Intra-arterial infusion of recombinant adenoviral human p53 gene combined chemotherapy for advanced oral cancer: A phase II double-blind randomized clinical trial.

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5507 Background: The p53 tumor suppressor gene has been shown as having multiple anti-tumor functions and being capable of enhancing the efficacy of chemo-therapy. This study is to investigates clinical outcomes of intra-arterial infusion ofrecombinant adenoviral human p53 gene (rAd-p53) combined with chemotherapy in treatment of advanced oral cancer. Methods: Ninety-nine patients with stage III or IV oral carcinoma, satisfying with the inclusion criteria, were randomly allocated to Group I (G1: n=35; rAd-p53 plus chemotherapy), Group II (G2: n=33; rAd-p53), or Group III (G3: n=31; chemotherapy). Intra-artery infusion of rAd-p53 were given through superficial temporal artery reverse intubation at a dose 1-4 ×1012 viral particles (VP) , once every 3 days for 6 times. Chemotherapy regimen consisted of oxaplatin 200 mg/m2 on day1, bleomycin 8 mg/m2 on day 2, 6, 8 and Methotrexate 30 mg/m2 on day1, 8, for squamous cell carcinoma (SCC), and oxaplatin 200 mg/m2 on day1, 5-Fu 200 mg/m2 on day1,3 and cyclophosphamide 400 mg/m2 on day2, 8 for adenoid cystic carcinoma (ACC). Results: The complete response rate (CR) in G1 (48.5%) was significantly higher than in G2 (16.7%) and G3 (17.2%). The overall response rates (RR) were 88.6%, 54.5%, and 51.6% for G1, G2 and G3, respectively. The 3-year overall survival (OS) of G1 (82.9%) was significantly higher than the patients in G2 (60.6%) and G3 (58.1%). All those patients receiving rAd-p53 had a self-limited fever. Positive Bax immunostaining was detected in all the patients receiving rAd-p53. Conclusions: Intra-arterial infusion of combined rAd-p53 and chemotherapy may represent an alternative to the current standard treatment for the late stage oral carcinoma.