Gemcitabine and continuous infusion of 5-fluorouracil in locally advanced and metastatic pancreatic cancer: a phase I-II study.

Published on May 1, 2004in Anticancer Research1.994
Cristina Oliani15
Estimated H-index: 15
M. Padovani2
Estimated H-index: 2
(University of Verona)
+ 6 AuthorsGianluigi Cetto17
Estimated H-index: 17
(University of Verona)
Background: Gemcitabine has been recently recognized as standard treatment in advanced pancreatic cancer. To potentiate its single-agent activity we conducted a phase I-II study with the primary objective of establishing the maximum tolererated dose (MTD) of gemcitabine and continuous infusion 5-FU in patients with locally advanced or metastatic pancreatic cancer. Patients and Methods Fifteen patients received a fixed dose of 5-FU 200 mg/mq protracted infusion for six months. Gemcitabine was administered weekly for three out of four weeks for six cycles at escalating doses of 800 mg/mq to 1100 mg/mq. Results: MTD was established at 1000 mg/mq of gemcitabine. Of the 11 evaluable patients, 7 patients had stable disease, 1 had partial response and 3 had progressive disease. Of the 14 patients evaluable at follow-up, median time to progression was 5 months. Median survival was 10 months. Conclusion: This study confirms the good tolerability of the combination, of gemcitabine with 5-FU. The number of cases of pancreatic cancer in 1990 was 27,000 in Europe and 30,000 deaths are estimated annually (1). Pancreatic cancer is the fifth most common cause of cancer-related mortality in the United States, following lung, colorectal, breast and prostate cancer. It is the fourth leading cause of death from cancer in men and the fifth leading cause of death from cancer in women. There is increased risk after the age of 30, while most commonly appears between the ages of 65 and 79 years. At present there is no known cause for the disease; however, it has been linked to cigarette smoking, socioeconomic status, alcohol consumption, chronic pancreatitis and diabetes (2). Chemotherapy has been proposed in the past, but in clinical studies different drugs and regimens have
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