Evaluation of: Fujii M, Tomita K, Nishijima W et al. Phase I/II study of S-1 plus cisplatin combination chemotherapy in patients with advanced/recurrent head and neck cancer. Jpn. J. Clin. Oncol. 40(3), 214-221 (2010). A combination of 5-fluorouracil (5-FU) and cisplatin is the most commonly used chemotherapy regimen in patients with advanced head and neck cancer (HNC). Japanese investigators replaced 5-FU with the oral fluoropyrimidine S-1 (40 mg/m(2) twice daily on days 1-14 every 4 weeks) to treat patients with locally advanced, recurrent, or metastatic HNC; and determined that the dose of cisplatin on day 8 should be 70 mg/m(2). The authors also studied the efficacy and safety of this regimen in a continuing Phase II trial. Treatment with S-1 plus cisplatin resulted in a confirmed response rate of 44.1% and a median overall survival duration of 16.7 months. The most common grade 3 or 4 adverse events included anorexia (26.5%), nausea (14.7%), and neutropenia/thrombocytopenia (11.8%). Despite inclusion of patients heterogeneous in disease status and incomplete response evaluation, this study demonstrated that S-1 in combination with cisplatin is feasible for treatment of advanced/recurrent HNC.