Gemcitabine combined with continuous infusion 5-fluorouracil in advanced and symptomatic pancreatic cancer: a clinical benefit-oriented phase II study

Abstract

Summary Gemcitabine and 5-fluorouracil are the only two compounds with reproducible activity against advanced pancreatic cancer (APC). We have evaluated a novel combination of gemcitabine and 5-fluorouracil on the clinical benefit response (CBR) end point. Eleven consecutive patients with symptomatic APC were entered in a two-stage phase II trial. Gemcitabine was administered by intravenous (i.v.) bolus injection at the dose of 1000 mg m -2 on days 1, 8, 15 and 5-fluorouracil 500 mg m -2 was given by continuous i.v. infusion on days 1-5. Treatment was repeated every 28 days. A CBR was achieved in 7/11 patients. The mean time to loss of CBR was 26.5 weeks (range 14-18, median 22). Toxicity was mild and no APC patient experienced WHO grade 3 toxicity. The gemcitabine/5-fluorouracil combination is well tolerated and produces a symptomatic relief in the majority of APC patients.

Integrated microRNA-mRNA analysis of pancreatic ductal adenocarcinoma

“…Despite the vast amount of accumulated knowledge regarding tumor biology, the efficacy of the available treatment strategies for pancreatic cancer has remained largely unchanged over the past decade. The first-line agent gemcitabine has been observed to show favorable clinical responses, including reduced pain and weight gain (Matano et al, 2000); despite this, the prognosis remains dismal, with a 5-year survival rate of 1-4%, and a median survival period of 4-6 months. In addition, the molecular basis for pancreatic cancer remains to be elucidated.…”

Metastatic cancer stem cells: A new target for anti-cancer therapy?

“…The introduction of the chemotherapeutic agent gemcitabine improved clinical response by reducing pain and loss of weight. 1 Nevertheless, with a 5 year survival rate of 1-4% and a median survival period of 4-6 months, 2-6 the prognosis of patients with pancreatic cancer has remained poor. Over the past few years increasing evidence has suggested that stem cells may play a crucial role in the development and progression of tumors.…”

Two Sequential Randomized Phase Ii Trials of Combination Chemotherapy With Methotrexate/5-Fluorouracil and Cisplatin/5-Fluorouracil for Advanced Pancreatic Cancer

“…A phase I/II trial of combination chemotherapy with gemcetabine and other cytotoxic or cytostatic agents has also been started in order to explore more effective modalities to improve survival and QOL for patients with unrespectable disease (Matano, Tagliaferri, et al, 2000).…”