title: Efficacy of recombinant adenoviral human p53 gene in treatment of malignant pleural or peritoneal effusions.
abstract: OBJECTIVE
  Once the malignant pleural or peritoneal effusion is developed it is difficult to control. This report presents a new method for controlling the malignant effusions.
  
  
  METHODS
  Forty-eight patients, 29 males and 19 females with an average age of 61.2 years old, who were satisfied with the study inclusion criteria, were recruited in this study. Twenty-seven and 21 patients had a malignant pleural and peritoneal effusion, respectively. After draining most of fluids, these patients received intra-cavity infusion of rAd-p53 once per week for 4 weeks, at dose of 2×10¹² viral particles (VP) diluted into 200 mL of saline solution for pleural effusions, and 4×10¹² VP diluted into 500 mL of saline solution for peritoneal effusions.
  
  
  RESULTS
  Participants were followed up for a median time of 13.6 month. A total of 11 cases, 7 with pleural effusions and 4 with peritoneal effusions achieved a complete response (CR), and 20 cases (12 pleural effusions and 8 peritoneal effusions) had a partial response (PR). The overall response rate is 64.6%. Patients' quality of life, assessed by using Karnofsky performance scale (KPS) scores, was improved by an average of 26.4. The one-year of overall survival rate was 54.2% with a median survival time of 12.5 months. There were no serious side effects observed except for self-limited fever found in 79.8% of the cases.
  
  
  CONCLUSIONS
  Intra-cavity infusion of rAd-p53 is an effective and safe treatment for the patients with malignant pleural or peritoneal effusions, especially for those patients who can't tolerate the standard treatments.
authors.affiliation: Department of Oncology, the General Hospital of Chinese PLA, Beijing 100853, China.
authors.forename: Xin
authors.initials: X
authors.lastname: Zhang
authors.forename: Yi
authors.initials: Y
authors.lastname: Hu
authors.forename: Jinliang
authors.initials: J
authors.lastname: Wang
authors.forename: Sujie
authors.initials: S
authors.lastname: Zhang
authors.forename: Haitao
authors.initials: H
authors.lastname: Tao
authors.forename: Sun
authors.initials: S
authors.lastname: Jing
authors.forename: Baishou
authors.initials: B
authors.lastname: Wu
mesh_terms: D000256:Adenoviridae / Q000235:genetics*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001201:Ascites / Q000235:genetics / Q000628:therapy*; D004274:DNA, Recombinant / Q000235:genetics*; D005260:Female; D015316:Genetic Therapy / Q000009:adverse effects / Q000379:methods*; D006801:Humans; D008297:Male; D008875:Middle Aged; D016066:Pleural Effusion, Malignant / Q000235:genetics / Q000628:therapy*; D012449:Safety; D016159:Tumor Suppressor Protein p53 / Q000235:genetics*
chemical_list: D004274:DNA, Recombinant; D016159:Tumor Suppressor Protein p53