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Zhongguo Fei Ai Za Zhi. 2013 Mar;16(3):153-6. doi: 10.3779/j.issn.1009-3419.2013.03.07.

Efficacy of recombinant adenoviral human p53 gene in treatment of malignant pleural or peritoneal effusions.

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1
Department of Oncology, the General Hospital of Chinese PLA, Beijing 100853, China.

Abstract

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.

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