2018
Phase II LAPACT trial of nab -paclitaxel ( nab -P) plus gemcitabine (G) for patients with locally advanced pancreatic cancer (LAPC).
Hammel P, Lacy J, Portales F, Sobrero A, Pazo Cid R, Manzano Mozo J, Terrebonne E, Dowden S, Shiansong Li J, Ong T, Nydam T, Philip P. Phase II LAPACT trial of nab -paclitaxel ( nab -P) plus gemcitabine (G) for patients with locally advanced pancreatic cancer (LAPC). Journal Of Clinical Oncology 2018, 36: 204-204. DOI: 10.1200/jco.2018.36.4_suppl.204.Peer-Reviewed Original ResearchProgression-free survivalDisease control rateOverall response rateTreatment failureAdverse eventsProgressive diseaseOverall survivalICS treatmentEastern Cooperative Oncology Group performance statusInvestigator's choiceGrade 3 peripheral neuropathyMedian progression-free survivalTreatment-emergent adverse eventsCycles of nabAdvanced pancreatic cancerKey secondary endpointMedian TTFTreatment-naive patientsPhase 2 trialUnacceptable adverse eventsPancreatic tumor burdenInduction therapyUnresectable LAPCInduction regimenNab-paclitaxel
2017
622PD nab-Paclitaxel (nab-P) plus gemcitabine (G) for patients (Pts) with locally advanced pancreatic cancer (LAPC): Interim efficacy and safety results from the Phase 2 LAPACT Trial
Philip P, Lacy J, Portales F, Sobrero A, Pazo-Cid R, Mozo J, Kim E, Dowden S, Zakari A, Borg C, Terrebonne E, Herrero F, Li J, Ong T, Nydam T, Hammel P. 622PD nab-Paclitaxel (nab-P) plus gemcitabine (G) for patients (Pts) with locally advanced pancreatic cancer (LAPC): Interim efficacy and safety results from the Phase 2 LAPACT Trial. Annals Of Oncology 2017, 28: v212. DOI: 10.1093/annonc/mdx369.006.Peer-Reviewed Original ResearchAdvanced pancreatic cancerNab-paclitaxelPancreatic cancerInterim efficacySafety resultsGemcitabinePatientsCancerTrials730P Interim health related quality of life (QoL) from LAPACT, a Phase 2 trial of nab-paclitaxel (nab-P) plus gemcitabine (G) for patients (Pts) with locally advanced pancreatic cancer (LAPC)
Portales F, Philip P, Hammel P, Buscaglia M, Pazo-Cid R, Mozo J, Kim E, Dowden S, Zakari A, Borg C, Terrebonne E, Herrero F, Li J, Ong T, Nydam T, Lacy J. 730P Interim health related quality of life (QoL) from LAPACT, a Phase 2 trial of nab-paclitaxel (nab-P) plus gemcitabine (G) for patients (Pts) with locally advanced pancreatic cancer (LAPC). Annals Of Oncology 2017, 28: v248-v249. DOI: 10.1093/annonc/mdx369.114.Peer-Reviewed Original ResearchAdvanced pancreatic cancerPhase 2 trialQuality of lifeNab-paclitaxelPancreatic cancerGemcitabinePatientsCancerTrialsInterim results of a multicenter phase II trial of nab -paclitaxel ( nab -P) plus gemcitabine (G) for patients (Pts) with locally advanced pancreatic cancer (LAPC).
