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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

Peeters, Koen C.M.J. MD*; Marijnen, Corrie A.M. MD, PhD†‡; Nagtegaal, Iris D. MD, PhD§; Kranenbarg, Elma Klein MSc*; Putter, Hein MD; Wiggers, Theo MD, PhD; Rutten, Harm MD, PhD#; Pahlman, Lars MD, PhD**; Glimelius, Bengt MD, PhD††§§; Leer, Jan Willem MD, PhD∥∥; van de Velde, Cornelis J.H. MD, PhD*for the Dutch Colorectal Cancer Group

doi: 10.1097/01.sla.0000257358.56863.ce
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Objective: To investigate the efficacy of preoperative short-term radiotherapy in patients with mobile rectal cancer undergoing total mesorectal excision (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. 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 × 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.

The TME trial, a randomized controlled trial investigated the efficacy of preoperative short-term radiotherapy in patients with rectal cancer treated with TME surgery. After a median follow-up of 6 years, there is still a significant effect of radiotherapy on local recurrence rate, there is however no effect on overall survival.

From the Departments of *Surgery, †Clinical Oncology, Leiden University Medical Center, Leiden, The Netherlands; ‡Department of Radiotherapy, The Netherlands Cancer Institute, Amsterdam, The Netherlands; §Department of Pathology, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands; ∥Department of Medical Statistics, Leiden University Medical Center, Leiden, The Netherlands; ¶Department of Surgical Oncology, Medical Center Groningen, Groningen, The Netherlands; #Department of Surgery, Catharina Hospital, Eindhoven, The Netherlands; Departments of **Surgery, ††Oncology, Akademiska Sjukhuset, Uppsala; §§Karolinska Institutet, Stockholm, Sweden; and ∥∥Joint Center for Radiation Oncology, Nijmegen, The Netherlands.

The TME trial has been funded by the Dutch Cancer Society and the Dutch Health Council.

Address for correspondence: Koen C.M.J. Peeters MD, Department of Surgery, Bronovo Ziekenhuis and Leiden University Medical Center, Bronovolaan 5 2597 AX Den Haag, The Netherlands 31 70 312 41 41. E-mail: k.c.m.j.peeters@lumc.nl

© 2007 Lippincott Williams & Wilkins, Inc.