Recombinant adenoviral human p53 gene intracavity infusion in treatment of malignant pleural effusions and peritoneal effusions.

Abstract

e13521 Background: Malignant pleural or peritoneal effusion adversely affects patients' quality of life. Once the effusions formed it is difficult to control. This report showed intra-cavity infusion of recombinant adenoviral human p53 gene (rAd-p53) was very effective for controlling malignant pleural or peritoneal effusion. Methods: Twenty-seven patients, 15 males and 12 females with a median age of 59 years old , were included this study. The malignant pleural effusions, consisting of 13 patients, were caused by primary lung cancers (12 cases) and breast cancer (1 case), and 14 cases of peritoneal effusions were caused by gastric cancer (5 cases), ovarian cancers (3 cases), primary live cancer (2 cases), pancreatic cancer (2 cases), esophageal cancer (1 case) and bile duct cancer (1 case). The rAd-p53 intra-cavity infusion was given after removing most of fluids. For intra-chest cavity infusion 2×1012 viral particles (VP) of rAd-p53 diluted into 200 ml of saline solution, and for intra-abdominal cavity infusion 4×1012 VP of rAd-p53 diluted into 500 ml of saline solution, were given weekly for 3 weeks. Results: A total of 3 cases, 2 with pleural effusion and 1 with peritoneal effusion achieved a complete response (CR), and 10 cases (7 pleural effusions and 3 peritoneal effusions) had a partial response (PR). The overall response rate is 48.1%. The CR was defined as the complete disappearance of pleural or peritoneal fluid and negative cytologic findings for >4 weeks, and the PR is defined as a decrease over 50% of the fluid without the need of drainage and negative cytologic findings for >4 weeks. The fluids in 8 cases with peritoneal effusions decreased by over 30% but less than 50%. The associated symptoms relieved in 23 patients (85.2%). There were no serious side effects observed except for self-limited fever found in all the cases. Conclusions: For some patients with malignant pleural or peritoneal effusions, Intra-cavity infusion of rAd-p53 is effective and safe controlling treatment.