title: Multicenter phase II trial of adjuvant therapy for resected pancreatic cancer using cisplatin, 5-fluorouracil, and interferon-alfa-2b-based chemoradiation: ACOSOG Trial Z05031.
abstract: BACKGROUND
  The American College of Surgeons Oncology Group sought to confirm the efficacy of a novel interferon-based chemoradiation regimen in a multicenter phase II trial.
  
  
  METHODS
  Patients with resected (R0/R1) adenocarcinoma of the pancreatic head were treated with adjuvant interferon-alfa-2b (3 million units s.c. on days 1, 3, and 5 of each week for 5.5 weeks), cisplatin (30 mg/m(2) i.v. weekly for 6 weeks), and continuous infusion 5-fluorouracil (5-FU; 175 mg·m(2)/day for 38 days) concurrently with external-beam radiation (50.4 Gy). Chemoradiation was followed by two 6-week courses of continuous infusion 5-FU (200 mg·m(2)/day). The primary study end point was 18-month overall survival from protocol enrollment (OS18); an OS18 ≥65% was considered a positive study outcome.
  
  
  RESULTS
  Eighty-nine patients were enrolled. Eighty-four patients were assessable for toxicity. The all-cause grade ≥3 toxicity rate was 95% (80 patients) during therapy. No long-term toxicity or toxicity-related deaths were noted. At 36-month median follow-up, the OS18 was 69% [95% confidence interval (CI) 60% to 80%]; the median disease-free survival and overall survival were 14.1 months (95% CI 11.0-20.1 months) and 25.4 months (95% CI 23.4-34.1 months), respectively.
  
  
  CONCLUSIONS
  Notwithstanding promising multi-institutional efficacy results, further development of this regimen will require additional modifications to mitigate toxic effects.
authors.affiliation: Department of Medical Oncology, Virginia Mason Medical Center, Seattle, WA 98111, USA. hemvjp@vmmc.org
authors.forename: V J
authors.initials: VJ
authors.lastname: Picozzi
authors.forename: R A
authors.initials: RA
authors.lastname: Abrams
authors.forename: P A
authors.initials: PA
authors.lastname: Decker
authors.forename: W
authors.initials: W
authors.lastname: Traverso
authors.forename: E M
authors.initials: EM
authors.lastname: O'Reilly
authors.forename: E
authors.initials: E
authors.lastname: Greeno
authors.forename: R C
authors.initials: RC
authors.lastname: Martin
authors.forename: L S
authors.initials: LS
authors.lastname: Wilfong
authors.forename: M L
authors.initials: ML
authors.lastname: Rothenberg
authors.forename: M C
authors.initials: MC
authors.lastname: Posner
authors.forename: P W T
authors.initials: PW
authors.lastname: Pisters
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy / Q000601:surgery; D011994:Recombinant Proteins; D016019:Survival Analysis
chemical_list: D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D002945:Cisplatin; D005472:Fluorouracil