistant stage IV squamous cell lung cancer (Lung-MAP substudy S1400F, NCT03373760)
Leighl NB, Redman MW, Rizvi N, Hirsch FR, Mack PC, Schwartz LH, Wade JL, Irvin WJ, Reddy SC, Crawford J, Bradley JD, Stinchcombe TE, Ramalingam SS, Miao J, Minichiello K, Herbst RS, Papadimitrakopoulou VA, Kelly K, Gandara DR. Phase II study of durvalumab plus tremelimumab as therapy for patients with previously treated anti-PD-1/PD-L1 resistant stage IV squamous cell lung cancer (Lung-MAP substudy S1400F, NCT03373760). Journal For ImmunoTherapy Of Cancer 2021, 9: e002973. PMID: 34429332, PMCID: PMC8386207, DOI: 10.1136/jitc-2021-002973.Peer-Reviewed Original ResearchConceptsDisease progressionAnti-programmed death ligand 1 therapyStage IV squamous cell lung cancerPrior anti-PD-1 therapyResponse rateAnti-PD-1 therapyDeath ligand 1 therapyMedian progression-free survivalSquamous cell lung cancerObjective response ratePhase II studyProgression-free survivalCell lung cancerSquamous lung carcinomaDurvalumab 1500Eligible patientsImmunotherapy combinationsPrimary endpointAdverse eventsII studyOverall survivalPartial responseTRIAL REGISTRATIONLung cancerLung carcinomaClinical characteristics and outcomes for 7,995 patients with SARS-CoV-2 infection
McPadden J, Warner F, Young HP, Hurley NC, Pulk RA, Singh A, Durant TJS, Gong G, Desai N, Haimovich A, Taylor RA, Gunel M, Dela Cruz CS, Farhadian SF, Siner J, Villanueva M, Churchwell K, Hsiao A, Torre CJ, Velazquez EJ, Herbst RS, Iwasaki A, Ko AI, Mortazavi BJ, Krumholz HM, Schulz WL. Clinical characteristics and outcomes for 7,995 patients with SARS-CoV-2 infection. PLOS ONE 2021, 16: e0243291. PMID: 33788846, PMCID: PMC8011821, DOI: 10.1371/journal.pone.0243291.Peer-Reviewed Original ResearchConceptsSARS-CoV-2 infectionYale New Haven HealthSARS-CoV-2Hospital mortalityRisk of admissionMale sexRisk factorsSARS-CoV-2 testingInvasive mechanical ventilationSevere acute respiratory syndrome virusBurden of diseaseRT-PCR testingAcademic health systemDiverse patient populationsRespiratory syndrome virusEthnic groupsAdult patientsClinical characteristicsDischarge dispositionRespiratory supportPrimary outcomeTreatment guidelinesMechanical ventilationRetrospective studyPatient populationPhase 2 Study of Talazoparib in Patients With Homologous Recombination Repair–Deficient Squamous Cell Lung Cancer: Lung-MAP Substudy S1400G
Owonikoko TK, Redman MW, Byers LA, Hirsch FR, Mack PC, Schwartz LH, Bradley JD, Stinchcombe TE, Leighl NB, Al Baghdadi T, Lara P, Miao J, Kelly K, Ramalingam SS, Herbst RS, Papadimitrakopoulou V, Gandara DR. Phase 2 Study of Talazoparib in Patients With Homologous Recombination Repair–Deficient Squamous Cell Lung Cancer: Lung-MAP Substudy S1400G. Clinical Lung Cancer 2021, 22: 187-194.e1. PMID: 33583720, PMCID: PMC8637652, DOI: 10.1016/j.cllc.2021.01.001.Peer-Reviewed Original ResearchConceptsPrimary analysis populationOverall response rateSquamous cell lung cancerDisease control rateCell lung cancerHomologous recombination repair deficiencyLung cancerOverall survivalControl rateMedian progression-free survivalHomologous recombination repair genesSingle-agent talazoparibPhase 2 studyProgression-free survivalRepair deficiencySquamous lung cancerRecombination repair genesMedian durationMedian ageAnalysis populationEligible populationResponse ratePatientsPARP inhibitorsFinding study
