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No survival difference between adjuvant 5-FU, gemcitabine in pancreatic cancer
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Results of the international ESPAC-3 trial indicated that there was no survival difference between adjuvant treatment of pancreatic ductal adenocarcinoma with the European standard of care, 5-FU/folinic acid, and the U.S. standard gemcitabine.
“There was absolutely no difference between the two regimens,” John P. Neoptolemos, MD, head of division of surgery and oncology at the University of Liverpool, said at the 2009 ASCO Annual Meeting. “This is extremely important because there has been a tendency to reject 5-FU in pancreatic cancer and now it is very much back on the stage.”
In the phase-3 ESPAC-3 trial 1,088 patients were randomly assigned within eight weeks of surgery to either 5-FU/folinic acid or gemcitabine for six months. The primary endpoint was OS. Median follow-up was 34 months.
Median OS was not significantly difference between the two arms (23 months vs. 23.6 months). However, patients assigned 5-FU/folinic acid reported more toxicities compared to patients assigned gemcitabine. The increase toxicities included grade-3/4 stomatitis (10% vs. 0), diarrhea (13% vs. 2%) and treatment-related hospitalizations (10% vs. 3.5%).
Given this safety profile, Neoptolemos said that gemcitabine is likely to be the preferred adjuvant therapy. – by Leah Lawrence
This trial suggests that there is no difference between 5-FU and gemcitabine if you give it after surgery alone, but it conflicts with other data suggesting a survival benefit with gemcitabine compared to 5-FU, as demonstrated in the RTOG 97-04. It is a negative trial. Their previous study, ESPAC-2, did suggest that adjuvant chemotherapy was beneficial with 5-FU. It doesn’t invalidate that adjuvant chemotherapy improves survival in pancreatic cancer it just suggests that there may not be as clear a difference between gemcitabine vs. 5-FU in the adjuvant setting as was seen in the ESPAC-2 trial.
- David Ilson, MD
HemOnc Today Editorial Board member
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