2016
Clinical and Histologic Features of Lichenoid Mucocutaneous Eruptions Due to Anti–Programmed Cell Death 1 and Anti–Programmed Cell Death Ligand 1 Immunotherapy
Shi VJ, Rodic N, Gettinger S, Leventhal JS, Neckman JP, Girardi M, Bosenberg M, Choi JN. Clinical and Histologic Features of Lichenoid Mucocutaneous Eruptions Due to Anti–Programmed Cell Death 1 and Anti–Programmed Cell Death Ligand 1 Immunotherapy. JAMA Dermatology 2016, 152: 1128-1136. PMID: 27411054, PMCID: PMC6108080, DOI: 10.1001/jamadermatol.2016.2226.Peer-Reviewed Original ResearchConceptsAnti-PD-1/PD-L1 therapyCutaneous adverse effectsPD-L1 therapyCell death 1Concurrent medicationsDeath-1Adverse effectsClinical morphologyAnti-PD-1/PD-L1 treatmentAnti-programmed cell death ligand-1 (PD-L1) immunotherapiesAnti-programmed cell death 1Non-small cell lung cancerDeath ligand 1 (PD-L1) immunotherapyPD-L1 antibody therapyCell death ligand 1Yale-New Haven HospitalMucocutaneous adverse effectsPD-L1 treatmentTreatment of rashTertiary care hospitalDeath ligand 1Lichenoid drug eruptionCell lung cancerSkin biopsy specimensRecent US FoodPossible Interaction of Anti–PD-1 Therapy with the Effects of Radiosurgery on Brain Metastases
Alomari AK, Cohen J, Vortmeyer AO, Chiang A, Gettinger S, Goldberg S, Kluger HM, Chiang VL. Possible Interaction of Anti–PD-1 Therapy with the Effects of Radiosurgery on Brain Metastases. Cancer Immunology Research 2016, 4: 481-487. PMID: 26994250, DOI: 10.1158/2326-6066.cir-15-0238.Peer-Reviewed Original ResearchConceptsStereotactic radiosurgeryBrain metastasesInitiation of immunotherapyPD-1 mAbImmune-modulating therapyModalities of treatmentRadiologic progressionSurgical resectionSystemic therapyDeath-1Radiologic findingsMetastatic malignancyReactive astrocytosisPathologic examinationTreatment regimensHistopathologic examinationWall infiltrationT lymphocytesPatientsTumor progressionMonoclonal antibodiesBiologic interactionsRadiation-induced changesImmunotherapyMalignancyAssociation of Acute Interstitial Nephritis With Programmed Cell Death 1 Inhibitor Therapy in Lung Cancer Patients
Shirali AC, Perazella MA, Gettinger S. Association of Acute Interstitial Nephritis With Programmed Cell Death 1 Inhibitor Therapy in Lung Cancer Patients. American Journal Of Kidney Diseases 2016, 68: 287-291. PMID: 27113507, DOI: 10.1053/j.ajkd.2016.02.057.Peer-Reviewed Original ResearchConceptsAcute interstitial nephritisPD-1 inhibitor therapyInhibitor therapyInterstitial nephritisLung cancerNon-small cell lung cancerAnti-PD-1 antibodyAcute kidney injuryImmune checkpoint inhibitorsT cell immunityCell lung cancerLung cancer patientsClinical trial dataRenal toleranceCheckpoint inhibitorsKidney injuryDeath-1Kidney biopsyCancer patientsPatientsTrial dataTherapyAdverse effectsDrugsNephritis
2013
Nivolumab (anti-PD-1; BMS-936558; ONO-4538) in patients with advanced solid tumors: Survival and long-term safety in a phase I trial.
Topalian S, Sznol M, Brahmer J, McDermott D, Smith D, Gettinger S, Taube J, Drake C, Pardoll D, Powderly J, Carvajal R, Sosman J, Atkins M, Antonia S, Spigel D, Lawrence D, Kollia G, Gupta A, Wigginton J, Hodi F. Nivolumab (anti-PD-1; BMS-936558; ONO-4538) in patients with advanced solid tumors: Survival and long-term safety in a phase I trial. Journal Of Clinical Oncology 2013, 31: 3002-3002. DOI: 10.1200/jco.2013.31.15_suppl.3002.Peer-Reviewed Original ResearchAdvanced solid tumorsLong-term safetySolid tumorsNon-small cell lung cancerLong-term safety profileDrug-related AEsDrug-related pneumonitisCo-inhibitory receptorsPhase III trialsPhase I trialCell lung cancerOngoing clinical developmentActivated T cellsCohort expansionMedian OSRECIST 1.0Efficacy outcomesUnacceptable toxicityIII trialsDeath-1Dose escalationI trialPD-1G3/G4Safety profileSurvival and long-term follow-up of the phase I trial of nivolumab (Anti-PD-1; BMS-936558; ONO-4538) in patients (pts) with previously treated advanced non-small cell lung cancer (NSCLC).
