EARLY EVALUATION OF ABDOMINAL HEPATIC IRRADIATION AND 5-FLUOROURACIL LEUCOVORIN INFUSION AFTER PANCREATICODUODENECTOMY

Purpose: To describe the toxicities of a combined modality adjuvant re gimen for patients with resectable periampullary adenocarcinoma. Metho ds and Materials: Fourteen patients with surgically resected periampul lary adenocarcinoma were treated with adjuvant therapy consisting of p rophylactic hepatic irradiation and pancreatic bed irradiation and con current infusional 5-fluorouracil and leucovorin (5-FU/LV). Starting w ithin 60 days of surgery, patients received radiation treatments of 1. 8 Gy per fraction to the liver and pancreatic bed (13 fractions), foll owed by 1.8 Gy per fraction to the pancreatic region (15 fractions). A ll radiation treatments mere given with infusional 5-FU (200 mg/m(2)/d ay) and leucovorin (5 mg/m(2)/day) for 5 out of every 7 days during th e 38-day treatment sequence. After a 1-month break, patients were sche duled to receive four cycles of infusional 5-FU/LV (2 weeks on/2 weeks off). Results: All 14 patients completed the initial combination trea tment. Toxicities were tolerable; three patients had Grade 3/4 toxicit ies that were primarily gastrointestinal in nature. Six patients requi red hospitalization during therapy for treatment-related toxicities. T wo patients required radiation treatment breaks of less than 1 week, a nd two others had radiation held for 2-4 weeks. Three patients require d chemotherapy dose reductions secondary to toxicities. Toxicities in the subsequent chemotherapy-alone cycles were few and primarily manife sted by Grade 2 rises in liver injury tests. Higher toxicity grades we re associated with tumor progression. Twelve patients have developed r ecurrent disease with an equal number of recurrences occurring in the pancreatic bed as in the liver over the 12-month median follow-up. Med ian survival for this cohort is 417 days, not significantly different from previously reported adjuvant trials in this patient population. C onclusion: These data indicate that adjuvant therapy with concomitant large-field radiation and infusional chemotherapy is feasible and asso ciated with manageable toxicities in patients undergoing pancreaticodu odenectomy for periampullary adenocarcinoma. Improvement in survival o ver other adjuvant regimens has not thus far been observed. Modificati on of this strategy may be required.