title: Cetuximab with concurrent chemoradiation for esophagogastric cancer: assessment of toxicity.
abstract: OBJECTIVE
  To determine the feasibility and toxicity of the addition of cetuximab with paclitaxel, carboplatin, and radiation for patients with esophagogastric cancer on a Phase II study.
  
  
  METHODS
  Patients with locoregional esophageal and proximal gastric cancer without distant organ metastases were eligible. All patients received cetuximab, paclitaxel, and carboplatin weekly for 6 weeks with 50.4 Gy radiation.
  
  
  RESULTS
  Sixty patients were enrolled, 57 with esophageal cancer and 3 with gastric cancer. Forty-eight had adenocarcinoma and 12 had squamous cell cancer. Fourteen of 60 patients (23%) had Grade 3 dermatologic toxicity consisting of a painful, pruritic acneiform rash on the face outside of the radiation field. The rates of Grades 3 and 4 esophagitis were 12% and 3%, respectively. Three patients had Grade 3/4 cetuximab hypersensitivity reactions and were not assessable for response. Forty of 57 patients (70%) had a complete clinical response after chemoradiation.
  
  
  CONCLUSIONS
  Cetuximab can be safely administered with chemoradiation for esophageal cancer. Dermatologic toxicity and hypersensitivity reactions were associated with the addition of cetuximab. There was no increase in esophagitis or other radiation-enhanced toxicity.
authors.affiliation: Brown University Oncology Group, Providence, RI, USA. hsafran@lifespan.org
authors.forename: Howard
authors.initials: H
authors.lastname: Safran
authors.forename: Mohan
authors.initials: M
authors.lastname: Suntharalingam
authors.forename: Thomas
authors.initials: T
authors.lastname: Dipetrillo
authors.forename: Thomas
authors.initials: T
authors.lastname: Ng
authors.forename: L Austin
authors.initials: LA
authors.lastname: Doyle
authors.forename: Mark
authors.initials: M
authors.lastname: Krasna
authors.forename: Angela
authors.initials: A
authors.lastname: Plette
authors.forename: Devon
authors.initials: D
authors.lastname: Evans
authors.forename: Harold
authors.initials: H
authors.lastname: Wanebo
authors.forename: Paul
authors.initials: P
authors.lastname: Akerman
authors.forename: Jeremy
authors.initials: J
authors.lastname: Spector
authors.forename: Nancy
authors.initials: N
authors.lastname: Kennedy
authors.forename: Teresa
authors.initials: T
authors.lastname: Kennedy
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy / Q000532:radiotherapy; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy / Q000532:radiotherapy; D000068818:Cetuximab; D004342:Drug Hypersensitivity / Q000209:etiology*; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy*; D004941:Esophagitis / Q000139:chemically induced; D005148:Facial Dermatoses / Q000139:chemically induced; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy*
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D016190:Carboplatin; D017239:Paclitaxel; D000068818:Cetuximab