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CONKO-001 was the trial that made chemotherapy after pancreatic cancer surgery routine: six months of gemcitabine doubled the time before the cancer came back and roughly doubled the share of patients alive at five years, from 10 to 21 percent.
CONKO-001 was a German and Austrian open-label phase 3 trial that randomised 368 patients with macroscopically complete resection of pancreatic cancer to six cycles of adjuvant gemcitabine or observation between 1998 and 2004. The primary endpoint was disease-free survival.
At a median follow-up of 136 months, median disease-free survival was 13.4 months with gemcitabine against 6.7 months with observation (hazard ratio 0.55), and overall survival was longer (hazard ratio 0.76), with five-year survival of 20.7 against 10.4 percent and ten-year survival of 12.2 against 7.7 percent. Gemcitabine alone remains the adjuvant option for patients who cannot tolerate combination chemotherapy, which is how the corpus's resectable pancreatic cancer page cites the trial. It 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.
368 randomised.
95% CI 11.6 to 15.3; 354 patients in the intention-to-treat analysis · 95% CI 6.0 to 7.5
Source95% CI 14.7 to 26.6 · 95% CI 5.9 to 15.0
Source95% CI 7.3 to 17.2 · 95% CI 3.6 to 11.8
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Disease-free survivalprimary | Adjuvant gemcitabine | - | 13.4 months | 0.55 (0.44 to 0.69) | <0.001 | link |
| Observation | - | 6.7 months | ||||
| Overall survival at 5 years | Adjuvant gemcitabine | - | 20.7% | 0.76 (0.61 to 0.95) | 0.01 | link |
| Observation | - | 10.4% | ||||
| Overall survival at 10 years | Adjuvant gemcitabine | - | 12.2% | - | - | link |
| Observation | - | 7.7% |
Adjuvant chemotherapy is standard after pancreatic cancer resection; gemcitabine alone remains the option for patients who cannot tolerate combinations.
The trial that made adjuvant gemcitabine standard in Europe and the control arm PRODIGE 24 and ESPAC-4 later beat.
Shares ESPAC-1, Resectable pancreatic ductal adenocarcinoma, Gemcitabine, Pancreatic ductal adenocarcinoma and the tag soc-trials.
Shares Charité Universitätsmedizin Berlin, 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, Gemcitabine, Pancreatic ductal adenocarcinoma, 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, Gemcitabine, Pancreatic ductal adenocarcinoma, Cytotoxic chemotherapy and the tag soc-trials.
Shares Charité Universitätsmedizin Berlin, Cytotoxic chemotherapy and the tag soc-trials.
Shares Resectable pancreatic ductal adenocarcinoma, Pancreatic ductal adenocarcinoma, 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.