2021
Tandem high-dose influenza vaccination is associated with more durable serologic immunity in patients with plasma cell dyscrasias
Branagan AR, Duffy E, Gan G, Li F, Foster C, Verma R, Zhang L, Parker TL, Seropian S, Cooper DL, Brandt D, Kortmansky J, Witt D, Ferencz TM, Dhodapkar KM, Dhodapkar MV. Tandem high-dose influenza vaccination is associated with more durable serologic immunity in patients with plasma cell dyscrasias. Blood Advances 2021, 5: 1535-1539. PMID: 33683337, PMCID: PMC7948269, DOI: 10.1182/bloodadvances.2020003880.Peer-Reviewed Original ResearchConceptsHigh-dose influenza vaccinationPlasma cell dyscrasiaInfluenza vaccinationProtective immunityCell dyscrasiaPCD patientsPlacebo-controlled clinical trialHigh-dose vaccinationHigh-dose vaccineInfluenza-specific immunityBurden of influenzaSaline placebo injectionsAge-based vaccinationHigher seroprotectionSerologic immunityPlacebo injectionsVaccine strategiesTiter responseClinical trialsFlu seasonPatientsVaccinationImmunityNovel coronavirusSeroprotection
2020
A phase 1b expansion study of TAS‐102 with oxaliplatin for refractory metastatic colorectal cancer
Cecchini M, Kortmansky JS, Cui C, Wei W, Thumar JR, Uboha NV, Hafez N, Lacy J, Fischbach NA, Sabbath KD, Gomez CM, Sporn JR, Stein S, Hochster HS. A phase 1b expansion study of TAS‐102 with oxaliplatin for refractory metastatic colorectal cancer. Cancer 2020, 127: 1417-1424. PMID: 33351187, PMCID: PMC8085021, DOI: 10.1002/cncr.33379.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsColorectal NeoplasmsDrug Administration ScheduleDrug CombinationsDrug Resistance, NeoplasmFemaleFluorouracilHumansIrinotecanLeucovorinMaleMiddle AgedOrganoplatinum CompoundsOxaliplatinProgression-Free SurvivalPyrrolidinesResponse Evaluation Criteria in Solid TumorsThymineTrifluridineConceptsMetastatic colorectal cancerOverall response rateRefractory metastatic colorectal cancerProgression-free survivalTAS-102Colorectal cancerDay 1Primary endpointOverall survivalDose escalationDay 5Median progression-free survivalPhase 1b studyMedian overall survivalResponse Evaluation CriteriaTreat populationDose expansionPartial responseStandard dosesUnexpected side effectsStudy treatmentTumor shrinkageUnexpected toxicitiesSide effectsNovel antimetaboliteMulticenter 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
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
2006
A phase II clinical and pharmacodynamic study of temsirolimus in advanced neuroendocrine carcinomas
Duran I, Kortmansky J, Singh D, Hirte H, Kocha W, Goss G, Le L, Oza A, Nicklee T, Ho J, Birle D, Pond G, Arboine D, Dancey J, Aviel-Ronen S, Tsao M, Hedley D, Siu L. A phase II clinical and pharmacodynamic study of temsirolimus in advanced neuroendocrine carcinomas. British Journal Of Cancer 2006, 95: 1148-1154. PMID: 17031397, PMCID: PMC2360568, DOI: 10.1038/sj.bjc.6603419.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic AgentsCarcinoid TumorCarcinoma, NeuroendocrineDisease ProgressionExanthemaFatigueFemaleFollow-Up StudiesHumansHyperglycemiaInfusions, IntravenousMaleMiddle AgedPancreatic NeoplasmsPhosphorylationProtein KinasesProto-Oncogene Proteins c-aktRibosomal Protein S6SirolimusSurvival AnalysisTOR Serine-Threonine KinasesTreatment OutcomeConceptsAdvanced neuroendocrine carcinomaNeuroendocrine carcinomaAdverse eventsOverall survivalFrequent drug-related adverse eventsDrug-related adverse eventsRash/desquamationTreat response ratePhase II studyPercentage of patientsHigher baseline levelsII studyWeekly dosesNeuroendocrine tumorsTumor responsePharmacodynamic analysisPharmacodynamic studiesTumor biopsiesTemsirolimusResponse rateBaseline levelsPatientsPathway downregulationArchival specimensPhosphorylation of S6
2005
