摘 要 原癌基因HER-2/neu在多种恶性肿瘤中有扩增及过表达，近30%的原发性乳腺癌患者有HER-2/neu过表达。针对HER-2靶点的特异性人源化抗体曲妥株单抗（trastuzumab；又名赫赛汀，Herceptin）在上世纪90年代已用于临床治疗。目前针对HER-2的肽疫苗、蛋白疫苗、细胞疫苗、DC相关疫苗、以及DNA疫苗等的研究，均已取得一定进展，如小肽E75（p369-399）与GM-CSF联合应用，在HLA-A2(+)/A3(+)乳腺癌患者的Ⅱ期临床试验中显示出一定疗效；针对编码HER-2的DNA疫苗已经进入临床试验阶段，这些疫苗均有可能成为乳腺癌治疗的又一个重要手段。但这些疫苗距临床实际使用尚有一定的距离，有许多问题有待解决和需要进一步的临床验证。

Abstract Overexpression of HER-2/neu oncogene is a frequent molecular event in multiple human cancers, including in approximately 30% of all primary breast cancer case. The humanized anti-HER-2 monoclonal antibody, trastuzumab (also named as herceptin), has been proven to be effective in patients with HER-2-associated metastatic breast cancer since 1990s. Great progress has been made in developing various vaccines targeting HER-2, including peptide vaccines, protein vaccines, cell vaccines, dendritic cell-associated vaccines, and DNA vaccines. For example, peptide E75 (p369-399) combined with granulocyte-macrophage colony-stimulating factor (GM-CSF) has been shown effective for HLA-A2(+)/A3(+) stage Ⅱ breast cancer patients, and HER-2-targeted DNA vaccine has already entered clinical trials. They might be important ways for treatment of breast cancer. Anyhow, there are still a lot of problems need to be addressed before their application in clinical practice.

国家高技术研究发展计划（863计划）项目（No. 2007AA02A249）资助