title: Survival and quality of life of patients with resected pancreatic adenocarcinoma treated with adjuvant interferon-based chemoradiation: a phase II trial.
abstract: OBJECTIVE
  We conducted a phase II trial to assess the survival duration and quality of life of patients who received adjuvant interferon-based chemoradiation for pancreatic adenocarcinoma after pancreaticoduodenectomy.
  
  
  METHODS
  Patients with a performance status of 0 or 1 were enrolled to receive interferon-alfa-2b (3 million units MWF), cisplatin (30 mg/m(2), 6 doses) and 5-fluorouracil (5-FU; 175 mg/m(2)/day), concurrent with external-beam radiation (50.4 Gy) and followed by 2 courses of systemic 5-FU. The protocol was modified to include an optional 9 day break in the middle of chemoradiation. Quality of life was assessed by use of validated instruments.
  
  
  RESULTS
  Twenty-eight patients were eligible for analysis. The operation of 15 (54%) patients was performed at other institutions. All patients had T3 tumors, 22 (79%) had positive lymph nodes and 4 (14%) had positive (R1) margins. 24 (86%) patients completed therapy. In all, 25 (89%) patients experienced grade 3 toxicity and 3 (11%) patients were hospitalized. The most common grade 3 events were leukopenia (15, 54%) and neutropenia (12, 43%). No grade 4 toxicity occurred. Overall quality of life decreased during chemoradiation but returned to baseline thereafter and was stable throughout surveillance. 19 patients have died; the median follow-up of the 9 survivors is 62 months. The median OS duration of treated patients was 42.3 (95% confidence interval 30.5-54.2) months.
  
  
  CONCLUSIONS
  Adjuvant interferon-based chemoradiation can be delivered safely and tolerably-though with substantial reversible toxicity-to patients of good performance status at an experienced cancer center. Therapy may be associated with an improvement in overall survival.
authors.affiliation: Department of Surgical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, USA.
authors.forename: Matthew H G
authors.initials: MH
authors.lastname: Katz
authors.forename: Robert
authors.initials: R
authors.lastname: Wolff
authors.forename: Christopher H
authors.initials: CH
authors.lastname: Crane
authors.forename: Gauri
authors.initials: G
authors.lastname: Varadhachary
authors.forename: Milind
authors.initials: M
authors.lastname: Javle
authors.forename: E
authors.initials: E
authors.lastname: Lin
authors.forename: Douglas B
authors.initials: DB
authors.lastname: Evans
authors.forename: Jeffrey E
authors.initials: JE
authors.lastname: Lee
authors.forename: Jason B
authors.initials: JB
authors.lastname: Fleming
authors.forename: Peter W T
authors.initials: PW
authors.lastname: Pisters
mesh_terms: D000230:Adenocarcinoma / Q000401:mortality* / Q000473:pathology / Q000628:therapy; D000328:Adult; D000368:Aged; 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; D005500:Follow-Up Studies; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000401:mortality / Q000473:pathology / Q000628:therapy; D009367:Neoplasm Staging; D010190:Pancreatic Neoplasms / Q000401:mortality* / Q000473:pathology / Q000628:therapy; D016577:Pancreaticoduodenectomy; D011379:Prognosis; D011788:Quality of Life; D018714:Radiotherapy, Adjuvant; D011994:Recombinant Proteins / Q000627:therapeutic use; D015996:Survival Rate
chemical_list: D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D002945:Cisplatin; D005472:Fluorouracil