title: Phase II trial of second-line chemotherapy with docetaxel and capecitabine in advanced esophageal squamous cell carcinoma.
abstract: We performed a phase II trial of docetaxel in combination with capecitabine to evaluate the antitumor response, toxicity, and survival in pre-treated patients with advanced esophageal squamous cell carcinoma. Patients with advanced esophageal squamous cell carcinoma who had failed first-line chemotherapy with cisplatin and 5-fluorouracil were enrolled in this study. Treatment consisted of oral capecitabine (825 mg/m(2) twice daily on days 1-14) plus 1-h intravenous docetaxel (60 mg/m(2) on day 1) every 3 weeks for up to 6 cycles. Between June 2008 and August 2011, thirty eligible patients with a median age of 58 years (range 38-68 years) were enrolled. Patients received a median of three cycles of treatment (range 1-6). The median follow-up was 15.4 months (range 1.0-31.5 months). Intent-to-treat efficacy analysis demonstrated an overall response rate of 23.3% (0 complete response and 7 partial response) and stable disease of 43.4 % (n = 13). The median time to progression was 3.0 months (95% CI 1.9-4.1 months). The median survival was 8.3 months (95% CI 6.8-9.8 months). Severe adverse events (grade 3/4) reported were as follows: neutropenia (33.3%, n = 10, including febrile neutropenia 6.7%, n = 2), anemia (16.7%, n = 5), thrombocytopenia (10 %, n = 3), hand-foot syndrome (13.3%, n = 4), and fatigue (10%, n = 3). Docetaxel plus capecitabine had a manageable adverse event profile and promising activity in advance esophageal squamous cell carcinoma as a second-line treatment.
authors.affiliation: Department of Internal Medicine, Cancer Hospital of Shantou University Medical College, 7 Raoping Road, Shantou, Guangdong, China.
authors.forename: Xuyuan
authors.initials: X
authors.lastname: Li
authors.forename: Wen
authors.initials: W
authors.lastname: Lin
authors.forename: Hongbiao
authors.initials: H
authors.lastname: Wang
authors.forename: Wenzhao
authors.initials: W
authors.lastname: Lin
authors.forename: Suiling
authors.initials: S
authors.lastname: Lin
authors.forename: Yingcheng
authors.initials: Y
authors.lastname: Lin
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000069287:Capecitabine; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy*; D002945:Cisplatin / Q000627:therapeutic use; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D000077143:Docetaxel; D004938:Esophageal Neoplasms / Q000188:drug therapy*; D000077277:Esophageal Squamous Cell Carcinoma; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D000069287:Capecitabine; D002945:Cisplatin; D005472:Fluorouracil