2020
SWOG S1400A (NCT02154490): A Phase II Study of Durvalumab for Patients With Previously Treated Stage IV or Recurrent Squamous Cell Lung Cancer (Lung-MAP Sub-study)
Borghaei H, Redman MW, Kelly K, Waqar SN, Robert F, Kiefer GJ, Stella PJ, Minichiello K, Gandara DR, Herbst RS, Papadimitrakopoulou VA. SWOG S1400A (NCT02154490): A Phase II Study of Durvalumab for Patients With Previously Treated Stage IV or Recurrent Squamous Cell Lung Cancer (Lung-MAP Sub-study). Clinical Lung Cancer 2020, 22: 178-186. PMID: 33358401, PMCID: PMC8686189, DOI: 10.1016/j.cllc.2020.10.015.Peer-Reviewed Original ResearchConceptsDisease control rateMedian overall survivalProgression-free survivalCell lung cancerAdverse eventsOverall survivalControl rateLung cancerRecurrent squamous cell lung cancerPhase II/III trialsDrug-related adverse eventsMedian progression-free survivalPrior platinum-based chemotherapyTreatment-related adverse eventsSquamous cell lung cancerPD-L1 dataPhase II studyPhase II trialPD-L1 antibodiesPlatinum-based chemotherapySingle-agent activityEvaluable patientsII trialPrimary endpointII studyBiomarker-driven therapies for previously treated squamous non-small-cell lung cancer (Lung-MAP SWOG S1400): a biomarker-driven master protocol
Redman MW, Papadimitrakopoulou VA, Minichiello K, Hirsch FR, Mack PC, Schwartz LH, Vokes E, Ramalingam S, Leighl N, Bradley J, Miao J, Moon J, Highleyman L, Miwa C, LeBlanc ML, Malik S, Miller VA, Sigal EV, Adam S, Wholley D, Sigman C, Smolich B, Blanke CD, Kelly K, Gandara DR, Herbst RS. Biomarker-driven therapies for previously treated squamous non-small-cell lung cancer (Lung-MAP SWOG S1400): a biomarker-driven master protocol. The Lancet Oncology 2020, 21: 1589-1601. PMID: 33125909, PMCID: PMC8109255, DOI: 10.1016/s1470-2045(20)30475-7.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overBiomarkers, TumorCarcinoma, Non-Small-Cell LungCarcinoma, Squamous CellClinical Decision-MakingDisease ProgressionFemaleHigh-Throughput Nucleotide SequencingHumansLung NeoplasmsMaleMiddle AgedMolecular Targeted TherapyNeoplasm Recurrence, LocalNeoplasm StagingPrecision MedicinePredictive Value of TestsProgression-Free SurvivalTime FactorsYoung AdultConceptsCell lung cancerNational Cancer InstituteTargeted therapy groupLung cancerLung-MAPMaster protocolsDocetaxel groupTherapy groupEastern Cooperative Oncology Group performance statusUnmet needMedian progression-free survivalNational Clinical Trials NetworkMedian overall survivalAdvanced lung cancerProgression-free survivalPlatinum-based chemotherapyClinical Trials NetworkNational InstituteClinical trial componentUS National Cancer InstituteNew screening protocolBristol-Myers SquibbAdditional substudyEligible patientsImmunotherapy combinationsThe value of interventional radiology in clinical trial teams: experience from the BATTLE lung cancer trials
