title: Phase II study of biweekly cetuximab in combination with irinotecan as second-line treatment in patients with platinum-resistant gastro-oesophageal cancer.
abstract: BACKGROUND
  The purpose of this phase II trial was to evaluate the efficacy and safety of cetuximab and irinotecan as second-line treatment in patients with gastro-oesophageal adenocarcinoma.
  
  
  METHODS
  Patients with failure to first-line platinum-based chemotherapy received cetuximab 500 mg/m(2) and irinotecan 180 mg/m(2) every second week until disease progression. Toxicity was evaluated according to The Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v. 3.0. Antitumour activity was assessed according to Response Evaluation Criteria in Solid Tumours (RECIST) v. 1.0.
  
  
  RESULTS
  Sixty-three patients were enrolled, median age was 60 years, median performance status was 1 (0-1), 35 patients had two or more organs involved. The median number of courses was 5 (range 1-25). Response rate was 11% (6 partial response (PR)) and 37% had stable disease. Median progression free survival was 2.8 months and overall survival (OS) was 6.1 months. Grade 3-4 toxicity included: diarrhoea (6%), fatigue (5%), vomiting (5%) and neutropenia (16%). Two patients developed febrile neutropenia. Forty-six patients (73%) had developed grade 1-2 skin rash. Patients developing skin rash had a prolonged survival with an OS at 7.1 months.
  
  
  CONCLUSIONS
  The combination of cetuximab and irinotecan is active as second-line therapy in patients with gastro-oesophageal cancer. Cetuximab induced skin rash was associated with prolonged survival.
authors.affiliation: Department of Oncology, Odense University Hospital, Odense, Denmark. k.schoennemann@ouh.regionsyddanmark.dk
authors.forename: K R
authors.initials: KR
authors.lastname: Schønnemann
authors.forename: M
authors.initials: M
authors.lastname: Yilmaz
authors.forename: J K
authors.initials: JK
authors.lastname: Bjerregaard
authors.forename: K M
authors.initials: KM
authors.lastname: Nielsen
authors.forename: P
authors.initials: P
authors.lastname: Pfeiffer
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality; 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 / Q000008:administration & dosage* / Q000009:adverse effects; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000068818:Cetuximab; D017024:Chemotherapy, Adjuvant; D004334:Drug Administration Schedule; D019008:Drug Resistance, Neoplasm / Q000187:drug effects; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000401:mortality; D005260:Female; D006801:Humans; D000077146:Irinotecan; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000627:therapeutic use; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000401:mortality; D016019:Survival Analysis
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D009944:Organoplatinum Compounds; D000077146:Irinotecan; D000068818:Cetuximab; D002166:Camptothecin