A large randomized study demonstrated no significant improvement in survival with Gemzar® (gemcitabine) versus 5-fluorouracil (5-FU) for the adjuvant (post-surgery) treatment of pancreatic cancer. These findings were recently published in the Journal of the American Medical Association.
Pancreatic cancer is the fourth leading cause of cancer death in this country. Treatment for early pancreatic cancer may involve surgery to remove as much of the cancer as possible followed by chemotherapy.
In this current European study, researchers conducted a randomized controlled Phase III trial to evaluate chemotherapy with 5-FU and folinic acid versus Gemzar among 1,088 patients with early-stage pancreatic cancer. All patients on this study had their cancer surgically removed prior to being randomized to adjuvant chemotherapy and were followed for at least two years.
- Median survival was 23.0 months for patients on the 5-FU/folinic acid arm versus 23.6 months on the Gemzar arm (P=.39).
- 14% of patients on the 5-FU/folinic acid arm experienced treatment-related serious side effects compared with 7.5% on the Gemzar arm.
- Progression-free survival was not significantly different between the two arms.
The researchers concluded that Gemzar did not significantly improve overall survival in patients with resected pancreatic cancer compared with 5-FU/folinic acid. Significantly, fewer patients experienced treatment-related side effects on the Gemzar arm.
 Neoptolemos JP, Stocken DD, Bassi C, et al. Adjuvant chemotherapy with Fluorouracil plus folinic acid vs gemcitabine following pancreatic cancer resection. Journal of the American Medical Association. 2010;304:1073-1081.