Adjuvant chemoradiotherapy for "unfavorable" carcinoma of the ampulla of vater - Preliminary report

Hypotheses: Adjuvant chemoradiotherapy decreases the risk of local recurren ce in patients with adenocarcinoma of the ampulla of Vater and high-risk fe atures. Adjuvant chemoradiotherapy for this population can be administered safely and without much morbidity. Design: Controlled, prospective, single-arm study. Setting: Tertiary care referral hospital. Patients: From June 1995 to March 1999, 12 patients (7 men and 5 women; med ian age, 66 years; age range, 38-78 years) with "unfavorable" ampullary car cinoma were treated with adjuvant chemoradiotherapy. All patients underwent pancreaticoduodenectomy, and all pathologic findings were confirmed at Sta nford University Medical Center, Stanford, Calif. Unfavorable features were defined as involved lymph nodes (n=10), involved surgical margins (n=1), p oorly differentiated histological features (n=3), tumor size greater than 2 cm (n=6), or the presence of neurovascular invasion (n=4). Interventions: Four to 6 weeks after undergoing pylorus-preserving pancreat icoduodenectomy with regional lymphadenectomy, patients began adjuvant chem oradiotherapy consisting of concurrent radiotherapy (45 Gy) and fluorouraci l by protracted venous infusion (225-250 mg/m(2) per day, 7 days per week) for 5 weeks. Main Outcome Measures: Local recurrence, distant recurrence, overall surviv al rate, and treatmeat-related toxic effects. Results: All patients completed the prescribed treatment course. Toxic effe cts were assessed twice a week during treatment and graded according to the National Cancer Institute Common Toxicity Criteria Scale. One patient requ ired a treatment interruption of 1 week for grade III nausea/vomiting. No g rade 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 pa tient was alive but had disease recurrence. Three patients died of this dis ease (liver metastases). Actuarial overall survival at 2 years was 89%, and median survival was 34 months. One surviving patient developed a local rec urrence and a lung lesion. Actuarial overall survival and median survival w ere better than in a parallel cohort with resected high-risk pancreatic can cer (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 Vat er is well tolerated and might improve control of this disease in patients with unfavorable features.