Preoperative versus Postoperative Chemoradiotherapy for Rectal Cancer

doi:10.1056/NEJMoa040694

Volume 351:1731-1740		October 21, 2004		Number 17

Preoperative versus Postoperative Chemoradiotherapy for Rectal Cancer

Rolf Sauer, M.D., Heinz Becker, M.D., Werner Hohenberger, M.D., Claus Rödel, M.D., Christian Wittekind, M.D., Rainer Fietkau, M.D., Peter Martus, Ph.D., Jörg Tschmelitsch, M.D., Eva Hager, M.D., Clemens F. Hess, M.D., Johann-H. Karstens, M.D., Torsten Liersch, M.D., Heinz Schmidberger, M.D., Rudolf Raab, M.D., for the German Rectal Cancer Study Group

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ABSTRACT

Background Postoperative chemoradiotherapy is the recommendedstandard therapy for patients with locally advanced rectal cancer.In recent years, encouraging results with preoperative radiotherapyhave been reported. We compared preoperative chemoradiotherapywith postoperative chemoradiotherapy for locally advanced rectalcancer.

Methods We randomly assigned patients with clinical stage T3or T4 or node-positive disease to receive either preoperativeor postoperative chemoradiotherapy. The preoperative treatmentconsisted of 5040 cGy delivered in fractions of 180 cGy perday, five days per week, and fluorouracil, given in a 120-hourcontinuous intravenous infusion at a dose of 1000 mg per squaremeter of body-surface area per day during the first and fifthweeks of radiotherapy. Surgery was performed six weeks afterthe completion of chemoradiotherapy. One month after surgery,four five-day cycles of fluorouracil (500 mg per square meterper day) were given. Chemoradiotherapy was identical in thepostoperative-treatment group, except for the delivery of aboost of 540 cGy. The primary end point was overall survival.

Results Four hundred twenty-one patients were randomly assignedto receive preoperative chemoradiotherapy and 402 patients toreceive postoperative chemoradiotherapy. The overall five-yearsurvival rates were 76 percent and 74 percent, respectively(P=0.80). The five-year cumulative incidence of local relapsewas 6 percent for patients assigned to preoperative chemoradiotherapyand 13 percent in the postoperative-treatment group (P=0.006).Grade 3 or 4 acute toxic effects occurred in 27 percent of thepatients in the preoperative-treatment group, as compared with40 percent of the patients in the postoperative-treatment group(P=0.001); the corresponding rates of long-term toxic effectswere 14 percent and 24 percent, respectively (P=0.01).

Conclusions Preoperative chemoradiotherapy, as compared withpostoperative chemoradiotherapy, improved local control andwas associated with reduced toxicity but did not improve overallsurvival.

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From the Departments of Radiation Therapy (R.S., C.R.) and Surgery (W.H.), University of Erlangen, Erlangen, Germany; the Departments of Surgery (H.B., T.L.) and Radiation Therapy (C.F.H., H.S.), University of Göttingen, Göttingen, Germany; the Institute of Pathology, University of Leipzig, Leipzig, Germany (C.W.); the Department of Radiation Therapy, University of Rostock, Rostock, Germany (R.F.); the Institute of Medical Informatics, Biometry, and Epidemiology, Charité University Medicine Berlin, Berlin (P.M.); the Department of Surgery, Krankenhaus der Barmherzigen Brüder, St. Veit an der Glan, Austria (J.T.); the Institute of Radiotherapy, Landeskrankenhaus Klagenfurt, Austria (E.H.); the Department of Radiation Therapy, Medizinische Hochschule Hannover, Hannover, Germany (J.-H.K.); and the Department of Surgery, Klinikum Oldenburg, Oldenburg, Germany (R.R.).

Address reprint requests to Dr. Sauer at the Department of Radiation Therapy, University of Erlangen, Universitätsstr. 27 91054, Erlangen, Germany, or at sekretariat{at}strahlen.med.uni-erlangen.de.

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N Engl J Med 2005; 352:509-511, Feb 3, 2005. Correspondence

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