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Int J Radiat Oncol Biol Phys. 2000 Jan 15;46(2):323-7.

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

Author information

1
Department of Radiotherapy, University Hospital Besan├žon, France. jean-fran├žois.bosset@ufc-chu.univ.fcomte.fr

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 T3 M0, 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/m2/d1-d5,. While the 5-FU dose was variable from 450 to 350 mg/m2/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 R1-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 R0-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/m2 for both CT courses. This approach is currently tested in a large EORTC phase III trial.

PMID:
10661338
[Indexed for MEDLINE]
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