2013 Jan;17(1):94-100; discussion p.Epub 2012 Nov 15.Hardacre JM1, Mulcahy M, Small W, Talamonti M, Obel J, Krishnamurthi S, Rocha-Lima CS, Safran H, Lenz HJ, Chiorean EG.Author information1Department of Surgery, University Hospitals Seidman Cancer Center and Case Western Reserve University, 11100 Euclid Avenue, Cleveland, OH 44106, USA.AbstractBACKGROUND: Despite continued investigation, limited progress has been made in the adjuvant treatment of resected pancreatic cancer.Novel or targeted therapies are needed.METHODS: Multi-institutional, open-label, dose-finding, phase 2 trial evaluating the use of algenpantucel-L (NewLink Genetics Corporation, Ames, IA) immunotherapy in addition to chemotherapy and chemoradiotherapy in the adjuvant setting for resected pancreatic cancer (ClinicalTrials.gov identifier, NCT00569387).The primary outcome was 12-month disease-free survival.Secondary outcomes included overall survival and toxicity.RESULTS: Seventy patients were treated with gemcitabine and 5-fluorouracil-based chemoradiotherapy as well as algenpantucel-L (mean 12 doses, range 1-14).

After a median follow-up of 21 months, the 12-month disease-free survival was 62 %, and the 12-month overall survival was 86 %.The most common adverse events were injection site pain and induration.CONCLUSIONS: The addition of algenpantucel-L to standard adjuvant therapy for resected pancreatic cancer may improve survival.A multi-institutional, phase 3 study is ongoing (ClinicalTrials.gov identifier, NCT01072981).PMID: 23229886 DOI: 10.1007/s11605-012-2064-6 [Indexed for MEDLINE] Publication typesClinical Trial, Phase IIMulticenter StudyMeSH termsAdenocarcinoma/mortalityAdenocarcinoma/therapy*AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy Protocols/therapeutic useCancer Vaccines/adverse effectsCancer Vaccines/therapeutic use*Chemoradiotherapy, AdjuvantChemotherapy, AdjuvantDeoxycytidine/administration & dosageDeoxycytidine/analogs & derivativesDrug Administration ScheduleFemaleFluorouracil/administration & dosageFollow-Up StudiesHumansImmunotherapy, Active*/adverse effectsImmunotherapy, Active*/methodsMaleMiddle AgedPancreatectomy*Pancreatic Neoplasms/mortalityPancreatic Neoplasms/therapy*Pancreaticoduodenectomy*Survival AnalysisTreatment OutcomeTrisaccharides/adverse effectsTrisaccharides/therapeutic use*SubstancesAlgenpantucel-LCancer VaccinesTrisaccharidesalpha-galactosyl epitopeDeoxycytidinegemcitabineFluorouracilSecondary source IDClinicalTrials.gov/NCT01072981ClinicalTrials.gov/NCT00569387Full Text SourcesSpringerOther Literature SourcesCited by Patents in - The LensMedicalClinicalTrials.govPancreatic cancer - Genetic AlliancePancreatic cancer 2 - Genetic AlliancePancreatic Cancer - MedlinePlus Health InformationMiscellaneousFLUOROURACIL - Hazardous Substances Data Bank

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