Therapy of locally unresectable pancreatic carcinoma: A randomized comparison of high dose (6000 rads) radiation alone, moderate dose radiation (4000 rads + 5-fluorouracil), and high dose radiation + 5-fluorouracil. The gastrointestinal tumor study group

TLDR

A randomized trial of 194 patients with locally unresectable pancreatic adenocarcinoma compared high‑dose (6000 rads) radiation alone, moderate‑dose (4000 rads) radiation plus 5‑fluorouracil, and high‑dose radiation plus 5‑fluorouracil. The addition of 5‑fluorouracil to radiation significantly extended median survival from 5.5 months to 10 months, with 40 % of patients alive at one year versus 10 % for radiation alone, and no survival advantage was seen between moderate‑dose and high‑dose radiation plus 5‑FU; pretreatment performance status and CEA level were also significant prognostic factors.

Abstract

One-hundred-ninety-four eligible and evaluable patients with histologically confirmed locally unresectable adenocarcinoma of the pancreas were randomly assigned to therapy with high-dose (6000 rads) radiation therapy alone, to moderate-dose (4000 rads) radiation + 5-fluorouracil (5-FU), and to high-dose radiation plus 5-FU. Median survival with radiation alone was only 51/2 months from date of diagnosis. Both 5-FU-containing treatment regimens produced a highly significant survival improvement when compared with radiation alone. Forty percent of patients treated with the combined regimens were still living at one year compared with 10% of patients treated with radiation only. Survival differences between 4000 rads plus 5-FU and 6000 rads plus 5-FU were not significant with an overall median survival of ten months. Significant prognostic variables, in addition to treatment, were pretreatment performance status and pretreatment CEA level.