2024
Lifileucel, an Autologous Tumor-infiltrating Lymphocyte Monotherapy, in Patients with Advanced Non-small Cell Lung Cancer Resistant to Immune Checkpoint Inhibitors
Schoenfeld A, Lee S, de Speville B, Gettinger S, Hafliger S, Sukari A, Papa S, Rodriguez-Moreno J, Finckenstein F, Fiaz R, Catlett M, Chen G, Qi R, Masteller E, Gontcharova V, He K. Lifileucel, an Autologous Tumor-infiltrating Lymphocyte Monotherapy, in Patients with Advanced Non-small Cell Lung Cancer Resistant to Immune Checkpoint Inhibitors. Cancer Discovery 2024, 14: 1389-1402. PMID: 38563600, PMCID: PMC11294887, DOI: 10.1158/2159-8290.cd-23-1334.Peer-Reviewed Original ResearchMetastatic non-small cell lung cancerAdverse eventsResistance to immune checkpoint inhibitorsPD-L1-negative tumorsPhase 2 multicenter studyLow tumor mutational burdenTreatment-emergent adverse eventsNon-small cell lung cancerTime of data cutoffRefractory to prior therapyPD-L1-negativeImmune checkpoint inhibitorsResistance to immunotherapyTumor mutational burdenCell lung cancerMultiple organ failurePotential treatment optionCheckpoint inhibitorsPrior therapyData cutoffPatient diedSystemic therapyMutational burdenSTK11 mutationsCardiac failure
2023
Safety and clinical activity of atezolizumab plus erlotinib in patients with non-small-cell lung cancer
Rudin C, Cervantes A, Dowlati A, Besse B, Ma B, Costa D, Schmid P, Heist R, Villaflor V, Spahn J, Li S, Cha E, Riely G, Gettinger S. Safety and clinical activity of atezolizumab plus erlotinib in patients with non-small-cell lung cancer. ESMO Open 2023, 8: 101160. PMID: 36871392, PMCID: PMC10163154, DOI: 10.1016/j.esmoop.2023.101160.Peer-Reviewed Original ResearchConceptsTreatment-related adverse eventsCell lung cancerAdverse eventsLung cancerClinical activityEpidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) efficacyGrade 3 treatment-related adverse eventsEGFR TKI-naive patientsMedian progression-free survivalEGFR mutation-positive NSCLCAdvanced EGFR mutation-positive NSCLCTyrosine kinase inhibitor efficacyDurable clinical activityTolerable safety profileMedian overall survivalMedian response durationObjective response ratePhase Ib trialSerious adverse eventsProgression-free survivalStage 2 patientsMutation-positive NSCLCEGFR-mutant NSCLCTKI-naive patientsAtezolizumab 1200
2022
Brief Report: Safety and Antitumor Activity of Alectinib Plus Atezolizumab From a Phase 1b Study in Advanced ALK-Positive NSCLC
Kim DW, Gadgeel S, Gettinger SN, Riely GJ, Oxnard GR, Mekhail T, Schmid P, Dowlati A, Heist RS, Wozniak AJ, Singh J, Cha E, Spahn J, Ou SI. Brief Report: Safety and Antitumor Activity of Alectinib Plus Atezolizumab From a Phase 1b Study in Advanced ALK-Positive NSCLC. JTO Clinical And Research Reports 2022, 3: 100367. PMID: 35875467, PMCID: PMC9304608, DOI: 10.1016/j.jtocrr.2022.100367.Peer-Reviewed Original ResearchTreatment-related adverse eventsPhase 1b studyAdverse eventsPositive NSCLCAntitumor activityGrade 3 treatment-related adverse eventsPreferred first-line treatment optionAdvanced ALK-positive NSCLCMedian progression-free survivalStage IIIB/IVFirst-line treatment optionDose of alectinibIIIB/IVImmune checkpoint inhibitorsMedian overall survivalObjective response rateProgression-free survivalDose-limiting toxicityALK-positive NSCLCAtezolizumab 1200Checkpoint inhibitorsStarting doseMedian durationOverall survivalCombination regimens
2021
A Phase I Study of APX005M and Cabiralizumab with or without Nivolumab in Patients with Melanoma, Kidney Cancer, or Non–Small Cell Lung Cancer Resistant to Anti-PD-1/PD-L1
