Gemcitabine and protracted 5-FU for advanced pancreatic cancer.: A phase II study

Background/Aims: Although chemotherapy in advanced pancreatic cancer procures dismal results, both 5-fluorouracil and gemcitabine have shown a modest activity. We report a phase II study of gemcitabine combined with protracted 5-fluorouracil. Methodology: Gemcitabine was given at 1000mg/m(2)/week. intravenously, in combination with concomitant 5-fluorouracil 200mg/m(2)/day as a protracted venous infusion, both 3 out of 4 weeks in patients with locally advanced or metastatic pancreatic adenocarcinoma. Twenty-nine patients were enrolled, among whom 27 were metastatic. Response rate, overall and progression-free survival were endpoints, as well as tolerance and clinical benefit. Results: We observed 3 (10%) partial responses, and 12 (42%) stabilizations within which the median disease control was 5.6 months. The median progression-free and overall survivals were 2.8 and 4 months, respectively. A clinical benefit was observed in 39% of patients. Myelosuppression was the main toxicity, but no grade 4 was observed. Other toxicities were mild. Conclusions: This combination chemotherapy was well tolerated in advanced pancreatic cancer patients.