Gemcitabine Improves Overall Survival in Early-Stage Pancreatic Cancer

A large, multicenter study has shown that the chemotherapy drug gemcitabine (Gemzar) more than doubles overall survival in patients who have undergone surgery for pancreatic cancer. The CONKO-001 trial is the first large-scaled phase III study to show a benefit for any chemotherapy agent given to early-stage pancreatic cancer patients after surgery to remove their tumors. The trial data were presented by Hanno Riess, md, phd, a professor at Charit University Medical School in Berlin and the leader of the CONKO study group (abstract LBA4504).

Gemcitabine is the standard treatment for pancreatic cancer that is too advanced for surgery. The CONKO-001 study examined whether it is beneficial earlier in the course of the disease. Previous results from this study, presented at ASCO’s Annual Meeting in 2005, showed that adjuvant gemcitabine improves disease-free survival (the length of time that no disease is found after treatment); investigators continued to follow these patients in order to determine whether the drug also improves overall survival.

“The ultimate goal of adjuvant therapy is improving the cure rate, and we have shown that this treatment more than doubles the overall survival 5 years after treatment,” said Professor Riess, md, phd. “Based on the earlier results of this study, this regimen is already more widely used in both Europe and the United States. These findings can reassure physicians that the drug is also extending lives.”

Key Results

The trial randomized 368 patients to receive postoperative gemcitabine or undergo observation, which included no specific anticancer treatment. All patients first had complete surgical removal of their tumor, with no detectable macroscopic disease remaining. Because pancreatic cancer is usually diagnosed at a late stage, only about 15% to 20% of patients are diagnosed at an earlier stage and are eligible for surgery.

Estimated disease-free survival at 3 and 5 years, respectively, was 23.5% and 16.5% for the gemcitabine group vs 7.5% and 5.5% for the observation group. Overall survival at 3 and 5 years was 36.5% and 21.0% for the gemcitabine group, vs 19.5% and 9.0% for the observation group. Gemcitabine was well-tolerated among patients and there were no differences in toxicity between the groups, except for white blood cell and platelet counts, which were lower in the gemcitabine group.