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Gemcitabine following pancreatic resection improved survival

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CHICAGO – Administering gemcitabine to patients with resected pancreatic cancer more than doubles their overall survival, according to the final results of the CONKO-001 trial presented during a Saturday press briefing at the 2008 ASCO Annual Meeting.

“Treatment with gemcitabine as compared to observation in patients with resected pancreatic cancer resulted in improved disease-free survival and overall survival,” Helmut Oettle, MD, PhD, said during the briefing. “Gemcitabine should be the standard of care for adjuvant treatment of pancreatic cancer.”

Oettle and colleagues at Charite University Medical School, Berlin, conducted a randomized, multicenter, phase-3 trial to test the efficacy and toxicity of gemcitabine in patients with pancreatic cancer after complete resection.

Patients were randomly assigned to either observation (n=182) or 1 g/m² gemcitabine (n=186) on days one, eight and 15 per four-week cycle for six months.

At three years, patients treated with gemcitabine had improved overall survival compared with those assigned to observation (36.5% vs. 19.5%). Clinical benefit remained at five years for patients treated with gemcitabine (21% vs. 9%).

Neuhaus P. #LBA4504. Presented at: the 2008 ASCO Annual Meeting; May 30-June 3; Chicago.

This trial is a major breakthrough. It is the first trial to show improvement not just in disease-free survival but in overall survival. We couldn’t say that prior to this study. There is controversy in this country about the best treatment following resection of pancreatic cancer. The Europeans have a tendency to treat with chemotherapy alone, but in this country there is a preference for a combination of radiation and chemotherapy. This trial will help to resolve a little bit of this issue. A trial comparing postoperative chemotherapy vs. postoperative chemotherapy plus radiation, which would solve this controversy, is not out yet.

-- Nicholas J. Petrelli, MD

Professor of Surgery, Thomas Jefferson University