ESPAC-4
ESPAC-4 showed that adding the tablet capecitabine to gemcitabine after pancreatic cancer surgery lengthened median survival from 25.5 to 28 months, and the pair became the adjuvant standard for people who cannot tolerate the harsher FOLFIRINOX regimen.
Overview
ESPAC-4 was an open-label phase 3 trial of the European Study Group for Pancreatic Cancer at 92 hospitals, randomising 730 analysed patients with resected pancreatic ductal adenocarcinoma to six cycles of gemcitabine or gemcitabine with capecitabine. The primary endpoint was overall survival.
Median overall survival was 28.0 months with the combination against 25.5 months with gemcitabine alone (hazard ratio 0.82), with 608 grade 3 to 4 adverse events in 226 patients on the combination against 481 in 196 patients on gemcitabine. The combination became a standard adjuvant option, later placed behind modified FOLFIRINOX (PRODIGE 24) for fit patients, which is how the corpus's resectable pancreatic cancer page cites it. The trial is registered only with the ISRCTN registry.
- Median 28 vs 25.5 months with Adjuvant gemcitabine + capecitabine compared with Adjuvant gemcitabine; about 2.5 months longer for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Put another way, the treated group had about 18 percent lower chance of the event at any given time (hazard ratio 0.82, likely range 0.68 to 0.98).
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- 63 vs 54 out of 100 reached this endpoint with Adjuvant gemcitabine + capecitabine compared with Adjuvant gemcitabine; 9 more per 100.
- On this measure the first group did worse, not better.
- This endpoint is not one of the standard survival or response measures; read it alongside the trial's primary result.
- These results apply to the people the trial enrolled: Resected pancreatic ductal adenocarcinoma within 12 weeks of surgery in the United Kingdom, Germany, France and Sweden: six cycles of adjuvant gemcitabine alone against gemcitabine plus capecitabine, with overall survival as the primary endpoint. People in a different situation may not see the same effect.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
732 registered.
95% CI 23.5 to 31.5 · 95% CI 22.7 to 27.9
Source226 of 359 patients, 608 events · 196 of 366 patients, 481 events
SourceSimilar pages
not linked directly; found by shared links- TrialCONKO-001
Shares Resectable pancreatic ductal adenocarcinoma, Gemcitabine, Cytotoxic chemotherapy, Pancreatic ductal adenocarcinoma and the tag soc-trials.
- TrialESPAC-3
Shares Resectable pancreatic ductal adenocarcinoma, Gemcitabine, Cytotoxic chemotherapy, Pancreatic ductal adenocarcinoma and the tag soc-trials.
- TrialESPAC-5
Shares Capecitabine, Gemcitabine, Cytotoxic chemotherapy, Pancreatic ductal adenocarcinoma and the tag soc-trials.
- TrialLAP07
Shares Capecitabine, Gemcitabine, Cytotoxic chemotherapy, Pancreatic ductal adenocarcinoma and the tag soc-trials.
- TrialNORPACT-1
Shares Resectable pancreatic ductal adenocarcinoma, Cytotoxic chemotherapy, Pancreatic ductal adenocarcinoma and the tag soc-trials.
- TrialCLASSIC
Shares Capecitabine, Cytotoxic chemotherapy and the tag soc-trials.
- TrialCONTINUUM
Shares Gemcitabine, Cytotoxic chemotherapy and the tag soc-trials.
- TrialPRECEDE
Shares Pancreatic ductal adenocarcinoma and the tag soc-trials.