CONKO-001: Final Results of the Randomized, Prospective, Multicenter Phase III Trial of Adjuvant Chemotherapy with Gemcitabine vs. Observation in Patients with Resected Pancreatic Cancer (PC)

Carolyn Vachani, RN, MSN, AOCN
The Abramson Cancer Center of the University of Pennsylvania
Last Modified: June 23, 2008

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CONKO-001: Final Results of the Randomized, Prospective, Multicenter Phase III Trial of Adjuvant Chemotherapy with Gemcitabine vs. Observation in Patients with Resected Pancreatic Cancer (PC)

This study has previously reported (Oettle H., et al. JAMA 2007) that the use of post-operative gemcitabine in patients with pancreatic cancer significantly delays the development of recurrent disease after complete resection and is generally well tolerated. This presentation is an update of their previously published results.

354 patients were randomly assigned to receive gemcitabine for 6 months after surgical resection or no therapy after surgical resection. Median overall survival was 22.8 months in the chemotherapy arm (arm A) versus 20.2 months in the supportive care arm (Arm B). The survival difference increased over time:

1 Year

2 Year

3 Year

5 Year

Arm A

72%

48.5%

36.5%

21%

Arm B

72.5%

40%

19.5%

9%

The findings from this study suggest that gemcitabine is safe and effective in the postoperative setting, and its use should be considered. It is important to keep in mind that the patient population enrolled in this study was a highly selected one, in that the postoperative CA 19-9 levels had to be less than 2.5 times the upper limit of normal. This is a requirement that might rule out many postoperative pancreatic cancer patients.

The optimal postoperative management regimen continues to be studied by several groups. The use of combined regimens and whether or not to include radiation therapy are among the treatments being studied. Hopefully these studies will help determine the optimal regimen for postoperative use.