Background: This prospective, nonrandomized study was conducted to compare the efficacy and toxicity of post-operative concurrent chemoradiation therapy (CCRT) using daily oral uracil-tegafur plus leucovorin (UFUR/LV) vs. weekly intravenous fluorouracil plus leucovorin (5-FU/LV) in patients with locally advanced rectal cancer.
Materials and methods: From November 1996 through December 2004, 30 patients with stage II or III rectal cancer were enrolled. Either 5-FU (400 to 450 mg/m2) plus LV (80 to 100 mg/m2) weekly or oral UFUR (250 to 300 mg/m2/d) plus oral LV (30 to 45 mg/m2/d) were given during radiotherapy. Radiation (50.4 to 60.4 Gy) was delivered to the tumor bed in 28-33 fractions.
Results: The mean survival, 2-year overall survival and disease-free survival were 36 months vs. 30 months, 68% vs. 66% and 55% vs. 50%, (p > 0.05), in the UFUR/LV and 5-FU/LV groups, respectively. There were no treatment-related deaths or grade 4 toxicity in either group. Grade 3 dermatitis, gastrointestinal and hematologic toxicity were noted in the 5-FU/LV group.
Conclusion: Because of a similar survival rate and lower toxicity, oral UFUR/LV is suggested as an alternative regimen to intravenous 5-FU/LV in post-operative CCRT of locally advanced rectal cancer.