2020
Phase 1 Trial of Pembrolizumab Administered Concurrently With Chemoradiotherapy for Locally Advanced Non–Small Cell Lung Cancer
Jabbour SK, Berman AT, Decker RH, Lin Y, Feigenberg SJ, Gettinger SN, Aggarwal C, Langer CJ, Simone CB, Bradley JD, Aisner J, Malhotra J. Phase 1 Trial of Pembrolizumab Administered Concurrently With Chemoradiotherapy for Locally Advanced Non–Small Cell Lung Cancer. JAMA Oncology 2020, 6: 848-855. PMID: 32077891, PMCID: PMC7042914, DOI: 10.1001/jamaoncol.2019.6731.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalCarboplatinCarcinoma, Non-Small-Cell LungChemoradiotherapyFemaleHumansImmune Checkpoint InhibitorsLung NeoplasmsMaleMiddle AgedNeoplasm StagingPaclitaxelProgrammed Cell Death 1 ReceptorTreatment OutcomeConceptsNon-small cell lung cancerProgression-free survivalStage III non-small cell lung cancerMedian progression-free survivalDose of pembrolizumabSafety expansion cohortPD-1 inhibitionCell lung cancerExpansion cohortLung cancerDay 29Eastern Cooperative Oncology Group performance status 0Advanced non-small cell lung cancerDay 1Cell death 1 (PD-1) inhibitionDeath ligand 1 (PD-L1) inhibitionDose-limiting toxic effectDeath-1 (PD-1) inhibitionDoses of pembrolizumabGrade 5 pneumonitisLeast grade 4Performance status 0PD-1 inhibitorsPhase 1 trialLeast grade 3
2019
Prospective phase I multi-institutional trial of PD-1 blockade with pembrolizumab during concurrent chemoradiation for locally advanced, unresectable non-small cell lung cancer.
Jabbour S, Berman A, Decker R, Lin Y, Feigenberg S, Gettinger S, Aggarwal C, Langer C, Simone C, Bradley J, Aisner J, Malhotra J. Prospective phase I multi-institutional trial of PD-1 blockade with pembrolizumab during concurrent chemoradiation for locally advanced, unresectable non-small cell lung cancer. Journal Of Clinical Oncology 2019, 37: 8511-8511. DOI: 10.1200/jco.2019.37.15_suppl.8511.Peer-Reviewed Original ResearchImmune-related adverse eventsStage III NSCLCDose limiting toxicitiesChemoradiation therapyPD-1iDay 29Unresectable non-small cell lung cancerDay 1Prospective phase I clinical trialNon-small cell lung cancerDeath ligand 1 (PD-L1) inhibitionPhase I clinical trialDefinitive chemoradiation therapyGrade 3 hyperglycemiaPD-1 blockadeFurther prospective studiesCell lung cancerMulti-institutional trialDose cohortsMedian PFSQ3 weeksConcurrent chemoradiationDefinitive RTAdverse eventsInterstitial nephritis
2015
Phase 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 dose