Phase II study of weekly paclitaxel, cisplatin, and 5-fluorouracil for advanced gastric cancer

Abstract

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. © The International Gastric Cancer Association and The Japanese Gastric Cancer Association 2011.