2023
Effect of a MUC5AC Antibody (NPC-1C) Administered With Second-Line Gemcitabine and Nab-Paclitaxel on the Survival of Patients With Advanced Pancreatic Ductal Adenocarcinoma
Huffman B, Mallick A, Horick N, Wang-Gillam A, Hosein P, Morse M, Beg M, Murphy J, Mavroukakis S, Zaki A, Schlechter B, Sanoff H, Manz C, Wolpin B, Arlen P, Lacy J, Cleary J. Effect of a MUC5AC Antibody (NPC-1C) Administered With Second-Line Gemcitabine and Nab-Paclitaxel on the Survival of Patients With Advanced Pancreatic Ductal Adenocarcinoma. JAMA Network Open 2023, 6: e2249720. PMID: 36602796, PMCID: PMC9856813, DOI: 10.1001/jamanetworkopen.2022.49720.Peer-Reviewed Original ResearchConceptsAdvanced pancreatic ductal adenocarcinomaPancreatic ductal adenocarcinomaObjective response rateProgression-free survivalSecond-line treatmentNab-paclitaxelOverall survivalClinical trialsDuctal adenocarcinomaRandomized phase II clinical trialMedian progression-free survivalGemcitabine/nab-paclitaxelCox proportional hazards analysisEnd pointPhase II clinical trialChemotherapy dose reductionsFirst-line FOLFIRINOXSecond-line gemcitabineMedian overall survivalPrimary end pointSecondary end pointsProportional hazards analysisSurvival of patientsLow performance statusPretreatment clinical variables
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
2020
Phase Ib/II open-label, randomized evaluation of 2L atezolizumab (atezo) + PEGPH20 versus control in MORPHEUS-pancreatic ductal adenocarcinoma (M-PDAC) and MORPHEUS-gastric cancer (M-GC).
Ko A, Lee J, ALSINA M, Ajani J, Bang Y, Chung H, Lacy J, Lopez C, Oh D, O'Reilly E, Siveke J, Allen S, Al-Sakaff N, Barak H, Lau J, Li S, Retiere A, Shemesh C, Zhang X, Kim K. Phase Ib/II open-label, randomized evaluation of 2L atezolizumab (atezo) + PEGPH20 versus control in MORPHEUS-pancreatic ductal adenocarcinoma (M-PDAC) and MORPHEUS-gastric cancer (M-GC). Journal Of Clinical Oncology 2020, 38: 4540-4540. DOI: 10.1200/jco.2020.38.15_suppl.4540.Peer-Reviewed Original ResearchSerious AEsPhase Ib/II trialPhase Ib/IIChemotherapy-free combinationsEarly efficacy signalsNew safety signalsDuration of responseSeparate randomized trialsRecombinant human hyaluronidaseGr 3Eligible ptsMedian PFSMetastatic PDACTumor hyaluronanCombination armMedian OSPrimary endpointII trialNab-paclitaxelPeripheral edemaEfficacy signalsExtracellular matrix modulatorsRandomized trialsPoor prognosisSafety profile
2018
A phase IB/II randomized study of mFOLFIRINOX (mFFOX) + pegylated recombinant human hyaluronidase (PEGPH20) versus mFFOX alone in patients with good performance status metastatic pancreatic adenocarcinoma (mPC): SWOG S1313 (NCT #01959139).
Ramanathan R, McDonough S, Philip P, Hingorani S, Lacy J, Kortmansky J, Thumar J, Chiorean E, Shields A, Behl D, Mehan P, Gaur R, Seery T, Guthrie K, Hochster H. A phase IB/II randomized study of mFOLFIRINOX (mFFOX) + pegylated recombinant human hyaluronidase (PEGPH20) versus mFFOX alone in patients with good performance status metastatic pancreatic adenocarcinoma (mPC): SWOG S1313 (NCT #01959139). Journal Of Clinical Oncology 2018, 36: 208-208. DOI: 10.1200/jco.2018.36.4_suppl.208.Peer-Reviewed Original ResearchMetastatic pancreatic adenocarcinomaPhase II studyOverall survivalII studyPhase Ib/IIProphylactic growth factor supportUntreated metastatic pancreatic adenocarcinomaRandomized phase II studyGemcitabine/nab-paclitaxelAdequate organ functionMedian overall survivalGrowth factor supportInterim futility analysisRecombinant human hyaluronidaseClinical trial informationDelivery of gemcitabineBolus 5FULMWH prophylaxisMedian OSTumor hyaluronanCombination armNab-paclitaxelPrimary endpointThromboembolic eventsStandard armPhase 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
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)
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 Research622PD 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 ResearchInterim 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
2014
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.
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 cancer