Weiss SA, Djureinovic D, Jessel S, Krykbaeva I, Zhang L, Jilaveanu L, Ralabate A, Johnson B, Levit NS, Anderson G, Zelterman D, Wei W, Mahajan A, Trifan O, Bosenberg M, Kaech SM, Perry CJ, Damsky W, Gettinger S, Sznol M, Hurwitz M, Kluger HM. A Phase I Study of APX005M and Cabiralizumab with or without Nivolumab in Patients with Melanoma, Kidney Cancer, or Non–Small Cell Lung Cancer Resistant to Anti-PD-1/PD-L1. Clinical Cancer Research 2021, 27: 4757-4767. PMID: 34140403, PMCID: PMC9236708, DOI: 10.1158/1078-0432.ccr-21-0903.Peer-Reviewed Original ResearchConceptsAnti-PD-1/PD-L1Non-small cell lung cancerCell lung cancerRenal cell carcinomaPD-L1Lung cancerDisease progressionCommon treatment-related adverse eventsPD-1/PD-L1 inhibitorsTreatment-related adverse eventsPhase 2 doseSubstantial clinical challengeUnconfirmed partial responseDose-limiting toxicityPD-L1 inhibitorsPhase I trialDose-escalation designPro-inflammatory cytokinesMultiple tumor typesAsymptomatic elevationStable diseaseIntolerable toxicityAdverse eventsMedian durationPartial responseSecond-line nivolumab in relapsed small-cell lung cancer: CheckMate 331☆
Spigel D, Vicente D, Ciuleanu T, Gettinger S, Peters S, Horn L, Audigier-Valette C, Aranda N, Juan-Vidal O, Cheng Y, Zhang H, Shi M, Luft A, Wolf J, Antonia S, Nakagawa K, Fairchild J, Baudelet C, Pandya D, Doshi P, Chang H, Reck M. Second-line nivolumab in relapsed small-cell lung cancer: CheckMate 331☆. Annals Of Oncology 2021, 32: 631-641. PMID: 33539946, DOI: 10.1016/j.annonc.2021.01.071.Peer-Reviewed Original ResearchConceptsSmall cell lung cancerRelapsed Small-Cell Lung CancerOverall survivalLung cancerMedian progression-free survivalTreatment-related adverse eventsBaseline lactate dehydrogenaseBaseline liver metastasesSecond-line nivolumabSelect baseline characteristicsTrials of nivolumabImproved overall survivalObjective response rateCombined positive scoreNew safety signalsProgression-free survivalPlatinum-based chemotherapyPrimary endpointAdverse eventsBaseline characteristicsLiver metastasesMedian durationStandard chemotherapySurvival benefitUnacceptable toxicity
2020
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.
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 evidencePatientsPembrolizumab 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 CriteriaPhase 1 study of epacadostat in combination with atezolizumab for patients with previously treated advanced nonsmall cell lung cancer
Hellmann MD, Gettinger S, Chow LQM, Gordon M, Awad MM, Cha E, Gong X, Zhou G, Walker C, Leopold L, Heist RS. Phase 1 study of epacadostat in combination with atezolizumab for patients with previously treated advanced nonsmall cell lung cancer. International Journal Of Cancer 2020, 147: 1963-1969. PMID: 32141617, PMCID: PMC7496129, DOI: 10.1002/ijc.32951.Peer-Reviewed Original ResearchConceptsNonsmall cell lung cancerTreatment-related adverse eventsDose-limiting toxicityCell lung cancerAdverse eventsLung cancerStage IIIB/IV nonsmall cell lung cancerFatal treatment-related adverse eventsAdvanced nonsmall cell lung cancerCell death ligand 1Grade 3 dehydrationGrade 3 hyponatremiaGrade 3/4 eventsPhase 1 studyPlatinum-based chemotherapyDeath ligand 1Dose of treatmentAutoimmune encephalitisEligible patientsIntravenous atezolizumabStable diseasePrimary endpointPartial responsePrior linesIDO expression
2019
S1206: A dose-finding study followed by a phase II randomized placebo-controlled trial of chemoradiotherapy (CRT) with or without veliparib in stage III non-small cell lung cancer (NSCLC).
