Preoperative radiotherapy combined with total mesorectal excision for resectable rectal cancer

Background: Short-term preoperative radiotherapy and total mesorectal excis ion have each been shown to improve local control of disease in patients wi th resectable rectal cancer. We conducted a multicenter, randomized trial t o determine whether the addition of preoperative radiotherapy increases the benefit of total mesorectal excision. Methods: We randomly assigned 1861 patients with resectable rectal cancer e ither to preoperative radiotherapy (5 Gy on each of five days) followed by total mesorectal excision (924 patients) or to total mesorectal excision al one (937 patients). The trial was conducted with the use of standardization and quality-control measures to ensure the consistency of the radiotherapy , surgery, and pathological techniques. Results: Of the 1861 patients randomly assigned to one of the two treatment groups, 1805 were eligible to participate. The overall rate of survival at two years among the eligible patients was 82.0 percent in the group assign ed to both radiotherapy and surgery and 81.8 percent in the group assigned to surgery alone (P=0.84). Among the 1748 patients who underwent a macrosco pically complete local resection, the rate of local recurrence at two years was 5.3 percent. The rate of local recurrence at two years was 2.4 percent in the radiotherapy-plus-surgery group and 8.2 percent in the surgery-only group (P<0.001). Conclusions: Short-term preoperative radiotherapy reduces the risk of local recurrence in patients with rectal cancer who undergo a standardized total mesorectal excision. (N Engl J Med 2001;345:638-46.) Copyright (C) 2001 Ma ssachusetts Medical Society.