title: Phase II study of biweekly gemcitabine followed by oxaliplatin and simplified 48-h infusion of 5-fluorouracil/leucovorin (GOFL) in advanced pancreatic cancer.
abstract: OBJECTIVE
  To evaluate the efficacy and safety profile of a triplet regimen consisting of gemcitabine, oxaliplatin, and infusional fluorouracil and leucovorin (LV) in advanced pancreatic carcinoma (APC).
  
  
  METHODS
  Chemotherapy-naïve patients with histo-/cytologically proven unresectable APC, and bi-dimensionally measurable diseases were eligible. Treatment consisted of fixed-dose rate (10 mg/m(2)/min) infusion of 800 mg/m(2) gemcitabine followed by 2-h infusion of 85 mg/m(2) oxaliplatin and then 48-h infusion of fluorouracil and LV (3,000 and 300 mg/m(2), respectively) every 2 weeks (the GOFL regimen). The primary end-point was objective response rate.
  
  
  RESULTS
  Forty-five patients were enrolled and received a median of seven [95% confidence interval (CI) 6.4-8.8] cycles of treatment. On intent-to-treat analysis, the overall response and disease-control rates were 33.3% (95% CI 21.4-48.0%) and 68.9% (95% CI 54.8-83.0%), respectively. Clinical benefit response was observed in 46.2% of initially symptomatic patients. The median time-to-tumor progression and overall survival were 5.1 (95% CI 4.0-6.3) months and 8.7 (95% CI, 6.1-11.3) months, respectively. Major grade 3-4 toxicities were neutropenia (28.9%, with 4.4% complicated with fever), peripheral sensory neuropathy (15.6%), nausea/vomiting (13.3%), and diarrhea (6.7%).
  
  
  CONCLUSIONS
  The triplet regimen is feasible and exhibits promising activity against APC, deserving further exploration.
authors.affiliation: National Institute of Cancer Research, National Health Research Institutes, 2F, No. 367, Sheng-Li Road, Tainan 70456, Taiwan.
authors.forename: Hui-Ju
authors.initials: HJ
authors.lastname: Ch'ang
authors.forename: Chin-Lun
authors.initials: CL
authors.lastname: Huang
authors.forename: Hsiu-Po
authors.initials: HP
authors.lastname: Wang
authors.forename: Her-Shyong
authors.initials: HS
authors.lastname: Shiah
authors.forename: Ming-Chu
authors.initials: MC
authors.lastname: Chang
authors.forename: Chang-Ming
authors.initials: CM
authors.lastname: Jan
authors.forename: Jen-Shi
authors.initials: JS
authors.lastname: Chen
authors.forename: Yu-Wen
authors.initials: YW
authors.lastname: Tien
authors.forename: Tsann-Long
authors.initials: TL
authors.lastname: Hwang
authors.forename: Jaw-Town
authors.initials: JT
authors.lastname: Lin
authors.forename: Ann-Lii
authors.initials: AL
authors.lastname: Cheng
authors.forename: Jacqueline
authors.initials: J
authors.lastname: Whang-Peng
authors.forename: Li-Tzong
authors.initials: LT
authors.lastname: Chen