2024
Phase II Trial of Afatinib in Patients With EGFR-Mutated Solid Tumors Excluding Lung Cancer: Results From NCI-MATCH ECOG-ACRIN Trial (EAY131) Subprotocol A
Gettinger S, Song Z, Reckamp K, Moscow J, Gray R, Wang V, McShane L, Rubinstein L, Patton D, Williams P, Hamilton S, Kong X, Tricoli J, Conley B, Arteaga C, Harris L, O'Dwyer P, Chen A, Flaherty K. Phase II Trial of Afatinib in Patients With EGFR-Mutated Solid Tumors Excluding Lung Cancer: Results From NCI-MATCH ECOG-ACRIN Trial (EAY131) Subprotocol A. JCO Precision Oncology 2024, 8: e2300725. PMID: 38986051, DOI: 10.1200/po.23.00725.Peer-Reviewed Original ResearchMeSH KeywordsAdultAfatinibAgedAged, 80 and overErbB ReceptorsFemaleHumansMaleMiddle AgedMutationNeoplasmsConceptsProgression-free survivalTyrosine kinase inhibitorsEGFR tyrosine kinase inhibitorsNCI-MATCHLung cancerGlioblastoma multiformeOverall survivalAdvanced non-small cell lung cancerNational Cancer Institute-Molecular AnalysisNon-small cell lung cancerEnd pointsTumor genomic testingTrial primary end pointPhase 2 trialPhase II trialSecondary end pointsPrimary end pointCell lung cancerCohort of patientsMedian OSStable diseaseAdenosquamous carcinomaProtocol therapyPartial responseArm A
2021
NTRK1 Fusions identified by non-invasive plasma next-generation sequencing (NGS) across 9 cancer types
Rolfo C, Drilon A, Hong D, McCoach C, Dowlati A, Lin JJ, Russo A, Schram AM, Liu SV, Nieva JJ, Nguyen T, Eshaghian S, Morse M, Gettinger S, Mobayed M, Goldberg S, Araujo-Mino E, Vidula N, Bardia A, Subramanian J, Sashital D, Stinchcombe T, Kiedrowski L, Price K, Gandara DR. NTRK1 Fusions identified by non-invasive plasma next-generation sequencing (NGS) across 9 cancer types. British Journal Of Cancer 2021, 126: 514-520. PMID: 34480094, PMCID: PMC8811064, DOI: 10.1038/s41416-021-01536-1.Peer-Reviewed Original ResearchConceptsPlasma next-generation sequencingNTRK1 fusionsTumor typesAdvanced-stage solid tumorsNTRK fusion-positive tumorsTarget resistance mechanismsTissue-based testingHigh positive predictive valuePrimary tumor typeIdentification of patientsNon-invasive screening methodNext-generation sequencingFusion-positive tumorsPositive predictive valueDurable responsesPediatric patientsNTRK fusionsDrivers of carcinogenesisClinical dataTRK inhibitorsClinical practiceCtDNA analysisPredictive valueSolid tumorsOncogenic driversClinical characteristics and outcomes of splenic infarction in cancer patients: a retrospective, single center report of 206 cases
Bewersdorf JP, Parmar N, Israel GM, Gettinger SN, Lee AI. Clinical characteristics and outcomes of splenic infarction in cancer patients: a retrospective, single center report of 206 cases. Journal Of Thrombosis And Thrombolysis 2021, 52: 854-862. PMID: 33765243, DOI: 10.1007/s11239-021-02428-0.Peer-Reviewed Original ResearchConceptsAtrial fibrillation/flutterSplenic infarctCancer patientsThromboembolic eventsRisk factorsHigh riskExact testMultivariable logistic regression modelYale-New Haven HospitalRetrospective cohort studyThromboembolic risk factorsUse of anticoagulationVenous thromboembolic eventsSingle-center reportsΧ2 testLow platelet countFisher's exact testNew Haven HospitalMultivariable regression modelsLow recurrence riskLogistic regression modelsPearson χ2 testAnticoagulation useClinical characteristicsCohort study
