Concomitant Radiotherapy with Protracted 5-fluorouracil Infusion in Locally Advanced Carcinoma of the Pancreas: A Phase Ii Study

Abstract

Aims and Background To evaluate the efficacy of combined radiation therapy and continuous infusion of 5-fluorouracil in patients with locally advanced carcinoma of the pancreas. Methods Between January 1992 and June 1999, 31 patients with locally advanced adenocarcinoma of the pancreas were treated in our Institute. In 20 patients, the tumor (65%) was located in the head of the pancreas and in 11 (35%) in the body or tail; 13 cases also showed involved nodes. Radiation therapy consisted in a median dose of 63 Gy in 33-36 fractions applied to the tumor and regional lymph nodes. Chemotherapy with 5-fluorouracil in continuous infusion, 250 mg/m2 daily, was administered in the first and fifth week of the radiation therapy. Thereafter, 22 patients received 3-10 cycles of adjuvant chemotherapy with same doses. Median follow-up of the series was 20 months. The toxicity of the treatment was scored according to WHO criteria. All patients underwent nutritional assessment at the time of radiochemotherapy. Results The median overall survival was 15.2 months (range, 4-42). At restaging, 17 cases (55%) showed no change and 14 (45%) a partial remission. At the end of radiochemotherapy in 8 (26%) of the cases there was indication for pancreatectomy, which was executed in 4 patients. At the time of the study, 2 patients (6.4%) were surgically proven disease free. Eleven of the 13 cases (85%) presenting involved nodes showed that the enlarged lymph nodes had disappeared. Nineteen patients (61%) are alive with clinical evidence of disease and 2 cases are alive with liver metastases; 8 patients (26%) died for disease. In 74% of cases there was complete pain control. Tolerance to the regimen was good. Nutritional assistance was evaluated and was found to be correlated to survival. Conclusions The results of the series confirm a good tolerance with low acute toxicity. Tumor down-staging and resectability rates were high, together with prolonged survival and a good quality of life.