title: Wilms' tumor 1 (WT1) peptide immunotherapy for gynecological malignancy.
abstract: BACKGROUND
  The object of this study was to investigate the safety and clinical response of immunotherapy targeting the WT1 (Wilms' tumor 1) gene product in patients with gynecological cancer.
  
  
  METHODS
  Twelve patients with WT1/human leukocyte antigen (HLA)-A*2402-positive gynecological cancer were included in a Phase II clinical trial of WT1 vaccine therapy. In all the patients, the tumors were resistant to standard therapy. The patients received intradermal injections of a HLA-A*2402-restricted, modified 9-mer WT1 peptide every week for 12 weeks. Tumor size, which was measured by computed tomography (CT), was determined every 4 weeks. The responses were analyzed according to Response Evaluation Criteria in Solid Tumors (RECIST).
  
  
  RESULTS
  The protocol was well tolerated; only local erythema occurred at the WT1 vaccine injection site. The clinical responses were as follows: stable disease (SD) in 3 patients and progressive disease (PD) in 9 patients. No patients had a complete (CR) or partial response (PR). The disease control rate was 25.0%.
  
  
  CONCLUSIONS
  Although a small, uncontrolled, nonrandomized trial, this study showed that WT1 vaccine therapy for patients with gynecological cancer was safe and produced a clinical response.
authors.affiliation: International Research and Educational Institute for Integrated Medical Sciences, Tokyo Women's Medical University, Tokyo, 162-8666, Japan. satoshi.ohno55@gmail.com
authors.forename: Satoshi
authors.initials: S
authors.lastname: Ohno
authors.forename: Satoru
authors.initials: S
authors.lastname: Kyo
authors.forename: Subaru
authors.initials: S
authors.lastname: Myojo
authors.forename: Satoshi
authors.initials: S
authors.lastname: Dohi
authors.forename: Junko
authors.initials: J
authors.lastname: Ishizaki
authors.forename: Ken-Ichi
authors.initials: K
authors.lastname: Miyamoto
authors.forename: Satoshi
authors.initials: S
authors.lastname: Morita
authors.forename: Jun-Ichi
authors.initials: J
authors.lastname: Sakamoto
authors.forename: Takayuki
authors.initials: T
authors.lastname: Enomoto
authors.forename: Tadashi
authors.initials: T
authors.lastname: Kimura
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Oka
authors.forename: Akihiro
authors.initials: A
authors.lastname: Tsuboi
authors.forename: Haruo
authors.initials: H
authors.lastname: Sugiyama
authors.forename: Masaki
authors.initials: M
authors.lastname: Inoue
mesh_terms: D000328:Adult; D000368:Aged; D019496:Cancer Vaccines / Q000627:therapeutic use*; D005260:Female; D005833:Genital Neoplasms, Female / Q000276:immunology / Q000628:therapy*; D015234:HLA-A Antigens / Q000096:biosynthesis / Q000276:immunology; D059871:HLA-A24 Antigen; D006801:Humans; D007271:Injections, Intradermal; D008875:Middle Aged; D010446:Peptide Fragments / Q000008:administration & dosage / Q000276:immunology; D025721:WT1 Proteins / Q000276:immunology*
chemical_list: D019496:Cancer Vaccines; D015234:HLA-A Antigens; C438506:HLA-A*24:02 antigen; D059871:HLA-A24 Antigen; D010446:Peptide Fragments; D025721:WT1 Proteins