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


METHODS
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.


RESULTS
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 5th- and 17th-week after treatment. The complete response (CR) of the combined therapy group was significantly higher than that of the control group in both ITT and PP (ITT: 65.63%, 87.50%, 90.63% versus 27.27%, 42.42%, 51.52%; PP: 67.21%, 90.16%, 93.44% versus 27.69%, 43.08%, 52.31%; P < 0.05, respectively). The most common h-R3-related adverse reactions were fever (4.3%), hypotension (2.9%), nausea (1.4%), dizziness (2.9%) and rash (1.4%), which could be reversible if treated properly. Radiotherapy combined with 100 mg h-R3 i. v. weekly was tolerable and did not aggravate the side effects of radiation. The quality of life in the combined therapy group was comparable to that in the control group.


CONCLUSIONS
This phase 1 multicenter clinical trial shows that h-R3 in combination with radiotherapy is effective and well-tolerated for the treatment of locoregionally advanced nasopharyngeal carcinoma.
Huang
Xiao-dong
XD
Department of Radiation Oncology, Cancer Hospital (Institute), Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.
Yi
Jun-lin
JL
Gao
Li
L
Xu
Guo-zhen
GZ
Jin
Jing
J
Yang
Wei-zhi
WZ
Lu
Tai-xiang
TX
Wu
Shao-xiong
SX
Wu
Ren-rui
RR
Hu
Wei-han
WH
Xie
Wei-chang
WC
Han
Fei
F
Gao
Yuan-hong
YH
Gao
Jian-ming
JM
Pan
Jian-ji
JJ
Chen
Chuan-ben
CB
Lang
Jin-yi
JY
Li
Tao
T
Dong
Yu
Y
Fu
Yu-bing
YB
Fan
Lin
L
Li
Bo-sen
BS
Li
Jing
J
Wang
Xiao-huai
XH
Chen
Bing-xu
BX
Gao
Xian-shu
XS
Zhang
Ping
P
Wu
Xiang-wei
XW
Hu
Bing-qiang
BQ
D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000473:pathology / Q000628:therapy*; D003131:Combined Modality Therapy; D066246:ErbB Receptors / Q000276:immunology*; D005260:Female; D005334:Fever / Q000209:etiology; D006801:Humans; D007022:Hypotension / Q000209:etiology; D008297:Male; D008875:Middle Aged; D009303:Nasopharyngeal Neoplasms / Q000473:pathology / Q000628:therapy*; D009367:Neoplasm Staging; D011788:Quality of Life; D011878:Radiotherapy / Q000009:adverse effects / Q000379:methods*; D012074:Remission Induction
D000911:Antibodies, Monoclonal; D066246:ErbB Receptors