Tam AL, Papadimitrakopoulou V, Wistuba II, Lee JJ, Ensor JE, Kim ES, Kalhor N, Blumenschein GR, Tsao AS, Heymach JV, Herbst RS, Hicks ME, Hong WK, Gupta S. The value of interventional radiology in clinical trial teams: experience from the BATTLE lung cancer trials. Clinical Radiology 2020, 76: 155.e25-155.e34. PMID: 33268083, DOI: 10.1016/j.crad.2020.09.024.Peer-Reviewed Original ResearchConceptsInterventional radiologistsClinical trial teamsTrial teamPercutaneous image-guided biopsyLung Cancer EliminationLung cancer trialsEvidence of viabilityImage-guided biopsyLesion scoring systemBiomarker analysisCancer trialsTargeted therapyCancer eliminationScore's abilityInterventional radiologyMultivariate analysisLesionsBiopsySolid massFollowing criteriaModerate agreementMultidisciplinary approachTrialsScoresBiomarkersA Phase II Study of Telisotuzumab Vedotin in Patients With c–MET-positive Stage IV or Recurrent Squamous Cell Lung Cancer (LUNG-MAP Sub-study S1400K, NCT03574753)
Waqar SN, Redman MW, Arnold SM, Hirsch FR, Mack PC, Schwartz LH, Gandara DR, Stinchcombe TE, Leighl NB, Ramalingam SS, Tanna SH, Raddin RS, Minichiello K, Bradley JD, Kelly K, Herbst RS, Papadimitrakopoulou VA. A Phase II Study of Telisotuzumab Vedotin in Patients With c–MET-positive Stage IV or Recurrent Squamous Cell Lung Cancer (LUNG-MAP Sub-study S1400K, NCT03574753). Clinical Lung Cancer 2020, 22: 170-177. PMID: 33221175, PMCID: PMC8044254, DOI: 10.1016/j.cllc.2020.09.013.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overAntibodies, MonoclonalAntineoplastic AgentsCarcinoma, Non-Small-Cell LungCarcinoma, Squamous CellCohort StudiesFemaleHumansLung NeoplasmsMaleMiddle AgedNeoplasm Recurrence, LocalNeoplasm StagingPneumoniaProgression-Free SurvivalProto-Oncogene Proteins c-metSurvival RateTreatment OutcomeConceptsSquamous cell carcinomaProgression-free survivalTelisotuzumab vedotinCohort 1Recurrent squamous cell lung cancerSquamous cell lung cancerGrade 5 eventsMET-positive tumorsSolid Tumors v1.1Disease control ratePhase II studyResponse Evaluation CriteriaCell lung cancerDuration of responseLack of efficacyEvaluable patientsStable diseasePrimary endpointSecondary endpointsUnacceptable toxicityII studyOverall survivalCell carcinomaControl rateLung cancerRandomized Trial of Afatinib Plus Cetuximab Versus Afatinib Alone for First-Line Treatment of EGFR-Mutant Non-Small-Cell Lung Cancer: Final Results From SWOG S1403.
Goldberg SB, Redman MW, Lilenbaum R, Politi K, Stinchcombe TE, Horn L, Chen EH, Mashru SH, Gettinger SN, Melnick MA, Herbst RS, Baumgart MA, Miao J, Moon J, Kelly K, Gandara DR. Randomized Trial of Afatinib Plus Cetuximab Versus Afatinib Alone for First-Line Treatment of EGFR-Mutant Non-Small-Cell Lung Cancer: Final Results From SWOG S1403. Journal Of Clinical Oncology 2020, 38: 4076-4085. PMID: 33021871, PMCID: PMC7768342, DOI: 10.1200/jco.20.01149.Peer-Reviewed Original ResearchConceptsProgression-free survivalLung cancerMutant NSCLCEGFR monoclonal antibody cetuximabSmall cell lung cancerAddition of cetuximabPrimary end pointTyrosine kinase inhibitor afatinibCell lung cancerEGFR-Mutant NonCombination of afatinibMonoclonal antibody cetuximabAdvanced diseaseAdverse eventsOverall survivalMulticenter trialLine treatmentEGFR-TKIAntibody cetuximabDose reductionInhibitor afatinibInterim analysisCetuximabInsufficient evidencePatientsAtezolizumab for First-Line Treatment of PD-L1–Selected Patients with NSCLC
