International Research and Educational Institute for Integrated Medical Sciences, Tokyo Women's Medical University, Tokyo, 162-8666, Japan.
Anticancer Res. 2009 Nov;29(11):4779-84.
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.
Twelve patients with WT1/human leukocyte antigen (HLA)-A2402-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-A2402-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).
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%.
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.
本研究旨在探讨针对 WT1（Wilms 瘤 1）基因产物的免疫疗法在妇科癌症患者中的安全性和临床反应。
12 例 WT1/人类白细胞抗原（HLA）-A2402 阳性妇科癌症患者纳入 WT1 疫苗治疗的 II 期临床试验。所有患者的肿瘤均对标准治疗耐药。患者每周接受一次 HLA-A2402 限制性、修饰的 9 肽 WT1 皮内注射，共 12 周。每 4 周通过计算机断层扫描（CT）测量肿瘤大小。根据实体瘤反应评估标准（RECIST）分析反应。
方案耐受良好；仅在 WT1 疫苗注射部位出现局部红斑。临床反应如下：3 例患者疾病稳定（SD），9 例患者疾病进展（PD）。无患者完全缓解（CR）或部分缓解（PR）。疾病控制率为 25.0%。
尽管这是一项小规模、非对照、非随机试验，但本研究表明 WT1 疫苗疗法治疗妇科癌症患者是安全的，并产生了临床反应。
