Continuous infusion of 5-FU with split-dose cisplatin: An effective treatment for advanced squamous-cell carcinoma of the head and neck

The purpose of this study was to determine if a combination chemotherapy, using continuous intravenous infusion of fluorouracil (5-FU) in combination with split-dose cisplatin, in patients with recurrent or metastatic head and neck squamous-cell could improve previously reported clinical outcomes.Forty-two patients with recurrent or metastatic head and neck squamous-cell cancer were treated by cisplatin (25 mg/m(2)/day on days 1-3) and 5-FU (750 mg/m(2)/day for 120 hours; continuous intravenous infusion on days 1 through 5) with a cycle that repeated every 3 weeks.Of the 42 patients, 8 (19.1%) showed complete response and 12 (28.5%) demonstrated a partial response, giving an overall response rate of 47.6%. Response rates were significantly different for patients undergoing initial treatment vs. re-treatment:73.6% (14/19) vs. 25.9% (6/23), respectively (χ(2)=9.45, P < 0.05). Median time to progression was 7.2 months and median overall survival was 13.7 months. The 1 year survival was 57.1%. Toxicity mainly included myelo-suppression, mucositis, nausea and vomiting.Chemotherapy with 5-FU by continuous intravenous infusion in combination with split-dose cisplatin is effective with a tolerable toxicity profile in patients with recurrent, or metastatic squamous-cell carcinoma of head and neck. The overall response was significantly higher in patients undergoing initial treatment in comparison with patients undergoing re-treatment after relapse.