Herbst RS, Giaccone G, de Marinis F, Reinmuth N, Vergnenegre A, Barrios CH, Morise M, Felip E, Andric Z, Geater S, Özgüroğlu M, Zou W, Sandler A, Enquist I, Komatsubara K, Deng Y, Kuriki H, Wen X, McCleland M, Mocci S, Jassem J, Spigel DR. Atezolizumab for First-Line Treatment of PD-L1–Selected Patients with NSCLC. New England Journal Of Medicine 2020, 383: 1328-1339. PMID: 32997907, DOI: 10.1056/nejmoa1917346.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsB7-H1 AntigenCarboplatinCarcinoma, Non-Small-Cell LungCarcinoma, Squamous CellCisplatinDeoxycytidineFemaleGemcitabineHumansLung NeoplasmsMaleMiddle AgedMutationSurvival AnalysisConceptsPD-L1 expressionBlood-based tumor mutational burdenProgression-free survivalPlatinum-based chemotherapyTumor mutational burdenOverall survivalWild-type tumorsAtezolizumab groupChemotherapy groupAdverse eventsPD-L1Mutational burdenHigh PD-L1 expressionPD-L1 expression statusTumor-infiltrating immune cellsMedian overall survivalFirst-line treatmentPD-L1 assaysPhase 3 trialLonger overall survivalSubgroup of patientsCell lung cancerAtezolizumab treatmentSquamous NSCLCTreat populationOsimertinib in Resected EGFR-Mutated Non–Small-Cell Lung Cancer
Wu YL, Tsuboi M, He J, John T, Grohe C, Majem M, Goldman JW, Laktionov K, Kim SW, Kato T, Vu HV, Lu S, Lee KY, Akewanlop C, Yu CJ, de Marinis F, Bonanno L, Domine M, Shepherd FA, Zeng L, Hodge R, Atasoy A, Rukazenkov Y, Herbst RS. Osimertinib in Resected EGFR-Mutated Non–Small-Cell Lung Cancer. New England Journal Of Medicine 2020, 383: 1711-1723. PMID: 32955177, DOI: 10.1056/nejmoa2027071.Peer-Reviewed Original ResearchMeSH KeywordsAcrylamidesAdultAgedAged, 80 and overAniline CompoundsAntineoplastic AgentsCarcinoma, Non-Small-Cell LungChemotherapy, AdjuvantDisease-Free SurvivalDouble-Blind MethodErbB ReceptorsFemaleHumansLung NeoplasmsLymphatic MetastasisMaleMiddle AgedMutationNeoplasm Recurrence, LocalNeoplasm StagingPneumonectomyProtein Kinase InhibitorsConceptsDisease-free survivalMutation-positive NSCLCIIIA diseasePlacebo groupOsimertinib groupStage IBLung cancerUntreated epidermal growth factor receptorNon-small cell lung cancerOverall populationStage IIEnd pointCentral nervous system diseaseSafety of osimertinibPrimary end pointSecondary end pointsPhase 3 trialOverall survival dataCell lung cancerNew safety concernsNervous system diseasesEpidermal growth factor receptorGrowth factor receptorAdjuvant therapyOverall survivalBiomarkers Associated with Beneficial PD-1 Checkpoint Blockade in Non–Small Cell Lung Cancer (NSCLC) Identified Using High-Plex Digital Spatial Profiling
Zugazagoitia J, Gupta S, Liu Y, Fuhrman K, Gettinger S, Herbst RS, Schalper KA, Rimm DL. Biomarkers Associated with Beneficial PD-1 Checkpoint Blockade in Non–Small Cell Lung Cancer (NSCLC) Identified Using High-Plex Digital Spatial Profiling. Clinical Cancer Research 2020, 26: 4360-4368. PMID: 32253229, PMCID: PMC7442721, DOI: 10.1158/1078-0432.ccr-20-0175.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerPD-1 checkpoint blockadeCell lung cancerCheckpoint blockadeLung cancerAdvanced non-small cell lung cancerUnivariate unadjusted analysisProgression-free survivalImmune cell countsMinority of patientsRobust predictive biomarkersBiomarkers of responseLarge independent cohortsSpatial profiling technologyDigital spatial profilingDigital spatial profiling (DSP) technologyOverall survivalClinical outcomesImmune predictorsHigher CD56NSCLC casesPredictive biomarkersUnadjusted analysesImmune parametersTissue microarrayLongitudinal analyses reveal immunological misfiring in severe COVID-19
