[Clinical research on recombinant human Ad-p53 injection combined with cisplatin in treatment of malignant pleural effusion induced by lung cancer].
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.
Zhao
Wei-Zhu
WZ
Department of Oncology,The First Affiliated Hospital of Liaoning Medical University,Jinzhou, Liaoning, 121001, P. R. China.
Wang
Ji-Kun
JK
Li
Wei
W
Zhang
Xiu-Li
XL
D000230:Adenocarcinoma / Q000628:therapy; D000260:Adenoviruses, Human / Q000235:genetics; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use; D002294:Carcinoma, Squamous Cell / Q000628:therapy; D002945:Cisplatin / Q000009:adverse effects / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D005260:Female; D005334:Fever / Q000209:etiology; D016158:Genes, p53; D015316:Genetic Therapy / Q000009:adverse effects; D006801:Humans; D007970:Leukopenia / Q000209:etiology; D008175:Lung Neoplasms / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000209:etiology; D016066:Pleural Effusion, Malignant / Q000628:therapy*; D011788:Quality of Life; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D016159:Tumor Suppressor Protein p53 / Q000009:adverse effects / Q000235:genetics / Q000627:therapeutic use*
D000970:Antineoplastic Agents; D011994:Recombinant Proteins; D016159:Tumor Suppressor Protein p53; D002945:Cisplatin