Phase II Study of S-1 plus Cisplatin as First-Line Therapy in Patients with Metastatic Esophageal Carcinoma.

BACKGROUND

Patients with metastatic esophageal squamous cell cancer (ESCC) need safer and more efficacious treatments. The aim of this phase II study was to investigate the efficacy and safety of S-1 plus cisplatin as first-line therapy in metastatic ESCC.

PATIENTS AND METHODS

50 patients with metastatic ESCC who had not received prior systemic chemotherapy for metastatic disease were enrolled. Patients received S-1 at 40 mg/m2 divided into 2 daily doses for 14 days and cisplatin at 75 mg/m2 on day 1 or 25 mg/m2 on days 1-3 intravenously, repeated every 21 days with a maximum of 6 cycles.

RESULTS

47 patients were assessable for response and 18 patients achieved a partial response, giving an overall response rate of 38.3%. Among those who had objective responses, a large percentage (72.2%) quickly showed remarkable tumor shrinkage during the first 2 cycles. 18 (38.3%) patients had stable disease. The median progression-free survival was 5.6 months, and the median overall survival was 12.0 months. Toxicity was mild to moderate and generally tolerable.

CONCLUSION

The combination of S-1 plus cisplatin was a well-tolerated and convenient chemotherapy regimen with promising efficacy.