Argiris A, Miao J, Cristea M, Chen A, Sands J, Decker R, Gettinger S, Daly M, Faller B, Albain K, Yanagihara R, Garland L, Byers L, Wang D, Koczywas M, Redman M, Kelly K, Gandara D. S1206: A dose-finding study followed by a phase II randomized placebo-controlled trial of chemoradiotherapy (CRT) with or without veliparib in stage III non-small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2019, 37: 8523-8523. DOI: 10.1200/jco.2019.37.15_suppl.8523.Peer-Reviewed Original ResearchNon-small cell lung cancerProgression-free survivalStage III non-small cell lung cancerAdverse eventsG3 anemiaG3 thrombocytopeniaOverall survivalUnresectable stage III non-small cell lung cancerPARP inhibitorsG3 adverse eventsG3 oral mucositisG3-4 neutropeniaG4 adverse eventsPhase II dosePlacebo-controlled trialCell lung cancerDose-finding studyPhase I partPhase IIBackbone regimenConsolidation carboplatinEvaluable patientsG3 fatigueG3 nauseaG3 neutropeniaProspective phase I multi-institutional trial of PD-1 blockade with pembrolizumab during concurrent chemoradiation for locally advanced, unresectable non-small cell lung cancer.
Jabbour S, Berman A, Decker R, Lin Y, Feigenberg S, Gettinger S, Aggarwal C, Langer C, Simone C, Bradley J, Aisner J, Malhotra J. Prospective phase I multi-institutional trial of PD-1 blockade with pembrolizumab during concurrent chemoradiation for locally advanced, unresectable non-small cell lung cancer. Journal Of Clinical Oncology 2019, 37: 8511-8511. DOI: 10.1200/jco.2019.37.15_suppl.8511.Peer-Reviewed Original ResearchImmune-related adverse eventsStage III NSCLCDose limiting toxicitiesChemoradiation therapyPD-1iDay 29Unresectable non-small cell lung cancerDay 1Prospective phase I clinical trialNon-small cell lung cancerDeath ligand 1 (PD-L1) inhibitionPhase I clinical trialDefinitive chemoradiation therapyGrade 3 hyperglycemiaPD-1 blockadeFurther prospective studiesCell lung cancerMulti-institutional trialDose cohortsMedian PFSQ3 weeksConcurrent chemoradiationDefinitive RTAdverse eventsInterstitial nephritisImmune Checkpoint Inhibitor–Associated Pericarditis
Altan M, Toki MI, Gettinger SN, Carvajal-Hausdorf DE, Zugazagoitia J, Sinard JH, Herbst RS, Rimm DL. Immune Checkpoint Inhibitor–Associated Pericarditis. Journal Of Thoracic Oncology 2019, 14: 1102-1108. PMID: 30851443, PMCID: PMC6617516, DOI: 10.1016/j.jtho.2019.02.026.Peer-Reviewed Original ResearchConceptsAdverse eventsCTLA-4 inhibitorsImmune checkpoint inhibitorsDeath-1/Pericardial window procedureCheckpoint inhibitorsThird patientClinical presentationCardiac toxicityHistopathologic findingsSide effectsPericarditisPatientsDeath ligandsPotential mechanismsWindow procedureInhibitorsImmunotherapyNSCLCCardiotoxicityAutopsiesTherapy
2018
Oncolytic virus immunotherapy: future prospects for oncology
