CONKO-001
Adjuvant chemotherapy with gemcitabine vs observation in patients undergoing curative-intent resection of pancreatic cancer (CONKO-001)
Phase 3N = 368
- Population
- Patients with gross complete (R0 or R1) resection of pancreatic cancer and no prior radiation or chemotherapy; 368 randomised, 354 eligible and analysed.
- Design
- Open-label, multicentre randomised phase 3 trial at 88 centres in Germany and Austria, July 1998 to December 2004, with stratification for resection, tumour and node status. Adjuvant gemcitabine 1 g/m2 on days 1, 8 and 15 every 4 weeks for 6 cycles versus observation, after gross complete (R0 or R1) resection with no prior radiation or chemotherapy. Primary endpoint disease-free survival; overall survival secondary. Registered as ISRCTN34802808 (not an NCT number). Arm sizes are the 354 eligible patients analysed (179 and 175) of 368 randomised. The 2013 report extends follow-up to September 2012.
- Primary endpoint
- DFS
- Arms
- Adjuvant gemcitabine (experimental, n = 179): Gemcitabine 1 g/m2 on days 1, 8, 15 every 4 weeks, 6 cycles
- Observation (control, n = 175): Observation after resection
- People
- Oettle H
Δ median DFS+6.5 monthsΔ 36-month DFS+16 pointsΔ median OS+1.9 monthsΔ 36-month OS+13.5 pointsDFSHR 0.55 (95% CI 0.44–0.69)Δ median DFS+6.7 months
Show the numbers
| Endpoint | Analysis | Adjuvant gemcitabine | Observation | Effect |
|---|---|---|---|---|
| DFSEligible patients, intention-to-treat (354 of 368 randomised) | primarymedian follow-up 53 monthsOettle 2007 | median 13.4 months (11.4–15.3); 23.5% at 3 y; 16.5% at 5 y | median 6.9 months (6.1–7.8); 7.5% at 3 y; 5.5% at 5 y | P<.001Log-rank test. Recurrent disease occurred in 133 patients (74%) in the gemcitabine group and 161 (92%) in the control group. |
| OSEligible patients, intention-to-treat (354 of 368 randomised) | primarymedian follow-up 53 monthsOettle 2007 | median 22.1 months (18.4–25.8); 34% at 3 y; 22.5% at 5 y | median 20.2 months (17.0–23.4); 20.5% at 3 y; 11.5% at 5 y | P=.06Secondary endpoint, reported in the primary publication; the abstract reports no difference in overall survival. Log-rank test. |
| DFSPatients eligible for intention-to-treat analysis (354 of 368 randomised) | long term-updatemedian follow-up 136 monthsOettle 2013 | median 13.4 months (11.6–15.3) | median 6.7 months (6.0–7.5) | HR 0.55 (95% CI 0.44–0.69)P<.001Follow-up ended in September 2012. The median observation-group value (6.7 months) differs slightly from the 2007 report (6.9 months), as published. |
| OSPatients eligible for intention-to-treat analysis (354 of 368 randomised) | long term-updatemedian follow-up 136 monthsOettle 2013 | 20.7% at 5 y (14.7–26.6%); 12.2% at 10 y (7.3–17.2%) | 10.4% at 5 y (5.9–15.0%); 7.7% at 10 y (3.6–11.8%) | HR 0.76 (95% CI 0.61–0.95)P=.01Median overall survival is not given in the abstract and is not recorded here. Overall survival was a secondary endpoint. |
| Endpoint | Analysis | Adjuvant gemcitabine | Observation | Effect |
|---|---|---|---|---|
| DFSEligible patients, intention-to-treat (354 of 368 randomised) | primarymedian follow-up 53 monthsOettle 2007 | median 13.4 months (11.4–15.3); 23.5% at 3 y; 16.5% at 5 y | median 6.9 months (6.1–7.8); 7.5% at 3 y; 5.5% at 5 y | P<.001Log-rank test. Recurrent disease occurred in 133 patients (74%) in the gemcitabine group and 161 (92%) in the control group. |
| OSEligible patients, intention-to-treat (354 of 368 randomised) | primarymedian follow-up 53 monthsOettle 2007 | median 22.1 months (18.4–25.8); 34% at 3 y; 22.5% at 5 y | median 20.2 months (17.0–23.4); 20.5% at 3 y; 11.5% at 5 y | P=.06Secondary endpoint, reported in the primary publication; the abstract reports no difference in overall survival. Log-rank test. |
| DFSPatients eligible for intention-to-treat analysis (354 of 368 randomised) | long term-updatemedian follow-up 136 monthsOettle 2013 | median 13.4 months (11.6–15.3) | median 6.7 months (6.0–7.5) | HR 0.55 (95% CI 0.44–0.69)P<.001Follow-up ended in September 2012. The median observation-group value (6.7 months) differs slightly from the 2007 report (6.9 months), as published. |
| OSPatients eligible for intention-to-treat analysis (354 of 368 randomised) | long term-updatemedian follow-up 136 monthsOettle 2013 | 20.7% at 5 y (14.7–26.6%); 12.2% at 10 y (7.3–17.2%) | 10.4% at 5 y (5.9–15.0%); 7.7% at 10 y (3.6–11.8%) | HR 0.76 (95% CI 0.61–0.95)P=.01Median overall survival is not given in the abstract and is not recorded here. Overall survival was a secondary endpoint. |
Data table
| Endpoint | HR | 95% CI |
|---|---|---|
| DFS | 0.55 | 0.44–0.69 |
| OS | 0.76 | 0.61–0.95 |
- Adjuvant gemcitabine (experimental)
- Observation (control)
Data table (modelled values)
| Months | Adjuvant gemcitabine | Observation |
|---|---|---|
| 0 | 100.0% | 100.0% |
| 16 | 61.0% | 49.7% |
| 32 | 28.0% | 10.4% |
| 49 | 17.9% | 5.7% |
| 65 | 16.5% | 5.5% |
- Adjuvant gemcitabine (experimental)
- Observation (control)
Data table (modelled values)
| Months | Adjuvant gemcitabine | Observation |
|---|---|---|
| 0 | 100.0% | 100.0% |
| 16 | 68.0% | 60.2% |
| 32 | 39.2% | 25.8% |
| 49 | 25.9% | 13.5% |
| 65 | 22.5% | 11.5% |
Appears in
Sources
Oettle H, Post S, Neuhaus P, Gellert K, Langrehr J, Ridwelski K, et al. Adjuvant chemotherapy with gemcitabine vs observation in patients undergoing curative-intent resection of pancreatic cancer: a randomized controlled trial. JAMA. 2007;297(3):267-77.
Oettle H, Neuhaus P, Hochhaus A, Hartmann JT, Gellert K, Ridwelski K, et al. Adjuvant chemotherapy with gemcitabine and long-term outcomes among patients with resected pancreatic cancer: the CONKO-001 randomized trial. JAMA. 2013;310(14):1473-81.