ESPAC-3
ESPAC-3 compared the two adjuvant chemotherapies then available after pancreatic cancer surgery and found they gave the same survival, about 23 months, but gemcitabine caused half as many serious side effects; a companion cohort in ampullary and bile duct cancers is still the main randomised evidence for adjuvant chemotherapy in those rarer tumours.
Overview
ESPAC-3 was the European Study Group for Pancreatic Cancer's phase 3 trial at 159 centres in Europe, Australasia, Japan and Canada. After ESPAC-1 established adjuvant chemotherapy, the observation arm was removed and 1,088 patients with resected pancreatic ductal adenocarcinoma were randomised to six months of fluorouracil with folinic acid or gemcitabine. The primary endpoint was overall survival.
Median survival was 23.0 months with fluorouracil and 23.6 months with gemcitabine (hazard ratio 0.94), with no difference in progression-free survival or quality of life, but treatment-related serious adverse events were twice as common with fluorouracil (14 against 7.5 percent). A periampullary cohort of 428 patients randomised between observation and the two regimens showed a survival benefit for chemotherapy after adjustment for prognostic factors, which is why the corpus's ampullary cancer page cites ESPAC-3 as its adjuvant evidence.
- Median 23 vs 23.6 months with Adjuvant fluorouracil + folinic acid compared with Adjuvant gemcitabine; about 0.6 months shorter 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 6 percent lower chance of the event at any given time (hazard ratio 0.94, likely range 0.81 to 1.08).
- The likely range for the hazard ratio crosses 1, so the difference could be due to chance.
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- 14 vs 7.5 out of 100 reached this endpoint with Adjuvant fluorouracil + folinic acid compared with Adjuvant gemcitabine; 6.5 more per 100.
- On this measure the first group did worse, not better.
- The p-value (<0.001) says a difference this large would rarely happen by chance; it does not say how large or how useful the difference is.
- 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 (and a separate periampullary cohort): six months of adjuvant fluorouracil with folinic acid against gemcitabine, with overall survival as the primary endpoint; an observation arm was dropped when ESPAC-1 showed chemotherapy helped. 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.
1,088 randomised.
95% CI 21.1 to 25.0; median follow-up 34.2 months · 95% CI 21.4 to 26.4
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survival, pancreatic ductal adenocarcinoma cohortprimary | Adjuvant fluorouracil + folinic acid | 551 | 23 months | 0.94 (0.81 to 1.08) | 0.39 | link |
| Adjuvant gemcitabine | 537 | 23.6 months | ||||
| Patients with treatment-related serious adverse events | Adjuvant fluorouracil + folinic acid | 551 | 14% | - | <0.001 | link |
| Adjuvant gemcitabine | 537 | 7.5% |
Similar pages
not linked directly; found by shared links- TrialESPAC-4
Shares Resectable pancreatic ductal adenocarcinoma, Gemcitabine, Cytotoxic chemotherapy, Pancreatic ductal adenocarcinoma and the tag soc-trials.
- TrialCONKO-001
Shares Resectable pancreatic ductal adenocarcinoma, Gemcitabine, Cytotoxic chemotherapy, Pancreatic ductal adenocarcinoma and the tag soc-trials.
- TrialBALLAD
Shares Leucovorin (folinic acid), Fluorouracil (5-FU), Cytotoxic chemotherapy and the tag soc-trials.
- TrialNORPACT-1
Shares Resectable pancreatic ductal adenocarcinoma, Fluorouracil (5-FU), Cytotoxic chemotherapy, Pancreatic ductal adenocarcinoma and the tag soc-trials.
- TrialESPAC-5
Shares Gemcitabine, Cytotoxic chemotherapy, Pancreatic ductal adenocarcinoma and the tag soc-trials.
- TrialLAP07
Shares Gemcitabine, Cytotoxic chemotherapy, Pancreatic ductal adenocarcinoma and the tag soc-trials.
- TrialInterAACT
Shares Fluorouracil (5-FU), Cytotoxic chemotherapy and the tag soc-trials.
- TrialCONTINUUM
Shares Gemcitabine, Cytotoxic chemotherapy and the tag soc-trials.