Phase Ⅱ trial of second-line chemotherapy with docetaxel and capecitabine in advanced esophageal squamous cell carcinoma / 肿瘤研究与临床

ABSTRACT

Objective To evaluate the effects of antitumor,toxicity and survival of second-line chemotherapy with docetaxel and capecitabine in patients with advanced esophageal squamous cell carcinoma.Methods Thirty eligible patients with measurable lesions received 1-hour intravenous treatment of docetaxel (60 mg/m2 on day 1) plus oral capecitabine (825 mg/m2 twice daily on days 1-14) every 3 weeks for up to 6 cycles.Results Patients received a median of two cycles of treatment (range 2-6).The median follow-up interview was 15.4 months (3.0-31.5 months).Intent-to-treat efficacy analysis demonstrated an overall response rate of 23.3 ％ (0 complete and 7 partial) and stability of 43.3 ％ (13 cases).The median time to progression was 3.0 months (95 ％ CI 1.929-4.071).The median survival was 8.3 months (95 ％ CI6.848-9.752).Severe adverse events (grade 3/4) reported were neutropenia (10 cases),anaemia (5 cases),thrombocytopenia (3 cases),hand-foot syndrome (4 cases),and fatigue (3 cases).Conclusion Docetaxel plus capecitabine have a manageable adverse event profile and promising activity in advance esophageal squamous cell carcinoma as a second-line treatment.