重组人p53腺病毒注射液联合同期放化疗治疗晚期非小细胞肺癌47例

RECOMBINANT ADENO-VIRAL HUMAN p53 GENE IN COMBINATION WITH CONCURRENT RADIO-CHEMOTHERAPY IN 47 PATIENTS WITH ADVANCED STAGE NON-SMALL CELL LUNG CANCER

目的评价支气管动脉灌注重组人p53腺病毒注射液联合同期放化疗治疗局部晚期非小细胞肺癌(non-small cell lung carcinoma,NscLc)的近期疗效和不良反应。方法病理确诊、免疫组织化学检测p53蛋白表达突变型的Ⅲ期NSCLC患者47例,行支气管动脉灌注重组人p53腺病毒注射液2次,依据肿瘤大小每次(2~6)×10^(12)病毒颗粒,注射时间为每周期化疗开始前3d;同期放化疗治疗,三维适形放疗中位剂量为60Gy/30次,化疗为足叶乙甙+顺铂(EP)方案,顺铂50mg/m^2,第1、8、29、36天静脉滴注,足叶乙甙50mg/m^2,第1~5天、第29~33天静脉滴注。结果随访率为100.0%。有效率76.6%,3级放射性食管炎7例(14.9%),3级放射性肺炎5例(10.6%)。随访1年以上者局部控制率为82.9%(29/35),年总生存率72.3%,1年无进展生存率51.1%。结论支气管动脉灌注重组人p53腺病毒注射液联合同期放化疗治疗局部晚期NSCLC近期疗效较好,不良反应可以耐受。

Objective To evaluate the efficacy and safety of recombinant adeno-viral human p53 gene（ rAd-p53 ） in combination with concurrent radio-chemotherapy in patients with unresectable stage Ⅲ non-small cell lung cancer（ NSCLC）. Methods Forty-seven patients with P53 protein mutant NSCLC Ⅲ were diagnosed through pathology,immunohistochemistry. All patients were treated by recombinant human p53 adenovirus injection twice through bronchial artery infusion before concurrent radio-chemotherapy 3 days,which based on tumor size every（ 2 -6 ）× 1012 VPs（ viral particles ）. Concurrent radio-chemotherapy was performed,and the average dose was 60Gy/30 fractions. EP chemotherapy was used,cisplatin was given by intravenous drip 50mg/m2 at 1,8,29 and 36 days. VP-16 was given by intravenous drip 50mg/m2 at 1 -5 and 29 -33 days. Results All patients completed treatment and evaluation of toxicities and efficacy. The overall response rates were 76. 6%. Seven patients had 3 level esophagitis（ 14 . 9%）,five patients had 3 level radiation pneumonitis（ 10 . 6% ）. Local control rate was 82. 9%（29/35）in the patients followed-up of more than 1 year. One-year overall survival rate was 72 . 3%,and one-year progression-free survival rate was 51 . 1%. Conclusion Trans-catheter bronchial arterial infusion rAd-p53 combined with concurrent radio-chemotherapy in patients with＆amp;nbsp;unresectable stage Ⅲ non-small cell lung cancer is a safe,effective therapy.