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

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 2×10(12) viral particles (VP) diluted into 200 mL of saline solution for pleural effusions, and 4×10(12) 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.