Treatment of metastatic pancreatic cancer with a combination of gemcitabine and 5-fluorouracil: a single center phase II study.

ABSTRACT

AIM: To determine the activity and toxicity of a combination of weekly gemcitabine and 5-fluorouracil bolus intravenously in patients with metastatic pancreatic cancer. PATIENTS AND METHODS: Twenty-one patients with previously untreated metastatic pancreatic cancer were included in this phase II study. The schedule was gemcitabine (1000 mg/m2 i.v.) and 5-fluorouracil (500 mg/m2 bolus i.v.) weekly for 3 weeks every month. RESULTS: Four patients (19%) achieved a partial response and three stable disease. A clinical benefit was obtained in 7 patients (33%). Median survival for all the patients was 6 months. The treatment was well tolerated and toxicity was mild. WHO grade 3 leukopenia occurred in 2 (9.5%) patients, grade 3 anemia in 4 (19%) patients, grade 3-4 thrombocytopenia in 4 (19%) patients, grade 1 diarrhea in 1 (4.7%) patient and grade 1 mucositis in 3 (14.2%) patients. CONCLUSION: The weekly administration of gemcitabine combined with 5-fluorouracil bolus i.v. is an active and well-tolerated regimen in metastatic pancreatic cancer. However, its efficacy is relatively limited.