title: A phase II study of paclitaxel and nedaplatin as front-line chemotherapy in Chinese patients with metastatic esophageal squamous cell carcinoma.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of paclitaxel-nedaplatin combination as a front-line regimen in Chinese patients with metastatic esophageal squamous cell carcinoma (ESCC).
  
  
  METHODS
  A two-center, open-label, single-arm phase II study was designed. Thirty-nine patients were enrolled and included in the intention-to-treat analysis of efficacy and adverse events. Patients received 175 mg/m² of paclitaxel over a 3 h infusion on 1 d, followed by nedaplatin 80 mg/m² in a 1 h infusion on 2 d every 3 wk until the documented disease progression, unacceptable toxicity or patient's refusal.
  
  
  RESULTS
  Of the 36 patients assessable for efficacy, there were 2 patients (5.1%) with complete response and 16 patients (41.0%) with partial response, giving an overall response rate of 46.1%. The median progression-free survival and median overall survival for all patients were 7.1 mo (95%CI: 4.6-9.7) and 12.4 mo (95%CI: 9.5-15.3), respectively. Toxicities were moderate and manageable. Grade 3/4 toxicities included neutropenia (15.4%), nausea (10.3%), anemia (7.7%), thrombocytopenia (5.1%), vomiting (5.1%) and neutropenia fever (2.6%).
  
  
  CONCLUSIONS
  The combination of paclitaxel and nedaplatin is active and well tolerated as a first-line therapy for patients with metastatic ESCC.
authors.affiliation: Yi-Fu He, Chu-Shu Ji, Bing Hu, Chang-Lu Hu, Feng-Shou Jiang, Jian Chen, Yi-Wei Yao, Wei Wang, Department of Medical Oncology, Anhui Provincial Hospital affliated to Anhui Medical University, Hefei 230001, Anhui Province, China.
authors.forename: Yi-Fu
authors.initials: YF
authors.lastname: He
authors.forename: Chu-Shu
authors.initials: CS
authors.lastname: Ji
authors.forename: Bing
authors.initials: B
authors.lastname: Hu
authors.forename: Ping-Sheng
authors.initials: PS
authors.lastname: Fan
authors.forename: Chang-Lu
authors.initials: CL
authors.lastname: Hu
authors.forename: Feng-Shou
authors.initials: FS
authors.lastname: Jiang
authors.forename: Jian
authors.initials: J
authors.lastname: Chen
authors.forename: Lei
authors.initials: L
authors.lastname: Zhu
authors.forename: Yi-Wei
authors.initials: YW
authors.lastname: Yao
authors.forename: Wei
authors.initials: W
authors.lastname: Wang
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary; D002681:China; D018450:Disease Progression; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D000077277:Esophageal Squamous Cell Carcinoma; D005260:Female; D006801:Humans; D057194:Intention to Treat Analysis; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D017239:Paclitaxel / Q000008:administration & dosage; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D009944:Organoplatinum Compounds; C053989:nedaplatin; D017239:Paclitaxel
keywords: Esophageal squamous cell cancer; Front-line chemotherapy; Nedaplatin; Paclitaxel