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A Randomized Trial of Chemoradiotherapy and Chemotherapy after Resection of Pancreatic Cancer
John P. Neoptolemos, M.D., Deborah D. Stocken, M.Sc., Helmut Friess, M.D., Claudio Bassi, M.D., Janet A. Dunn, M.Sc., Helen Hickey, B.Sc., Hans Beger, M.D., Laureano Fernandez-Cruz, M.D., Christos Dervenis, M.D., François Lacaine, M.D., Massimo Falconi, M.D., Paolo Pederzoli, M.D., Akos Pap, M.D., David Spooner, M.D., David J. Kerr, M.D., Markus W. Büchler, M.D.,
for the European Study Group for Pancreatic Cancer
ABSTRACT
Background The 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.
Methods In 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.
Results The 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.
Conclusions Adjuvant chemotherapy has a significant survival benefit in patients with resected pancreatic cancer, whereas adjuvant chemoradiotherapy has a deleterious effect on survival.
New England J Medicine
Volume 350:1200-1210 March 18, 2004 Number 12
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 Gastrointestinal Cancers Symposium,
Orlando, FL January 22, 2007

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