AIM: Recombinant human adenovirus-p53 injection (rAd-p53) is the first marketed gene therapeutic drug worldwide. This study aimed to evaluate the safety and primary efficacy of rAd-p53 administrated on advanced solid tumors. METHODS: 24 patients with advanced solid tumor treated with rAd-p53 were reviewed, including 5 cases of renal carcinoma, 4 of nasopharyngeal carcinoma, 4 of colorectal carcinoma, 2 of melanoma, 1 of non-small-celllung cancer, 1 of esophageal carcinoma, 1 of gastric cardia carcinoma, 1 of thymic carcinoma, 1 of duodenal carcinoma, 1 of thyroid carcinoma, 1 of pancreatic carcinoma, 1 of endometrial carcinoma and 1 of rhabdomyosarcoma. RAd-p53 was weekly administrated at the dose of 1?10~ 12 VP, and 4 times of administration was defined as one cycle. Administration approach included intratumoral injection,intrabronchial drop in, intraperitoneal injection, intra-arterial infusion and intravenous drip. Combined therapy was given with chemotherapy in 18 cases, radiotherapy in 2, concomitant chemotherapy and radiotherapy in 1, abdominal thermotherapy and orally gefitinib in 1, cytokine immunotherapy in 1 and without combination therapy in 1. RESULTS: 23 cases underwent 35 cycles of therapy except for 1 case discontinued because of early progression. Among the 21 evaluable cases 5 PR, 5 SD and 11 PD were observed. Overall response rate was 23.8%(5/21) and disease control rate was 47.6%(10/21). Grade I-II injection site pain, chill, fever and myalgia were the most frequent side effects. Grade III fever developed in 2 cases and grade III-IV myelosuppression in 4 cases combined with chemotherapy. Furthermore, severe ostealgia occurred in 2 cases and transient hypotension in 1. CONCLUSION: RAd-p53 is tolerable in patients with advanced solid tumor. A further randomized clinical trial is necessary to confirm the antitumor activity of rAd-p53 combined with conventional strategies.

OBJECTIVE: Nasopharyngeal Carcinoma (NPC) can be successfully treated by radiotherapy, if the tumor is confined to nasopharynx, but clinical onset is usually delayed to more advanced stages, when prognosis is poor. The objective is to determine efficacy of a new program for early NPC detection, which entails stratification of the NPC risk of target population according to serum levels of 3 Epstein Barr Virus (EBV) antibodies. METHOD: The sera of 1373 healthy adult residents from Zhongshan were collected and analyzed in this study from Mar 16, 2007 to Dec 31, 2007. The levels of EBNA1/IgA, zta/IgG and EBNA1/IgG were tested by ELISA. To stratify the subjects of 1373 adults into high, moderate and normal NPC risk groups by regression analysis of the levels of the EBV antibody. The high-risk groups of nasopharyngeal carcinoma risk could be followed-up every 3-6 month. RESULT: NPC risk of 1379 adults was stratified according to serum levels of the 3 EBV antibodies. Eleven (0.8%) were identified to be of high risk for NPC, having high levels of all three antibodies and/or IgA EBNA level > 3 rod. Clinical examination of high risk subjects detected 5 NPC cases, 3 cases detected in the first instance and 2 in follow-up examination 3 to 6 months hence. Three cases were diagnosed with UICC Stage I tumor (60%), one in the first instance and 2 in follow-up, and the 5 cases account for all NPC cases detected from the entire cohort over 28 months(100%). CONCLUSION The new program affords an efficient and efficacious means for early NPC detection.
Antibodies, Viral ; blood ; China ; epidemiology ; Early Detection of Cancer ; methods ; Epstein-Barr Virus Nuclear Antigens ; immunology ; Humans ; Male ; Middle Aged ; Multiphasic Screening ; Nasopharyngeal Neoplasms ; blood ; diagnosis ; epidemiology ; virology ; Risk Assessment