[Recombinant adenovirus p53 agent injection combined with radiotherapy in treatment of nasopharyngeal carcinoma: a phase II clinical trial].
OBJECTIVE
To evaluate the efficacy and toxicity of recombinant adenovirus p53 agent (SBN-1) combined with radiotherapy in treatment of nasopharyngeal carcinoma.


METHODS
Twenty-nine cases with nasopharyngeal carcinoma were randomly divided into two groups: gene therapy + radiotherapy group (GTRT group, n = 16, SBN-1 was injected intratumorally once a week for 8 weeks, and radiotherapy with the dosage of 60-70 Gy was given 3 days after the first injection of SBN-1) and radiotherapy group (RT group, n = 213, the same regimen of radiotherapy was given only). CT and MRI were conducted 4, 8, and 12 weeks after to evaluate the size of tumor. Then the patients were followed-up every month. Toxicity was evaluated by physical examination, KPS scoring, blood, urine, and feces routines, serum BUN, creatine, AST, ALT, LDH, and AKP, electrocardiography, and X-ray.


RESULTS
The tumors of the patients group were reduced by 70.9 +/- 18.1% and 49.4 +/- 22.8% in the GTRT group and the RT group respectively (P < 0.001) 4 weeks after treatment; and were reduced by 94.9 +/- 10.2% and 80.4 +/- 17.0% in the GTRT group and RT group respectively (P < 0.001) 8 weeks after treatment. The rates of complete regression of tumor 12 weeks after the treatment were 75% and 15% in the GTRT group and RT group respectively (P < 0.005). 3 cases presented mild, self-limited fever and no other side effects were noted.


CONCLUSIONS
Local injection of SBN-1 combined with radiotherapy to treat nasopharyngeal carcinoma is safe and significantly more effective than single radiotherapy.
Chen
Chuan-ben
CB
Fujian Tumor Hospital, Fu Jian Medical University, Fuzhou 350014, China.
Pan
Jian-ji
JJ
Xu
Lu-ying
LY
D000256:Adenoviridae / Q000235:genetics; D000328:Adult; D000368:Aged; D003131:Combined Modality Therapy; D005260:Female; D016158:Genes, p53; D015316:Genetic Therapy / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D009303:Nasopharyngeal Neoplasms / Q000628:therapy*; D011878:Radiotherapy / Q000009:adverse effects