Background: Our previous phase I study provided evidence that weekly paclitaxel, cisplatin, and bolus 5-fluorouracil (weekly PCF) was effective and well tolerated in patients with advanced gastric cancer. This study was conducted to confirm the efficacy and toxicity of weekly PCF.
Methods: Eligibility criteria were as follows: pathological confirmation; measurable lesion(s); and no history of treatment with taxanes, platinum-based compounds, or intravenous 5-fluorouracil (1 regimen of pre-treatment with oral 5-fluorouracil agents was allowed). Paclitaxel (80 mg/m(2), 1 h), cisplatin (25 mg/m(2), 2 h), and 5-fluorouracil (600 mg/m(2), bolus) were administered on days 1, 8, and 15, every 4 weeks.
Results: Between March 2006 and May 2009, 46 patients were enrolled and 45 were assessed. Eighteen had a history of pre-treatment with oral 5-fluorouracil agents. The response rate was 56% [95% confidence interval (CI) 41-70%]. Median progression-free survival was 160 days (95% CI 145-214 days). Median overall survival was 552 days (95% CI 350-843 days). Grade 3-4 major adverse reactions observed were neutropenia (76%), leucopenia (38%), anaemia (27%), febrile neutropenia (22%), exacerbation of performance status (16%), and anorexia (13%).
Conclusion: A weekly PCF regimen is promising for advanced gastric cancer, although it is associated with moderate hematological and minimal non-hematological toxicities.