CONKO-001
After macroscopic complete resection of pancreatic cancer, does six months of gemcitabine improve outcomes compared with observation?
Reported outcome visualization
Key results
At median follow-up 136 months, median DFS was 13.4 vs 6.7 months (HR 0.55, 95% CI 0.44–0.69; P<.001). Median OS was 22.8 vs 20.2 months (HR 0.76, 95% CI 0.61–0.95; P=.01). Five-year OS was 20.7% vs 10.4%; 10-year OS 12.2% vs 7.7%.
Absolute Effect
Five-year OS absolute gain 10.3 percentage points; NNT ≈10 at 5 years. Five-year DFS was 16.6% vs 7.0%, an absolute gain 9.6 points; NNT ≈11 at 5 years. These are landmark survival differences.
NNT: ≈10, based on 5-year overall survival; ≈11 based on 5-year disease-free survival.
NNH: Not quantifiable from the verified fixed-time toxicity data used in this summary; see toxicity and treatment burden below.
Time-to-event interpretation: Hazard ratios and median survival are relative/time-to-event measures; they are not converted into NNT unless a fixed-time absolute event estimate is available.
Toxicity and treatment burden
Gemcitabine causes myelosuppression, fatigue, flu-like symptoms and hepatic abnormalities. Toxicity and completion should be contextualized against later adjuvant regimens; no NNH is derived here without a selected verified fixed-time toxicity endpoint.
Follow-up, limitations and maturity
Follow-up: Median follow-up 136 months.
Observation comparator is historical; modern adjuvant mFOLFIRINOX is preferred for many fit patients. Trial supports adjuvant chemotherapy generally but does not establish gemcitabine as the most effective contemporary regimen.
Clinical interpretation
Adjuvant gemcitabine improved long-term disease-free and overall survival versus observation, establishing a treatment benefit after resection but not the current optimal regimen.
Primary publication and sources
Oettle H, et al. JAMA. 2013;310:1473–1481.
Current-practice context · reviewed 15 October 2026
CONKO-001 established adjuvant chemotherapy over observation after pancreatic cancer resection. For fit patients, modified FOLFIRINOX is generally preferred based on PRODIGE 24; gemcitabine plus capecitabine or gemcitabine alone may be appropriate depending on performance status, comorbidity and tolerance. Do not interpret CONKO-001 as showing gemcitabine is the most effective contemporary regimen.