2021
Second-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 evidencePatientsClinical Activity and Safety of Atezolizumab in a Phase 1 Study of Patients With Relapsed/Refractory Small-Cell Lung Cancer
Chiang AC, Sequist LVD, Gilbert J, Conkling P, Thompson D, Marcoux JP, Gettinger S, Kowanetz M, Molinero L, O'Hear C, Fassò M, Lam S, Gordon MS. Clinical Activity and Safety of Atezolizumab in a Phase 1 Study of Patients With Relapsed/Refractory Small-Cell Lung Cancer. Clinical Lung Cancer 2020, 21: 455-463.e4. PMID: 32586767, DOI: 10.1016/j.cllc.2020.05.008.Peer-Reviewed Original ResearchConceptsSmall cell lung cancerRefractory small cell lung cancerImmune-related response criteriaTreatment-related adverse eventsProgression-free survivalOverall survivalLung cancerMedian investigator-assessed progression-free survivalGrade treatment-related adverse eventsInvestigator-assessed progression-free survivalTumor-specific T cell immunityMetastatic small cell lung cancerSolid Tumors version 1.1T-effector gene signaturePD-L1 mRNA expressionSafety of atezolizumabAntitumor activityMedian overall survivalResponse Evaluation CriteriaCohort of patientsPD-L1 signalingPhase 1 studyT cell immunityDuration of responseEligible patientsFirst-Line Therapy Using Brigatinib vs. Crizotinib in Patients With Advanced Anaplastic Lymphoma Kinase-Positive Non-Small Cell Lung Cancer: Results From a Phase 3 Trial
Hochmair M, Camidge, Kim H, Ahn M, Yang J, Han J, Lee K, Delmonte A, Campelo G, Kim D, Griesinger F, Felip E, Califano R, Spira A, Gettinger S, Tiseo M, Ni Q, Zhang P, Popat S. First-Line Therapy Using Brigatinib vs. Crizotinib in Patients With Advanced Anaplastic Lymphoma Kinase-Positive Non-Small Cell Lung Cancer: Results From a Phase 3 Trial. Pneumologie 2020, 74: 131-131. DOI: 10.1055/s-0039-3403360.Peer-Reviewed Original Research
2019
Expression and clinical significance of PD-L1, B7-H3, B7-H4 and TILs in human small cell lung Cancer (SCLC)
Carvajal-Hausdorf D, Altan M, Velcheti V, Gettinger SN, Herbst RS, Rimm DL, Schalper KA. Expression and clinical significance of PD-L1, B7-H3, B7-H4 and TILs in human small cell lung Cancer (SCLC). Journal For ImmunoTherapy Of Cancer 2019, 7: 65. PMID: 30850021, PMCID: PMC6408760, DOI: 10.1186/s40425-019-0540-1.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overB7 AntigensB7-H1 AntigenBiomarkers, TumorFemaleFluorescent Antibody TechniqueHumansKaplan-Meier EstimateLung NeoplasmsLymphocytes, Tumor-InfiltratingMaleMiddle AgedNeoplasm GradingNeoplasm StagingPrognosisRetrospective StudiesSmall Cell Lung CarcinomaV-Set Domain-Containing T-Cell Activation Inhibitor 1ConceptsSmall cell lung cancerCell lung cancerB7-H4B7-H3Lung cancerPD-L1Non-small cell lung cancerBackgroundSmall cell lung cancerAnti-tumor immune responseHuman small cell lung cancerQuantitative immunofluorescenceB7 family ligandsLevels of TILsMultiplexed quantitative immunofluorescenceLevels of CD3Effector T cellsImmune checkpoint blockersPromising clinical activityTissue microarray formatLymphocyte subsetsCheckpoint blockersOverall survivalLung malignancyClinicopathological variablesMarker levels
2018
EGFR-Mutant Adenocarcinomas That Transform to Small-Cell Lung Cancer and Other Neuroendocrine Carcinomas: Clinical Outcomes
