A phase II study of oral UFT and leucovorin concurrently with pelvic irradiation as neoadjuvant chemoradiation for rectal cancer.

BACKGROUND Neoadjuvant chemoradiation with continuous infusion (CI) of 5-fluorouracil (5FU) is widely used in rectal cancer. The aim of this study was to evaluate the use of oral tegafur-uracil (UFT) and leucovorin (LV) instead of CI 5FU. PATIENTS AND METHODS Patients had resectable T3-4 or low T2 rectal adenocarcinoma. Chemoradiation consisted of pelvic irradiation (45 Gy in fractions of 1.8 Gy) and oral UFT (240 mg/m2/day) and LV (30 mg/day) given during the first 28 days of radiotherapy. RESULTS Thirty-two patients were treated; 81% had T3-4 tumors and 25% had N+ disease. Toxicity, predominantly gastrointestinal, was generally mild. Grade 3 toxicity occurred in only one patient. Pathological down-staging was noted in 13 patients (42%) and pathological complete response in 3 (10%). Sphincter preservation was possible in 71% of patients undergoing surgery. CONCLUSION Neoadjuvant chemoradiation with oral UFT/LV is well-tolerated and active against rectal cancer. Formal comparison with the current standard treatment is warranted.