Concomitant radiotherapy with protracted 5-fluorouracil infusion in locally advanced carcinoma of the pancreas: a phase II study

Tumori. 2001 Nov-Dec;87(6):398-401. doi: 10.1177/030089160108700609.

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 anti 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.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II

MeSH terms

  • Adenocarcinoma / drug therapy*
  • Adenocarcinoma / pathology
  • Adenocarcinoma / radiotherapy*
  • Adult
  • Aged
  • Antimetabolites, Antineoplastic / administration & dosage
  • Antimetabolites, Antineoplastic / adverse effects
  • Antimetabolites, Antineoplastic / therapeutic use*
  • Chemotherapy, Adjuvant
  • Drug Administration Schedule
  • Female
  • Fluorouracil / administration & dosage
  • Fluorouracil / adverse effects
  • Fluorouracil / therapeutic use*
  • Humans
  • Infusions, Intravenous
  • Male
  • Middle Aged
  • Pancreatic Neoplasms / drug therapy*
  • Pancreatic Neoplasms / pathology
  • Pancreatic Neoplasms / radiotherapy*
  • Radiotherapy Dosage
  • Radiotherapy, Adjuvant
  • Survival Analysis
  • Treatment Outcome

Substances

  • Antimetabolites, Antineoplastic
  • Fluorouracil