A phase 2 study of fluorouracil/leucovorin in combination with paclitaxel and oxaliplatin as a salvage treatment in patients with refractory or relapsed advanced gastric cancer

Abstract

The aim of this study was to evaluate the efficacy and safety of paclitaxel plus oxaliplatin plus fluorouracil/leucovorin (POF) as salvage chemotherapy in pretreated advanced gastric cancer. Fifty-two pretreated patients with the advanced gastric cancer were eligible for this study. The POF regimen consisted of a 3-hour infusion of paclitaxel (135 mg/m²) followed by oxaliplatin (85 mg/m²) and leucovorin (400 mg/m²), administered simultaneously over a 2-hour infusion period, followed by an infusion of fluorouracil (2400 mg/m²) over a 46-hour period, every 14 days. From an intention-to-treat analysis, overall response rate and stable disease rate were 28·8 and 38·5%, respectively. The median time to progression and overall survival were 4·1 and 7·9 months, respectively. Grade 3 or 4 neutropaenia, thrombocytopaenia, fatigue, and neuropathy were 38·5, 15·4, 17·3, and 15·4%, respectively. The POF regimen is active in pretreated advanced gastric cancer as salvage chemotherapy, with a favourable toxicity profile.

Keywords:

• Advanced gastric cancer
• Fluorouracil
• Oxaliplatin
• Paclitaxel
• Salvage chemotherapy

Acknowledgements

We thank the statistician professor Jingrong Xiao of statistics department, Fujian Provincial Cancer Hospital, Fuzhou, PR China, for the assistances with statistical analysis of this study and the emergency specialist Megan Cox of A & E department, Princess Marina Hospital, Goborone, Botswana, for the assistances with language editing of this article.