Brahmer J, Horn L, Antonia S, Spigel D, Gandhi L, Sequist L, Sankar V, Ahlers C, Wigginton J, Kollia G, Gupta A, Gettinger S. Survival and long-term follow-up of the phase I trial of nivolumab (Anti-PD-1; BMS-936558; ONO-4538) in patients (pts) with previously treated advanced non-small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2013, 31: 8030-8030. DOI: 10.1200/jco.2013.31.15_suppl.8030.Peer-Reviewed Original ResearchNon-small cell lung cancerAdvanced non-small cell lung cancerPhase I trialOverall survivalMedian OSI trialCommon drug-related AEsDrug-related AEsMedian overall survivalPrior chemotherapy regimenAcceptable safety profilePhase 1 studyCell lung cancerPD-1 receptorImmune checkpoint receptorsDrug-related deathsT cell activationNSCLC ptsOS benefitChemotherapy regimenDose cohortsCheckpoint receptorsDeath-1Safety profileDiscontinuation criteria
2012
Anti-PD-1 (BMS-936558, MDX-1106) in patients with advanced solid tumors: Clinical activity, safety, and a potential biomarker for response.
Topalian S, Brahmer J, Hodi F, McDermott D, Smith D, Gettinger S, Taube J, Drake C, Pardoll D, Antonia S, Spigel D, Atkins M, Lawrence D, McDonald D, Jure-Kunkel M, Korman A, Kollia G, Gupta A, Wigginton J, Sznol M. Anti-PD-1 (BMS-936558, MDX-1106) in patients with advanced solid tumors: Clinical activity, safety, and a potential biomarker for response. Journal Of Clinical Oncology 2012, 30: cra2509-cra2509. DOI: 10.1200/jco.2012.30.18_suppl.cra2509.Peer-Reviewed Original ResearchPD-1/PD-L1 pathwayPD-L1 pathwayPotential predictive biomarkersBMS-936558Predictive biomarkersNon-small cell lung cancerPre-treatment tumor biopsiesCastrate-resistant prostate cancerCo-inhibitory receptorsPD-L1 expressionPD-1 ligandsCell lung cancerOverall tumor burdenActivated T cellsCohort expansionEvaluable ptsRECIST 1.0Advanced NSCLCMedian durationDeath-1PD-1PD-L1Therapy cyclesNew lesionsTumor burdenSafety, Activity, and Immune Correlates of Anti–PD-1 Antibody in Cancer
Topalian SL, Hodi FS, Brahmer JR, Gettinger SN, Smith DC, McDermott DF, Powderly JD, Carvajal RD, Sosman JA, Atkins MB, Leming PD, Spigel DR, Antonia SJ, Horn L, Drake CG, Pardoll DM, Chen L, Sharfman WH, Anders RA, Taube JM, McMiller TL, Xu H, Korman AJ, Jure-Kunkel M, Agrawal S, McDonald D, Kollia GD, Gupta A, Wigginton JM, Sznol M. Safety, Activity, and Immune Correlates of Anti–PD-1 Antibody in Cancer. New England Journal Of Medicine 2012, 366: 2443-2454. PMID: 22658127, PMCID: PMC3544539, DOI: 10.1056/nejmoa1200690.Peer-Reviewed Original ResearchConceptsAnti-PD-1 antibodyCell lung cancerRenal cell cancerObjective responseLung cancerAdverse eventsPD-L1Drug-related adverse eventsPD-1 ligand expressionCastration-resistant prostate cancerImmune-related causesPretreatment tumor specimensAdverse event profilePD-L1 expressionPD-1-PDCumulative response rateBMS-936558Immune correlatesL1 pathwayAdvanced melanomaComplete responseDeath-1PD-1Negative tumorsPositive tumors