Systemic chemotherapy with cisplatin plus 5-FU (PF) for recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN): efficacy and safety of a lower dose of PF (80/800) at a single institution in Japan.

OBJECTIVE Prognosis in patients with recurrent or metastatic squamous cell carcinoma of the head and neck is poor, and systemic chemotherapy has an only modest impact on the outcome. Chemotherapy with cisplatin plus 5-FU (PF) is widely used, but the standard dosage, PF (100/1000; cisplatin 100 mg/m(2) day 1 and 5-FU 1000 mg/m(2)/24 h by continuous intravenous infusion on days 1 through 4), is relatively toxic for palliative use, and PF (80/800; cisplatin 80 mg/m(2) day 1 and 5-FU 800 mg/m(2)/24 h by continuous intravenous infusion on days 1 through 5) is more commonly used in Japan, albeit without clear comparative data. We retrospectively analyzed the efficacy and safety of this regimen in our institution. METHODS Thirty of 43 patients with recurrent or metastatic head and neck cancer treated with PF in our institution between 2001 and 2006 were analyzed. Entry criteria included histologically proven squamous cell carcinoma and recurrent or metastatic disease. RESULTS The most common chemotherapy-related Grade 3 or 4 toxicities were nausea (16.6%), anorexia (40%), stomatitis (6.6%) and leukopenia (10%), all of which were manageable. Complete response was achieved in one patient and partial response in eight, giving an overall response rate of 30%. Median progression-free survival was 3.0 months. Estimated 2-year survival rate was 16.7% and median overall survival was 9.8 months. Of the 30 patients, 5 (16.7%) survived more than 2 years, all of whom had primary oropharyngeal cancer. CONCLUSIONS In this retrospective analysis, chemotherapy with PF (80/800) for recurrent or metastatic head and neck cancer appeared to have equal efficacy and better safety than PF (100/1000).