Fixed-Dose-Rate Gemcitabine Infusion in Patients with Advanced Pancreatic or Biliary Tree Adenocarcinoma

Abstract

Aims and background

Gemcitabine is an effective agent in pancreatic adenocarcinoma. Fixed-dose-rate gemcitabine has an interesting biological and clinical rationale, with successful results in previous studies. We conducted a trial to confirm efficacy and toxicity of fixed-dose-rate gemcitabine in patients with pancreatic or biliary tree adenocarcinoma.

Methods

Eligible patients with locally advanced or metastatic pancreatic or biliary tree adenocarcinoma received fixed-dose-rate gemcitabine at a dose of 1500 mg/m² at a rate of 10 mg/m²/min weekly for 3 weeks every 28 days. Efficacy measures were overall survival, response rate and progression-free survival.

Results

Sixty-two patients were enrolled, and 59 were assessable for response. Seven patients (11.3%) had a partial response, 26 stable disease (41.9%) and 26 progressive disease (41.9%). Median time to progression was 21 weeks and median overall survival, 37.71 weeks. Main toxicities were grade 3–4 neutropenia (45.2%) and grade 2–3 asthenia (54.8%). No toxic deaths were documented.

Conclusions

Fixed-dose-rate gemcitabine has a relevant antitumor activity but with significant toxicity. It represents an interesting schedule and could be combined with other biological or chemotherapeutic agents.