title: Adjuvant therapy with the monoclonal antibody Edrecolomab plus fluorouracil-based therapy does not improve overall survival of patients with stage III colon cancer.
abstract: OBJECTIVE
  Edrecolomab (ED) is a murine monoclonal antibody targeting the EpCam antigen. This phase III randomized multicenter trial investigated the benefit of adding ED to fluorouracil (FU) based therapy in patients with stage III colorectal cancer.
  
  
  METHODS
  Patients with stage III colon cancer were randomly assigned to one of two treatments after curative surgery. Patients in arm 1 received five infusions of ED together with FU-based chemotherapy; patients in arm 2 received FU-based chemotherapy alone. The primary end point was overall survival (OS).
  
  
  RESULTS
  One thousand eight hundred thirty-nine patients were randomly assigned; results were analyzed on an intent-to-treat basis. Patient characteristics were well-balanced across treatment arms. Five-year follow-up has been completed. Patients randomly assigned to ED plus FU-based therapy showed a 5-year survival rate of 69.6% while for patients receiving FU-based therapy, the rate was 68.2%. The hazard ratio for death with ED plus FU-based therapy compared to FU-based therapy was 0.896 (95% CI, 0.752 to 1.068), which was not statistically significant (P = .220). The adverse effect profiles of the two treatment arms were similar, with the main adverse effects being diarrhea, abdominal pain, and nausea. Anaphylaxis occurred in fewer than 1% of patients receiving ED.
  
  
  CONCLUSIONS
  For patients with stage III colon cancer, the addition of ED to FU-based therapy had no statistically significant effect on OS.
authors.affiliation: 1250 South Collegeville Rd, Collegeville, PA 19426, USA.
authors.forename: Anthony L A
authors.initials: AL
authors.lastname: Fields
authors.forename: Alan
authors.initials: A
authors.lastname: Keller
authors.forename: Lee
authors.initials: L
authors.lastname: Schwartzberg
authors.forename: Stephen
authors.initials: S
authors.lastname: Bernard
authors.forename: Carl
authors.initials: C
authors.lastname: Kardinal
authors.forename: Alan
authors.initials: A
authors.lastname: Cohen
authors.forename: Joe
authors.initials: J
authors.lastname: Schulz
authors.forename: Peter
authors.initials: P
authors.lastname: Eisenberg
authors.forename: John
authors.initials: J
authors.lastname: Forster
authors.forename: Paul
authors.initials: P
authors.lastname: Wissel
mesh_terms: D000911:Antibodies, Monoclonal / Q000008:administration & dosage; D058846:Antibodies, Monoclonal, Murine-Derived; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000401:mortality* / Q000473:pathology; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D005500:Follow-Up Studies; D006801:Humans; D007390:International Agencies; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011379:Prognosis; D011788:Quality of Life; D012307:Risk Factors; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D058846:Antibodies, Monoclonal, Murine-Derived; C400149:Edrecolomab; D005472:Fluorouracil