[Clinical research on recombinant human Ad-p53 injection combined with cisplatin in treatment of malignant pleural effusion induced by lung cancer].

Background And Objective: p53 gene is one of cancer suppressor genes and its mutation and deletion induces almost all human cancers. This study was to evaluate the clinical efficacy and toxicity of recombinant human Ad-p53 injection (rAd-p53) combined with cisplatin in treatment of malignant pleural effusion induced by lung cancer.

Methods: A total of 35 cases of malignant pleural effusion were randomly divided into the combined group (n=17) and the single-agent group (n=18). On the basis of systemic treatment (vinorelbine 25 mg/m2, Days 1-8, every 3 weeks), the combined group were given intracavitary administration of rAd-p53 (1x1012 VP) and cisplatin (40 mg/m2) once a week for 4 weeks. The single-agent group were given the same intracavitary administration as the combined group but without rAd-p53 therapy.

Results: The total effective rates in the combined group and the single-agent group were 82.35% and 50.00% (P<0.05), respectively. The total modification rates in the combined group and the single-agent group were 64.70% and 33.33% (P<0.05), respectively. The toxicities in the two groups were fever, stethalgia, nausea/vomiting and leukopenia. The toxic reaction in combined group was mainly self-limited fever (P<0.05), which disappeared automatically after 36 h.

Conclusions: rAd-p53 and cisplatin is safe and effective for malignant pleural effusion induced by lung cancer. It is worthy of application in clinical treatment.