title: Addition of algenpantucel-L immunotherapy to standard adjuvant therapy for pancreatic cancer: a phase 2 study.
abstract: BACKGROUND
  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).
authors.affiliation: Department of Surgery, University Hospitals Seidman Cancer Center and Case Western Reserve University, 11100 Euclid Avenue, Cleveland, OH 44106, USA. jeffrey.hardacre@UHhospitals.org
authors.forename: Jeffrey M
authors.initials: JM
authors.lastname: Hardacre
authors.forename: Mary
authors.initials: M
authors.lastname: Mulcahy
authors.forename: William
authors.initials: W
authors.lastname: Small
authors.forename: Mark
authors.initials: M
authors.lastname: Talamonti
authors.forename: Jennifer
authors.initials: J
authors.lastname: Obel
authors.forename: Smitha
authors.initials: S
authors.lastname: Krishnamurthi
authors.forename: Caio S
authors.initials: CS
authors.lastname: Rocha-Lima
authors.forename: Howard
authors.initials: H
authors.lastname: Safran
authors.forename: Heinz-Joseph
authors.initials: HJ
authors.lastname: Lenz
authors.forename: E Gabriela
authors.initials: EG
authors.lastname: Chiorean
mesh_terms: D000230:Adenocarcinoma / Q000401:mortality / Q000628:therapy*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D019496:Cancer Vaccines / Q000009:adverse effects / Q000627:therapeutic use*; D059186:Chemoradiotherapy, Adjuvant; D017024:Chemotherapy, Adjuvant; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D005500:Follow-Up Studies; D006801:Humans; D016233:Immunotherapy, Active / Q000009:adverse effects / Q000379:methods; D008297:Male; D008875:Middle Aged; D010180:Pancreatectomy; D010190:Pancreatic Neoplasms / Q000401:mortality / Q000628:therapy*; D016577:Pancreaticoduodenectomy; D016019:Survival Analysis; D016896:Treatment Outcome; D014312:Trisaccharides / Q000009:adverse effects / Q000627:therapeutic use*; D000093542:Gemcitabine
chemical_list: C581566:Algenpantucel-L; D019496:Cancer Vaccines; D014312:Trisaccharides; C076569:alpha-galactosyl epitope; D003841:Deoxycytidine; D005472:Fluorouracil; D000093542:Gemcitabine