Efficacy of Recombinant Adenoviral Human p53 Gene in Treatment of Malignant Pleural or Peritoneal Effusions

• Published in: Zhongguo fei ai za zhi 2013-03, Vol.16 (3), p.153-156
• Main Authors: Zhang, Xin, Hu, Yi, Wang, Jinliang, Zhang, Sujie, Tao, Haitao, Jing, Sun, Wu, Baishou
• Format: Article
• Language: English
• Subjects: Adenoviridae - genetics; Adenoviruses; Adult; Aged; Aged, 80 and over; Apoptosis; Ascites - genetics; Ascites - therapy; Cancer therapies; Cell cycle; Chemotherapy; Clinical Experience; DNA, Recombinant - genetics; Female; Fever; Gene expression; Gene therapy; Genetic Therapy - adverse effects; Genetic Therapy - methods; Humans; Intra-cavity infusion; Liver cancer; Male; Malignant effusion; Medical prognosis; Middle Aged; p53 gene; Patients; Pleural Effusion, Malignant - genetics; Pleural Effusion, Malignant - therapy; Quality of life; Response rates; Safety; Tumor Suppressor Protein p53 - genetics; Tumors; 临床治疗; 临床经验; 患者; 癌症; 肺癌
• ISSN: 1009-3419; 1999-6187
• DOI: 10.3779/j.issn.1009-3419.2013.03.07

Background and 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.