2023
Representativeness of Patients Enrolled in the Lung Cancer Master Protocol (Lung-MAP)
Vaidya R, Unger J, Qian L, Minichiello K, Herbst R, Gandara D, Neal J, Leal T, Patel J, Dragnev K, Waqar S, Edelman M, Sigal E, Adam S, Malik S, Blanke C, LeBlanc M, Kelly K, Gray J, Redman M. Representativeness of Patients Enrolled in the Lung Cancer Master Protocol (Lung-MAP). JCO Precision Oncology 2023, 7: e2300218. PMID: 37677122, PMCID: PMC10581630, DOI: 10.1200/po.23.00218.Peer-Reviewed Original ResearchConceptsCharacteristics of patientsLung-MAPMaster protocolsNSCLC populationCell lung cancer trialsSEER registry dataPatients 65 yearsPrecision medicine clinical trialsPatient exclusion criteriaLung cancer trialsRepresentativeness of patientsMedicine clinical trialsNSCLC trialsOlder patientsMedicaid/More patientsSubgroup analysisCancer trialsClinical trialsVulnerable patientsRegistry dataExclusion criteriaPatientsNSCLC studiesSociodemographic characteristicsQuality-of-life outcomes and risk prediction for patients randomized to nivolumab plus ipilimumab vs nivolumab on LungMAP-S1400I
Unger J, Qian L, Redman M, Tavernier S, Minasian L, Sigal E, Papadimitrakopoulou V, Leblanc M, Cleeland C, Dzingle S, Summers T, Chao H, Madhusudhana S, Villaruz L, Crawford J, Gray J, Kelly K, Gandara D, Bazhenova L, Herbst R, Gettinger S, Moinpour C. Quality-of-life outcomes and risk prediction for patients randomized to nivolumab plus ipilimumab vs nivolumab on LungMAP-S1400I. Journal Of The National Cancer Institute 2023, 115: 437-446. PMID: 36625510, PMCID: PMC10086628, DOI: 10.1093/jnci/djad003.Peer-Reviewed Original ResearchConceptsQuality of lifeComposite risk modelAppetite lossSeverity scoreWeek 13Advanced squamous cell lung cancerWeek 7Baseline patient-reported outcomesRandomized phase III trialSquamous cell lung cancerPhase III trialsRisk of progressionShortness of breathCell lung cancerPatient-reported outcomesRisk of deathMultivariable linear regressionEffect of treatmentEvaluable patientsPrimary endpointIII trialsOverall survivalMedian ageAdvanced cancerPrognostic relevanceInterplay 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 carcinomaPatient Knowledge and Expectations About Return of Genomic Results in a Biomarker-Driven Master Protocol Trial (SWOG S1400GEN)
Roth JA, Trivedi MS, Gray SW, Patrick DL, Delaney DM, Watabayashi K, Litwin P, Shah P, Crew KD, Yee M, Redman MW, Unger JM, Papadimitrakopoulou V, Johnson J, Kelly K, Gandara D, Herbst RS, Hershman DL, Ramsey SD. Patient Knowledge and Expectations About Return of Genomic Results in a Biomarker-Driven Master Protocol Trial (SWOG S1400GEN). JCO Oncology Practice 2021, 17: e1821-e1829. PMID: 33797955, PMCID: PMC9810137, DOI: 10.1200/op.20.00770.Peer-Reviewed Original ResearchConceptsMaster protocolsPatient knowledgeCell lung cancerOncology clinical trialsMost participantsMaster protocol trialsMedian ageEligible participantsLung cancerLung-MAPClinical trialsOdds ratioGenomic resultsCancer riskProtocol trialSociodemographic factorsCancer treatmentPilot studyCancer diagnosisTelephone surveyRiskCorrect responsesDemographic factorsCancerDescriptive statisticsClinical 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 populationA Burned-Out CD8+ T-cell Subset Expands in the Tumor Microenvironment and Curbs Cancer Immunotherapy
Sanmamed MF, Nie X, Desai SS, Villaroel-Espindola F, Badri T, Zhao D, Kim AW, Ji L, Zhang T, Quinlan E, Cheng X, Han X, Vesely MD, Nassar AF, Sun J, Zhang Y, Kim TK, Wang J, Melero I, Herbst RS, Schalper KA, Chen L. A Burned-Out CD8+ T-cell Subset Expands in the Tumor Microenvironment and Curbs Cancer Immunotherapy. Cancer Discovery 2021, 11: 1700-1715. PMID: 33658301, PMCID: PMC9421941, DOI: 10.1158/2159-8290.cd-20-0962.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerTumor-infiltrating lymphocytesExhausted T cellsTIL subsetsTumor microenvironmentCancer immunotherapyT cellsAdvanced non-small cell lung cancerPatient-derived tumor xenograft modelAnti-PD therapyT cell subsetsCell lung cancerPotential tissue biomarkersBaseline tumor tissueLung cancer tissuesSingle-cell mass cytometryTumor xenograft modelApoptotic CD8Dysfunctional CD8Immunotherapy resistancePD-1Activation markersAdjacent nontumoral tissuesPathway-dependent mannerLung cancerPhase 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 samples