2020
Yale Cancer Center Precision Medicine Tumor Board: new technology, new drugs, and the value of repeat testing
Hafez N, Walther Z, Eder JP, Sklar JL, Gettinger SN, Finberg KE, Goldberg SB. Yale Cancer Center Precision Medicine Tumor Board: new technology, new drugs, and the value of repeat testing. The Lancet Oncology 2020, 21: 343-344. PMID: 32950226, DOI: 10.1016/s1470-2045(20)30010-3.Peer-Reviewed Case Reports and Technical Notes
2019
Incidence of pancreatitis with the use of immune checkpoint inhibitors (ICI) in advanced cancers: A systematic review and meta-analysis
George J, Bajaj D, Sankaramangalam K, Yoo JW, Joshi NS, Gettinger S, Price C, Farrell JJ. Incidence of pancreatitis with the use of immune checkpoint inhibitors (ICI) in advanced cancers: A systematic review and meta-analysis. Pancreatology 2019, 19: 587-594. PMID: 31076344, DOI: 10.1016/j.pan.2019.04.015.Peer-Reviewed Original ResearchConceptsImmune checkpoint inhibitorsIncidence of pancreatitisImmune side effectsPD-1 inhibitorsLipase elevationCheckpoint inhibitorsClinical trialsSide effectsSystematic reviewCTLA-4 agentsGrade 2 pancreatitisCTLA-4 inhibitorsLong-term complicationsNon-melanoma cancersICI combinationsICI useTerm complicationsAdvanced cancerTrue incidenceCTLA-4Appropriate treatmentPancreatitisSolid tumorsTumor typesPatients
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 therapyCollateral 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 riskPatientsDiabetesCancerInhibitorsKetoacidosisAutoimmuneAutoantibodiesPancreatitisComplicationsSyndrome
2017
Immuno-thermal ablations – boosting the anticancer immune response
Slovak R, Ludwig JM, Gettinger SN, Herbst RS, Kim HS. Immuno-thermal ablations – boosting the anticancer immune response. Journal For ImmunoTherapy Of Cancer 2017, 5: 78. PMID: 29037259, PMCID: PMC5644150, DOI: 10.1186/s40425-017-0284-8.Peer-Reviewed Original ResearchConceptsImmune responseImmune effectsRobust antitumor responseAnticancer immune responseImmune modulating drugsUse of immunomodulationSystemic antitumor activityCheckpoint blockadeAntitumor responseAblative therapyCombination therapyRadiofrequency ablationAblative techniquesModulating drugsAnimal modelsAntitumor activityThermal ablationTherapeutic appealImmunomodulationTherapyAblationResponseMonotherapyImmunomodulatorsCryoablation
2015
An Advanced Practice Nurse Coordinated Multidisciplinary Intervention for Patients with Late-Stage Cancer: A Cluster Randomized Trial
McCorkle R, Jeon S, Ercolano E, Lazenby M, Reid A, Davies M, Viveiros D, Gettinger S. An Advanced Practice Nurse Coordinated Multidisciplinary Intervention for Patients with Late-Stage Cancer: A Cluster Randomized Trial. Journal Of Palliative Medicine 2015, 18: 962-969. PMID: 26305992, PMCID: PMC4638201, DOI: 10.1089/jpm.2015.0113.Peer-Reviewed Original ResearchConceptsLate-stage cancerSelf-reported clinical outcomesSecondary outcomesPalliative carePatient outcomesMonths postbaselinePrimary patient-reported outcomesEarly palliative careComprehensive cancer carePatient-reported outcomesAdvanced practice nursesWhole patient careLinear mixed model analysisUsual carePrimary outcomeClinical outcomesMultidisciplinary clinicPractice nursesCancer careClinic levelMultidisciplinary interventionTrial designMixed model analysisGeneral linear mixed model analysisTranslational studiesPrecipitation of Autoimmune Diabetes With Anti-PD-1 Immunotherapy
