Wilms' tumor 1 (WT1) peptide immunotherapy for gynecological malignancy.
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.
Ohno
Satoshi
S
International Research and Educational Institute for Integrated Medical Sciences, Tokyo Women's Medical University, Tokyo, 162-8666, Japan. satoshi.ohno55@gmail.com
Kyo
Satoru
S
Myojo
Subaru
S
Dohi
Satoshi
S
Ishizaki
Junko
J
Miyamoto
Ken-Ichi
K
Morita
Satoshi
S
Sakamoto
Jun-Ichi
J
Enomoto
Takayuki
T
Kimura
Tadashi
T
Oka
Yoshihiro
Y
Tsuboi
Akihiro
A
Sugiyama
Haruo
H
Inoue
Masaki
M
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*
D019496:Cancer Vaccines; D015234:HLA-A Antigens; C438506:HLA-A*24:02 antigen; D059871:HLA-A24 Antigen; D010446:Peptide Fragments; D025721:WT1 Proteins