Preoperative radiochemotherapy in rectal cancer: Long-term results of a phase II trial

Purpose: To assess toxicity and long-term results of preoperative chemoradiotherapy in rectal cancer. Methods and Materials: Between 1989 and 1997, as a phase II study, 66 patients with T-3 M-0 rectal cancer received preoperatively a 45 Gy dose pelvic radiotherapy (XRT) combined with two 5-day chemotherapy courses (CT) of 5-Fluorouracil (5-FU) and Leucovorin (LV) delivered the first and fifth week of XRT, For each CT course, LV:20 mg/m(2)/d(1)-d(5). While the 5-FU dose was variable from 450 to 350 mg/m(2)/d first course and 370 to 350 mg/m2/d second course. Surgery was planned 3 weeks later, Results: XRT-CT was stopped in 1 patient due to progressive disease. CT was stopped in 1 patient due to toxicity, Grades 2 and 3 diarrhea were observed in 8 and 3 patients, respectively. One patient died from acute diarrhea due to deviation from recommendations; 60 patients went to surgery. Among the 58 patients operated on for cure, 5 had an R-1-resection, After a 4.5-year median follow-up, the 5-year pelvic disease-free survival was 92% for the whole group and 96% in the R-0-resection group. Conclusion: Preoperative combined XRT-5-FU-LV is feasible if optimal XRT and patients are carefully managed. The recommended 5-FU daily dose is 350 mg/m(2) for both CT courses. This approach is currently tested in a large EORTC phase III trial. (C) 2000 Elsevier Science Inc.