The randomized controlled TME trial after a median follow - up of 6 years : increased local control but no survival benefi t in irradiated patients with resectable rectal carcinoma A report from the TME trial

Objective. To investigate the effi cacy of preoperative short term radiotherapy in patients with mobile rectal cancer undergoing TME surgery. Summary Background Data. Local 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 (TME). Long term results are reported after a median follow-up of 6 years. Methods. 1861 patients with resectable rectal cancer were randomized between TME preceded by 5x5 Gy or TME alone. No chemotherapy was allowed. There was no age limit. Surgery, radiotherapy as well as pathological examination were standardized. Primary endpoint was local control. Results: Median follow-up of surviving patients was 6·1 years. Five year local recurrence risk of patients undergoing a macroscopically complete local resection was 5·6% in case of preoperative radiotherapy compared to 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 signifi cant eff ect of radiotherapy in reducing local recurrence risk for patients with nodal involvement, for patients with lesions between 5 and 10 centimetres from the anal verge, and for patients with uninvolved circumferential resection margins. Conclusions. With increasing follow-up, there is a persisting overall eff ect of preoperative short term radiotherapy on local control in patients with clinically resectable rectal cancer. However, there is no eff ect on overall survival. Since survival is mainly determined by distant metastases, eff orts should be directed towards preventing systemic disease. The randomized controlled TME trial after a median follow-up of 6 years 115