• PeetersKoen C M JKCDepartment of Surgery, Leiden University Medical Center, Leiden, The Netherlands. k.c.m.j.peeters@lumc.nl, Corrie A M Marijnen, Iris D Nagtegaal, Elma Klein Kranenbarg, Hein Putter, Theo Wiggers, Harm Rutten, Lars Pahlman, Bengt Glimelius, Jan Willem Leer, Cornelis J H van de Velde, and Dutch Colorectal Cancer Group.
• Department of Surgery, Leiden University Medical Center, Leiden, The Netherlands. k.c.m.j.peeters@lumc.nl
• Ann. Surg. 2007 Nov 1; 246 (5): 693-701.

ObjectiveTo investigate the efficacy of preoperative short-term radiotherapy in patients with mobile rectal cancer undergoing total mesorectal excision (TME) surgery.Summary Background DataLocal recurrence is a major problem in rectal cancer treatment. Preoperative short-term radiotherapy has shown to improve local control and survival in combination with conventional surgery. The TME trial investigated the value of this regimen in combination with total mesorectal excision. Long-term results are reported after a median follow-up of 6 years.MethodsOne thousand eight hundred and sixty-one patients with resectable rectal cancer were randomized between TME preceded by 5 x 5 Gy or TME alone. No chemotherapy was allowed. There was no age limit. Surgery, radiotherapy, and pathologic examination were standardized. Primary endpoint was local control.ResultsMedian follow-up of surviving patients was 6.1 year. Five-year local recurrence risk of patients undergoing a macroscopically complete local resection was 5.6% in case of preoperative radiotherapy compared with 10.9% in patients undergoing TME alone (P < 0.001). Overall survival at 5 years was 64.2% and 63.5%, respectively (P = 0.902). Subgroup analyses showed significant effect of radiotherapy in reducing local recurrence risk for patients with nodal involvement, for patients with lesions between 5 and 10 cm from the anal verge, and for patients with uninvolved circumferential resection margins.ConclusionsWith increasing follow-up, there is a persisting overall effect of preoperative short-term radiotherapy on local control in patients with clinically resectable rectal cancer. However, there is no effect on overall survival. Since survival is mainly determined by distant metastases, efforts should be directed towards preventing systemic disease.

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