A Phase II Study on Continuous Infusional Paclitaxel and 5-Fu as First-line Chemotherapy for Patients with Advanced Esophageal Cancer

Objective: This study was performed to evaluated the efficacy and safety of continuous infusional paclitaxeland 5-Fu as first-line chemotherapy in patients with advanced esophageal squamous cell cancer (ESCC).
Methods:A total of 22 patients with advanced esophageal squamous cell cancer with no indications for surgery and radiationtherapy, or recurrent patients were enrolled from October 2008 to November 2010. All were treated with PTX 20mg/m2 was administered through a 16 hours continuous intravenous infusion on days 1 to 3, 8 and 9. DDP 3.75mg/m2 was given on days 1 to 4 and 8 to 11, continuous infusional 5-FU over 24-hours on days 1 to 5 and 8 to 12at a dose of 375 mg/m2, and folacin 60 mg orally synchronized with 5-Fu. The treatment was repeated every 21days for at least two cycles.
Results: 22 cases of all enrolled patients could be evaluated for the effect of treatment:2 cases were CR, 9 cases PR, 5 cases SD and 2 cases PD, giving an overall response rate of 68.2%(15/22). Themedian time to progression was 7.0 months. The adverse reactions related to chemotherapy were tolerable; themost common toxic effects were marrow depression, alopecia, and fatigue.
Conclusion: Low-dose continuousinfusional PTX over 16-hours and 5-fu over 24-hours is a promising regimen with good tolerability in treatingpatients with advanced esophageal squamous cell cancer.