OBJECTIVETo investigate the time to progression (TTP) and overall survival in patients with previously untreated metastatic or relapsed esophageal squamous cell carcinoma treated with chemotherapy (paclitaxel plus cisplatin) combined with radiotherapy versus chemotherapy alone, and also to evaluate the efficacy and toxicity of the regimen.

METHODSIn this prospective and non-randomized study, 47 patients with definite measurable lesion and having no previous chemotherapy were enrolled. All patients were treated with paclitaxel 175 mg/m2 by 2-hour iv infusion on d1 and cisplatin 75 mg/m2 by iv infusion on d1, which were repeated every 21 days. After 2-6 cycles of chemotherapy, those who gained CR, PR or SD were non-randomly assinged into radiotherapy group (group A) or non-radiotherapy group (group B).

RESULTSTotally, 47 patients were enrolled into this study, and all of them were valuable for response. One patient achieved complete response (CR), 19 partial response (PR), 24 stable disease (SD), and 3 were found to have disease progression (PD). The overall response rate of chemotherapy was 42.6% (95% CI, 0.28-0.58). Twenty-one of these 47 patients were sequentially treated with radiotherapy. The median survival and TTP was 13 months and 10 months in the group A , versus 11 months and 5 months in the group B (P < 0.024, P < 0.015), respectively. The most common toxicities were neutropenia and alopecia. There were no grade 4 clinical toxicity and treatment-related death in this series. Systemic adverse effects frequently occurred during radiotherapy were esophagitis and fatigue, which were tolerable.

CONCLUSIONThe combined therapy using chemotherapy (paclitaxel + cisplatin) followed by radiotherapy is effective, tolerable, and statistically superior to chemotherapy alone in patients with metastatic or relapsed esophageal squamous cell carcinoma.