A Phase I Clinical Trial of the Sequential Combination of Irinotecan Followed by Flavopiridol
Shah MA, Kortmansky J, Motwani M, Drobnjak M, Gonen M, Yi S, Weyerbacher A, Cordon-Cardo C, Lefkowitz R, Brenner B, O'Reilly E, Saltz L, Tong W, Kelsen DP, Schwartz GK. A Phase I Clinical Trial of the Sequential Combination of Irinotecan Followed by Flavopiridol. Clinical Cancer Research 2005, 11: 3836-3845. PMID: 15897584, DOI: 10.1158/1078-0432.ccr-04-2651.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Combined Chemotherapy ProtocolsBilirubinCamptothecinCell Cycle ProteinsCyclin-Dependent Kinase Inhibitor p21Drug Administration ScheduleDrug InteractionsFemaleFlavonoidsHumansIntracellular Signaling Peptides and ProteinsIrinotecanMaleMaximum Tolerated DoseMiddle AgedNeoplasmsPiperidinesTreatment OutcomeTumor Suppressor Protein p53ConceptsCombination therapyCycle 1 dose-limiting toxicitiesPhase I clinical trialDose-limiting diarrheaPhase II dosePosttreatment tumor biopsiesSignificant pharmacokinetic interactionsAdvanced solid tumorsDose-limiting toxicityPhase I trialBaseline serum bilirubinColorectal cancer xenograftsWild-type p53 tumorsMumol/LBaseline bilirubinFlavopiridol concentrationsStable diseasePartial responseI trialPharmacokinetic interactionsSerum bilirubinDifferentiation-related gene-1Responsive diseaseHepatocellular cancerCancer xenograftsPhase I Trial of the Cyclin-Dependent Kinase Inhibitor and Protein Kinase C Inhibitor 7-Hydroxystaurosporine in Combination With Fluorouracil in Patients With Advanced Solid Tumors
Kortmansky J, Shah MA, Kaubisch A, Weyerbacher A, Yi S, Tong W, Sowers R, Gonen M, O'Reilly E, Kemeny N, Ilson DI, Saltz LB, Maki RG, Kelsen DP, Schwartz GK. Phase I Trial of the Cyclin-Dependent Kinase Inhibitor and Protein Kinase C Inhibitor 7-Hydroxystaurosporine in Combination With Fluorouracil in Patients With Advanced Solid Tumors. Journal Of Clinical Oncology 2005, 23: 1875-1884. PMID: 15699481, DOI: 10.1200/jco.2005.03.116.Peer-Reviewed Original ResearchConceptsPeripheral blood mononuclear cellsMononuclear cellsPlasma concentrationsProtein kinase C inhibitorMean maximal plasma concentrationUCN-01Kinase C inhibitorPhase I clinical trialPhase II doseAdvanced solid tumorsPhase II trialMaximal plasma concentrationSignificant interpatient variabilityReverse transcriptase-polymerase chain reactionAlpha-1-acid glycoproteinC inhibitorFibonacci designFU dosePrior fluoropyrimidinesStable diseaseCyclin-dependent kinase inhibitorII trialObjective responseWeekly infusionsI trial
1995
Quality of Life in Phase II Trials: a Study of Methodology and Predictive Value in Patients With Advanced Breast Cancer Treated With Paclitaxel Plus Granulocyte Colony-Stimulating Factor
Seidman A, Portenoy R, Yao T, Lepore J, Mont E, Kortmansky J, Onetto N, Ren L, Grechko J, Beltangady M, Usakewicz J, Southrada M, Houston C, McCabe M, Salvaggio R, Thaler H, Norton L. Quality of Life in Phase II Trials: a Study of Methodology and Predictive Value in Patients With Advanced Breast Cancer Treated With Paclitaxel Plus Granulocyte Colony-Stimulating Factor. Journal Of The National Cancer Institute 1995, 87: 1316-1322. PMID: 7544834, DOI: 10.1093/jnci/87.17.1316.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerQuality of lifePhase II clinical trialStandard prognostic factorsGranulocyte colony-stimulating factorTumor responseBreast cancerColony-stimulating factorPrognostic factorsLife scoresSerial assessmentClinical trialsLife instrumentsGrade 4 nonhematologic toxicityLife assessmentRecombinant human granulocyte colony-stimulating factorStandard prognostic indicatorsAdvanced breast cancerPhase II trialExtent of diseaseMajority of patientsPartial tumor responseExtensive prior chemotherapyHuman granulocyte colony-stimulating factorBase-line scores