Raja J, Ludwig JM, Gettinger SN, Schalper KA, Kim HS. Oncolytic virus immunotherapy: future prospects for oncology. Journal For ImmunoTherapy Of Cancer 2018, 6: 140. PMID: 30514385, PMCID: PMC6280382, DOI: 10.1186/s40425-018-0458-z.Peer-Reviewed Original ResearchConceptsOncolytic virusesSevere immune-related adverse eventsImmune-related adverse eventsAnti-tumor immune responseEarly-stage clinical trialsImmune checkpoint inhibitorsSerious adverse effectsOncolytic viral therapyLimited therapeutic responseAnti-cancer treatmentLocal target cellsCheckpoint inhibitorsSalvage therapyTolerability profileCytotoxic chemotherapyAdverse eventsImmune dysregulationOncologic careTherapeutic optionsTumor bedSuch therapyTherapeutic responseClinical trialsNovel therapiesViral therapyFIR: Efficacy, Safety, and Biomarker Analysis of a Phase II Open-Label Study of Atezolizumab in PD-L1–Selected Patients With NSCLC
Spigel DR, Chaft JE, Gettinger S, Chao BH, Dirix L, Schmid P, Chow LQM, Hicks RJ, Leon L, Fredrickson J, Kowanetz M, Sandler A, Funke R, Rizvi NA. FIR: Efficacy, Safety, and Biomarker Analysis of a Phase II Open-Label Study of Atezolizumab in PD-L1–Selected Patients With NSCLC. Journal Of Thoracic Oncology 2018, 13: 1733-1742. PMID: 29775807, PMCID: PMC7455890, DOI: 10.1016/j.jtho.2018.05.004.Peer-Reviewed Original ResearchConceptsTreatment-related adverse eventsObjective response ratePD-L1 expressionAdverse eventsCohort 1Immune cell PD-L1 expressionInvestigator-assessed objective response ratePhase II open-label studyResponse rateIC PD-L1 expressionTumor cellsBaseline tumor samplesOpen-label studyPhase II studyProgression-free survivalResponse Evaluation CriteriaDuration of responseAtezolizumab monotherapyAdvanced NSCLCBrain metastasesMonotherapy studiesPrimary endpointSecondary endpointsII studyOverall survivalSafety and clinical activity of atezolizumab monotherapy in metastatic non-small-cell lung cancer: final results from a phase I study
Horn L, Gettinger SN, Gordon MS, Herbst RS, Gandhi L, Felip E, Sequist LV, Spigel DR, Antonia SJ, Balmanoukian A, Cassier PA, Liu B, Kowanetz M, O'Hear C, Fassò M, Grossman W, Sandler A, Soria JC. Safety and clinical activity of atezolizumab monotherapy in metastatic non-small-cell lung cancer: final results from a phase I study. European Journal Of Cancer 2018, 101: 201-209. PMID: 30077125, DOI: 10.1016/j.ejca.2018.06.031.Peer-Reviewed Original ResearchConceptsTreatment-related adverse eventsBaseline PD-L1 expressionObjective response ratePD-L1 expressionPD-L1Immune cellsGrade treatment-related adverse eventsSurvival rateCell lung cancer cohortLong-term clinical benefitTumor-infiltrating immune cellsTumor cellsPhase IPrevious systemic therapySingle-agent atezolizumabCell lung cancerExploratory subgroup analysisLung cancer cohortAtezolizumab monotherapyAdverse eventsDurable responsesMedian durationSystemic therapyAnticancer immunityPD-1Long-term survival follow-up of atezolizumab in combination with platinum-based doublet chemotherapy in patients with advanced non–small-cell lung cancer
Liu SV, Camidge DR, Gettinger SN, Giaccone G, Heist RS, Hodi FS, Ready NE, Zhang W, Wallin J, Funke R, Waterkamp D, Foster P, Iizuka K, Powderly J. Long-term survival follow-up of atezolizumab in combination with platinum-based doublet chemotherapy in patients with advanced non–small-cell lung cancer. European Journal Of Cancer 2018, 101: 114-122. PMID: 30053670, DOI: 10.1016/j.ejca.2018.06.033.