title: Clinical and immune responses in resected colon cancer patients treated with anti-idiotype monoclonal antibody vaccine that mimics the carcinoembryonic antigen.
abstract: OBJECTIVE
  We generated an anti-idiotype antibody, designated CeaVac, that is an internal image of the carcinoembryonic antigen (CEA). We previously demonstrated that the majority of patients with advanced colorectal cancer generate specific anti-CEA responses. The purpose of the current study was to treat patients with surgically resected colon cancer with CeaVac to determine the immune response and clinical outcome to treatment with vaccine. We also compared the immune responses between patients treated with fluorouracil (5-FU) chemotherapy regimens plus vaccine versus vaccine alone.
  
  
  METHODS
  Thirty-two patients with resected Dukes' B, C, and D, and incompletely resected Dukes' D disease were treated with 2 mg of CeaVac every other week for four injections and then monthly until tumor recurrence or progression. Fourteen patients were treated concurrently with 5-FU chemotherapy regimens.
  
  
  RESULTS
  All 32 patients entered onto this trial generated high-titer immunoglobulin G and T-cell proliferative immune responses against CEA. The 5-FU regimens did not have a qualitative or quantitative effect on the immune response. Three of 15 patients with Dukes' B and C disease progressed at 19, 24, and 35 months. Seven of eight patients with completely resected Dukes' D disease remained on study from 12 to 33 months; one patient with resected Dukes' D disease relapsed at 9 months. One patient with incompletely resected Dukes' D disease remained on study at 14 months without evidence of progression; eight experienced disease progression at 6 to 31 months.
  
  
  CONCLUSIONS
  CeaVac consistently generated a potent anti-CEA humoral and cellular immune response in all 32 patients entered onto this trial. A number of very high-risk patients continue on study. 5-FU regimens, which are the standard of care for patients with Dukes' C disease, did not affect the immune response. These data warrant a phase III trial for patients with resected colon cancer.
authors.affiliation: Division of Hematology/Oncology, Department of Internal Medicine, and Barrett Cancer Center for Prevention, Treatment and Research, University of Cincinnati Medical Center, Cincinnati, OH 45219-2316, USA. kenneth.foon@uc.edu
authors.forename: K A
authors.initials: KA
authors.lastname: Foon
authors.forename: W J
authors.initials: WJ
authors.lastname: John
authors.forename: M
authors.initials: M
authors.lastname: Chakraborty
authors.forename: R
authors.initials: R
authors.lastname: Das
authors.forename: A
authors.initials: A
authors.lastname: Teitelbaum
authors.forename: J
authors.initials: J
authors.lastname: Garrison
authors.forename: O
authors.initials: O
authors.lastname: Kashala
authors.forename: S K
authors.initials: SK
authors.lastname: Chatterjee
authors.forename: M
authors.initials: M
authors.lastname: Bhattacharya-Chatterjee
mesh_terms: D000276:Adjuvants, Immunologic / Q000627:therapeutic use; D000536:Aluminum Hydroxide / Q000627:therapeutic use; D000818:Animals; D000888:Antibodies, Anti-Idiotypic / Q000276:immunology; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use; D015496:CD4-Positive T-Lymphocytes / Q000276:immunology; D019496:Cancer Vaccines / Q000627:therapeutic use*; D002272:Carcinoembryonic Antigen / Q000276:immunology* / Q000627:therapeutic use*; D003110:Colonic Neoplasms / Q000276:immunology / Q000473:pathology / Q000628:therapy*; D005472:Fluorouracil / Q000627:therapeutic use; D006801:Humans; D007111:Immunity, Cellular; D007074:Immunoglobulin G / Q000276:immunology; D051379:Mice; D008807:Mice, Inbred BALB C; D009367:Neoplasm Staging; D012503:Saponins / Q000627:therapeutic use
chemical_list: D000276:Adjuvants, Immunologic; D000888:Antibodies, Anti-Idiotypic; D000911:Antibodies, Monoclonal; D000964:Antimetabolites, Antineoplastic; D019496:Cancer Vaccines; D002272:Carcinoembryonic Antigen; D007074:Immunoglobulin G; D012503:Saponins; D000536:Aluminum Hydroxide; C078785:saponin QA-21V1; D005472:Fluorouracil