Clinical results of recombinant adenoviral human p53 gene in treatment of malignant pleural effusions caused by advanced lung cancers.

Abstract

e19026 Background: Management of the malignant pleural effusion caused by advanced or recurrent lung cancer is a big challenge for clinicians due to multiple reasons: patients’ poor conditions, resistance to chemo- or radio-therapy, intolerance to an aggressive treatment, et al. This report presents a new safe treatment for controlling this type of tough conditions. Methods: Fifty-six patients, 39 males and 17 females with an average age of 64.2 years old were included in this study. All these patients had either a lung cancer in advanced stage or a recurrent cancer after a radical tumorectomy, with malignant pleural effusion. After draining most of the effusion fluid, the patients received intra-cavity infusion of rAed-p53 once per week for 4 weeks, at dose of 2×1012 viral particles (VP) diluted into 300 ml of saline solution. The complete response is defined as the complete disappearance of pleural or peritoneal fluid and negative cytologic findings for >4 weeks, and the partial response is defined as a decrease over 50% of the fluid without the need of drainage and negative cytologic findings for >4 weeks. Results: Participants were followed up for a median time of 15 month. Fifty patients (26.8%) achieved a complete response (CR) and 23 (41.1%) achieved a partial response (PR). The overall response rate is 67.9%. Patients’ quality of life, assessed by using Karnofsky performance scale (KPS) scores, was improved by an average of 27.2. The one-year of overall survival rate was 48.2% with a median survival time of 11.0 months. There were no serious side effects observed except for self-limited fever found in 82.6% of the cases. Conclusions: Intra-cavity infusion of rAd-p53 is a safe and effective method for controlling the malignant pleural effusion for patients with advanced lung cancer and in a poor condition, especially for those who can’t tolerate the standard treatments.