Marcoux N, Gettinger SN, O’Kane G, Arbour KC, Neal JW, Husain H, Evans TL, Brahmer JR, Muzikansky A, Bonomi PD, del Prete S, Wurtz A, Farago AF, Dias-Santagata D, Mino-Kenudson M, Reckamp KL, Yu HA, Wakelee HA, Shepherd FA, Piotrowska Z, Sequist LV. EGFR-Mutant Adenocarcinomas That Transform to Small-Cell Lung Cancer and Other Neuroendocrine Carcinomas: Clinical Outcomes. Journal Of Clinical Oncology 2018, 37: 278-285. PMID: 30550363, PMCID: PMC7001776, DOI: 10.1200/jco.18.01585.Peer-Reviewed Original ResearchMeSH KeywordsAdenocarcinoma of LungAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorCarcinoma, Non-Small-Cell LungClass I Phosphatidylinositol 3-KinasesErbB ReceptorsFemaleGenetic Predisposition to DiseaseHumansLung NeoplasmsMaleMiddle AgedMutationNeoplasm GradingNorth AmericaPhenotypeRetinoblastoma Binding ProteinsRetrospective StudiesSmall Cell Lung CarcinomaTime FactorsTreatment OutcomeTumor Suppressor Protein p53Ubiquitin-Protein LigasesConceptsNon-small cell lung cancerSmall cell lung cancerEGFR-mutant non-small cell lung cancerSCLC transformationLung cancerNeuroendocrine carcinomaEGFR mutationsDe novo small cell lung cancersInitial lung cancer diagnosisHigh-grade neuroendocrine carcinomaEGFR tyrosine kinase inhibitorsT790M positivityMedian overall survivalCell lung cancerTyrosine kinase inhibitorsHigh response rateEGFR-mutant adenocarcinomaLung cancer diagnosisCNS metastasesCheckpoint inhibitorsMedian survivalOverall survivalClinical courseMixed histologyClinical outcomesLBA5 Efficacy and safety of nivolumab (nivo) monotherapy versus chemotherapy (chemo) in recurrent small cell lung cancer (SCLC): Results from CheckMate 331
Reck M, Vicente D, Ciuleanu T, Gettinger S, Peters S, Horn L, Audigier-Valette C, Pardo N, Juan-Vidal O, Cheng Y, Zhang H, Shi M, Wolf J, Antonia S, Nakagawa K, Selvaggi G, Baudelet C, Chang H, Spigel D. LBA5 Efficacy and safety of nivolumab (nivo) monotherapy versus chemotherapy (chemo) in recurrent small cell lung cancer (SCLC): Results from CheckMate 331. Annals Of Oncology 2018, 29: x43. DOI: 10.1093/annonc/mdy511.004.Peer-Reviewed Original ResearchBrigatinib versus Crizotinib in ALK-Positive Non–Small-Cell Lung Cancer
Camidge DR, Kim HR, Ahn MJ, Yang JC, Han JY, Lee JS, Hochmair MJ, Li JY, Chang GC, Lee KH, Gridelli C, Delmonte A, Garcia Campelo R, Kim DW, Bearz A, Griesinger F, Morabito A, Felip E, Califano R, Ghosh S, Spira A, Gettinger SN, Tiseo M, Gupta N, Haney J, Kerstein D, Popat S. Brigatinib versus Crizotinib in ALK-Positive Non–Small-Cell Lung Cancer. New England Journal Of Medicine 2018, 379: 2027-2039. PMID: 30280657, DOI: 10.1056/nejmoa1810171.Peer-Reviewed Original ResearchConceptsProgression-free survivalALK-positive NSCLCAdvanced ALK-positive NSCLCObjective response rateFirst interim analysisALK inhibitorsLung cancerIntracranial responseInterim analysisNext-generation anaplastic lymphoma kinase (ALK) inhibitorResponse rateConfirmed objective response rateEnd pointSmall cell lung cancerBlinded independent central reviewAnaplastic lymphoma kinase inhibitorsEfficacy of brigatinibPrimary end pointSecondary end pointsPhase 3 trialALK-Positive NonCell lung cancerIndependent central reviewNew safety concernsCrizotinib groupExploratory Analysis of Brigatinib Activity in Patients With Anaplastic Lymphoma Kinase-Positive Non-Small-Cell Lung Cancer and Brain Metastases in Two Clinical Trials.
