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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.
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.
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
Source95% CI 26.5 to 38.0 · 95% CI 25.2 to 32.0
Source95% CI 39.0 to 82.3 · 95% CI 27.9 to 41.6
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survivalprimary | Adjuvant gemcitabine + capecitabine | 364 | 28 months | 0.82 (0.68 to 0.98) | 0.032 | link |
| Adjuvant gemcitabine | 366 | 25.5 months | ||||
| Patients with grade 3 to 4 adverse events | Adjuvant gemcitabine + capecitabine | 359 | 63% | - | - | link |
| Adjuvant gemcitabine | 366 | 54% | ||||
| Overall survival, long-term follow-up (median 104 months) | Adjuvant gemcitabine + capecitabine | 365 | 31.6 months | 0.83 (0.71 to 0.98) | 0.031 | link |
| Adjuvant gemcitabine | 367 | 28.4 months | ||||
| Overall survival after R0 resection (long-term) | Adjuvant gemcitabine + capecitabine | - | 49.9 months | 0.63 (0.47 to 0.84) | 0.002 | link |
| Adjuvant gemcitabine | - | 32.2 months |
Shares ESPAC-1, Paula Ghaneh, Liverpool University Hospitals HPB centre (Aintree), Resectable pancreatic ductal adenocarcinoma and the tag soc-trials.
Shares Daniel Palmer, Paula Ghaneh, Liverpool University Hospitals HPB centre (Aintree), Pancreatic cancer roadmap: from Whipple's operation to gemcitabine, FOLFIRINOX, adjuvant chemotherapy, PARP inhibition, KRAS inhibition, vaccines and the surveillance question and the tag soc-trials.
Shares Pancreatic cancer roadmap: from Whipple's operation to gemcitabine, FOLFIRINOX, adjuvant chemotherapy, PARP inhibition, KRAS inhibition, vaccines and the surveillance question, Capecitabine, Gemcitabine, Pancreatic ductal adenocarcinoma and the tag soc-trials.
Shares Resectable pancreatic ductal adenocarcinoma, Pancreatic ductal adenocarcinoma, Cytotoxic chemotherapy and the tag soc-trials.
Shares Capecitabine, Cytotoxic chemotherapy and the tag soc-trials.
Shares Gemcitabine, Cytotoxic chemotherapy and the tag soc-trials.
Shares Pancreatic cancer roadmap: from Whipple's operation to gemcitabine, FOLFIRINOX, adjuvant chemotherapy, PARP inhibition, KRAS inhibition, vaccines and the surveillance question, Pancreatic ductal adenocarcinoma and the tag soc-trials.
Shares Gemcitabine, Cytotoxic chemotherapy and the tag soc-trials.