Gemcitabine in combination with 5‐fluorouracil with or without folinic acid in the treatment of pancreatic cancer

Pancreatic cancer is one of the most frequently reported gastrointestinal tumors and has been reported to have a 5‐year survival rate of < 5%. It is most commonly diagnosed at an advanced stage and until recently, the most frequently administered treatment for patients with advanced disease has been palliative 5‐fluorouracil (5‐FU)‐based chemotherapy. However, in clinical trials, the novel antinucleoside gemcitabine is currently considered the standard of care and has demonstrated both a survival benefit over 5‐FU and an improvement in disease‐related symptoms in those patients with advanced disease. The current review presents an overview of recently completed and ongoing clinical trials of gemcitabine/5‐FU combination therapy for pancreatic cancer. In these trials, the administration of 5‐FU varied widely from bolus injection to 24‐hour infusion to protracted infusion over several weeks. These variations make a definitive judgment of this combination difficult, especially because the majority of the data represent only Phase I and Phase II study results. Although a recently completed randomized Phase III trial of gemcitabine plus bolus 5‐FU versus gemcitabine failed to show a clinically meaningful survival benefit for the combination arm, current data indicate that other gemcitabine/5‐FU combinations might provide a therapeutic advantage over gemcitabine alone. However, the results of ongoing Phase III studies must be reviewed before a definitive statement can be made regarding the value of this combination in the treatment of pancreatic cancer. Cancer 2002;95:912–22. © 2002 American Cancer Society. DOI 10.1002/cncr.10758