Background: Radiotherapy plus bolus 5-fluorouracil (5-FU) is generally accepted as the standard treatment for locally advanced pancreatic carcinoma. To intensify the antitumor effect of chemotherapy, the authors administered protracted 5-FU infusion with concurrent radiotherapy. The aim of this study was to determine the feasibility and effectiveness of this combined therapy.
Methods: Twenty patients, all of whom had histologically confirmed exocrine pancreatic carcinoma that was nonresectable but confined to the pancreatic region, were enrolled in a Phase II trial of protracted 5-fluorouracil infusion (200 mg/m2/day) with concurrent radiotherapy (50.4 gray in 28 fractions over 5.5 weeks). Chemotherapy began on the first day of radiation and continued through the entire radiation course. Thereafter, weekly infusions (500 mg/m2) were administered until disease progression.
Results: Of the 20 patients, 17 (85%) completed the scheduled course of chemoradiotherapy. Grade 3 or worse toxicity, graded according to World Health Organization criteria, was observed in 4 patients (20%). Two patients (10%) achieved partial response, and disease remained stable in 16 patients (80%). After the completion of combined therapy, serum CA 19-9 levels were reduced by more than 50% in 10 of 12 patients (83%) who had pretreatment CA 19-9 levels of 100 U/mL or greater. The median progression free survival and 1-year progression free survival rate were 4.9 months and 29.5%, respectively. The median overall survival and 1-year overall survival rate were 10.3 months and 41.8%, respectively.
Conclusions: This treatment showed moderate activity against locally advanced pancreatic carcinoma and was accompanied by an acceptable toxicity level.