alexa Phase II Study of Post-surgery Radiotherapy Combined with Recombinant Adeno-viral Human P53 Gene Therapy in Treatment of Oral Cancer
ISSN: 1948-5956

Journal of Cancer Science & Therapy
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Research Article

Phase II Study of Post-surgery Radiotherapy Combined with Recombinant Adeno-viral Human P53 Gene Therapy in Treatment of Oral Cancer

Sanxia Liu1#, Peng Chen2#, Min Hu2*, Ye Tao2, Lijie Chen2, Huawei Liu2, Jiazhi Wang2, Jinchao Luo2 and Gui Gao2

1Department of Stomatology, Nankai University of Medicine, Tianjin 300071, China

2Department of Stomatology, 301 Military General Hospital, Beijing 100853, China

#Co-first authors

*Corresponding Author:
Min Hu
Department of Stomatology
301 Military General Hospital
Beijing 100853, China
E-mail: [email protected]

Received Date: May 23, 2012; Accepted Date: July 07, 2012; Published Date: July 09, 2012

Citation: Liu S, Chen P, Hu M, Tao Y, Chen L, et al. (2012) Phase II Study of Post-surgery Radiotherapy Combined with Recombinant Adeno-viral Human P53 Gene Therapy in Treatment of Oral Cancer. J Cancer Sci Ther 4:193-195. doi: 10.4172/1948-5956.1000140

Copyright: © 2012 Liu S, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

 

Abstract

Objective: To evaluate benefits of Recombinant Adeno-viral Human p53 (rAd-p53) gene therapy combined with radiotherapy in prevention of oral cancer recurrence after a radical resection. Methods: A total of 215 patients with resectable Tongue Cancer (TCa) and 268 patients with resectable Gingival Carcinoma (GCa) satisfying the inclusion criteria and were randomly assigned to two groups: the Experiment Group (EG) and the Control Group (CG). The EG received multi-point injections of rAd-p53 into the wound surface at a dose of 1 × 1012 Viral Particles (VP) after a radical resection. Both EG and CG were given radiotherapy at a total dose of 60 Gy three weeks after surgery. All these patients will be followed at least for 3 years. Results: Among these 483 cases, 107 patients (57 in EG and 50 in CG) finished 3-years follow-up. Two cases (2/27) of TCa and 2 (2/30) in GCa patients had a local recurrence in EG, but 8 (8/24) TCa and 8 (8/26) GCa patients in CG had a local recurrence. Both recurrent rates of TCa (33.3%) and GCa (30.8%) in CG are statistically significantly higher than that of TCa (7.4%) and GCa (6.7%) in EG, respectively. The overall recurrent rate in EG is 7.0%, which is also statistically significantly lower than that (32%) in CG. Overall 3-years survival (OS) rate of EG is 100% and the progress free survival (PFS) rate is 93.0% and the minimum PFS time is 29 months. The 3-years OS and PFS rates of CG are 94.0% and 68.0%, respectively. Except for self-limited fever, no other adverse reaction was found to be relative to rAd-p53. Conclusions: Post-tumorectomy wound surface injection of rAd-p53 combining with radiotherapy is safe, and may prevent local recurrence and increase both OS and PFS rate for the patients with TCa or GCa

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