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

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 × 10 12 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.