A phase III study of gemcitabine in combination with 5-FU vs. gemcitabine alone in patients with advanced pancreatic carcinoma (E2297): an Eastern Cooperative oncology Group (ECOG) trial

Li Liu, MD

University of Pennsylvania Cancer
Last Modified: May 14, 2001

Presenter: J. Berlin
Affiliation: ECOG, USA


    The vast majority of patients with pancreatic cancer are diagnosed with locally advanced unrespectable or advanced disease for which there is no curative therapy. Many chemotherapeutic agents have been evaluated in patients with pancreatic cancer. Gemcitabine (gem) and 5-FU are the most commonly used agents. The combination of gem and 5-FU has been noted to have a marked synergistic cytotoxic effect against pancreatic cancer cells in "in vitro" assays.

Materials and Methods:

  • A total of 327 patients with advanced pancreatic carcinoma were included in this randomized study.
  • Patients were treated with either gem + 5- fu (164 patients) or gem alone (163 patients). Gem dose was 1000mg/m2 weekly x 3 of 4 weeks and 5-FU dose was 600 mg/m2 weekly x 3 of 4 weeks.


  • The response rate was 5.6% in gem alone arm and 6.9% in gem + 5-FU arm.
  • Both treatment groups were well tolerated.
  • The median survival was 5.4 months on gem + 5-FU and 6.7 months for patients on gem alone (p=0.09).
  • The overall survival was the same between two groups.
  • Older age and poor performance status were associated with poorer prognosis.

Authors' Conclusions

  • The combination of gem and 5-FU did not produce a significant increase in survival for patients with advanced pancreatic carcinoma. The addition of 5-FU to gem did not add more toxicity.

Clinical/Scientific Implications:

  • Pancreatic adenocarcinoma is traditionally considered a chemoresistant tumor because of the low response rate; in addition, the median duration of survival has been generally less than 6 months. New active agents or chemotherapy regimens are needed to improve patients' quality of life and survival.

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