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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.
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.
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% |
Shares ESPAC-1, Paula Ghaneh, Liverpool University Hospitals HPB centre (Aintree), Resectable pancreatic ductal adenocarcinoma and the tag soc-trials.
Shares Paula Ghaneh, Liverpool University Hospitals HPB centre (Aintree), Gemcitabine, Pancreatic ductal adenocarcinoma and the tag soc-trials.
Shares ESPAC-1, Resectable pancreatic ductal adenocarcinoma, Gemcitabine, Pancreatic ductal adenocarcinoma and the tag soc-trials.
Shares Leucovorin (folinic acid), Fluorouracil (5-FU), Cytotoxic chemotherapy and the tag soc-trials.
Shares Resectable pancreatic ductal adenocarcinoma, Fluorouracil (5-FU), Pancreatic ductal adenocarcinoma, Cytotoxic chemotherapy and the tag soc-trials.
Shares Gemcitabine, Pancreatic ductal adenocarcinoma, Cytotoxic chemotherapy and the tag soc-trials.
Shares Fluorouracil (5-FU), Cytotoxic chemotherapy and the tag soc-trials.
Shares Gemcitabine, Cytotoxic chemotherapy and the tag soc-trials.