Camidge DR, Kim DW, Tiseo M, Langer CJ, Ahn MJ, Shaw AT, Huber RM, Hochmair MJ, Lee DH, Bazhenova LA, Gold KA, Ou SI, West HL, Reichmann W, Haney J, Clackson T, Kerstein D, Gettinger SN. Exploratory Analysis of Brigatinib Activity in Patients With Anaplastic Lymphoma Kinase-Positive Non-Small-Cell Lung Cancer and Brain Metastases in Two Clinical Trials. Journal Of Clinical Oncology 2018, 36: 2693-2701. PMID: 29768119, DOI: 10.1200/jco.2017.77.5841.Peer-Reviewed Original ResearchConceptsIntracranial progression-free survivalBaseline brain metastasesALK-positive NSCLCBrain metastasesIntracranial ORRArm ALung cancerAnaplastic Lymphoma Kinase-Positive NonMedian intracranial progression-free survivalPhase I/II trialNext-generation ALK inhibitorsSmall cell lung cancerMeasurable brain metastasesPrior brain radiotherapyResults Most patientsPrimary end pointProgression-free survivalCell lung cancerIndependent review committeeInitial disease progressionAnaplastic lymphoma kinase (ALK) geneIntracranial efficacyII trialPrior radiationBrain radiotherapy
2017
1531PD Clinical outcomes for EGFR-mutant adenocarcinomas (AC) that transform to small cell lung cancer (SCLC)
Marcoux N, Piotrowska Z, Farago A, Hata A, Mooradian M, Drapkin B, Muzikansky A, Gettinger S, Mino-Kenudson M, Sequist L. 1531PD Clinical outcomes for EGFR-mutant adenocarcinomas (AC) that transform to small cell lung cancer (SCLC). Annals Of Oncology 2017, 28: v540-v541. DOI: 10.1093/annonc/mdx386.005.Peer-Reviewed Original Research
2016
Deferring Radiation Therapy for Brain Metastases in Patients With EGFR-Mutant Non-Small Cell Lung Cancer: A Multi-Institutional Analysis
Magnuson W, Amini A, Patil T, Kavanagh B, Camidge D, Braunstein S, Boreta L, Attia A, Rana N, Contessa J, Gettinger S, Lester-Coll N, Yu J, Chiang V. Deferring Radiation Therapy for Brain Metastases in Patients With EGFR-Mutant Non-Small Cell Lung Cancer: A Multi-Institutional Analysis. International Journal Of Radiation Oncology • Biology • Physics 2016, 96: s57-s58. DOI: 10.1016/j.ijrobp.2016.06.149.Peer-Reviewed Original Research1425PD Clinical activity, safety and predictive biomarkers results from a phase Ia atezolizumab (atezo) trial in extensive-stage small cell lung cancer (ES-SCLC)
Sequist L, Chiang A, Gilbert J, Gordon M, Conkling P, Thompson D, Marcoux J, Antonia S, Liu B, Shames D, Lopez-Chavez A, O'Hear C, Fasso M, Gettinger S. 1425PD Clinical activity, safety and predictive biomarkers results from a phase Ia atezolizumab (atezo) trial in extensive-stage small cell lung cancer (ES-SCLC). Annals Of Oncology 2016, 27: vi493. DOI: 10.1093/annonc/mdw389.03.Peer-Reviewed Original ResearchCheckMate 331: An open-label, randomized phase III trial of nivolumab versus chemotherapy in patients (pts) with relapsed small cell lung cancer (SCLC) after first-line platinum-based chemotherapy (PT-DC).
Horn L, Reck M, Gettinger S, Spigel D, Antonia S, Rupnow B, Pieters A, Selvaggi G, Fairchild J, Peters S. CheckMate 331: An open-label, randomized phase III trial of nivolumab versus chemotherapy in patients (pts) with relapsed small cell lung cancer (SCLC) after first-line platinum-based chemotherapy (PT-DC). Journal Of Clinical Oncology 2016, 34: tps8578-tps8578. DOI: 10.1200/jco.2016.34.15_suppl.tps8578.Peer-Reviewed Original ResearchImpact of Deferring Radiation Therapy in Patients With Epidermal Growth Factor Receptor–Mutant Non-Small Cell Lung Cancer Who Develop Brain Metastases
