• DOI:10.1056/NEJMOA032295
• Corpus ID: 25745560

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

@article{Neoptolemos2004ART,
  title={A randomized trial of chemoradiotherapy and chemotherapy after resection of pancreatic cancer.},
  author={John P. Neoptolemos and Deborah D Stocken and Helmut Friess and Claudio Bassi and Janet A Dunn and Helen Hickey and Hans G. Beger and Laureano Fern{\'a}ndez‐Cruz and Christos G. Dervenis and François Lacaine and Massimo Falconi and Paolo Pederzoli and {\'A} {\'A}kos Pap and David Spooner and David J Kerr and Markus W. B{\"u}chler},
  journal={The New England journal of medicine},
  year={2004},
  volume={350 12},
  pages={
          1200-10
        }
}

• J. Neoptolemos, D. Stocken, +13 authors M. Büchler
• Published 18 March 2004
• Medicine
• The New England journal of medicine

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.