2022
Phase 3, multicenter, randomized study of CPI-613 with modified FOLFIRINOX (mFFX) versus FOLFIRINOX (FFX) as first-line therapy for patients with metastatic adenocarcinoma of the pancreas (AVENGER500).
Philip P, Bahary N, Mahipal A, Kasi A, Lima C, Alistar A, Oberstein P, Golan T, Sahai V, Metges J, Lacy J, Fountzilas C, Lopez C, Ducreux M, Hammel P, Salem M, Bajor D, Benson A, Buyse M, Van Cutsem E. Phase 3, multicenter, randomized study of CPI-613 with modified FOLFIRINOX (mFFX) versus FOLFIRINOX (FFX) as first-line therapy for patients with metastatic adenocarcinoma of the pancreas (AVENGER500). Journal Of Clinical Oncology 2022, 40: 4023-4023. DOI: 10.1200/jco.2022.40.16_suppl.4023.Peer-Reviewed Original ResearchProgression-free survivalMetastatic pancreatic cancerOverall response rateMedian overall survivalFirst-line therapyCPI-613Experimental armRandomized phase 3 trialStandard first-line therapyTreatment-emergent adverse eventsDoses of irinotecanTreatment-naïve patientsPhase 3 trialDuration of responseLimited treatment optionsPatient reported outcomesTest armIntolerable toxicityPrimary endpointSecondary endpointsAdverse eventsOverall survivalMetastatic adenocarcinomaTreatment optionsControl arm
2021
Clinical outcomes of first line FOLFIRINOX vs . gemcitabine plus nab-paclitaxel in metastatic pancreatic cancer at the Yale Smilow Hospital System
Patel T, Miccio J, Cecchini M, Srikumar T, Stein S, Kortmanksy J, Johung K, Lacy J. Clinical outcomes of first line FOLFIRINOX vs . gemcitabine plus nab-paclitaxel in metastatic pancreatic cancer at the Yale Smilow Hospital System. Journal Of Gastrointestinal Oncology 2021, 0: 0-0. PMID: 35070386, PMCID: PMC8748034, DOI: 10.21037/jgo-21-202.Peer-Reviewed Original ResearchMetastatic pancreatic cancerFirst-line FOLFIRINOXTreatment discontinuationFFX groupDose modificationOverall survivalNab-paclitaxelPancreatic cancerGN groupComparative effectivenessMedian TTDFirst-line settingMedian overall survivalOutcomes of patientsTreatment-related toxicityFirst-line therapyKaplan-Meier methodRate of hospitalizationElectronic medical record systemAdjuvant gemcitabineChemotherapy toxicityDiscontinuation ratesLine therapyMedical record systemTreatment toxicity
2016
Final analysis of a phase II study of modified FOLFIRINOX in locally advanced and metastatic pancreatic cancer.
Stein S, James E, Cong X, Deng Y, Salem R, Cha C, Chang B, Hochster H, Doddamane I, Boustani A, Patel V, Kortmansky J, Li J, Staugaard C, Lacy J. Final analysis of a phase II study of modified FOLFIRINOX in locally advanced and metastatic pancreatic cancer. Journal Of Clinical Oncology 2016, 34: 395-395. DOI: 10.1200/jco.2016.34.4_suppl.395.Peer-Reviewed Original Research
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
2014
Interim analysis of a phase II study of dose-modified FOLFIRINOX (mFOLFIRINOX) in locally advanced (LAPC) and metastatic pancreatic cancer (MPC).
James E, Yao X, Cong X, Li J, Hahn C, Kaley K, Kortmansky J, Fischbach N, Chang B, Salem R, Cha C, Stein S, Hochster H, Lacy J. Interim analysis of a phase II study of dose-modified FOLFIRINOX (mFOLFIRINOX) in locally advanced (LAPC) and metastatic pancreatic cancer (MPC). Journal Of Clinical Oncology 2014, 32: e15226-e15226. DOI: 10.1200/jco.2014.32.15_suppl.e15226.Peer-Reviewed Original ResearchInterim analysis of a phase II study of dose-modified FOLFIRINOX (mFOLFIRINOX) in locally advanced (LAPC) and metastatic pancreatic cancer (MPC).
James E, Yao X, Cong X, Stein S, Kaley K, Hahn C, Cha C, Salem R, Hochster H, Lacy J. Interim analysis of a phase II study of dose-modified FOLFIRINOX (mFOLFIRINOX) in locally advanced (LAPC) and metastatic pancreatic cancer (MPC). Journal Of Clinical Oncology 2014, 32: 256-256. DOI: 10.1200/jco.2014.32.3_suppl.256.Peer-Reviewed Original ResearchMetastatic pancreatic cancerAdvanced pancreatic cancerPancreatic cancerFebrile neutropeniaResponse rateEvaluable ptsProphylactic pegfilgrastimInterim analysisPhase II open-label studyGrade 3/4 toxicitiesOpen-label studyPhase II studyFDG-PET scansSimilar response ratesECOG PSNeoadjuvant FOLFIRINOXUnderwent resectionII studySurgical resectionUnacceptable toxicityPET responseFOLFIRINOXRetrospective analysisDose reductionLabel study
2012
Single institution experience with FOLFIRINOX in advanced pancreatic cancer (PC).
Gunturu K, Thumar J, Hochster H, Stein S, Yao X, Cong X, Lacy J. Single institution experience with FOLFIRINOX in advanced pancreatic cancer (PC). Journal Of Clinical Oncology 2012, 30: e14534-e14534. DOI: 10.1200/jco.2012.30.15_suppl.e14534.Peer-Reviewed Original ResearchAdvanced pancreatic cancerMetastatic pancreatic cancerPancreatic cancerOverall survivalMetastatic PCProphylactic pegfilgrastimAdvanced unresectable pancreatic cancerECOG PS 0/1Efficacy of FOLFIRINOXGrade 3/4 fatigueUnresectable pancreatic cancerYale Cancer CenterSingle institution experienceKaplan-Meier methodWarrants further evaluationDose attenuationChemotherapy 5PS 0/1Free survivalSurgical resectionUnacceptable toxicityImproved tolerabilityPhysician's discretionRetrospective reviewInstitution experienceSingle-institution experience with FOLFIRINOX in advanced pancreatic cancer (PC).
Gunturu K, Thumar J, Hochster H, Stein S, Yao X, Cong X, Hahn C, Kaley K, Lacy J. Single-institution experience with FOLFIRINOX in advanced pancreatic cancer (PC). Journal Of Clinical Oncology 2012, 30: 330-330. DOI: 10.1200/jco.2012.30.4_suppl.330.Peer-Reviewed Original ResearchAdvanced pancreatic cancerPancreatic cancerProphylactic pegfilgrastimMetastatic PCFull dosesAdvanced unresectable pancreatic cancerECOG PS 0Efficacy of FOLFIRINOXRelative dose intensityUnresectable pancreatic cancerYale Cancer CenterMetastatic pancreatic cancerSingle institution experienceWarrants further evaluationCycle 1Age 60 yrEquivalent response ratesDose attenuationChemotherapy 5Evaluable ptsFebrile neutropeniaUnderwent resectionDose intensitySurgical resectionUnacceptable toxicity