title: Clinical trial of a 7-peptide cocktail vaccine with oral chemotherapy for patients with metastatic colorectal cancer.
abstract: OBJECTIVE
  The combination of a peptide vaccine and tegafur-uracil plus leucovorin (UFT/LV) were evaluated in patients with metastatic colorectal cancer refractory to standard chemotherapy.
  
  
  METHODS
  Thirty human leukocyte antigen (HLA)-A2402-positive patients were enrolled in the study. In a cycle of treatment, a vaccine comprising of seven synthetic peptides (five tumor antigen-derived and two vascular endothelial growth factor receptor-derived) was injected weekly, and oral chemotherapy, UFT/LV was given daily for four weeks followed by one week of rest. The immunological and clinical responses were evaluated at the end of every five weeks.
  
  
  RESULTS
  Notable adverse events included grade 1 injection site redness/induration in 25 patients. Tumor imaging showed partial response in three patients, stable disease in 15, and progressive disease in 12. Survival analysis indicated that patients who exhibited positive cytotoxic T lymphocyte responses to all seven peptides had longer overall survival compared to other patients.
  
  
  CONCLUSIONS
  A 7-peptide vaccine used with UFT/LV is safe and is recommended for further trials in patients with metastatic colorectal cancer.
authors.affiliation: Department of Surgery, Kinki University Faculty of Medicine, Osaka-sayama, Osaka, Japan okuno@surg.med.kindai.ac.jp.
authors.forename: Kiyotaka
authors.initials: K
authors.lastname: Okuno
authors.affiliation: Department of Surgery, Kinki University Faculty of Medicine, Osaka-sayama, Osaka, Japan.
authors.forename: Fumiaki
authors.initials: F
authors.lastname: Sugiura
authors.affiliation: Department of Surgery, Kinki University Faculty of Medicine, Osaka-sayama, Osaka, Japan.
authors.forename: Keisuke
authors.initials: K
authors.lastname: Inoue
authors.affiliation: Institute of Immunotherapy for Cancer, Kinki University Faculty of Medicine, Osaka-sayama, Osaka, Japan.
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Sukegawa
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D014408:Biomarkers, Tumor / Q000276:immunology*; D019496:Cancer Vaccines / Q000627:therapeutic use*; D015179:Colorectal Neoplasms / Q000401:mortality / Q000556:secondary / Q000628:therapy*; D003131:Combined Modality Therapy; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009367:Neoplasm Staging; D011379:Prognosis; D015996:Survival Rate; D022223:Vaccines, Subunit / Q000627:therapeutic use*
chemical_list: D014408:Biomarkers, Tumor; D019496:Cancer Vaccines; D022223:Vaccines, Subunit
keywords: 7-peptide vaccine; Cancer vaccine; clinical trial; metastatic colorectal cancer; oral chemotherapy; refractory to standard chemotherapy