title: Evaluation of efficacy and safety for recombinant human adenovirus-p53 in the control of the malignant pleural effusions via thoracic perfusion.
abstract: A certain number of studies have showed that p53 gene transfer has an anti-tumor activity in vitro and in vivo. This study was to evaluate the efficacy and safety of thoracic perfusion of recombinant human adenovirus p53 (rAd-p53, Gendicine) for controlling malignant pleural effusion (MPE). We searched for the relevant studies from the database of MEDLINE, Web of Science, EMBASE, Cochrance Library and CNKI to collect the trials concerning the efficacy and safety of rAd-p53 to treat MPE. Fourteen randomised controlled trials (RCTs) with 879 patients were involved in this analysis. The rAd-p53 combined with chemotherapeutic agents significantly improved the overall response rate (ORR) (P < 0.001; odds ratio = 3.73) and disease control rate (DCR) (P < 0.001; odds ratio = 2.32) of patients with MPE as well as the quality of life (QOL) of patients (P < 0.001; odds ratio = 4.27), compared with that of chemotherapeutic agents alone. In addition, the participation of rAd-p53 did not have an obvious impact on the most of incidence of adverse reactions (AEs) (P < 0.05) except the fever (P < 0.001). However, the fever was self-limited and could be tolerated well. The application of rAd-p53 through thoracic perfusion for treating MPE had a better efficacy and safety, which could be a potential choice for controlling MPE.
authors.affiliation: Department of Respiratory Medicine, The First Affiliated Hospital, Xi'an Medical University, Xi'an, China.|Research Center of Prevention and Treatment of Respiratory Disease, Shaanxi Province, 710077, Xi'an, China.
authors.forename: Rong
authors.initials: R
authors.lastname: Biaoxue
authors.affiliation: Department of Respiratory Medicine, Gansu Provincial Hospital, Lanzhou, China.
authors.forename: Pan
authors.initials: P
authors.lastname: Hui
authors.affiliation: Institute of Epidemiology and Health Statistics, School of Public Health, Lanzhou University, Lanzhou, China.
authors.forename: Gao
authors.initials: G
authors.lastname: Wenlong
authors.affiliation: Department of Respiratory Medicine, Second Affiliated Hospital, Xi'an Jiaotong University, Xi'an, China.
authors.forename: Yang
authors.initials: Y
authors.lastname: Shuanying
mesh_terms: D000260:Adenoviruses, Human / Q000235:genetics; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001688:Biological Products / Q000008:administration & dosage* / Q000009:adverse effects; D004337:Drug Carriers; D005260:Female; D015316:Genetic Therapy / Q000009:adverse effects / Q000379:methods*; D005822:Genetic Vectors; D006801:Humans; D008297:Male; D008875:Middle Aged; D016066:Pleural Effusion, Malignant / Q000188:drug therapy*; D016032:Randomized Controlled Trials as Topic; D011994:Recombinant Proteins / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome; D016159:Tumor Suppressor Protein p53 / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D000970:Antineoplastic Agents; D001688:Biological Products; D004337:Drug Carriers; D011994:Recombinant Proteins; D016159:Tumor Suppressor Protein p53