2021
Five-Year Outcomes From the Randomized, Phase III Trials CheckMate 017 and 057: Nivolumab Versus Docetaxel in Previously Treated Non–Small-Cell Lung Cancer
Borghaei H, Gettinger S, Vokes EE, Chow LQM, Burgio MA, de Castro Carpeno J, Pluzanski A, Arrieta O, Frontera OA, Chiari R, Butts C, Wójcik-Tomaszewska J, Coudert B, Garassino MC, Ready N, Felip E, García MA, Waterhouse D, Domine M, Barlesi F, Antonia S, Wohlleber M, Gerber DE, Czyzewicz G, Spigel DR, Crino L, Eberhardt WEE, Li A, Marimuthu S, Brahmer J. Five-Year Outcomes From the Randomized, Phase III Trials CheckMate 017 and 057: Nivolumab Versus Docetaxel in Previously Treated Non–Small-Cell Lung Cancer. Journal Of Clinical Oncology 2021, 39: 723-733. PMID: 33449799, PMCID: PMC8078445, DOI: 10.1200/jco.20.01605.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overCarcinoma, Non-Small-Cell LungClinical Trials, Phase III as TopicDisease ProgressionDocetaxelFemaleHumansImmune Checkpoint InhibitorsImmunotherapyLung NeoplasmsMaleMiddle AgedNivolumabProgression-Free SurvivalRandomized Controlled Trials as TopicTime FactorsTubulin ModulatorsYoung AdultConceptsTreatment-related adverse eventsNivolumab-treated patientsProgression-free survivalPhase III trialsOverall survivalCheckMate 017Advanced NSCLCIII trialsOS ratesLung cancerGrade 4 treatment-related adverse eventsFirst-line platinum-based chemotherapyNon-small cell lung cancerRandomized phase III trialEnd pointDeath-1 inhibitorsDocetaxel-treated patientsExploratory landmark analysisPrimary end pointSecondary end pointsFive-year outcomesNew safety signalsPlatinum-based chemotherapyCell lung cancerECOG PS
2019
A phase II study of autologous tumor infiltrating lymphocytes (TIL, LN-144/LN-145) in patients with solid tumors.
Chesney J, Lutzky J, Thomas S, Nieva J, Munoz Couselo E, Martin-Liberal J, Rodriguez-Moreno J, Cacovean A, Li H, Fardis M, Gettinger S. A phase II study of autologous tumor infiltrating lymphocytes (TIL, LN-144/LN-145) in patients with solid tumors. Journal Of Clinical Oncology 2019, 37: tps2648-tps2648. DOI: 10.1200/jco.2019.37.15_suppl.tps2648.Peer-Reviewed Original ResearchImmune checkpoint inhibitorsPrior immune checkpoint inhibitorsObjective response rateTIL therapyAdoptive cell therapySystemic therapyCohort 1Cohort 3RECIST 1.1Metastatic melanomaNeck cancerPhase 2 multicenterPrior systemic therapyDurable complete responseOpen-label studyPhase II studyMetastatic melanoma patientsCo-primary endpointsHigh mutational burdenAutologous tumorECOG PSMeasurable diseaseAcceptable toxicityCheckpoint inhibitorsImmunogenic tumors
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