title: Phase II randomized trial of autologous formalin-fixed tumor vaccine for postsurgical recurrence of hepatocellular carcinoma.
abstract: OBJECTIVE
  We conducted a Phase II clinical trial with randomized patients to determine whether autologous formalin-fixed tumor vaccine (AFTV) protects against postsurgical recurrence of hepatocellular carcinoma (HCC).
  
  
  METHODS
  Forty-one patients with HCC who had undergone curative resection were randomly allocated to the vaccine treatment (n = 19) or no adjuvant control group (n = 22). Three intradermal vaccinations were administered at 2-week intervals beginning 4-6 weeks after hepatic resection. A delayed-type hypersensitivity test was performed before and after vaccination. Primary and secondary end points are recurrence-free survival and overall survival, respectively. Observation continued until the majority of surviving patients had lived >12 months after the curative resection.
  
  
  RESULTS
  In a median follow-up of 15 months, the risk of recurrence in vaccinated patients was reduced by 81% (95% confidence interval, 33-95%; P = 0.003). Vaccination significantly prolonged the time to first recurrence (P = 0.003) and improved recurrence-free survival (P = 0.003) and overall survival rates (P = 0.01). AFTV played a significant role in preventing recurrence in patients with small tumors. Adverse effects were limited to grade 1 or 2 skin toxicities such as erythema, dry desquamation, and pruritus.
  
  
  CONCLUSIONS
  AFTV therapy is a safe, feasible, and effective treatment for preventing postoperational recurrence of HCC. Patients with low tumor burdens benefit from the treatment. This treatment should be advanced to a large-scale randomized trial.
authors.affiliation: Department of Hepatobiliary Surgery, First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.
authors.forename: Ming
authors.initials: M
authors.lastname: Kuang
authors.forename: Bao G
authors.initials: BG
authors.lastname: Peng
authors.forename: Ming D
authors.initials: MD
authors.lastname: Lu
authors.forename: Li J
authors.initials: LJ
authors.lastname: Liang
authors.forename: Jie F
authors.initials: JF
authors.lastname: Huang
authors.forename: Qiang
authors.initials: Q
authors.lastname: He
authors.forename: Yun P
authors.initials: YP
authors.lastname: Hua
authors.forename: Saeri
authors.initials: S
authors.lastname: Totsuka
authors.forename: Shu Q
authors.initials: SQ
authors.lastname: Liu
authors.forename: Kam W
authors.initials: KW
authors.lastname: Leong
authors.forename: Tadao
authors.initials: T
authors.lastname: Ohno
mesh_terms: D000368:Aged; D019496:Cancer Vaccines / Q000009:adverse effects / Q000627:therapeutic use*; D006528:Carcinoma, Hepatocellular / Q000401:mortality / Q000473:pathology / Q000601:surgery*; D018572:Disease-Free Survival; D005260:Female; D005557:Formaldehyde; D006801:Humans; D008111:Liver Function Tests; D008113:Liver Neoplasms / Q000401:mortality / Q000473:pathology / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000276:immunology*; D016019:Survival Analysis; D013997:Time Factors
chemical_list: D019496:Cancer Vaccines; D005557:Formaldehyde