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCarboplatinCarcinoma, Non-Small-Cell LungDisease-Free SurvivalFemaleFollow-Up StudiesHumansLung NeoplasmsMaleMiddle AgedNeutropeniaSurvival AnalysisTime FactorsTreatment OutcomeConceptsObjective response rateProgression-free survivalCell lung cancerOverall survivalLung cancerAnti-programmed death ligand 1 antibodyGrade III/IV adverse eventsConfirmed objective response rateMedian progression-free survivalPlatinum-based doublet chemotherapyStandard first-line therapyDeath ligand 1 antibodyCell death protein 1Availability of immunotherapyMedian overall survivalFirst-line therapyLigand 1 antibodyDeath protein 1Actionable gene alterationsLong-term survivalDoublet chemotherapyImmunotherapy combinationsNab-PacNab-paclitaxelAdverse eventsCollateral Damage: Insulin-Dependent Diabetes Induced With Checkpoint Inhibitors
Stamatouli AM, Quandt Z, Perdigoto AL, Clark PL, Kluger H, Weiss SA, Gettinger S, Sznol M, Young A, Rushakoff R, Lee J, Bluestone JA, Anderson M, Herold KC. Collateral Damage: Insulin-Dependent Diabetes Induced With Checkpoint Inhibitors. Diabetes 2018, 67: dbi180002. PMID: 29937434, PMCID: PMC6054443, DOI: 10.2337/dbi18-0002.Peer-Reviewed Original ResearchMeSH KeywordsAnimalsAntineoplastic Agents, ImmunologicalAutoimmune DiseasesB7-H1 AntigenDiabetes Mellitus, Type 1Genetic Predisposition to DiseaseGenotypeHLA-DR4 AntigenHumansHypoglycemic AgentsInsulinInsulin SecretionIsoantibodiesKetosisModels, ImmunologicalNeoplasmsPancreasPancreatitisProgrammed Cell Death 1 ReceptorConceptsInsulin-dependent diabetesCheckpoint inhibitorsAdverse eventsHLA-DR4Classic type 1 diabetesPD-L1 checkpoint inhibitorsEvidence of pancreatitisImmune adverse eventsSolid organ cancersType 1 diabetesPeridiagnosis periodPositive autoantibodiesL1 antibodyInsulin-DependentHigh riskPatientsDiabetesCancerInhibitorsKetoacidosisAutoimmuneAutoantibodiesPancreatitisComplicationsSyndromeNivolumab versus docetaxel in previously treated advanced non-small-cell lung cancer (CheckMate 017 and CheckMate 057): 3-year update and outcomes in patients with liver metastases
Vokes EE, Ready N, Felip E, Horn L, Burgio MA, Antonia SJ, Frontera O, Gettinger S, Holgado E, Spigel D, Waterhouse D, Domine M, Garassino M, Chow LQM, Blumenschein G, Barlesi F, Coudert B, Gainor J, Arrieta O, Brahmer J, Butts C, Steins M, Geese WJ, Li A, Healey D, Crinò L. Nivolumab versus docetaxel in previously treated advanced non-small-cell lung cancer (CheckMate 017 and CheckMate 057): 3-year update and outcomes in patients with liver metastases. Annals Of Oncology 2018, 29: 959-965. PMID: 29408986, DOI: 10.1093/annonc/mdy041.Peer-Reviewed Original ResearchConceptsBaseline liver metastasesImproved overall survivalLiver metastasesCell lung cancerOverall survivalOS benefitCheckMate 017Nonsquamous NSCLCLung cancerSubgroup analysisAnti-programmed death-1 (PD-1) antibody nivolumabNivolumab-treated patientsImmune checkpoint inhibitorsPrimary end pointHepatic adverse eventsPhase III trialsFavorable safety profileNew safety concernsCheckMate 057Advanced NSCLCCheckpoint inhibitorsAdverse eventsIII trialsOS ratesAntibody nivolumabFive-Year Follow-Up of Nivolumab in Previously Treated Advanced Non-Small-Cell Lung Cancer: Results From the CA209-003 Study.
