title: Gemcitabine and Infusional 5-Fluorouracil in Advanced Pancreatic Cancer: A Clinical Benefit Response-Oriented Phase II Study.
abstract: OBJECTIVE
  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.
  
  
  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%).
  
  
  CONCLUSIONS
  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.
authors.forename: Jung Hye
authors.initials: JH
authors.lastname: Choi
authors.forename: Myung Ju
authors.initials: MJ
authors.lastname: Ahn
authors.forename: Seock Ah
authors.initials: SA
authors.lastname: Im
authors.forename: Bong Seog
authors.initials: BS
authors.lastname: Kim
authors.forename: Ho Suk
authors.initials: HS
authors.lastname: Oh
authors.forename: Heung Woo
authors.initials: HW
authors.lastname: Lee
authors.forename: Yeung Chul
authors.initials: YC
authors.lastname: Mun
authors.forename: Chu Myung
authors.initials: CM
authors.lastname: Seong
authors.forename: Soon Nam
authors.initials: SN
authors.lastname: Lee
authors.forename: Young Yeul
authors.initials: YY
authors.lastname: Lee
authors.forename: Il Young
authors.initials: IY
authors.lastname: Choi
authors.forename: In Soon
authors.initials: IS
authors.lastname: Kim
keywords: 5-fluorouracil; Clinical benefit response; Gemcitabine; Pancreas neoplasm