2020
Multicenter Phase II Study of Cabazitaxel in Advanced Gastroesophageal Cancer: Association of HER2 Expression and M2-Like Tumor-Associated Macrophages with Patient Outcome
Shah MA, Enzinger P, Ko AH, Ocean AJ, Philip PA, Thakkar PV, Cleveland K, Lu Y, Kortmansky J, Christos PJ, Zhang C, Kaur N, Elmonshed D, Galletti G, Sarkar S, Bhinder B, Pittman ME, Plotnikova OM, Kotlov N, Frenkel F, Bagaev A, Elemento O, Betel D, Giannakakou P, Lenz HJ. Multicenter Phase II Study of Cabazitaxel in Advanced Gastroesophageal Cancer: Association of HER2 Expression and M2-Like Tumor-Associated Macrophages with Patient Outcome. Clinical Cancer Research 2020, 26: 4756-4766. PMID: 32641434, PMCID: PMC8209413, DOI: 10.1158/1078-0432.ccr-19-3920.Peer-Reviewed Original ResearchMeSH KeywordsAdenocarcinomaAdultAgedAged, 80 and overEsophageal NeoplasmsEsophagogastric JunctionFemaleGene AmplificationGene Expression Regulation, NeoplasticHumansKaplan-Meier EstimateMaleMiddle AgedProgression-Free SurvivalReceptor, ErbB-2Response Evaluation Criteria in Solid TumorsStomach NeoplasmsTaxoidsTumor-Associated MacrophagesConceptsProgression-free survivalMulticenter phase II studyPhase II studyPFS ratesII studyMacrophage signatureHER2 amplificationGastric cancerEfficacy targetAdvanced gastroesophageal cancerM2 macrophage signaturePrior taxane therapyCommon adverse eventsAdvanced gastric cancerMetastatic gastric cancerM2-like tumorImproved disease controlPrior therapyRECIST 1.1Taxane efficacyPrimary endpointTaxane therapyAdverse eventsGastroesophageal cancerMetastatic disease
2019
Phase IB/II Randomized Study of FOLFIRINOX Plus Pegylated Recombinant Human Hyaluronidase Versus FOLFIRINOX Alone in Patients With Metastatic Pancreatic Adenocarcinoma: SWOG S1313
Ramanathan RK, McDonough SL, Philip PA, Hingorani SR, Lacy J, Kortmansky JS, Thumar J, Chiorean EG, Shields AF, Behl D, Mehan PT, Gaur R, Seery T, Guthrie KA, Hochster HS. Phase IB/II Randomized Study of FOLFIRINOX Plus Pegylated Recombinant Human Hyaluronidase Versus FOLFIRINOX Alone in Patients With Metastatic Pancreatic Adenocarcinoma: SWOG S1313. Journal Of Clinical Oncology 2019, 37: jco.18.01295. PMID: 30817250, PMCID: PMC6494359, DOI: 10.1200/jco.18.01295.Peer-Reviewed Original ResearchConceptsMetastatic pancreatic cancerMedian overall survivalCombination armOverall survivalHazard ratioControl armPhase II open-label studyTreatment-related grade 3Adequate organ functionPhase II dosageOpen-label studyPrimary end pointMetastatic pancreatic adenocarcinomaOS hazard ratioHA statusDose-finding studyInterim futility analysisRecombinant human hyaluronidaseEnoxaparin prophylaxisThromboembolic eventsPerformance statusProlong survivalRandomized studyFutility analysisGood PS
2017
Phase II Study of Modified FOLFOX6 With Bevacizumab in Metastatic Gastroesophageal Adenocarcinoma
Li J, Yao X, Kortmansky JS, Fischbach NA, Stein S, Deng Y, Zhang Y, Doddamane I, Karimeddini D, Hochster HS, Lacy J. Phase II Study of Modified FOLFOX6 With Bevacizumab in Metastatic Gastroesophageal Adenocarcinoma. American Journal Of Clinical Oncology 2017, 40: 146-151. PMID: 25144267, DOI: 10.1097/coc.0000000000000114.Peer-Reviewed Original ResearchConceptsMetastatic gastroesophageal adenocarcinomaProgression-free survivalGastroesophageal adenocarcinomaOverall survivalTreatment-related grade 3/4 toxicityResponse rateMedian progression-free survivalProspective phase II trialLonger progression-free survivalCisplatin-based regimensConfirmed response rateEfficacy of bevacizumabFirst-line bevacizumabOxaliplatin-based regimenUntreated metastatic adenocarcinomaGrade 3/4 toxicitiesMedian overall survivalAddition of bevacizumabPhase II studyPhase II trialModified FOLFOX6GI perforationHemorrhagic eventsII trialII study
