title: Cetuximab Plus irinotecan in pretreated metastatic colorectal cancer progressing on irinotecan: the LABEL study.
abstract: BACKGROUND
  The aim of this multicenter phase II study was to demonstrate the activity of the epidermal growth factor receptor (EGFR)-targeting monoclonal antibody cetuximab combined with irinotecan in the treatment of Latin American patients with EGFR-expressing metastatic colorectal cancer (mCRC) in whom previous treatment with an irinotecan-containing regimen had failed.
  
  
  METHODS
  Patients received cetuximab, as a 400 mg/m2 initial infusion followed by 250 mg/m2 weekly, plus the same irinotecan regimen that had previously failed, until the occurrence of disease progression or unacceptable toxicity. The primary endpoint was response. Secondary endpoints included progression-free survival (PFS), duration of response, overall survival (OS), and safety.
  
  
  RESULTS
  Seventy-nine patients received treatment. One patient had a complete response, 20 had partial responses, and disease was stabilized in 23 patients, giving an overall response rate of 27% and a disease control rate of 56%. The median duration of response was 23.9 weeks. Median PFS was 17.4 weeks, median OS was 9.2 months, and the 12-month OS rate was 38%. The most common adverse events according to System Organ Class were skin and subcutaneous tissue disorders (91% of the patients). Grade 3/4 adverse events occurred in 45 patients (57%), with the most common being diarrhea (20%), neutropenia (11%), and rash (6%). Seven patients (9%) had grade 3/4 acne-like skin rash. No grade 3/4 infusion-related reactions were reported.
  
  
  CONCLUSIONS
  Cetuximab in combination with irinotecan is active and tolerable in Latin American patients with mCRC progressing on irinotecan, with a safety profile similar to that described in European studies.
authors.affiliation: Oncology Center, Hospital SírioLibanês, São Paulo, Brazil. buzaidac@yahoo.com.br
authors.forename: Antonio C
authors.initials: AC
authors.lastname: Buzaid
authors.forename: Clarissa de Cerqueira
authors.initials: Cde C
authors.lastname: Mathias
authors.forename: Florencia
authors.initials: F
authors.lastname: Perazzo
authors.forename: Sergio D
authors.initials: SD
authors.lastname: Simon
authors.forename: Luis
authors.initials: L
authors.lastname: Fein
authors.forename: Jorge
authors.initials: J
authors.lastname: Hidalgo
authors.forename: Andre M
authors.initials: AM
authors.lastname: Murad
authors.forename: Regina
authors.initials: R
authors.lastname: Esser
authors.forename: Stefanie
authors.initials: S
authors.lastname: Senger
authors.forename: Guillermo
authors.initials: G
authors.lastname: Lerzo
mesh_terms: D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D000068818:Cetuximab; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D018450:Disease Progression; D005260:Female; D006801:Humans; D000077146:Irinotecan; D008297:Male; D009362:Neoplasm Metastasis; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000077146:Irinotecan; D000068818:Cetuximab; D002166:Camptothecin