Lucas C, Wong P, Klein J, Castro TBR, Silva J, Sundaram M, Ellingson MK, Mao T, Oh JE, Israelow B, Takahashi T, Tokuyama M, Lu P, Venkataraman A, Park A, Mohanty S, Wang H, Wyllie AL, Vogels CBF, Earnest R, Lapidus S, Ott IM, Moore AJ, Muenker MC, Fournier JB, Campbell M, Odio CD, Casanovas-Massana A, Herbst R, Shaw A, Medzhitov R, Schulz W, Grubaugh N, Dela Cruz C, Farhadian S, Ko A, Omer S, Iwasaki A. Longitudinal analyses reveal immunological misfiring in severe COVID-19. Nature 2020, 584: 463-469. PMID: 32717743, PMCID: PMC7477538, DOI: 10.1038/s41586-020-2588-y.Peer-Reviewed Original ResearchConceptsSevere COVID-19Moderate COVID-19Immune signaturesDisease outcomeCOVID-19Disease trajectoriesInterleukin-5Early immune signaturesInnate cell lineagesType 2 effectorsT cell numbersPoor clinical outcomeWorse disease outcomesImmune response profileCoronavirus disease 2019Distinct disease trajectoriesCytokine levelsImmunological correlatesImmune profileClinical outcomesEarly elevationImmune profilingIL-13Immunoglobulin EDisease 2019Chemoradiotherapy efficacy is predicted by intra-tumour CD8+/FoxP3+ double positive T cell density in locally advanced N2 non–small-cell lung carcinoma
Boulle G, Velut Y, Mansuet-Lupo A, Gibault L, Blons H, Fournel L, Boni A, Cremer I, Wislez M, Duchatelle V, Trédaniel J, Hammond S, Herbst R, Alifano M, Giraud P, Damotte D. Chemoradiotherapy efficacy is predicted by intra-tumour CD8+/FoxP3+ double positive T cell density in locally advanced N2 non–small-cell lung carcinoma. European Journal Of Cancer 2020, 135: 221-229. PMID: 32610210, DOI: 10.1016/j.ejca.2020.04.040.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overB7-H1 AntigenCarcinoma, Non-Small-Cell LungCD8-Positive T-LymphocytesChemoradiotherapyChemoradiotherapy, AdjuvantFemaleForkhead Transcription FactorsHumansLung NeoplasmsLymphocytes, Tumor-InfiltratingMaleMiddle AgedNeoplasm StagingRetrospective StudiesTime FactorsTreatment OutcomeTumor MicroenvironmentConceptsT-cell densityCell lung carcinomaN2 NSCLCPatient survivalLung carcinomaClinical dataT cellsRadiotherapy efficacyIII-N2 NSCLCSurgery/chemotherapyPD-L1 expressionStandard of careImmunogenic cell deathDouble-positive cellsAction of radiotherapyIII-N2Immune environmentAbscopal effectChemoradiotherapy efficacyImmune infiltrationImmune cellsPositive cellsMultivariate analysisRadiotherapyTumor samplesPembrolizumab for management of patients with NSCLC and brain metastases: long-term results and biomarker analysis from a non-randomised, open-label, phase 2 trial
Goldberg SB, Schalper KA, Gettinger SN, Mahajan A, Herbst RS, Chiang AC, Lilenbaum R, Wilson FH, Omay SB, Yu JB, Jilaveanu L, Tran T, Pavlik K, Rowen E, Gerrish H, Komlo A, Gupta R, Wyatt H, Ribeiro M, Kluger Y, Zhou G, Wei W, Chiang VL, Kluger HM. Pembrolizumab for management of patients with NSCLC and brain metastases: long-term results and biomarker analysis from a non-randomised, open-label, phase 2 trial. The Lancet Oncology 2020, 21: 655-663. PMID: 32251621, PMCID: PMC7380514, DOI: 10.1016/s1470-2045(20)30111-x.Peer-Reviewed Original ResearchConceptsBrain metastasis responseYale Cancer CenterPD-L1 expressionPhase 2 trialUntreated brain metastasesBrain metastasesAdrenal insufficiencyAdverse eventsMetastasis responseCNS diseaseCancer CenterCohort 2Cohort 1Eastern Cooperative Oncology Group performance statusTreatment-related serious adverse eventsModified Response Evaluation CriteriaStage IV NSCLCTreatment-related deathsAcute kidney injuryPD-1 blockadeSerious adverse eventsSolid Tumors criteriaPhase 2 studyProportion of patientsResponse Evaluation CriteriaComprehensive T cell repertoire characterization of non-small cell lung cancer
