title: Documenting the natural history of patients with resected stage II adenocarcinoma of the colon after random assignment to adjuvant treatment with edrecolomab or observation: results from CALGB 9581.
abstract: OBJECTIVE
  We conducted a randomized trial comparing adjuvant treatment with edrecolomab versus observation in patients with resected, low-risk, stage II colon cancer. This study also prospectively studied patient- and tumor-specific markers of treatment outcome.
  
  
  METHODS
  After surgical resection, patients with stage II colon cancer were randomly assigned to either five infusions of edrecolomab at 28-day intervals or observation without adjuvant therapy.
  
  
  RESULTS
  Final accrual included 1,738 patients; 865 patients received edrecolomab, and 873 patients were observed without adjuvant treatment. Median follow-up time was 7.9 years. There were no significant outcome differences between study arms (overall survival [OS], P = .71; disease-free survival, P = .64). The combined 5-year all-cause OS was 0.86 (95% CI, 0.84 to 0.88), and the combined 5-year disease-specific OS was 0.93 (95% CI, 0.91 to 0.94). The relationships between demographic and histopathologic factors and survival differed for all-cause and disease-specific survival outcomes, but no combined prognostic factor model was found to adequately classify patients at higher risk of recurrence or death as a result of colon cancer.
  
  
  CONCLUSIONS
  Edrecolomab did not prolong survival. Consequently, this large study with a long duration of follow-up provided unique data concerning the natural history of resected stage II colon cancer. Prognostic factors identified in previous retrospective and pooled analyses were associated with survival outcomes in this stage II patient cohort. Results from ongoing molecular marker studies may enhance our ability to determine the risk profile of these patients.
authors: Cancer and Leukemia Group B Statistical Center, Duke University Medical Center, Hock Plaza, 2424 Erwin Rd, Room 8040, Durham, NC 27705, USA. niedz001@mc.duke.edu
authors: Donna
authors: D
authors: Niedzwiecki
authors: Monica M
authors: MM
authors: Bertagnolli
authors: Robert S
authors: RS
authors: Warren
authors: Carolyn C
authors: CC
authors: Compton
authors: Nancy E
authors: NE
authors: Kemeny
authors: Al Bowen
authors: AB
authors: Benson
authors: S Gail
authors: SG
authors: Eckhardt
authors: Steven
authors: S
authors: Alberts
authors: Gity N
authors: GN
authors: Porjosh
authors: David J
authors: DJ
authors: Kerr
authors: Anthony
authors: A
authors: Fields
authors: Philippe
authors: P
authors: Rougier
authors: J Marc
authors: JM
authors: Pipas
authors: Joel H
authors: JH
authors: Schwartz
authors: James
authors: J
authors: Atkins
authors: Mark
authors: M
authors: O'Rourke
authors: Michael C
authors: MC
authors: Perry
authors: Richard M
authors: RM
authors: Goldberg
authors: Robert J
authors: RJ
authors: Mayer
authors: Thomas A
authors: TA
authors: Colacchio
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000601:surgery; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D058846:Antibodies, Monoclonal, Murine-Derived; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D003110:Colonic Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000601:surgery; D003131:Combined Modality Therapy; D013505:Digestive System Surgical Procedures; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D009367:Neoplasm Staging; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D058846:Antibodies, Monoclonal, Murine-Derived; D000970:Antineoplastic Agents; C400149:Edrecolomab