2016
Final analysis of a phase II study of modified FOLFIRINOX in locally advanced and metastatic pancreatic cancer
Stein SM, James ES, Deng Y, Cong X, Kortmansky JS, Li J, Staugaard C, Indukala D, Boustani AM, Patel V, Cha CH, Salem RR, Chang B, Hochster HS, Lacy J. Final analysis of a phase II study of modified FOLFIRINOX in locally advanced and metastatic pancreatic cancer. British Journal Of Cancer 2016, 114: 737-743. PMID: 27022826, PMCID: PMC4984865, DOI: 10.1038/bjc.2016.45.Peer-Reviewed Original ResearchMeSH KeywordsAdenocarcinomaAdultAgedAntineoplastic Combined Chemotherapy ProtocolsCamptothecinFemaleFluorouracilFollow-Up StudiesHumansIrinotecanLeucovorinLiver NeoplasmsLung NeoplasmsLymphatic MetastasisMaleMiddle AgedNeoplasm StagingOrganoplatinum CompoundsOxaliplatinPancreatic NeoplasmsPeritoneal NeoplasmsPrognosisProspective StudiesSurvival RateConceptsProgression-free survivalAdvanced pancreatic cancerPhase II studyOverall survivalAdverse eventsPancreatic cancerII studyResponse rateMedian progression-free survivalMulticentre phase II studyFluorodeoxyglucose positron emission tomographyUse of FOLFIRINOXMedian overall survivalHistorical control patientsMetastatic pancreatic cancerFirst prospective studyPositron emission tomographyControl patientsMetastatic diseaseProspective studyProspective dataFOLFIRINOXLAPCEmission tomographyPatients
2009
A Phase II Study of Flavopiridol (Alvocidib) in Combination with Docetaxel in Refractory, Metastatic Pancreatic Cancer
Carvajal RD, Tse A, Shah MA, Lefkowitz RA, Gonen M, Gilman-Rosen L, Kortmansky J, Kelsen DP, Schwartz GK, O'Reilly E. A Phase II Study of Flavopiridol (Alvocidib) in Combination with Docetaxel in Refractory, Metastatic Pancreatic Cancer. Pancreatology 2009, 9: 404-409. PMID: 19451750, PMCID: PMC4053191, DOI: 10.1159/000187135.Peer-Reviewed Original ResearchConceptsPhase II studyPancreatic adenocarcinomaII studyRisk/benefit equationGrade 3 diarrheaGrade 3 fatigueTransient stable diseaseGrade 4 neutropeniaMetastatic pancreatic adenocarcinomaMetastatic pancreatic cancerCombination of flavopiridolCell cycle dysregulationPrimary endpointStable diseaseMedian survivalObjective responseAdverse eventsPatient populationTumor sizePan-cyclinPancreatic cancerClinical activityTumor measurementsDose reductionPatients
2007
A phase I study of erlotinib in combination with gemcitabine and radiation in locally advanced, non-operable pancreatic adenocarcinoma
Duffy A, Kortmansky J, Schwartz G, Capanu M, Puleio S, Minsky B, Saltz L, O’Reilly E, Kelsen D. A phase I study of erlotinib in combination with gemcitabine and radiation in locally advanced, non-operable pancreatic adenocarcinoma. Annals Of Oncology 2007, 19: 86-91. PMID: 17878176, DOI: 10.1093/annonc/mdm441.Peer-Reviewed Original ResearchMeSH KeywordsAdenocarcinomaAdultAgedAntimetabolites, AntineoplasticAntineoplastic Combined Chemotherapy ProtocolsCombined Modality TherapyDeoxycytidineDisease ProgressionErlotinib HydrochlorideFemaleGemcitabineHumansMaleMaximum Tolerated DoseMiddle AgedNeutropeniaPancreatic NeoplasmsProtein Kinase InhibitorsQuinazolinesRadiotherapy, AdjuvantSurvival AnalysisThrombocytopeniaTreatment OutcomeConceptsDose level 1Radiation therapyDaily erlotinibAdvanced pancreas cancerDose level 2Dose of erlotinibGemcitabine-based chemoradiationMTD of erlotinibAdvanced pancreatic cancerElevated liver enzymesPartial response rateDose-limiting toxicityPoor prognostic cancerDose delaysDose gemcitabineGemcitabine 1000Stable diseaseWeekly gemcitabineMedian survivalOverall survivalAdditional patientsPancreas cancerPancreatic cancerPancreatic adenocarcinomaLiver enzymes