CONKO-001
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.
Overview
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.
- Median 13.4 vs 6.7 months with Adjuvant gemcitabine compared with Observation; about 6.7 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 45 percent lower chance of the event at any given time (hazard ratio 0.55, likely range 0.44 to 0.69).
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- 20.7 vs 10.4 out of 100 alive at 5 years with Adjuvant gemcitabine compared with Observation; 10.3 more per 100.
- Roughly one extra person helped for every 10 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- Put another way, the treated group had about 24 percent lower chance of the event at any given time (hazard ratio 0.76, likely range 0.61 to 0.95).
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- 12.2 vs 7.7 out of 100 alive at 10 years with Adjuvant gemcitabine compared with Observation; 4.5 more per 100.
- Roughly one extra person helped for every 22 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- These results apply to the people the trial enrolled: Macroscopically complete resection of pancreatic cancer in Germany and Austria: six months of adjuvant gemcitabine against observation, with disease-free 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.
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% |
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