Originally published as JCO Early Release 10.1200/JCO.2008.18.9670 on December 22 2008

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Effect of Recombinant Adenovirus-p53 Combined With Radiotherapy on Long-Term Prognosis of Advanced Nasopharyngeal Carcinoma

From the Department of Radiotherapy, Peking University School of Oncology, Beijing Cancer Hospital and Institute, Beijing; and Fujian Province Cancer Hospital, Fuzhou, People's Republic of China.

Corresponding author: Shan-wen Zhang, MD, Department of Radiotherapy, Peking University School of Oncology, Beijing Cancer Hospital and Institute, 52 Fucheng Rd, Haidian District, Beijing 100036, People's Republic of China; e-mail: zhangshw4641{at}sina.com.

Purpose To centrally assess the safety, efficacy, and 6-year follow-up of recombinant adenovirus-p53 (rAd-p53) combined with radiotherapy (RT) for patients with nasopharyngeal carcinoma (NPC).

Patients and Methods A randomized controlled clinical study on rAd-p53 combined with RT in 42 patients with NPC was compared with a control group of 40 patients with NPC treated with RT alone. In the group receiving rAd-p53 combined with RT, rAd-p53 was intratumorally injected once a week for 8 weeks. Concurrent RT (70 Gy in 35 fractions) was given to the nasopharyngeal tumor and neck lymph node. Patients and tumors were monitored for adverse events and responses.

Results rAd-p53–specific p53 mRNA was detected in postinjection of rAd-p53 biopsies from 16 (94.1%) of 17 patients. Upregulation of p21/WAF1 and Bax and downregulation of vascular endothelial growth factor were observed in postinjection tumor biopsy. Complete response rate in the group receiving rAd-p53 combined with RT was observed at 2.73 times that of the group receiving RT alone (66.7% v 24.4%). Six-year follow-up data showed that rAd-p53 significantly increased the 5-year locoregional tumor control rate by 25.3% for patients with NPC treated with irradiation (P = .002). The 5-year overall survival rate and 5-year disease-free survival rate of the group receiving rAd-p53 combined with RT were 7.5% (P = .34) and 11.7% (P = .21) higher than those of the group receiving RT alone. No dose-limiting toxicity or adverse events appeared, except for transient fever after rAd-p53 administration.

Conclusion In patients with NPC, rAd-p53 was safe and biologically active. Our results indicated that rAd-p53 improves radiotherapeutic tumor control and survival rate in patients with NPC.

Supported by the National Science Committee.

J.P. and S.Z. contributed equally to this article.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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