Abstract
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/m 2/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.
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