Bier H, Reiffen K A, Haas I, Stasiecki P
Department of Otolaryngology/Head and Neck Surgery, Heinrich Heine University Hospital, Düsseldorf, Germany.
Eur Arch Otorhinolaryngol. 1995;252(7):433-9. doi: 10.1007/BF00167315.
The murine IgG2a monoclonal antibody (mAb) EMD 55900 was produced against the human epidermoid carcinoma cell line A431, with binding occurring to the polypeptide chain of the external domain of human epidermal growth factor receptor (EGF-R). In the present clinical study, 12 patients with advanced squamous cell carcinoma of the larynx or hypopharynx received a single dose of either 20, 100 or 400 mg EMD 55900 3 days prior to laryngectomy and neck dissection. Clinical signs and laboratory parameters of toxicity, development of human anti-mouse antibodies, and mAb plasma concentrations were monitored. In tumor specimens studied from primary tumors and lymph node metastases, expression of EGF-R, distribution of EMD 55900, and occupation of EGF-R by EMD 55900 (double staining) were determined by immunohistochemistry. Single-dose administration of EMD 55900 was very well tolerated in all patients, and good (100 mg) to excellent (400 mg) homogeneous binding of mAb to EGF-R was obtained in the advanced laryngeal and hypopharyngeal carcinomas studied.
鼠源IgG2a单克隆抗体（mAb）EMD 55900是针对人表皮样癌细胞系A431制备的，其与人表皮生长因子受体（EGF-R）胞外结构域的多肽链发生结合。在本临床研究中，12例晚期喉或下咽鳞状细胞癌患者在喉切除术和颈部清扫术前3天接受了单次剂量为20、100或400 mg的EMD 55900。监测了临床体征、毒性实验室参数、人抗鼠抗体的产生以及单克隆抗体的血浆浓度。通过免疫组织化学测定了在原发性肿瘤和淋巴结转移灶的肿瘤标本中EGF-R的表达、EMD 55900的分布以及EMD 55900对EGF-R的占据情况（双重染色）。所有患者对EMD 55900的单剂量给药耐受性良好，在所研究的晚期喉癌和下咽癌中，单克隆抗体与EGF-R获得了良好（100 mg）至优异（400 mg）的均匀结合。
