title: Outcome of pancreaticoduodenectomy and impact of adjuvant therapy for ampullary carcinomas.
abstract: OBJECTIVE
  To determine the clinical outcomes and potential impact of adjuvant chemoradiation in patients undergoing surgical resection of ampullary carcinoma.
  
  
  METHODS
  Between 1988 and 1997, 39 patients underwent pancreaticoduodenectomy for ampullary adenocarcinomas. Clinical and pathologic factors, adjuvant therapy records, and disease status were obtained from chart review. Thirteen (33%) patients received adjuvant chemoradiation. Radiation therapy was delivered to the surgical bed and regional nodes to a median dose of 4,860 cGy with concurrent bolus or continuous infusion of 5-fluorouracil. Outcomes measures included locoregional control, disease-free survival, and overall survival. Univariate analysis was used to assess the impact of various patient- and tumor-related factors and the use of adjuvant therapy. Twenty (51%) patients with tumor invasion into the pancreas (T3) or node-positive disease were classified in a "high-risk" subgroup.
  
  
  RESULTS
  After a median follow-up of 45 months for survivors, overall 3-year survival was 55%. Survival was significantly worse for patients with positive nodes (23% vs. 73%, p < 0.001) and high-risk status (30% vs. 80%, p = 0.002). Disease-free survival was 54% at 3 years. There were 3 postoperative deaths, and these patients (all high risk) are excluded from further analysis on adjuvant therapy. In univariate analysis, the use of adjuvant chemoradiation had no clear impact on local-regional control or overall survival. However, by controlling for risk status in multivariate analysis, the use of adjuvant therapy reached statistical significance for overall survival (p = 0. 03). Among the high-risk patients, 7 (77%) of 9 patients receiving adjuvant therapy remained disease-free during follow-up compared with only 1 (14%) of 7 patients not receiving adjuvant therapy (p = 0.012).
  
  
  CONCLUSIONS
  Despite the relatively favorable prognosis of ampullary carcinomas compared with other pancreaticobiliary tumors, patients with nodal metastases or T3 disease are at high risk for disease relapse. The use of adjuvant chemoradiation may improve long-term disease control in these patients.
authors.affiliation: Departments of Radiation Oncology, University of Pennsylvania School of Medicine, Philadelphia, PA 19104, USA. lee@xrt.upenn.edu
authors.forename: J H
authors.initials: JH
authors.lastname: Lee
authors.forename: R
authors.initials: R
authors.lastname: Whittington
authors.forename: N N
authors.initials: NN
authors.lastname: Williams
authors.forename: M F
authors.initials: MF
authors.lastname: Berry
authors.forename: D J
authors.initials: DJ
authors.lastname: Vaughn
authors.forename: D G
authors.initials: DG
authors.lastname: Haller
authors.forename: E F
authors.initials: EF
authors.lastname: Rosato
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000532:radiotherapy* / Q000601:surgery; D000328:Adult; D000368:Aged; D014670:Ampulla of Vater / Q000601:surgery; D000704:Analysis of Variance; D017024:Chemotherapy, Adjuvant; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy* / Q000601:surgery; D016577:Pancreaticoduodenectomy; D018714:Radiotherapy, Adjuvant; D016896:Treatment Outcome