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 2×10¹² 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.