A randomized trial of chemoradiotherapy and chemotherapy after resection of pancreatic cancer

JP Neoptolemos, Deborah Stocken, H Friess, C Bassi, Janet Dunn, H Hickey, H Beger, L Fernandez-Cruz, C Dervenis, F Lacaine, M Falconi, P Pederzoli, A Pap, David Spooner, DJ Kerr, MW Buchler

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1980 Citations (Scopus)


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
Early online date25 Feb 2004
Publication statusPublished - 25 Feb 2004


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