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Randomized Controlled Trial Multicenter Study Clinical Trial
A randomized trial of chemoradiotherapy and chemotherapy after resection of pancreatic cancer.
- John P Neoptolemos, Deborah D Stocken, Helmut Friess, Claudio Bassi, Janet A Dunn, Helen Hickey, Hans Beger, Laureano Fernandez-Cruz, Christos Dervenis, François Lacaine, Massimo Falconi, Paolo Pederzoli, Akos Pap, David Spooner, David J Kerr, Markus W Büchler, and European Study Group for Pancreatic Cancer.
- Department of Surgery, Liverpool University, Liverpool, United Kingdom.
- N. Engl. J. Med. 2004 Mar 18; 350 (12): 1200-10.
BackgroundThe effect of adjuvant treatment on survival in pancreatic cancer is unclear. We report the final results of the European Study Group for Pancreatic Cancer 1 Trial and update the interim results.MethodsIn a multicenter trial using a two-by-two factorial design, we randomly assigned 73 patients with resected pancreatic ductal adenocarcinoma to treatment with chemoradiotherapy alone (20 Gy over a two-week period plus fluorouracil), 75 patients to chemotherapy alone (fluorouracil), 72 patients to both chemoradiotherapy and chemotherapy, and 69 patients to observation.ResultsThe analysis was based on 237 deaths among the 289 patients (82 percent) and a median follow-up of 47 months (interquartile range, 33 to 62). The estimated five-year survival rate was 10 percent among patients assigned to receive chemoradiotherapy and 20 percent among patients who did not receive chemoradiotherapy (P=0.05). The five-year survival rate was 21 percent among patients who received chemotherapy and 8 percent among patients who did not receive chemotherapy (P=0.009). The benefit of chemotherapy persisted after adjustment for major prognostic factors.ConclusionsAdjuvant chemotherapy has a significant survival benefit in patients with resected pancreatic cancer, whereas adjuvant chemoradiotherapy has a deleterious effect on survival.Copyright 2004 Massachusetts Medical Society
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