Objective: This study was performed to assess the efficacy and safety profiles of the combination treatment with S-1 and Cisplatin in patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN).
Design: Eligibility criteria co...
Objective: This study was performed to assess the efficacy and safety profiles of the combination treatment with S-1 and Cisplatin in patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN).
Design: Eligibility criteria consisted of histologically confirmed SCCHN, stage III or IV with no evidence of distant metastasis, evaluable lesions, adequate organ function, age of 20-80 years, and a performance status of 2 or less. Cisplatin was infused over 1 hour on day 1 (75 mg/m²) and S-1 was administered orally for 14 consecutive days (days 2-15). The dosages of S-1 were assigned according to the patients' body surface area (BSA): 50 mg twice a day (B5A<1.5m²),or 60 mg twice a day (B5A>1.5m²). Each course was repeated every 3 weeks. After 2 courses, tumor response was evaluated by CT scan and laryngoscopy. If the patients achieved a response (complete response: CR, or partial response: PR), they received one more course of chemotherapy before undergoing radical treatment such as radiotherapy or operation.
Results: All 30 patients were assessable for toxicity, and 29 patients for response. Theoverall response was 89.7 % (CR:9, PR:17). 2 year estimated overall survival rate was 79.2 %. Adverse reactions occurred 128 times during 81 courses in the 30 cases. The most common grade 3/4 adverse event was neutropenia, which occurred in 8 patients. Non-hematological grade 3 or 4 toxicity included nausea and vomiting in 4 patients, stomatitis in 2 patients, and diarrhea in 1 patient.
Conclusion: S-1 plus cisplatin combination chemotherapy is effective against locally advanced SCCHN with mild toxicity.