title: Randomized, controlled phase II study of post-surgery radiotherapy combined with recombinant adenoviral human p53 gene therapy in treatment of oral cancer.
abstract: The aim of this study is to evaluate clinical benefits of recombinant adenoviral human p53 (rAd-p53) gene therapy combined with radiotherapy in prevention of oral cancer recurrence after a radical resection. A total of 51 patients with tongue cancer (TCa) and 56 patients with gingival carcinoma (GCa) satisfying the inclusion criteria were randomly assigned to two groups: the experiment group (EG) and the control group (CG). The EG group received multipoint injections of rAd-p53 into the surgical wound surface at a dose of 1 × 10¹² viral particles after a radical resection. Patients in both EG and CG were given radiotherapy at a total dose of 60 Gy at 3 weeks after surgery. All these patients were followed up for at least 3 years. 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 those of TCa (7.4%) and GCa (6.7%) in EG, respectively. The overall recurrent rate in EG is 7%, which is also statistically significantly lower than that (32%) in CG. The 3-year overall survival (OS) rate and 3-year disease-free survival (DFS) rate of EG is 100% and 93%, respectively. The 3-year OS and DFS rates of CG are 94 and 68%, respectively. Mild or medium fever and flu-like symptoms were more frequently observed in EG and were considered to be associated with application of rAd-p53. Post-tumorectomy wound surface injection of rAd-p53 combining with radiotherapy is a safe and effective regimen for the patients with TGa or GCa.
authors.affiliation: Medical College in Nankai University, Tianjin, China.
authors.forename: S
authors.initials: S
authors.lastname: Liu
authors.forename: P
authors.initials: P
authors.lastname: Chen
authors.forename: M
authors.initials: M
authors.lastname: Hu
authors.forename: Y
authors.initials: Y
authors.lastname: Tao
authors.forename: L
authors.initials: L
authors.lastname: Chen
authors.forename: H
authors.initials: H
authors.lastname: Liu
authors.forename: J
authors.initials: J
authors.lastname: Wang
authors.forename: J
authors.initials: J
authors.lastname: Luo
authors.forename: G
authors.initials: G
authors.lastname: Gao
mesh_terms: D000256:Adenoviridae; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002277:Carcinoma / Q000235:genetics / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery; D018572:Disease-Free Survival; D005260:Female; D015316:Genetic Therapy; D005822:Genetic Vectors; D005887:Gingival Neoplasms / Q000235:genetics / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery; D006801:Humans; D008297:Male; D008875:Middle Aged; D011184:Postoperative Period; D014062:Tongue Neoplasms / Q000235:genetics / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery; D016159:Tumor Suppressor Protein p53 / Q000235:genetics / Q000627:therapeutic use*
chemical_list: C495901:TP53 protein, human; D016159:Tumor Suppressor Protein p53