title: Adjuvant active specific immunotherapy for stage II and III colon cancer with an autologous tumor cell vaccine: Eastern Cooperative Oncology Group Study E5283.
abstract: OBJECTIVE
  A randomized phase III clinical trial of adjuvant active specific immunotherapy (ASI) with an autologous tumor cell-bacillus Calmette-Guérin (BCG) vaccine was conducted to determine whether surgical resection plus ASI was more beneficial than resection alone in stage II and III colon cancer patients.
  
  
  METHODS
  Patients (n = 412) with colon cancer (297 with stage II disease, 115 with stage III disease) were randomly allocated to an observation arm or to a treatment arm in which they received three weekly intradermal vaccine injections of 10(7) irradiated autologous tumor cells beginning approximately 4 weeks after surgery. The first two weekly injections also contained 10(7) BCG organisms. Patients were observed for determination of time to recurrence and disease-free and overall survival.
  
  
  RESULTS
  This was a negative study in that after a 7.6-year median follow-up period, there were no statistically significant differences in clinical outcomes between the treatment arms. However, there were disease-free survival (P =.078) and overall survival (P =.12) trends in favor of ASI when treatment compliance was evaluated, ie, patients who received the intended treatment had a delayed cutaneous hypersensitivity (DCH) response to the third vaccination (induration >/=5 mm). Also, the magnitude of the DCH response correlated with improved prognosis. The 5-year survival proportion was 84.6% for those with indurations greater than 10 mm, compared with 45.0% for those with indurations less than 5 mm.
  
  
  CONCLUSIONS
  When all randomized patients were evaluated, no significant clinical benefit was seen with ASI in surgically resected colon cancer patients with stage II or III colon cancer. However, there was an indication that treatment compliance with effective immunization results in disease-free and overall survival benefits.
authors.affiliation: Rush-Presbyterian-St. Luke's Medical Center, Chicago, IL 60612, USA.
authors.forename: J E
authors.initials: JE
authors.lastname: Harris
authors.forename: L
authors.initials: L
authors.lastname: Ryan
authors.forename: H C
authors.initials: HC
authors.lastname: Hoover
authors.forename: R K
authors.initials: RK
authors.lastname: Stuart
authors.forename: M M
authors.initials: MM
authors.lastname: Oken
authors.forename: A B
authors.initials: AB
authors.lastname: Benson
authors.forename: E
authors.initials: E
authors.lastname: Mansour
authors.forename: D G
authors.initials: DG
authors.lastname: Haller
authors.forename: J
authors.initials: J
authors.lastname: Manola
authors.forename: M G
authors.initials: MG
authors.lastname: Hanna
mesh_terms: D000276:Adjuvants, Immunologic / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001500:BCG Vaccine / Q000627:therapeutic use*; D019496:Cancer Vaccines / Q000627:therapeutic use*; D003110:Colonic Neoplasms / Q000401:mortality / Q000473:pathology / Q000601:surgery / Q000628:therapy*; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015996:Survival Rate; D014481:United States / Q000453:epidemiology
chemical_list: D000276:Adjuvants, Immunologic; D001500:BCG Vaccine; D019496:Cancer Vaccines