Preoperative Radiotherapy Combined with Total Mesorectal Excision for Resectable Rectal Cancer
Ellen Kapiteijn, M.D., Corrie A.M. Marijnen, M.D., Iris D. Nagtegaal, M.D., Hein Putter, Ph.D., Willem H. Steup, M.D., Ph.D., Theo Wiggers, M.D., Ph.D., Harm J.T. Rutten, M.D., Ph.D., Lars Pahlman, M.D., Ph.D., Bengt Glimelius, M.D., Ph.D., J. Han J.M. van Krieken, M.D., Ph.D., Jan W.H. Leer, M.D., Ph.D., Cornelis J.H. van de Velde, M.D., Ph.D., for the Dutch Colorectal Cancer Group
Background Short-term preoperative radiotherapy and total mesorectalexcision have each been shown to improve local control of diseasein patients with resectable rectal cancer. We conducted a multicenter,randomized trial to determine whether the addition of preoperativeradiotherapy increases the benefit of total mesorectal excision.
Methods We randomly assigned 1861 patients with resectable rectalcancer either to preoperative radiotherapy (5 Gy on each offive days) followed by total mesorectal excision (924 patients)or to total mesorectal excision alone (937 patients). The trialwas conducted with the use of standardization and quality-controlmeasures to ensure the consistency of the radiotherapy, surgery,and pathological techniques.
Results Of the 1861 patients randomly assigned to one of thetwo treatment groups, 1805 were eligible to participate. Theoverall rate of survival at two years among the eligible patientswas 82.0 percent in the group assigned to both radiotherapyand surgery and 81.8 percent in the group assigned to surgeryalone (P=0.84). Among the 1748 patients who underwent a macroscopicallycomplete local resection, the rate of local recurrence at twoyears was 5.3 percent. The rate of local recurrence at two yearswas 2.4 percent in the radiotherapy-plus-surgery group and 8.2percent in the surgery-only group (P<0.001).
Conclusions Short-term preoperative radiotherapy reduces therisk of local recurrence in patients with rectal cancer whoundergo a standardized total mesorectal excision.
Source Information
From the Departments of Surgery (E.K., C.J.H.V.), Clinical Oncology (C.A.M.M.), and Medical Statistics (H.P.), Leiden University Medical Center, Leiden; the Departments of Pathology (I.D.N., J.H.J.M.K.) and Radiotherapy (J.W.H.L.), University Medical Center St. Radboud, Nijmegen; the Department of Surgery, Leyenburg Hospital, The Hague (W.H.S.); the Department of Surgery, University Hospital Groningen, Groningen (T.W.); and the Department of Surgery, Catharina Hospital, Eindhoven (H.J.T.R.) all in the Netherlands; and the Departments of Surgery (L.P.) and Oncology (B.G.), Akademiska Sjukhuset, Uppsala, Sweden.
Address reprint requests to Dr. van de Velde at the Department of Surgery K6-R, Leiden University Medical Center, P.O. Box 9600, 2300 RC Leiden, the Netherlands, or at velde{at}lumc.nl.
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