Multi-center phase II clinical trial of humanized anti-epidermal factor receptor monoclonal antibody h-R3 combined with radiotherapy for locoregionally advanced nasopharyngeal carcinoma

• Published in: Zhōnghuá zhŏngliú zázhì Vol. 29; no. 3; p. 197
• Main Authors: Huang, Xiao-dong, Yi, Jun-lin, Gao, Li, Xu, Guo-zhen, Jin, Jing, Yang, Wei-zhi, Lu, Tai-xiang, Wu, Shao-xiong, Wu, Ren-rui, Hu, Wei-han, Xie, Wei-chang, Han, Fei, Gao, Yuan-hong, Gao, Jian-ming, Pan, Jian-ji, Chen, Chuan-ben, Lang, Jin-yi, Li, Tao, Dong, Yu, Fu, Yu-bing, Fan, Lin, Li, Bo-sen, Li, Jing, Wang, Xiao-huai, Chen, Bing-xu, Gao, Xian-shu, Zhang, Ping, Wu, Xiang-wei, Hu, Bing-qiang
• Format: Journal Article
• Language: Chinese
• Published: China 01.03.2007
• Subjects: Adult; Aged; Antibodies, Monoclonal - adverse effects; Antibodies, Monoclonal - therapeutic use; Carcinoma, Squamous Cell - pathology; Carcinoma, Squamous Cell - therapy; Combined Modality Therapy; Female; Fever - etiology; Humans; Hypotension - etiology; Male; Middle Aged; Nasopharyngeal Neoplasms - pathology; Nasopharyngeal Neoplasms - therapy; Neoplasm Staging; Quality of Life; Radiotherapy - adverse effects; Radiotherapy - methods; Receptor, Epidermal Growth Factor - immunology; Remission Induction
• ISSN: 0253-3766

To evaluate the efficacy and safty of the humanized anti-epidermal factor receptor monoclonal antibody h-R3 in combination with radiotherapy for locoregionally advanced nasopharyngeal carcinoma. Totally, 137 patients from 7 medical center around China were randomly divided into combined therapy group or control group. There was no difference in Karnofsky performance score between two groups. All patients in both groups received radical conventionally fractionated radiotherapy to the total dose of D(T) 70-76 Gy. For the combined therapy group, h-R3 was added at a dose of 100 mg i.v. weekly for 8 weeks started at the beginning of radiotherapy. Of the 137 eligilbe patients, 70 were in the combined therapy group treated by h-R3 plus radiotherapy and 67 in the control group by radiotherapy alone. The intent-to-treat (ITT) population consisted of 130 patients, while the per-protocol (PP) population was composed of 126 patients. The efficacy was assessed respectively at three point of time: the end of treatment, the