The TME trial after a median follow-up of 6 years: increased local control but no survival benefit in irradiated patients with resectable rectal carcinoma.
OBJECTIVE
To investigate the efficacy of preoperative short-term radiotherapy in patients with mobile rectal cancer undergoing total mesorectal excision (TME) surgery.


BACKGROUND
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. Long-term results are reported after a median follow-up of 6 years.


METHODS
One 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.


RESULTS
Median 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.


CONCLUSIONS
With 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.
Peeters
Koen C M J
KC
Department of Surgery, Leiden University Medical Center, Leiden, The Netherlands. k.c.m.j.peeters@lumc.nl
Marijnen
Corrie A M
CA
Nagtegaal
Iris D
ID
Kranenbarg
Elma Klein
EK
Putter
Hein
H
Wiggers
Theo
T
Rutten
Harm
H
Pahlman
Lars
L
Glimelius
Bengt
B
Leer
Jan Willem
JW
van de Velde
Cornelis J H
CJ
D000230:Adenocarcinoma / Q000401:mortality / Q000532:radiotherapy* / Q000601:surgery*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D018714:Radiotherapy, Adjuvant; D012004:Rectal Neoplasms / Q000401:mortality / Q000532:radiotherapy* / Q000601:surgery*; D015996:Survival Rate; D013997:Time Factors; D016896:Treatment Outcome