Gemcitabine and Infusional 5-Fluorouracil in Advanced Pancreatic Cancer: A Clinical Benefit Response-Oriented Phase II Study.
- Author:
Jung Hye CHOI
1
;
Myung Ju AHN
;
Seock Ah IM
;
Bong Seog KIM
;
Ho Suk OH
;
Heung Woo LEE
;
Yeung Chul MUN
;
Chu Myung SEONG
;
Soon Nam LEE
;
Young Yeul LEE
;
Il Young CHOI
;
In Soon KIM
Author Information
1. Department of Internal Medicine, Hanyang University, Korea. ahnmj@hanyang.ac.kr
- Publication Type:Original Article
- Keywords:
Pancreas neoplasm;
Gemcitabine;
5-fluorouracil;
Clinical benefit response
- MeSH:
Body Weight Changes;
Drug Therapy, Combination;
Female;
Fluorouracil*;
Follow-Up Studies;
Humans;
Infusions, Intravenous;
Injections, Intravenous;
Karnofsky Performance Status;
Neutropenia;
Pancreatic Neoplasms*;
Thrombocytopenia
- From:Cancer Research and Treatment
2003;35(3):213-217
- CountryRepublic of Korea
- Language:English
-
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.
