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
2168
Branagan A, Duffy E, Parker T, Seropian S, Foster C, Zhang L, Verma R, Gan G, Zelterman D, Brandt D, Kortmansky J, Witt D, Dhodapkar M. 2168. Journal Of Clinical And Translational Science 2017, 1: 31-32. PMCID: PMC6799516, DOI: 10.1017/cts.2017.118.Peer-Reviewed Original ResearchPlasma cell disordersInfluenza vaccination strategiesInfluenza vaccinationInfluenza infection ratesVaccination strategiesCell disordersInfluenza infectionClinical correlatesInfection rateInfluenza vaccineRandomized studySingle vaccineDisorder patientsFlu seasonGrade 2 adverse eventsHigh-dose influenza vaccinationHigh-dose influenza vaccineLaboratory-confirmed influenza infectionHigh-dose vaccineSerologic response rateCell-mediated immunityFlu-like illnessNovel vaccination strategiesT cell subpopulationsT cell responsiveness
2016
Lower Rates of Influenza Infection Following Two Dose Series of High Dose Vaccination in Plasma Cell Disorders: Results of a Randomized, Double-Blind, Placebo-Assisted Clinical Trial
Branagan A, Duffy E, Parker T, Seropian S, Foster C, Zhang L, Verma R, Zelterman D, Gan G, Brandt D, Kortmansky J, Witt D, Ferencz T, Dhodapkar M. Lower Rates of Influenza Infection Following Two Dose Series of High Dose Vaccination in Plasma Cell Disorders: Results of a Randomized, Double-Blind, Placebo-Assisted Clinical Trial. Blood 2016, 128: 2139. DOI: 10.1182/blood.v128.22.2139.2139.Peer-Reviewed Original ResearchHigh-dose influenza vaccinePlasma cell disordersInfluenza vaccinationCell-mediated immunityInfluenza vaccineInfluenza infectionCell disordersClinical correlatesVaccination strategiesPCD patientsRandomized studySingle vaccineClinical trialsDose seriesFlu seasonInfection rateHigh-dose influenza vaccinationLaboratory-confirmed influenza infectionTwo-dose vaccination strategyHigh-dose vaccinationHigh-dose vaccineInfluenza vaccination strategiesPresent randomized studySerologic response rateSeasonal influenza vaccination