Hughes J, Vudattu N, Sznol M, Gettinger S, Kluger H, Lupsa B, Herold KC. Precipitation of Autoimmune Diabetes With Anti-PD-1 Immunotherapy. Diabetes Care 2015, 38: e55-e57. PMID: 25805871, PMCID: PMC4370325, DOI: 10.2337/dc14-2349.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsPhase 1b study of the mammalian target of rapamycin inhibitor sirolimus in combination with nanoparticle albumin–bound paclitaxel in patients with advanced solid tumors
Abu-Khalaf MM, Baumgart MA, Gettinger SN, Doddamane I, Tuck DP, Hou S, Chen N, Sullivan C, Lezon-Geyda K, Zelterman D, Hatzis C, Deshpande H, Digiovanna MP, Azodi M, Schwartz PE, Harris LN. Phase 1b study of the mammalian target of rapamycin inhibitor sirolimus in combination with nanoparticle albumin–bound paclitaxel in patients with advanced solid tumors. Cancer 2015, 121: 1817-1826. PMID: 25649370, DOI: 10.1002/cncr.29254.Peer-Reviewed Original ResearchConceptsDose-limiting toxicityIntravenous nab-paclitaxelPhase 1b studyAdvanced solid tumorsNab-paclitaxelFDG activityDay 1Solid tumorsNanoparticle albumin-bound paclitaxelMammalian targetWeekly oral doseAcceptable safety profileRapamycin inhibitor sirolimusAlbumin-bound paclitaxelClinical trial endpointsExploratory gene expression analysisPositron emission tomographyStable diseaseTaxane therapyPartial responseWeekly doseComplete responseOral sirolimusPharmacodynamic assessmentOral doseCombination Therapy with Anti–CTLA-4 and Anti–PD-1 Leads to Distinct Immunologic Changes In Vivo
Das R, Verma R, Sznol M, Boddupalli CS, Gettinger SN, Kluger H, Callahan M, Wolchok JD, Halaban R, Dhodapkar MV, Dhodapkar KM. Combination Therapy with Anti–CTLA-4 and Anti–PD-1 Leads to Distinct Immunologic Changes In Vivo. The Journal Of Immunology 2015, 194: 950-959. PMID: 25539810, PMCID: PMC4380504, DOI: 10.4049/jimmunol.1401686.Peer-Reviewed Original ResearchMeSH KeywordsAntibodies, MonoclonalAntigens, SurfaceAntineoplastic Combined Chemotherapy ProtocolsCTLA-4 AntigenCytokinesGene Expression ProfilingGene Expression Regulation, NeoplasticHumansImmunophenotypingIpilimumabLymphocytes, Tumor-InfiltratingNeoplasmsNivolumabProgrammed Cell Death 1 ReceptorSignal TransductionT-Lymphocyte SubsetsConceptsPD-1T cellsCTLA-4Checkpoint blockadeCombination therapyReceptor occupancyCombination immune checkpoint blockadeCTLA-4 immune checkpointsPD-1 receptor occupancyTransitional memory T cellsAnti-PD-1 therapyAnti CTLA-4Immune-based combinationsPD-1 blockadeSoluble IL-2RImmune checkpoint blockadeNK cell functionMemory T cellsTherapy-induced changesT cell activationTumor T cellsHuman T cellsRemarkable antitumor effectImmunologic changesImmunologic effects
2014
Predictive correlates of response to the anti-PD-L1 antibody MPDL3280A in cancer patients
