ESPAC-3: adjuvant fluorouracil plus folinic acid versus gemcitabine after pancreatic cancer resection
After surgery for pancreatic cancer, six months of gemcitabine gave the same survival as fluorouracil with folinic acid, about 23 months, with half as many serious side effects.
Overview
Phase 3 trial at 159 centres in Europe, Australasia, Japan and Canada: 1,088 patients with resected pancreatic ductal adenocarcinoma were randomised to six months of fluorouracil plus folinic acid (551) or gemcitabine (537). The primary endpoint was overall survival.
After a median follow-up of 34.2 months and 753 deaths, median survival was 23.0 months with fluorouracil and 23.6 months with gemcitabine (hazard ratio 0.94, p 0.39); progression-free survival and quality of life did not differ. Treatment-related serious adverse events occurred in 14 percent of fluorouracil patients and 7.5 percent of gemcitabine patients.
- Median overall survival 23.0 months (95% CI 21.1 to 25.0) with fluorouracil plus folinic acid versus 23.6 months (21.4 to 26.4) with gemcitabine; hazard ratio 0.94 (0.81 to 1.08).
- Treatment-related serious adverse events in 14 percent versus 7.5 percent of patients (p < 0.001).
Either regimen was acceptable adjuvant therapy in 2010, with gemcitabine preferred for tolerability; combination regimens (ESPAC-4, PRODIGE 24) have since superseded both.
- Open-label; the observation arm was dropped after ESPAC-1, so the trial does not itself test chemotherapy against no chemotherapy.
Similar pages
not linked directly; found by shared links- Key paperCONKO-001: adjuvant gemcitabine and long-term outcomes after resected pancreatic cancer
Shares JAMA, Resectable pancreatic ductal adenocarcinoma, Gemcitabine, Pancreatic ductal adenocarcinoma.
- TrialGlufosfamide Versus 5-FU in Second Line Metastatic Pancreatic Cancer
Shares Fluorouracil (5-FU), Gemcitabine, Pancreatic ductal adenocarcinoma.
- Key paperESPAC-4: adjuvant gemcitabine plus capecitabine versus gemcitabine alone after resection of pancreatic cancer
Shares Resectable pancreatic ductal adenocarcinoma, Gemcitabine, Pancreatic ductal adenocarcinoma.
- Key paperLAP07: chemoradiotherapy versus continued chemotherapy for locally advanced pancreatic cancer controlled after four months of gemcitabine
Shares JAMA, Gemcitabine, Pancreatic ductal adenocarcinoma.
- Key paperBurris 1997: gemcitabine becomes the first standard treatment for advanced pancreatic cancer
Shares Resectable pancreatic ductal adenocarcinoma, Fluorouracil (5-FU), Gemcitabine, Pancreatic ductal adenocarcinoma.
- TrialSafety and Efficacy of Immuncell-LC With Gemcitabine in Resectable Pancreatic Cancer
Shares Resectable pancreatic ductal adenocarcinoma, Gemcitabine, Pancreatic ductal adenocarcinoma.
- TrialESPAC-4
Shares Resectable pancreatic ductal adenocarcinoma, Gemcitabine, Pancreatic ductal adenocarcinoma.
- Key paperLAP07: chemoradiotherapy versus chemotherapy after four months of gemcitabine in locally advanced pancreatic cancer
Shares JAMA, Gemcitabine, Pancreatic ductal adenocarcinoma.