title: Prospective, open, multicentre Phase I/II trial to assess safety and efficacy of neoadjuvant radiochemotherapy with docetaxel and cisplatin for esophageal carcinoma.
abstract: OBJECTIVE
  Esophageal squamous cell carcinoma is increasingly treated with trimodality therapy. The objective of this Phase I/II clinical study is to assess the efficacy and safety of neoadjuvant radiochemotherapy with docetaxel and cisplatin and radiotherapy in patients with esophagectomy for locally advanced squamous cell carcinoma of the esophagus with neoadjuvant chemoradiotherapy.
  
  
  METHODS
  Patients with esophageal squamous cell carcinoma received radiochemotherapy (50 Gy/25 fractions during Weeks 1-5) using a three-dimensional conformal radiation therapy or intensity-modulated radiation therapy technique together with weekly docetaxel (20 mg/m(2) at dose levels 1 and 2, 25 mg/m(2) at dose level 3 on Weeks 1-5) and cisplatin (30 mg/m(2) at dose level 1, 40 mg/m(2) at dose levels 2 and 3 on Weeks 1-5) from January 2009 to December 2011. The dose-limiting toxicities and maximum tolerated dose were the primary endpoints and overall response rate and progression-free survival were the secondary endpoints.
  
  
  RESULTS
  Over this timeframe, a total of 49 patients completed trimodality therapy. Thirteen patients were treated at dose level 1, 21 patients at dose level 2 and 15 patients at dose level 3.The maximum tolerated dose for docetaxel was 20 mg/m(2) and cisplatin 40 mg/m(2). The complete response or partial response was observed in 26.5% (13/49) of patients. Thirty-four patients (69.4%) were treated with neoadjuvant radiochemotherapy followed by surgical resection. The median progression-free survival and median overall survival for all patients (n = 49) were 8 and 17.2 months, respectively. The median overall survival was 27.5 months for patients treated at dose level 2.
  
  
  CONCLUSIONS
  Neoadjuvant radiochemotherapy with docetaxel 20 mg/m(2) and cisplatin 40 mg/m(2) was effective and tolerable induction regimen in patients with esophageal tumors.
authors.affiliation: Department of Radiotherapy of Tumor Hospital, The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi Province mhbxian@126.com 869491533@qq.com.
authors.forename: Hong-Bing
authors.initials: HB
authors.lastname: Ma
authors.affiliation: Department of Neurology, Xi'an Center Hospital, Xi'an, Shaanxi Province.
authors.forename: Zheng-Li
authors.initials: ZL
authors.lastname: Di
authors.affiliation: Department of Radiotherapy of Tumor Hospital, The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi Province.
authors.forename: Jiao
authors.initials: J
authors.lastname: Wen
authors.affiliation: Department of Radiotherapy of Tumor Hospital, The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi Province.
authors.forename: Yue
authors.initials: Y
authors.lastname: Ke
authors.affiliation: Department of Radiotherapy, The Affiliated Hospital of Yanan University, Yanan, Shaanxi Province.
authors.forename: Xiaodong
authors.initials: X
authors.lastname: Sun
authors.affiliation: Department of Radiotherapy, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi Province, China mhbxian@126.com 869491533@qq.com.
authors.forename: Juan
authors.initials: J
authors.lastname: Ren
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy / Q000601:surgery / Q000628:therapy*; D059248:Chemoradiotherapy; D002945:Cisplatin / Q000008:administration & dosage; D018572:Disease-Free Survival; D000077143:Docetaxel; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004938:Esophageal Neoplasms / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy / Q000601:surgery / Q000628:therapy*; D016629:Esophagectomy; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000379:methods*; D009367:Neoplasm Staging; D011446:Prospective Studies; D020266:Radiotherapy, Conformal; D050397:Radiotherapy, Intensity-Modulated; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D002945:Cisplatin
keywords: cisplatin; docetaxel; esophageal cancer; neoadjuvant radiochemotherapy