title: Cetuximab shows activity in colorectal cancer patients with tumors that do not express the epidermal growth factor receptor by immunohistochemistry.
abstract: OBJECTIVE
  To establish evidence of activity, or lack thereof, of cetuximab-based therapy in patients with refractory colorectal cancer with tumors that do not demonstrate epidermal growth factor receptor (EGFR) expression by immunohistochemistry (IHC).
  
  
  METHODS
  Pharmacy computer records were reviewed to identify all patients who received cetuximab at Memorial Sloan-Kettering Cancer Center in a nonstudy setting during the first 3 months of cetuximab's commercial availability. Medical records of these patients were then reviewed to identify colorectal cancer patients who had experienced failure with a prior irinotecan-based regimen and who had a pathology report indicating an EGFR-negative tumor by IHC. Pathology slides from these patients were reviewed by a reference pathologist to confirm EGFR negativity, and computed tomography scans during cetuximab-based therapy were reviewed by a reference radiologist. Response rates were reported using WHO criteria.
  
  
  RESULTS
  Sixteen chemotherapy-refractory, EGFR-negative colorectal cancer patients who received cetuximab in a nonstudy setting were identified. Fourteen of these patients received cetuximab plus irinotecan, and two received cetuximab monotherapy. In the 16 patients, four major objective responses were seen (response rate, 25%; 95% CI, 4% to 46%).
  
  
  CONCLUSIONS
  Colorectal cancer patients with EGFR-negative tumors have the potential to respond to cetuximab-based therapies. EGFR analysis by current IHC techniques does not seem to have predictive value, and selection or exclusion of patients for cetuximab therapy on the basis of currently available EGFR IHC does not seem warranted.
authors.affiliation: Gastrointestinal Oncology Service, Memorial Sloan-Kettering Cancer Center, H-816, New York, NY 10021, USA. chungk@mskcc.org
authors.forename: Ki Young
authors.initials: KY
authors.lastname: Chung
authors.forename: Jinru
authors.initials: J
authors.lastname: Shia
authors.forename: Nancy E
authors.initials: NE
authors.lastname: Kemeny
authors.forename: Manish
authors.initials: M
authors.lastname: Shah
authors.forename: Gary K
authors.initials: GK
authors.lastname: Schwartz
authors.forename: Archie
authors.initials: A
authors.lastname: Tse
authors.forename: Audrey
authors.initials: A
authors.lastname: Hamilton
authors.forename: Dorothy
authors.initials: D
authors.lastname: Pan
authors.forename: Deborah
authors.initials: D
authors.lastname: Schrag
authors.forename: Lawrence
authors.initials: L
authors.lastname: Schwartz
authors.forename: David S
authors.initials: DS
authors.lastname: Klimstra
authors.forename: Daniel
authors.initials: D
authors.lastname: Fridman
authors.forename: David P
authors.initials: DP
authors.lastname: Kelsen
authors.forename: Leonard B
authors.initials: LB
authors.lastname: Saltz
mesh_terms: D000368:Aged; D000911:Antibodies, Monoclonal / Q000494:pharmacology / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents / Q000494:pharmacology / Q000627:therapeutic use*; D000972:Antineoplastic Agents, Phytogenic / Q000627:therapeutic use; D002166:Camptothecin / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000068818:Cetuximab; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000378:metabolism / Q000473:pathology; D066246:ErbB Receptors / Q000145:classification* / Q000187:drug effects; D005260:Female; D006801:Humans; D007150:Immunohistochemistry; D000077146:Irinotecan; D008297:Male; D016347:Medical Records Systems, Computerized; D008875:Middle Aged
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D000972:Antineoplastic Agents, Phytogenic; D000077146:Irinotecan; D066246:ErbB Receptors; D000068818:Cetuximab; D002166:Camptothecin