# CONKO-001: adjuvant gemcitabine and long-term outcomes after resected pancreatic cancer

Source: https://onco.cc/key-papers/paper-conko-001-adjuvant-gemcitabine-long-term-oettle-jama-2013/  
OnCo record `paper-conko-001-adjuvant-gemcitabine-long-term-oettle-jama-2013` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Six months of gemcitabine after complete removal of pancreatic cancer doubled the time to relapse and roughly doubled five-year survival, from 10 to 21 percent, in the trial that established adjuvant chemotherapy for the disease.

## Summary

Long-term report of the German and Austrian open-label phase 3 CONKO-001 trial: 368 patients randomised between 1998 and 2004 to six months of adjuvant gemcitabine or observation, 354 analysed by intention to treat, median follow-up 136 months.

Median disease-free survival was 13.4 months with gemcitabine against 6.7 months with observation (hazard ratio 0.55); overall survival was improved (hazard ratio 0.76, p 0.01), with five-year survival 20.7 against 10.4 percent and ten-year survival 12.2 against 7.7 percent.

## Fields

- Kind: Key paper
- Last checked: 2026-09-22
- Journal: JAMA
- Year: 2013
- DOI: 10.1001/jama.2013.279201
- Authors: Oettle H, Neuhaus P, Hochhaus A, et al.
- Findings: Median disease-free survival 13.4 months (95% CI 11.6 to 15.3) versus 6.7 months (6.0 to 7.5); hazard ratio 0.55 (0.44 to 0.69), p < 0.001.; Overall survival hazard ratio 0.76 (0.61 to 0.95), p 0.01; five-year survival 20.7 versus 10.4 percent; ten-year survival 12.2 versus 7.7 percent.
- What it means: Adjuvant chemotherapy is standard after pancreatic cancer resection; gemcitabine alone remains the option for patients who cannot tolerate combinations.
- Caveats: Later methodological critiques raised concerns about randomisation and surgical standardisation.; Registered with ISRCTN only (ISRCTN34802808).

## Sources

- JAMA 2013: https://doi.org/10.1001/jama.2013.279201
- PubMed: https://pubmed.ncbi.nlm.nih.gov/24104372/

## Connected records

- cancers: [Pancreatic ductal adenocarcinoma](https://onco.cc/cancers/pancreatic/), [Resectable pancreatic ductal adenocarcinoma](https://onco.cc/cancers/resectable-pdac/)
- drugs: [Gemcitabine](https://onco.cc/drugs/gemcitabine/)
- trials: [CONKO-001](https://onco.cc/trials/conko-001/)
- journals: [JAMA](https://onco.cc/journals/jama/)

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