|
A correction has been published: N Engl J Med 2007;357(7):728.
|
 | |||||||||||||||||||||||||||||||||||||||
 | |||||||||||||||||||||||||||||||||||||||
| |||||||||||||||||||||||||||||||||||||||
Background Preoperative radiotherapy is recommended for selected patients with rectal cancer. We evaluated the addition of chemotherapy to preoperative radiotherapy and the use of postoperative chemotherapy in the treatment of rectal cancer.
Methods We randomly assigned patients with clinical stage T3 or T4 resectable rectal cancer to receive preoperative radiotherapy, preoperative chemoradiotherapy, preoperative radiotherapy and postoperative chemotherapy, or preoperative chemoradiotherapy and postoperative chemotherapy. Radiotherapy consisted of 45 Gy delivered over a period of 5 weeks. One course of chemotherapy consisted of 350 mg of fluorouracil per square meter of body-surface area per day and 20 mg of leucovorin per square meter per day, both given for 5 days. Two courses were combined with preoperative radiotherapy in the group receiving preoperative chemoradiotherapy and the group receiving preoperative chemoradiotherapy and postoperative chemotherapy; four courses were planned postoperatively in the group receiving preoperative radiotherapy and postoperative chemotherapy and the group receiving preoperative chemoradiotherapy and postoperative chemotherapy. The primary end point was overall survival.
Results We enrolled 1011 patients in the trial. There was no significant difference in overall survival between the groups that received chemotherapy preoperatively (P=0.84) and those that received it postoperatively (P=0.12). The combined 5-year overall survival rate for all four groups was 65.2%. The 5-year cumulative incidence rates for local recurrences were 8.7%, 9.6%, and 7.6% in the groups that received chemotherapy preoperatively, postoperatively, or both, respectively, and 17.1% in the group that did not receive chemotherapy (P=0.002). The rate of adherence to preoperative chemotherapy was 82.0%, and to postoperative chemotherapy was 42.9%.
Conclusions In patients with rectal cancer who receive preoperative radiotherapy, adding fluorouracil-based chemotherapy preoperatively or postoperatively has no significant effect on survival. Chemotherapy, regardless of whether it is administered before or after surgery, confers a significant benefit with respect to local control. (ClinicalTrials.gov number, NCT00002523
[ClinicalTrials.gov]
.)
Source Information
From the Department of Radiation Therapy, University of Franche-Comté, Besançon, France (J.-F.B.); European Organization for Research and Treatment of Cancer Data Center, Brussels (L.C.); Department of Radiation Therapy, University François Rabelais, Tours, France (G.C.); Department of Radiation Therapy, Clinic Ste-Catherine, Avignon, France (L.M.); Department of Radiation Therapy, Cancer Center Dijon, Dijon, France (P.M.); Institut for Oncology and Radiology, Belgrade, Serbia (L.R.-J.); Department of Radiation Therapy, University of Poitiers, Poitiers, France (A.D.); Department of Radiation Therapy, Cancer Center Nantes, Nantes, France (E.B.); Department of Radiation Therapy, Rambam Medical Center, Haifa, Israel (A.B.); and Department of Surgery, Cancer Center Strasbourg, Strasbourg, France (J.-C.O.).
Address reprint requests to Dr. Bosset at the Besançon University Hospital, Department of Radiotherapy, Blvd. Fleming, F-25030 Besançon CEDEX, France, or at jean-francois.bosset{at}ufc-chu.univ-fcomte.fr.
This article has been cited by other articles:
HOME | SUBSCRIBE | SEARCH | CURRENT ISSUE | PAST ISSUES | COLLECTIONS | PRIVACY | HELP | beta.nejm.org Comments and questions? Please contact us. The New England Journal of Medicine is owned, published, and copyrighted © 2008 Massachusetts Medical Society. All rights reserved. |
Previous