Herbst RS, Soria JC, Kowanetz M, Fine GD, Hamid O, Gordon MS, Sosman JA, McDermott DF, Powderly JD, Gettinger SN, Kohrt HE, Horn L, Lawrence DP, Rost S, Leabman M, Xiao Y, Mokatrin A, Koeppen H, Hegde PS, Mellman I, Chen DS, Hodi FS. Predictive correlates of response to the anti-PD-L1 antibody MPDL3280A in cancer patients. Nature 2014, 515: 563-567. PMID: 25428504, PMCID: PMC4836193, DOI: 10.1038/nature14011.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedB7-H1 AntigenBiomarkersChemokine CX3CL1Clinical ProtocolsCTLA-4 AntigenDisease-Free SurvivalFemaleGene Expression Regulation, NeoplasticHumansImmunotherapyLymphocytes, Tumor-InfiltratingMaleMiddle AgedNeoplasmsTreatment OutcomeYoung Adult
2013
Phase I Study of the Hedgehog Pathway Inhibitor IPI-926 in Adult Patients with Solid Tumors
Jimeno A, Weiss GJ, Miller WH, Gettinger S, Eigl BJ, Chang AL, Dunbar J, Devens S, Faia K, Skliris G, Kutok J, Lewis KD, Tibes R, Sharfman WH, Ross RW, Rudin CM. Phase I Study of the Hedgehog Pathway Inhibitor IPI-926 in Adult Patients with Solid Tumors. Clinical Cancer Research 2013, 19: 2766-2774. PMID: 23575478, PMCID: PMC3694426, DOI: 10.1158/1078-0432.ccr-12-3654.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAlanine TransaminaseAlopeciaArea Under CurveAspartate AminotransferasesDose-Response Relationship, DrugDrug Administration ScheduleFatigueFemaleFollow-Up StudiesHedgehog ProteinsHumansMaleMetabolic Clearance RateMiddle AgedNauseaNeoplasmsSignal TransductionSpasmTreatment OutcomeVeratrum AlkaloidsConceptsBasal cell carcinomaDose-limiting toxicityInhibitor-naïve patientsIPI-926Alanine aminotransferaseSolid tumorsAspartate aminotransferaseAccelerated titration scheduleDose-escalation cohortsPhase II doseResponse Evaluation CriteriaSingle-agent activityHuman phase ISolid Tumors assessmentHematologic toxicityStarting doseAdult patientsStandard therapyMuscle spasmTitration scheduleReversible elevationCell carcinomaQD dosingTumor assessmentPharmacokinetic profile
2012
Safety, 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
2011
HER-1, 2, and 3
Gettinger S. HER-1, 2, and 3. Journal Of Thoracic Oncology 2011, 6: s1793-s1796. PMID: 22005533, DOI: 10.1097/01.jto.0000407561.68910.a1.Peer-Reviewed Original Research
2010
Phase 1 Study of Aflibercept Administered Subcutaneously to Patients with Advanced Solid Tumors
Tew WP, Gordon M, Murren J, Dupont J, Pezzulli S, Aghajanian C, Sabbatini P, Mendelson D, Schwartz L, Gettinger S, Psyrri A, Cedarbaum JM, Spriggs DR. Phase 1 Study of Aflibercept Administered Subcutaneously to Patients with Advanced Solid Tumors. Clinical Cancer Research 2010, 16: 358-366. PMID: 20028764, PMCID: PMC4211604, DOI: 10.1158/1078-0432.ccr-09-2103.Peer-Reviewed Original ResearchConceptsAdvanced solid tumorsSolid tumorsDrug-related grade 3Vascular endothelial growth factor trapDose of afliberceptDose-escalation studyDose-proportional increaseInjection site reactionsPhase 1 studyManageable side effectsVascular endothelial growth factorWarrants further evaluationFavorable pharmacokinetic profileProgression of diseaseNovel antiangiogenic agentsEndothelial growth factorCommon toxicitiesStable diseasePulmonary embolismCerebral ischemiaSubcutaneous dosesSafety profileSingle doseSite reactionsSubcutaneous formulation