[Phase II clinical trial of h-R3 combined radiotherapy for locoregionally advanced nasopharyngeal carcinoma].
OBJECTIVE
Anti-epidermal growth factor receptor (EGFR) monoclonal antibodies are easily to produce human anti-murine antibody response at present clinical use. This may influence therapeutic effect. This study was to evaluate the short-term and long-term efficacy and toxicity of the humanized anti-EGFR monoclonal antibody h-R3 in combination with radiotherapy for locoregionally advanced nasopharyngeal carcinoma (NPC).


METHODS
Patients with newly diagnosed stage III-IVb (UICC 1997) NPC, who had moderate or strong EGFR expression, were randomized into radiotherapy alone group or radiotherapy combined h-R3 group. Similar dosage and technique of radiotherapy was administered in both groups. The combination group received weekly intravenous infusion of 100 mg h-R3 during radiotherapy. The short-term efficacy was evaluated according to WHO criteria. The survival was analyzed by Kaplan-Meier method.


RESULTS
A total of 35 patients were enrolled, 17 in radiotherapy alone group and 18 in combination group. During treatment, only 1 patient withdrew from the combination group. The overall complete remission (CR) rates at the end of treatment, 5 and 17 weeks after treatment were significantly higher in combination group than in radiotherapy alone group (72.2% vs. 35.3%, 83.3% vs. 41.2%, and 83.3% vs. 47.1%, P<0.05). Median follow-up time was 31.9 months (range, 4.2-40.7 months). No significant differences in 3-year locoregional control, distant metastasis-free survival and overall survival rates between the 2 groups were found. Except for 1 patient suffered from grade 2 vomiting, no patient developed other adverse events in combination group. No significant differences in radiotherapy-related adverse events between the 2 groups were observed.


CONCLUSIONS
h-R3 is a safe drug which may enhance the response of advanced NPC patients to radiotherapy. However, h-R3 seems not to significantly affect the long-term outcomes.
Wu
Ren-Rui
RR
State Key Laboratory of Oncology in South China, Guangzhou, Guangdong, 510060, PR China.
Wu
Shao-Xiong
SX
Zhao
Chong
C
Xie
Fang-Yun
FY
Gao
Jian-Ming
JM
Hu
Wei-Han
WH
Gao
Yuan-Hong
YH
Li
Feng-Yan
FY
Cui
Tian-Tian
TT
Lu
Tai-Xiang
TX
D000328:Adult; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D002277:Carcinoma / Q000378:metabolism / Q000473:pathology / Q000628:therapy*; D003131:Combined Modality Therapy; D066246:ErbB Receptors / Q000276:immunology* / Q000378:metabolism; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009303:Nasopharyngeal Neoplasms / Q000378:metabolism / Q000473:pathology / Q000532:radiotherapy / Q000628:therapy*; D009367:Neoplasm Staging; D010315:Particle Accelerators; D011882:Radiotherapy, High-Energy; D012074:Remission Induction; D015996:Survival Rate
D000911:Antibodies, Monoclonal; D066246:ErbB Receptors