, Volume 64, Issue 6, pp 1173-1179
Date: 25 Mar 2009

Phase II study of biweekly gemcitabine followed by oxaliplatin and simplified 48-h infusion of 5-fluorouracil/leucovorin (GOFL) in advanced pancreatic cancer

Rent the article at a discount

Rent now

* Final gross prices may vary according to local VAT.

Get Access

Abstract

Purpose

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).

Patients and 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/m2/min) infusion of 800 mg/m2 gemcitabine followed by 2-h infusion of 85 mg/m2 oxaliplatin and then 48-h infusion of fluorouracil and LV (3,000 and 300 mg/m2, 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.

This article describes the triplet regimen, GOFL (Gemcitabine, Oxaliplatin, Fluorouracil, Leucovorin), being feasible and exhibiting promising activity against advanced pancreatic cancer. This phase II study revealed that GOFL might have better therapeutic efficacy and toxicity profile compared to the current standard gemcitabine monotherapy.
Employment/leadership position: None; Intellectual property rights/inventor/patent holder: None; Consultant/advisory role: None; Ownership interest: None; Expert testimony: None; Other: None.