title: Cetuximab efficacy in patients treated routinely in university hospitals.
abstract: BACKGROUND
  The aim of this study was to evaluate the efficacy and tolerance of cetuximab (Cx) in patients with irinotecan-refractory metastatic colorectal cancer (IRMCRC) treated routinely at five university hospitals.
  
  
  METHODS
  Data from all patients treated with Cx (N=105) during the study period (between January 2004 and September 2005) were included in the analysis.
  
  
  RESULTS
  Median number of Cx infusions was 12 (range: 1 to 62). Objective response rate was 24.8%; stable disease in 23.8%; progression in 34.3%; 17.1% of the patients were not evaluable. Digestive and hematological adverse events were grade III in 20% and 12%, respectively, and grade IV in 12% and 11%, respectively. Response rates were higher in patients with acne-like rashes than in patients without (P=0.005). Median time to tumor progression (TTP; intention-to-treat) was 3.9 months (95% CI: 2.6-4.8). Median overall survival after Cx initiation was 8.3 months (95% CI: 6.310.7). Four prognostic factors were significantly associated with a shorter TTP: center (Center 4: HR=2.25, 95% CI: 1.16-4.35, P=0.017); absence of hepatic metastases (HR=2.5, 95% CI: 1.434.37, P=0.001); WHO performance status (HR=1.47, 95% CI: 1.10-1.96, P=0.008); and number of metastatic sites (HR=1.30, 95% CI: 1.05-1.60, P=0.014).
  
  
  CONCLUSIONS
  This analysis of a random population of IRMCRC patients supports Cx efficacy and feasibility, and is in agreement with the results of the BOND study.
authors.affiliation: Hôpital Ambroise-Paré, APHP, Boulogne, Université de Versailles Saint-Quentin-en-Yvelines, UFR Paris Ile-de-France Ouest. jbbachet@worldonline.fr
authors.forename: Jean-Baptiste
authors.initials: JB
authors.lastname: Bachet
authors.forename: Pauline
authors.initials: P
authors.lastname: Afchain
authors.forename: Christophe
authors.initials: C
authors.lastname: Fermanian
authors.forename: Mohamed
authors.initials: M
authors.lastname: Bouchahda
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Mitry
authors.forename: Bruno
authors.initials: B
authors.lastname: Landi
authors.forename: Thierry
authors.initials: T
authors.lastname: André
authors.forename: Astrid
authors.initials: A
authors.lastname: Lièvre
authors.forename: Christophe
authors.initials: C
authors.lastname: Louvet
authors.forename: Philippe
authors.initials: P
authors.lastname: Aegerter
authors.forename: Francis
authors.initials: F
authors.lastname: Levi
authors.forename: Philippe
authors.initials: P
authors.lastname: Rougier
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D000068818:Cetuximab; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D018450:Disease Progression; D019008:Drug Resistance, Neoplasm; D005260:Female; D005602:France; D006785:Hospitals, University; D006801:Humans; D000077146:Irinotecan; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D011379:Prognosis; D012042:Registries
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D000077146:Irinotecan; D000068818:Cetuximab; D002166:Camptothecin