Magnuson WJ, Yeung JT, Guillod PD, Gettinger SN, Yu JB, Chiang VL. Impact of Deferring Radiation Therapy in Patients With Epidermal Growth Factor Receptor–Mutant Non-Small Cell Lung Cancer Who Develop Brain Metastases. International Journal Of Radiation Oncology • Biology • Physics 2016, 95: 673-679. PMID: 27034176, DOI: 10.1016/j.ijrobp.2016.01.037.Peer-Reviewed Original ResearchConceptsWhole-brain radiation therapyUpfront EGFR-TKIIntracranial progression-free survivalUpfront radiation therapyProgression-free survivalBrain metastasesEGFR-TKI groupEGFR-TKIEGFR-mutant NSCLCOverall survivalRadiation therapyEpidermal Growth Factor Receptor–Mutant NonDisease-specific Graded Prognostic AssessmentUpfront EGFR tyrosine kinase inhibitorsEGFR-TKI resistance mutationSmall cell lung cancerEGFR tyrosine kinase inhibitorsEGFR-TKI useMedian overall survivalSimilar overall survivalUpfront RT groupInferior overall survivalCell lung cancerMutant lung adenocarcinomaEpidermal growth factor receptor
2013
Late recurrence of basaloid carcinoma initially treated as a small cell lung cancer
Shumaster V, Bae JW, Gettinger SN, Cai G, Kim AW. Late recurrence of basaloid carcinoma initially treated as a small cell lung cancer. Journal Of Thoracic Disease 2013, 5: e68-70. PMID: 23585963, PMCID: PMC3621916, DOI: 10.3978/j.issn.2072-1439.2013.03.01.Peer-Reviewed Case Reports and Technical Notes
2012
1231PD Impact of Crizotinib Treatment on Patient-Reported Symptoms and Quality of Life (QOL) in Advanced Alk-Positive Non-Small Cell Lung Cancer (NSCLC)
Blackhall F, Evans T, Han J, Salgia R, Moro-Sibilot D, Gettinger S, Crino L, Wilner K, Reisman A, Iyer S. 1231PD Impact of Crizotinib Treatment on Patient-Reported Symptoms and Quality of Life (QOL) in Advanced Alk-Positive Non-Small Cell Lung Cancer (NSCLC). Annals Of Oncology 2012, 23: ix402. DOI: 10.1016/s0923-7534(20)33882-5.Peer-Reviewed Original ResearchAdvanced ALK-positive NSCLCGlobal QOLPatient-reported symptomsALK-positive NSCLCQuality of lifePatient-reported outcomesMeaningful improvementsSmall cell lung cancerEffect of crizotinibEfficacy of crizotinibLung cancer moduleMajority of patientsALK-Positive NonLung cancer symptomsCell lung cancerEnd of treatmentHigh response rateHigher symptom severityCrizotinib treatmentCancer QuestionnaireSecondary endpointsMedian ageConclusions TreatmentCancer ModuleQLQ-C30
2011
Genotypic and Histological Evolution of Lung Cancers Acquiring Resistance to EGFR Inhibitors
Sequist LV, Waltman BA, Dias-Santagata D, Digumarthy S, Turke AB, Fidias P, Bergethon K, Shaw AT, Gettinger S, Cosper AK, Akhavanfard S, Heist RS, Temel J, Christensen JG, Wain JC, Lynch TJ, Vernovsky K, Mark EJ, Lanuti M, Iafrate AJ, Mino-Kenudson M, Engelman JA. Genotypic and Histological Evolution of Lung Cancers Acquiring Resistance to EGFR Inhibitors. Science Translational Medicine 2011, 3: 75ra26. PMID: 21430269, PMCID: PMC3132801, DOI: 10.1126/scitranslmed.3002003.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerSmall cell lung cancerCell lung cancerLung cancerEpidermal growth factor receptorEGFR mutationsDrug resistanceEGFR inhibitorsDrug-resistant non-small cell lung cancerEGFR T790M mutationEGFR tyrosine kinase inhibitorsMET gene amplificationEGFR inhibitor treatmentT790M mutationTyrosine kinase inhibitorsDrug-resistant tumorsGrowth factor receptorSerial biopsiesSCLC treatmentMechanisms of resistanceHistological evolutionResistant tumorsTumor biopsiesSuch cancersInhibitor treatment
2007
A phase II trial of VNP40101M in patients with relapsed or refractory small cell lung cancer (SCLC) with or without brain metastases
Mekhail T, Gettinger S, Blumenschein G, Axelrod R, Haigentz M, Guarino M, Cahill A, Spigel D, Greco F. A phase II trial of VNP40101M in patients with relapsed or refractory small cell lung cancer (SCLC) with or without brain metastases. Journal Of Clinical Oncology 2007, 25: 7724-7724. DOI: 10.1200/jco.2007.25.18_suppl.7724.Peer-Reviewed Original ResearchSmall cell lung cancerBrain metastasesBrain metsSCLC patientsRelapse groupVNP40101MGrade 3Refractory small cell lung cancerNon-hematologic toxicitiesRefractory SCLC patientsPhase II trialCell lung cancerBlood-brain barrierResistant tumor cell linesECOG PSEvaluable diseaseEvaluable ptsLine chemotherapyPrior chemotherapyRelapse diseaseSensitive relapseStable diseaseII trialRECIST criteriaStarting dose