Gemcitabine improves overall survival for patients with early-stage pancreatic cancer, the first chemotherapeutic drug to provide a benefit for these patients, according to a presentation at the annual meeting of the American Society of Clinical Oncology.

The large, multicenter study showed that gemcitabine more than doubled overall survival in patients who have undergone surgery for pancreatic cancer. Gemcitabine is the standard treatment for pancreatic cancer that is too advanced for surgery.

The CONKO-001 study examined whether gemcitabine is beneficial earlier in the course of the disease. Previous results from this study, presented at in 2005, showed that adjuvant gemcitabine improved disease-free survival; 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 five years after treatment," said Hanno Riess, MD, PhD, a professor at Charite University Medical School in Berlin and the leader of the CONKO study group.

"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."

The trial randomized 368 patients to postoperative gemcitabine or observation with
no specific anticancer treatment. All patients had already undergone complete surgical resection of their tumor. Only about 15 to 20 percent of patients are diagnosed at an earlier stage that makes surgery possible.

Estimated disease-free survival at three and five years, respectively, was 23.5 percent and 16.5 percent for gemcitabine versus 7.5 percent and 5.5 percent for the observation group. Overall survival at three and five years was 36.5 percent and 21.0 percent for gemcitabine versus 19.5 percent and 9.0 percent for observation.

Gemcitabine was well-tolerated among patients and there were no differences in toxicity between groups except for white blood cell and platelet counts, which were
lower in the gemcitabine group.

Additional studies are already underway comparing treatment with gemcitabine alone to treatment with gemcitabine plus the targeted therapies erlotinib or sorafenib in patients who have undergone successful surgical resection.