RANDOMIZED TRIAL OF SURGERY ALONE VERSUS SURGERY FOLLOWED BY RADIOTHERAPY FOR MOBILE CANCER OF THE RECTUM

Background Although surgery is the treatment of choice for rectal canc er, local recurrence is common even after apparently curative resectio n. We aimed to assess the role of postoperative radiotherapy in reduci ng rates of local recurrence, and improving disease-free and overall s urvival in patients with mobile Dukes' stage B and C rectal cancers. M ethods We carried out a prospective, randomised trial of surgery alone (n=235) versus surgery followed 4-6 weeks later by radiotherapy (n=23 4), of 40 Gy in 20 fractions of 2 Gy over 4 weeks. The 469 patients, f rom 46 hospitals in the UK and the Republic of Ireland, were randomise d between 1984 and 1989, and followed up for a minimum of 5 years or t o death. Findings 284 patients died, 145 of 235 allocated surgery alon e and 139 of 234 allocated postoperative radiotherapy. The hazard rati o for overall survival was 0.84 (95% CI 0.65-1.07, p=0.17). At 5 years ' follow-up 79 patients who received surgery alone and 48 who received postoperative radiotherapy had had local recurrence (hazard ratio 0.5 4 [0.38-0.77], p=0.001). The corresponding numbers with distant recurr ence were 83 and 75 (hazard ratio 0.85 [0.63-1.114], p=0.18). The haza rd ratio for disease-free survival was 0.85 (0.65-1.08; p=0.18). Radio therapy was generally well tolerated; assessment of late events showed serious late bowel complications to be rare and not significantly inc reased after radiotherapy, even when this followed anterior resection. Interpretation Our results have provided further evidence of the abil ity of postoperative radiotherapy to delay and prevent local recurrenc e of rectal cancer. Although the local recurrence rate in the control group is in keeping with other multicentre trials of the mid to late 1 980s, it is undoubtedly higher than would be regarded as acceptable no w. The combination of larger trials required to provide definitive ans wers on the impact that postoperative radiotherapy will have on surviv al.