RANDOMIZED TRIAL OF SURGERY ALONE VERSUS RADIOTHERAPY FOLLOWED BY SURGERY FOR POTENTIALLY OPERABLE LOCALLY ADVANCED RECTAL-CANCER

Background Survival rates after surgery for rectal cancer remain at ab out 40% at 5 years from diagnosis, The aim of this study was to find o ut whether local recurrence rate could be reduced and survival increas ed by a moderately high dose of preoperative radiotherapy in patients with locally advanced, but otherwise operable, carcinoma of the rectum . Methods We carried out a prospective randomised trial of surgery alo ne (n=140) versus surgery preceded by 40 Gy radiotherapy (n=139) given in 20 fractions of 2 Gy over 4 weeks. The patients, from 20 regional centres throughout the UK, were enrolled between 1981 and 1989, and fo llowed up for a minimum of 5 years or to death. Findings 217 patients died, 114 of 140 allocated surgery alone and 103 of 139 allocated preo perative radiotherapy: median survival limes were 24 months and 31 mon ths, respectively. The hazard ratio for overall survival was 0.79 (95% CI 0.60-1.04, p=0.10). At 5 years' follow-up 65 patients allocated su rgery alone and 50 who received preoperative radiotherapy bad local re currence (hazard ratio 0.68 [0.47-0.98], p=0.04); the corresponding nu mbers of patients with distant recurrence were 67 and 49 (hazard ratio 0.66 [0.46-0.95], p=0.02). There was a significant benefit of radioth erapy on disease-free survival (hazard ratio 0.76 [0.58-1.0], p=0.05). There was no increase in postoperative or late complications in the r adiotherapy group, Interpretation Our results provide further evidence that preoperative radiotherapy can reduce the rate of local recurrenc e of rectal cancer in patients with locally advanced disease. However, survival results are still equivocal, and so we must await the result s of a metaanalysis of all radiotherapy trials from which precise and definitive results, particularly for survival, may be obtained.