The efficacy and toxicity of S-1 and cisplatin as first-line chemotherapy in recurrent or metastatic head and neck squamous cell carcinoma

Purpose To assess the clinical activity and toxicity of a combination chemotherapy regimen of S-1 and cisplatin in patients with recurrent and/or metastatic head and neck squamous cell carcinoma (HNSCC) in a retrospective study. Methods A total of 49 patients were treated in an outpatient setting with S-1 80 mg/m² on days 1-14 and with cisplatin 70 mg/m² on day 1 every 3 weeks for a maximum of six cycles as a first-line palliative chemotherapy. Patients who achieved complete response (CR), partial response (PR) or stable disease (SD) after six cycles received S-1 monotherapy as a maintenance therapy. Results The median patient age was 55 years (range 33-79), 89.8 % were male, and the Eastern Cooperative Oncology Group performance status distribution was 0/1/2 (20.4 %/73.5 %/6.1 %). Of the 43 evaluable patients, 2 (4.1 %) achieved CR and 20 (40.8 %) had a PR, for an overall response rate of 44.9 %. Thirteen patients (26.6 %) had SD. The median number of chemotherapy treatments was 4 (range 1-18). Nine patients received maintenance S-1 monotherapy after six cycles of combination chemotherapy. With a mean 10.5 months (range 1.3-25.1) of follow-up, the median progression-free and overall survival were 4.5 (95 % CI, 3.7-5.3 months) and 10.8 months (95 % CI, 5.9-15.6 months), respectively. The main grade 3-4 toxicities were neutropenia (37 %), anemia (16 %) and general weakness (8 %). Other toxicities, including nausea/ vomiting, mucositis and neuropathy, were mostly grade 1-2 and easily manageable. Conclusions The combination of S-1/cisplatin therapy had a favorable efficacy with manageable toxicity as a firstline chemotherapy regimen for advanced head and neck squamous cell carcinoma patients.