Reuben A, Zhang J, Chiou SH, Gittelman RM, Li J, Lee WC, Fujimoto J, Behrens C, Liu X, Wang F, Quek K, Wang C, Kheradmand F, Chen R, Chow CW, Lin H, Bernatchez C, Jalali A, Hu X, Wu CJ, Eterovic AK, Parra ER, Yusko E, Emerson R, Benzeno S, Vignali M, Wu X, Ye Y, Little LD, Gumbs C, Mao X, Song X, Tippen S, Thornton RL, Cascone T, Snyder A, Wargo JA, Herbst R, Swisher S, Kadara H, Moran C, Kalhor N, Zhang J, Scheet P, Vaporciyan AA, Sepesi B, Gibbons DL, Robins H, Hwu P, Heymach JV, Sharma P, Allison JP, Baladandayuthapani V, Lee JJ, Davis MM, Wistuba II, Futreal PA, Zhang J. Comprehensive T cell repertoire characterization of non-small cell lung cancer. Nature Communications 2020, 11: 603. PMID: 32001676, PMCID: PMC6992630, DOI: 10.1038/s41467-019-14273-0.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerCell lung cancerT cellsLung cancerAdoptive T-cell therapyEarly-stage NSCLC patientsT cell repertoire analysisT cell responsesLungs of patientsT-cell therapyNSCLC patientsInferior survivalClinicopathologic featuresImmune landscapeViral infectionSolid tumorsTherapeutic efficacyCell responsesCell therapyPatientsRepertoire analysisLungTumorsImmunotherapyConsiderable proportion
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 trialsRamucirumab plus pembrolizumab in patients with previously treated advanced non-small-cell lung cancer, gastro-oesophageal cancer, or urothelial carcinomas (JVDF): a multicohort, non-randomised, open-label, phase 1a/b trial
Herbst RS, Arkenau HT, Santana-Davila R, Calvo E, Paz-Ares L, Cassier PA, Bendell J, Penel N, Krebs MG, Martin-Liberal J, Isambert N, Soriano A, Wermke M, Cultrera J, Gao L, Widau RC, Mi G, Jin J, Ferry D, Fuchs CS, Petrylak DP, Chau I. Ramucirumab plus pembrolizumab in patients with previously treated advanced non-small-cell lung cancer, gastro-oesophageal cancer, or urothelial carcinomas (JVDF): a multicohort, non-randomised, open-label, phase 1a/b trial. The Lancet Oncology 2019, 20: 1109-1123. PMID: 31301962, DOI: 10.1016/s1470-2045(19)30458-9.Peer-Reviewed Original ResearchMeSH KeywordsAdenocarcinomaAgedAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Non-Small-Cell LungCarcinoma, Transitional CellDose-Response Relationship, DrugEsophageal NeoplasmsFemaleHumansLung NeoplasmsMaleMiddle AgedStomach NeoplasmsConceptsGastro-oesophageal junction adenocarcinomaTreatment-related adverse eventsCell lung cancerPhase 1a/b trialSerious adverse eventsDose-limiting toxicityAdverse eventsJunction adenocarcinomaUrothelial carcinomaLung cancerDay 1VEGF receptor 2Abdominal painPrevious therapyAdvanced gastricEastern Cooperative Oncology Group performance statusAntigen-specific T-cell migrationMore treatment-related adverse eventsTreatment-related serious adverse eventsAdditional dose-limiting toxicitiesCell lung cancer cohortGrade 3 abdominal painSingle-agent checkpoint inhibitorsB trialAntitumour activity