Lacy J, Portales F, Hammel P, Pazo Cid R, Manzano Mozo J, Kim E, Dowden S, Borg C, Sastre J, Bathini V, Terrebonne E, Lopez-Trabada D, Rivera F, Asselah J, Damiani A, Hwang J, Ong T, Nydam T, Shiansong Li J, Philip P. Interim results of a multicenter phase II trial of nab -paclitaxel ( nab -P) plus gemcitabine (G) for patients (Pts) with locally advanced pancreatic cancer (LAPC). Journal Of Clinical Oncology 2017, 35: 358-358. DOI: 10.1200/jco.2017.35.4_suppl.358.Peer-Reviewed Original ResearchDisease control rateAdverse eventsMetastatic PCQOL scoresTreatment phaseDay 1Investigator's choiceMulticenter phase II trialInterim resultsCycles of nabECOG performance statusImproved symptom scoresQLQ-PAN26 questionnairesAdvanced pancreatic cancerG treatmentPhase II trialUnacceptable adverse eventsEORTC QLQ-C30Quality of lifeMPACT trialUnresectable LAPCII trialMost patientsNab-paclitaxelPerformance status
2016
LAPACT: An open-label, multicenter phase II trial of nab -paclitaxel ( nab -P) plus gemcitabine (Gem) in patients (pts) with locally advanced pancreatic cancer (LAPC).
Philip P, Lacy J, Dowden S, Sastre J, Bathini V, Cardin D, Ma W, Sobrero A, Koski S, Borg C, Tonini G, Rivera F, Hwang J, Knoble J, Al Baghdadi T, Saif W, Meiri E, Kayitalire L, Li J, Hammel P. LAPACT: An open-label, multicenter phase II trial of nab -paclitaxel ( nab -P) plus gemcitabine (Gem) in patients (pts) with locally advanced pancreatic cancer (LAPC). Journal Of Clinical Oncology 2016, 34: tps477-tps477. DOI: 10.1200/jco.2016.34.4_suppl.tps477.Peer-Reviewed Original ResearchCycles of nabDisease control rateProgressive diseaseOverall survivalEastern Cooperative Oncology Group performance statusMulticenter phase II trialPhase III MPACT trialAdequate organ functionAdvanced pancreatic cancerCycles of therapySafety of nabEffective systemic therapyImproved local controlPhase II trialProgression-free survivalLonger overall survivalOverall response rateQuality of lifeMedian TTFMPACT trialSignificant ascitesUnresectable LAPCExploratory endpointsPrimary endpointSecondary endpoints
2014
Measurement of circulating tumor DNA as a cancer biomarker in gastrointestinal malignancies using a novel next-generation sequencing method.
James E, Narayan A, Stein S, Lacy J, Patel A, Hochster H. Measurement of circulating tumor DNA as a cancer biomarker in gastrointestinal malignancies using a novel next-generation sequencing method. Journal Of Clinical Oncology 2014, 32: 217-217. DOI: 10.1200/jco.2014.32.3_suppl.217.Peer-Reviewed Original ResearchGastrointestinal malignanciesMultiple time pointsTumor DNAAdvanced pancreatic cancerTime pointsCohort of patientsTumor DNA levelsChemo-radiation therapyMetastatic colon cancerAdjuvant settingCancer biomarkersMutant ctDNABevacizumab therapyTumor mutation profilesLiver metastasesGI tumorsGI cancersPancreatic cancerUltra-deep sequencingKRAS mutationsKRAS G12D mutationColon cancerAdditional longitudinal dataInformed consentLiquid biopsySecond-line gemcitabine plus nab-paclitaxel (G+A) for advanced pancreatic cancer (APC) after first-line FOLFIRINOX: Single institution retrospective review of efficacy and toxicity.
Zhang Y, Hochster H, Stein S, Lacy J. Second-line gemcitabine plus nab-paclitaxel (G+A) for advanced pancreatic cancer (APC) after first-line FOLFIRINOX: Single institution retrospective review of efficacy and toxicity. Journal Of Clinical Oncology 2014, 32: 344-344. DOI: 10.1200/jco.2014.32.3_suppl.344.Peer-Reviewed Original ResearchAdvanced pancreatic cancerTreatment failureOverall survivalRetrospective reviewDose reductionActive first-line regimenSingle-institution retrospective reviewFirst-line FOLFIRINOXInitial dose reductionSecond-line gemcitabineYale Cancer CenterFirst-line regimenSingle institution experienceDose densityFurther dose reductionPaucity of dataECOG PSHematologic toxicityLine regimenNab-paclitaxelUnacceptable toxicityInstitution experienceCA 19Cancer CenterPancreatic cancerInterim 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