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

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish
Pages (from-to)1200-1210
Number of pages11
JournalNew England Journal of Medicine
Volume350
Issue number12
DOIs
Publication statusPublished - Mar 18 2004

ASJC Scopus subject areas

  • Medicine(all)

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