2023
Quality-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 relevance
2022
Association of depth of target lesion response to brigatinib with outcomes in patients with ALK inhibitor-naive ALK+ NSCLC in ALTA-1L.
Camidge D, Kim H, Ahn M, Yang J, Han J, Hochmair M, Lee K, Delmonte A, Campelo R, Kim D, Griesinger F, Felip E, Califano R, Spira A, Thomas M, Gettinger S, Tiseo M, Liu Y, Zhang P, Popat S. Association of depth of target lesion response to brigatinib with outcomes in patients with ALK inhibitor-naive ALK+ NSCLC in ALTA-1L. Journal Of Clinical Oncology 2022, 40: 9072-9072. DOI: 10.1200/jco.2022.40.16_suppl.9072.Peer-Reviewed Original ResearchBlinded independent review committeeTarget lesion assessmentTarget lesion responseLesion shrinkageLesion responseLesion assessmentCochran-Armitage trend analysisRandomized phase 3 trialShrinkage groupPhase 3 trialDepth of responseIndependent review committeeLonger median timeMajority of ptsAssociation of depthRECIST v1.1PFS eventsMedian ageOS ratesMedian timeStudy endTarget lesionsLower riskDeep responsesBrigatinib
2019
O1-4-2 [Encore] Brigatinib (BRG) vs Crizotinib (CRZ) in Patients (Pts) With ALK Inhibitor-Naive Advanced ALK+ NSCLC from ALTA-1L
Yang J, Kim H, Ahn M, Han J, Hochmair M, Lee K, Delmonte A, Campelo M, Kim D, Felip E, Califano R, Spira A, Gettinger S, Tiseo M, Haney J, Kerstein D, Popat S, Camidge D. O1-4-2 [Encore] Brigatinib (BRG) vs Crizotinib (CRZ) in Patients (Pts) With ALK Inhibitor-Naive Advanced ALK+ NSCLC from ALTA-1L. Annals Of Oncology 2019, 30: vi83. DOI: 10.1093/annonc/mdz339.006.Peer-Reviewed Original ResearchIntracranial ORRInterim analysisPFS eventsBlinded independent review committeeAsymptomatic CNS metastasesBaseline brain metastasesMost common gradeSecondary efficacy endpointsFirst interim analysisIndependent review committeeCNS metastasisMedian iPFSMedian PFSPrior chemotherapyAdvanced diseaseEfficacy endpointPrimary endpointBrain metastasesData cutoffSystemic therapyALK-TKIMedian ageMulticenter studyCommon gradeCrizotinib1543P Brigatinib (BRG) in Asian vs non-Asian patients (pts) with crizotinib (CRZ)-refractory ALK+ NSCLC in the phase II ALTA trial
Lee D, Kim D, Camidge D, Langer C, Huber R, Tiseo M, West H, Groen H, Reckamp K, Hochmair M, Leighl N, Hansen K, Gettinger S, Paz-Ares L, Kim E, Smit E, Kim S, Ni Q, Zhang P, Ahn M. 1543P Brigatinib (BRG) in Asian vs non-Asian patients (pts) with crizotinib (CRZ)-refractory ALK+ NSCLC in the phase II ALTA trial. Annals Of Oncology 2019, 30: v634-v635. DOI: 10.1093/annonc/mdz260.065.Peer-Reviewed Original ResearchBristol-Myers SquibbCNS metastasesTakeda Pharmaceutical Company LimitedBoehringer IngelheimARIAD PharmaceuticalsClovis OncologyRoche/GenentechEli LillyMerck SharpBaseline CNS metastasesIntracranial objective responseMost common gradeObjective response rateProgression-free survivalDuration of responseIndependent review committeeNon-Asian patientsPierre FabreMedian DoRMedian iPFSMedian PFSRECIST v1.1Objective responseOverall survivalMedian age
2017
Brigatinib (BRG) in crizotinib (CRZ)-refractory ALK+ non-small cell lung cancer (NSCLC): Updates from ALTA, a pivotal randomized phase 2 trial.
Ahn M, Camidge D, Tiseo M, Reckamp K, Holmskov Hansen K, Kim S, Huber R, West H, Groen H, Hochmair M, Leighl N, Gettinger S, Langer C, Paz-Ares L, Smit E, Kim E, Reichmann W, Kerstein D, Kim D. Brigatinib (BRG) in crizotinib (CRZ)-refractory ALK+ non-small cell lung cancer (NSCLC): Updates from ALTA, a pivotal randomized phase 2 trial. Journal Of Clinical Oncology 2017, 35: e20503-e20503. DOI: 10.1200/jco.2017.35.15_suppl.e20503.Peer-Reviewed Original ResearchNon-small cell lung cancerObjective response rateRandomized phase 2 trialPhase 2 trialAdverse eventsBrain metastasesMost common treatment-emergent adverse eventsCommon treatment-emergent adverse eventsTreatment-emergent adverse eventsIntracranial objective response rateBaseline brain metastasesPulmonary adverse eventsPhase 1/2 trialCell lung cancerRECIST v1.1Primary endpointNSCLC patientsMedian ageAcceptable safetyLung cancerDisease progressionDose reductionDose levelsResponse rateBrigatinib
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
Lung Cancer in Older Patients
Gettinger S, Tanoue L. Lung Cancer in Older Patients. Respiratory Medicine 2011, 89-109. DOI: 10.1007/978-1-60761-727-3_5.Peer-Reviewed Original ResearchYears of ageLung cancerOlder patientsBest supportive careMajority of patientsCancer-related mortalityStandard of careNovel therapeutic approachesLung cancer diagnosisAdvanced diseaseElderly patientsSupportive careMedian ageClinical trialsClinical studiesAggressive approachTherapeutic approachesPatientsCancerOlder populationYounger counterpartsCancer diagnosisAgeMortalityDisease