Cancer Res Treat.  2003 Jun;35(3):213-217.

Gemcitabine and Infusional 5-Fluorouracil in Advanced Pancreatic Cancer: A Clinical Benefit Response-Oriented Phase II Study

• Choi JH
• Ahn MJ
• Im SA
• Kim BS
• Oh HS
• Lee HW
• Mun YC
• Seong CM
• Lee SN
• Lee YY
• Choi IY
• Kim IS

Abstract

PURPOSE
Gemcitabine and 5-fluorouracil (5-FU) are two compounds with reproducible activity against advanced pancreatic carcinomas. To evaluate the activity and feasibility of this combination chemotherapy, a multi-institutional phase II study was performed. MATERIALS AND METHODS: Twenty patients (male: female 15: 5, median age: 60.5 years), with histologically verified locally advanced or metastatic pancreatic carcinomas, were enrolled between April 2000 and March 2002. Gemcitabine was administered by intravenous injection at the doses of 1, 000 mg/m2 on days 1, 8 and 15, and 5-FU 800 mg/m2/day, was given by continuous intravenous infusion on days 1~5. The treatment was repeated every 4 weeks. The clinical benefit response (CBR) was a composite of the pain, Karnofsky performance status and body weight change measurement.
RESULTS
Nineteen of the twenty patients were assessable for response. The median follow-up duration was 4.6 months (0.4~15.2 months). Five patients achieved a partial response and eight a stable disease. The overall response rate was 25.0%. The CBR was assessable in 12 patients. The overall CBR was 41.7% (5/12). The median survival of all the patients was 8.0 months. Grade 3~4 toxicities included neutropenia (9.3%) and thrombocytopenia (5.3%). CONCLUSION: This study suggested that gemcitabine, combined with infusional 5-FU, was well tolerated, and produced modest antitumor activity and symptomatic relief in advanced pancreatic cancer patients.

Keyword

Pancreas neoplasm; Gemcitabine; 5-fluorouracil; Clinical benefit response

MeSH Terms

Body Weight Changes
Drug Therapy, Combination
Female
Fluorouracil*
Follow-Up Studies
Humans
Infusions, Intravenous
Injections, Intravenous
Karnofsky Performance Status
Neutropenia
Pancreatic Neoplasms*
Thrombocytopenia
Fluorouracil