title: Adjuvant chemoradiotherapy for "unfavorable" carcinoma of the ampulla of Vater: preliminary report.
abstract: OBJECTIVE
  Adjuvant chemoradiotherapy decreases the risk of local recurrence in patients with adenocarcinoma of the ampulla of Vater and high-risk features. Adjuvant chemoradiotherapy for this population can be administered safely and without much morbidity.
  
  
  METHODS
  Controlled, prospective, single-arm study.
  
  
  METHODS
  Tertiary care referral hospital.
  
  
  METHODS
  From June 1995 to March 1999, 12 patients (7 men and 5 women; median age, 66 years; age range, 38-78 years) with "unfavorable" ampullary carcinoma were treated with adjuvant chemoradiotherapy. All patients underwent pancreaticoduodenectomy, and all pathologic findings were confirmed at Stanford University Medical Center, Stanford, Calif. Unfavorable features were defined as involved lymph nodes (n = 10), involved surgical margins (n = 1), poorly differentiated histological features (n = 3), tumor size greater than 2 cm (n = 6), or the presence of neurovascular invasion (n = 4).
  
  
  METHODS
  Four to 6 weeks after undergoing pylorus-preserving pancreaticoduodenectomy with regional lymphadenectomy, patients began adjuvant chemoradiotherapy consisting of concurrent radiotherapy (45 Gy) and fluorouracil by protracted venous infusion (225-250 mg/m(2) per day, 7 days per week) for 5 weeks.
  
  
  METHODS
  Local recurrence, distant recurrence, overall survival rate, and treatment-related toxic effects.
  
  
  RESULTS
  All patients completed the prescribed treatment course. Toxic effects were assessed twice a week during treatment and graded according to the National Cancer Institute Common Toxicity Criteria Scale. One patient required a treatment interruption of 1 week for grade III nausea/vomiting. No grade IV or V toxic effects were observed. At median follow-up of 24 months (range, 13-50 months), 8 of 12 patients were alive and disease free. One patient was alive but had disease recurrence. Three patients died of this disease (liver metastases). Actuarial overall survival at 2 years was 89%, and median survival was 34 months. One surviving patient developed a local recurrence and a lung lesion. Actuarial overall survival and median survival were better than in a parallel cohort with resected high-risk pancreatic cancer (n = 26) treated with the same adjuvant chemoradiotherapy regimen (median survival, 34 vs 14 months; P<.004).
  
  
  CONCLUSIONS
  Adjuvant chemoradiotherapy for carcinoma of the ampulla of Vater is well tolerated and might improve control of this disease in patients with unfavorable features.
authors.affiliation: Department of Radiation Oncology, Stanford University Medical Center, 300 Pasteur Dr, Stanford, CA 94305, USA.
authors.forename: V K
authors.initials: VK
authors.lastname: Mehta
authors.forename: G A
authors.initials: GA
authors.lastname: Fisher
authors.forename: J M
authors.initials: JM
authors.lastname: Ford
authors.forename: J C
authors.initials: JC
authors.lastname: Poen
authors.forename: M A
authors.initials: MA
authors.lastname: Vierra
authors.forename: H A
authors.initials: HA
authors.lastname: Oberhelman
authors.forename: A J
authors.initials: AJ
authors.lastname: Bastidas
mesh_terms: D000206:Actuarial Analysis; D014670:Ampulla of Vater; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use; D017024:Chemotherapy, Adjuvant; D018281:Cholangiocarcinoma / Q000188:drug therapy* / Q000532:radiotherapy* / Q000601:surgery; D003138:Common Bile Duct Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy* / Q000601:surgery; D005260:Female; D005472:Fluorouracil / Q000627:therapeutic use; D005500:Follow-Up Studies; D006801:Humans; D008197:Lymph Node Excision; D008297:Male; D016577:Pancreaticoduodenectomy; D011446:Prospective Studies; D011879:Radiotherapy Dosage; D018714:Radiotherapy, Adjuvant; D015996:Survival Rate; D013997:Time Factors
chemical_list: D000964:Antimetabolites, Antineoplastic; D005472:Fluorouracil