title: Cetuximab in combination with chemoradiotherapy in Chinese patients with non-resectable, locally advanced esophageal squamous cell carcinoma: a prospective, multicenter phase II trail.
abstract: OBJECTIVE
  This multicenter phase II trial investigated cetuximab combined with chemoradiotherapy in patients with esophageal squamous cell carcinoma (ESCC).
  
  
  METHODS
  Eligible patients with non-resectable, locally-advanced ESCC received cetuximab 400mg/m(2) loading dose on day 1; and on day 1 of the 2nd-7th weeks: cetuximab 250mg/m(2), paclitaxel 45mg/m(2), and cisplatin 20mg/m(2), concurrent with 59.4Gy/33 fractions of radiation therapy. Primary endpoint was clinical response rate. Secondary endpoints included overall survival (OS), progression-free survival (PFS), safety, and KRAS status.
  
  
  RESULTS
  Of 55 patients enrolled, 45 completed therapy. Forty-four patients had a clinical response: 29 complete response and 15 partial response. One-year PFS and OS of 45 evaluable patients were 84.23% and 93.33%, respectively, and 2-year PFS and OS were 74.87% and 80.00%, respectively. Non-hematologic adverse events were generally grade 1 or 2; primarily rash (92.7%), mucositis (45.5%), fatigue (41.8%), and nausea (38.2%). Grade 3 hematologic adverse events included neutropenia (32.7%) and anemia (1.8%). No KRAS mutations were identified in 50 evaluated samples.
  
  
  CONCLUSIONS
  Cetuximab can be safely administered with chemoradiotherapy to patients with locally-advanced ESCC and may improve clinical response rate.
authors.affiliation: Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Jinan, China.
authors.forename: Xue
authors.initials: X
authors.lastname: Meng
authors.forename: Jianhua
authors.initials: J
authors.lastname: Wang
authors.forename: Xindong
authors.initials: X
authors.lastname: Sun
authors.forename: Lvhua
authors.initials: L
authors.lastname: Wang
authors.forename: Ming
authors.initials: M
authors.lastname: Ye
authors.forename: Pingbo
authors.initials: P
authors.lastname: Feng
authors.forename: Guangying
authors.initials: G
authors.lastname: Zhu
authors.forename: You
authors.initials: Y
authors.lastname: Lu
authors.forename: Chun
authors.initials: C
authors.lastname: Han
authors.forename: Shuchai
authors.initials: S
authors.lastname: Zhu
authors.forename: Zhongxing
authors.initials: Z
authors.lastname: Liao
authors.forename: Jinming
authors.initials: J
authors.lastname: Yu
mesh_terms: D000328:Adult; D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000401:mortality / Q000628:therapy*; D000068818:Cetuximab; D059248:Chemoradiotherapy; D066246:ErbB Receptors / Q000037:antagonists & inhibitors*; D004938:Esophageal Neoplasms / Q000401:mortality / Q000628:therapy*; D000077277:Esophageal Squamous Cell Carcinoma; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D066246:ErbB Receptors; D000068818:Cetuximab
keywords: Cetuximab; Chemoradiotherapy; Esophagus carcinoma; Phase II