2018
FIR: Efficacy, Safety, and Biomarker Analysis of a Phase II Open-Label Study of Atezolizumab in PD-L1–Selected Patients With NSCLC
Spigel DR, Chaft JE, Gettinger S, Chao BH, Dirix L, Schmid P, Chow LQM, Hicks RJ, Leon L, Fredrickson J, Kowanetz M, Sandler A, Funke R, Rizvi NA. FIR: Efficacy, Safety, and Biomarker Analysis of a Phase II Open-Label Study of Atezolizumab in PD-L1–Selected Patients With NSCLC. Journal Of Thoracic Oncology 2018, 13: 1733-1742. PMID: 29775807, PMCID: PMC7455890, DOI: 10.1016/j.jtho.2018.05.004.Peer-Reviewed Original ResearchConceptsTreatment-related adverse eventsObjective response ratePD-L1 expressionAdverse eventsCohort 1Immune cell PD-L1 expressionInvestigator-assessed objective response ratePhase II open-label studyResponse rateIC PD-L1 expressionTumor cellsBaseline tumor samplesOpen-label studyPhase II studyProgression-free survivalResponse Evaluation CriteriaDuration of responseAtezolizumab monotherapyAdvanced NSCLCBrain metastasesMonotherapy studiesPrimary endpointSecondary endpointsII studyOverall survival
2017
A phase Ib/II study of cabozantinib (XL184) with or without erlotinib in patients with non-small cell lung cancer
Wakelee HA, Gettinger S, Engelman J, Jänne PA, West H, Subramaniam DS, Leach J, Wax M, Yaron Y, Miles DR, Lara PN. A phase Ib/II study of cabozantinib (XL184) with or without erlotinib in patients with non-small cell lung cancer. Cancer Chemotherapy And Pharmacology 2017, 79: 923-932. PMID: 28352985, PMCID: PMC5403837, DOI: 10.1007/s00280-017-3283-z.Peer-Reviewed Original ResearchConceptsObjective response ratePhase Ib/II studyII studyPhase INon-small cell lung cancerFrequent dose-limiting toxicityPhase IIDose of cabozantinibDose-limiting toxicityResultsSixty-four patientsCell lung cancerMulti-kinase inhibitorProgressive NSCLCStable diseaseCombination armPartial responseFrequent AEsErlotinib treatmentLung cancerEGFR mutationsErlotinib pharmacokineticsCabozantinibPatientsPrimary objectiveResponse rate
2015
Clinical activity and safety from a phase II study (FIR) of MPDL3280A (anti-PDL1) in PD-L1–selected patients with non-small cell lung cancer (NSCLC).
Spigel D, Chaft J, Gettinger S, Chao B, Dirix L, Schmid P, Chow L, Chappey C, Kowanetz M, Sandler A, Funke R, Rizvi N. Clinical activity and safety from a phase II study (FIR) of MPDL3280A (anti-PDL1) in PD-L1–selected patients with non-small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2015, 33: 8028-8028. DOI: 10.1200/jco.2015.33.15_suppl.8028.Peer-Reviewed Original Research
2010
Activity of IPI-504, a Novel Heat-Shock Protein 90 Inhibitor, in Patients With Molecularly Defined Non–Small-Cell Lung Cancer
Sequist LV, Gettinger S, Senzer NN, Martins RG, Jänne PA, Lilenbaum R, Gray JE, Iafrate AJ, Katayama R, Hafeez N, Sweeney J, Walker JR, Fritz C, Ross RW, Grayzel D, Engelman JA, Borger DR, Paez G, Natale R. Activity of IPI-504, a Novel Heat-Shock Protein 90 Inhibitor, in Patients With Molecularly Defined Non–Small-Cell Lung Cancer. Journal Of Clinical Oncology 2010, 28: 4953-4960. PMID: 20940188, PMCID: PMC4676802, DOI: 10.1200/jco.2010.30.8338.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAnaplastic Lymphoma KinaseBenzoquinonesCarcinoma, Non-Small-Cell LungErbB ReceptorsFemaleGene RearrangementHSP90 Heat-Shock ProteinsHumansLactams, MacrocyclicLung NeoplasmsMaleMiddle AgedMutationProspective StudiesProtein-Tyrosine KinasesReceptor Protein-Tyrosine KinasesConceptsObjective response rateProgression-free survivalCell lung cancerIPI-504Lung cancerEpidermal growth factor receptor tyrosine kinase inhibitor therapyUnited States cancer centersTyrosine kinase inhibitor therapyState Cancer CenterCommon adverse eventsLiver function abnormalitiesPhase II studyOverall study populationKinase inhibitor therapyHeat shock protein 90 inhibitorNovel heat shock protein 90 inhibitorALK gene rearrangementStable diseaseAdvanced NSCLCAdverse eventsFunction abnormalitiesII studyPartial responseInhibitor therapyPrimary outcomeA phase Ib/II study of XL184 (BMS 907351) with and without erlotinib (E) in patients (pts) with non-small cell lung cancer (NSCLC).
Wakelee H, Gettinger S, Engelman J, Janne P, West H, Subramaniam D, Leach J, Wax M, Yaron Y, Lara P. A phase Ib/II study of XL184 (BMS 907351) with and without erlotinib (E) in patients (pts) with non-small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2010, 28: 3017-3017. DOI: 10.1200/jco.2010.28.15_suppl.3017.Peer-Reviewed Original ResearchPhase I/II Study of Inhaled Doxorubicin Combined with Platinum-Based Therapy for Advanced Non–Small Cell Lung Cancer
Otterson GA, Villalona-Calero MA, Hicks W, Pan X, Ellerton JA, Gettinger SN, Murren JR. Phase I/II Study of Inhaled Doxorubicin Combined with Platinum-Based Therapy for Advanced Non–Small Cell Lung Cancer. Clinical Cancer Research 2010, 16: 2466-2473. PMID: 20371682, PMCID: PMC4262532, DOI: 10.1158/1078-0432.ccr-09-3015.Peer-Reviewed Original ResearchMeSH KeywordsAdenocarcinomaAdministration, InhalationAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Large CellCarcinoma, Non-Small-Cell LungCarcinoma, Squamous CellCisplatinDocetaxelDoxorubicinFemaleHumansLung NeoplasmsMaleMaximum Tolerated DoseMiddle AgedSurvival RateTaxoidsTreatment OutcomeConceptsNon-small cell lung cancerCell lung cancerAdvanced non-small cell lung cancerDose-limiting toxicityLung cancerEvaluable patientsPhase I/II studyDose level 1Phase II dosePulmonary function testsDoses of cisplatinStable diseaseII studyProgressive diseaseExpiratory volumePulmonary functionFunction testsVital capacityPulmonary toxicityAdequate organPatientsCancerLevel 1Phase ILevel 2
2009
Axitinib: The evidence of its potential in the treatment of advanced thyroid cancer
Deshpande HA, Gettinger S, Sosa JA. Axitinib: The evidence of its potential in the treatment of advanced thyroid cancer. Core Evidence 2009, Volume 4: 43-48. PMID: 20694064, PMCID: PMC2899774, DOI: 10.2147/ce.s5996.Peer-Reviewed Original ResearchThyroid cancerVascular endothelial growth factor receptor 1Common grade 3Refractory thyroid cancerUse of axitinibGood tolerability profilePhase II studyAdvanced thyroid cancerGrowth factor receptor 1Greater side effectsFactor receptor 1Growth factor receptorStable diseaseTolerability profileII studyHistological typeCancer deathGrade 3New small molecule inhibitorsRare diseaseSide effectsSmall molecule inhibitorsResponse rateNew treatmentsReceptor 1