2024
Pembrolizumab Plus Binimetinib With or Without Chemotherapy for MSS/pMMR Metastatic Colorectal Cancer: Outcomes From KEYNOTE-651 Cohorts A, C, and E
Chen E, Kavan P, Tehfe M, Kortmansky J, Sawyer M, Chiorean E, Lieu C, Polite B, Wong L, Fakih M, Spencer K, Chaves J, Li C, Leconte P, Adelberg D, Kim R. Pembrolizumab Plus Binimetinib With or Without Chemotherapy for MSS/pMMR Metastatic Colorectal Cancer: Outcomes From KEYNOTE-651 Cohorts A, C, and E. Clinical Colorectal Cancer 2024, 23: 183-193. PMID: 38653648, DOI: 10.1016/j.clcc.2024.03.002.Peer-Reviewed Original ResearchObjective response rateMetastatic colorectal cancerCohort ACohort CCohort EDose escalationInvestigator-assessed objective response rateColorectal cancerResponse rateModified toxicity probability interval designDose reductionSafety findingsPrimary endpointPembrolizumabBinimetinibLeucovorinE. CONCLUSIONSChemotherapyPatientsCohortIrinotecanOxaliplatinCancerInterval designWeeksPembrolizumab Plus mFOLFOX7 or FOLFIRI for Microsatellite Stable/Mismatch Repair-Proficient Metastatic Colorectal Cancer: KEYNOTE-651 Cohorts B and D
Kim R, Tehfe M, Kavan P, Chaves J, Kortmansky J, Chen E, Lieu C, Wong L, Fakih M, Spencer K, Zhao Q, Predoiu R, Li C, Leconte P, Adelberg D, Chiorean E. Pembrolizumab Plus mFOLFOX7 or FOLFIRI for Microsatellite Stable/Mismatch Repair-Proficient Metastatic Colorectal Cancer: KEYNOTE-651 Cohorts B and D. Clinical Colorectal Cancer 2024, 23: 118-127.e6. PMID: 38762348, DOI: 10.1016/j.clcc.2024.03.001.Peer-Reviewed Original ResearchMetastatic colorectal cancerObjective response rateCohort BCohort DAdverse eventsColorectal cancerT-cell-inflamed gene expression profileInvestigator-assessed objective response ratePD-L1 combined positive scoreTreatment-related adverse eventsResponse rateCombined positive scoreDose-limiting toxicityMedian follow-upTumor mutational burdenDecreased neutrophil countPrimary end pointMismatch repair-proficientStandard of careBiomarker analysisMethods PatientsRECIST v1.1PD-L1HER2 expressionMutational burden
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
2015
Final analysis of a phase II study of Yale-modified FOLFIRINOX (mFOLFIRINOX) in metastatic pancreatic cancer (MPC).
James E, Cong X, Yao X, Hahn C, Kaley K, Li J, Kortmansky J, Fischbach N, Cha C, Salem R, Stein S, Hochster H, Lacy J. Final analysis of a phase II study of Yale-modified FOLFIRINOX (mFOLFIRINOX) in metastatic pancreatic cancer (MPC). Journal Of Clinical Oncology 2015, 33: 395-395. DOI: 10.1200/jco.2015.33.3_suppl.395.Peer-Reviewed Original ResearchMetastatic pancreatic cancerResponse rateProphylactic pegfilgrastimEntire cohortPhase II open-label studyFinal analysisECOG PS 0ECOG PS 0/1Grade 3/4 toxicitiesOpen-label studyPhase II studyBolus 5FUPS 0/1Febrile neutropeniaLAPC patientsPeritoneal diseaseII studyPS 0Surgical resectionUnacceptable toxicityImproved tolerabilityPeripheral neuropathyMetastatic sitesPancreatic cancerFOLFIRINOX
2013
Phase II study of mFOLFOX with bevacizumab (Bev) in metastatic gastroesophageal and gastric (GE) adenocarcinoma (AC).
Li J, Kortmansky J, Fischbach N, Stein S, Yao X, Hochster H, Lacy J. Phase II study of mFOLFOX with bevacizumab (Bev) in metastatic gastroesophageal and gastric (GE) adenocarcinoma (AC). Journal Of Clinical Oncology 2013, 31: 4084-4084. DOI: 10.1200/jco.2013.31.15_suppl.4084.Peer-Reviewed Original ResearchCisplatin-based regimensOverall survivalGE adenocarcinomaResponse rateMetastatic sitesProspective phase II trialECOG PS 0/1Grade 3/4 toxicitiesMedian overall survivalPhase II studyPhase II trialPhase III studyDVT/PELiver 19Median TTPPrior gastrectomyPS 0/1GI perforationHemorrhagic eventsII studyII trialIII studyMedian survivalMedian ageGastric adenocarcinoma
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