CONKO-001: adjuvant gemcitabine and long-term outcomes after resected pancreatic cancer
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.
Overview
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.
- 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.
Adjuvant chemotherapy is standard after pancreatic cancer resection; gemcitabine alone remains the option for patients who cannot tolerate combinations.
- Later methodological critiques raised concerns about randomisation and surgical standardisation.
- Registered with ISRCTN only (ISRCTN34802808).
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