Gettinger S, Horn L, Jackman D, Spigel D, Antonia S, Hellmann M, Powderly J, Heist R, Sequist LV, Smith DC, Leming P, Geese WJ, Yoon D, Li A, Brahmer J. Five-Year Follow-Up of Nivolumab in Previously Treated Advanced Non-Small-Cell Lung Cancer: Results From the CA209-003 Study. Journal Of Clinical Oncology 2018, 36: 1675-1684. PMID: 29570421, DOI: 10.1200/jco.2017.77.0412.Peer-Reviewed Original ResearchConceptsLigand 1 expressionOverall survivalAdvanced NSCLCProgressive diseaseOS ratesLung cancerAdvanced non-small cell lung cancerNon-small cell lung cancerLong-term OSPhase III studyProportion of patientsResponse Evaluation CriteriaKaplan-Meier methodLong-term survivorsCell lung cancerEarly phase INivolumab 1Nivolumab treatmentStable diseaseNonsquamous NSCLCAdverse eventsDurable responsesFirst doseFormer smokersIII studySafety and feasibility of immuno-cryotherapy.
Raja J, Ghodadra A, Gettinger S, Kluger H, Sznol M, Schalper K, "Kevin" Kim H. Safety and feasibility of immuno-cryotherapy. Journal Of Clinical Oncology 2018, 36: 34-34. DOI: 10.1200/jco.2018.36.5_suppl.34.Peer-Reviewed Original ResearchAdverse eventsImage-guided cryotherapyGrade 3Metastatic non-small cell lung cancerNon-small cell lung cancerImmune checkpoint inhibitor resistanceImmune checkpoint inhibitor therapyAdverse Events criteriaCheckpoint inhibitor resistanceCheckpoint inhibitor therapyCTLA-4 blockadeDisease control rateHigher adverse eventsImmune checkpoint inhibitionPrimary end pointImmune checkpoint therapyCell lung cancerTypes of malignanciesCases of diarrheaProgression of diseaseSystemic immunotherapyMetastatic NSCLCPeriprocedural periodSecondary endpointsSite hematoma
2017
Continued use of afatinib with the addition of cetuximab after progression on afatinib in patients with EGFR mutation-positive non-small-cell lung cancer and acquired resistance to gefitinib or erlotinib
Horn L, Gettinger S, Camidge DR, Smit EF, Janjigian YY, Miller VA, Pao W, Freiwald M, Fan J, Wang B, Chand VK, Groen HJM. Continued use of afatinib with the addition of cetuximab after progression on afatinib in patients with EGFR mutation-positive non-small-cell lung cancer and acquired resistance to gefitinib or erlotinib. Lung Cancer 2017, 113: 51-58. PMID: 29110849, DOI: 10.1016/j.lungcan.2017.08.014.Peer-Reviewed Original ResearchMeSH KeywordsAdultAfatinibAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Non-Small-Cell LungCetuximabCohort StudiesDiarrheaDisease ProgressionDrug Resistance, NeoplasmErbB ReceptorsErlotinib HydrochlorideExanthemaFemaleGefitinibHumansKaplan-Meier EstimateLung NeoplasmsMaleMiddle AgedMutationQuinazolinesConceptsEGFR mutation-positive NSCLCEpidermal growth factor receptorMutation-positive NSCLCCell lung cancerAdverse eventsAfatinib monotherapyMedian PFSLung cancerDrug-related grade 3/4 adverse eventsFrequent drug-related adverse eventsDrug-related adverse eventsGrade 3/4 adverse eventsAddition of cetuximabIntolerable adverse eventsPhase Ib trialT790M-negative tumorsPercent of patientsPredictable safety profileAfatinib dailyGrowth factor receptorIb trialSafety profileClinical activityDry skinSeparate cohort