重组人p53腺病毒注射液联合同期放化疗治疗老年T4N0-2M0局部晚期非小细胞肺癌26例临床分析

A PRIMARY REPORT OF RECOMBINANT ADENO-VIRAL HUMAN P53 GENE (RAD-P53) IN COMBINATION WITH CONCURRENT RADIO-CHEMOTHREPY IN PATIENTS WITH T4N0-2M0 STAGE NON-SMALL CELL LUNG CANCER IN ELDERLY

目的评价支气管动脉灌注今又生（重组人p53腺病毒注射液）联合EP方案同期放化疗治疗老年T4N0-2M0局部晚期非小细胞肺癌患者的近期疗效和不良反应。方法2010年1月－2012年12月经病理确诊、免疫组化检测p53蛋白表达突变型的老年（65岁≤年龄≤75岁）T4N0—2M0局部晚期NSCLC患者26例，行支气管动脉灌注今又生2次，每次4×10^12VPs，注射时间分别为化疗周期开始前3d。联合同期放化疗治疗，化疗为EP方案，顺铂：50mg／m^2，dl、8、29、36静脉滴注，足叶乙甙：50mg／m2，d1～5、d29～33静脉滴注。采取3D—CRT放疗，中位剂量为60Gy／30次，每周5次。结果随访率为100％。有效率76．9％（20／26），3级放射性食管炎4例（15．4％）、3级放射性肺炎3例（11．5％）。1年总生存率73．1％，1年无进展生存率57．7％。结论支气管动脉灌注今又生联合同期放化疗治疗老年T4N0—2M0局部晚期非小细胞肺癌取得较好近期疗效、不良反应可以耐受，值得推广。

Objective To evaluate the efficacy and safety of recombinant adeno- viral human p53 gene（rAd - p53） in combination with concurrent radio - chemothrepy in patients with Stage of T4N0 - 2 non - small cell lung cancer （NSCLC） in elderly. Methods From January 2010 to December 2012,26 patients received three - dimentional conformal radiotherapy of 60 Gy/30 fractions over 6 weeks and concurrent chemotherapy of cisplatin 50mg/m2 , dl, 8,29,36 and VP - 16 d1 - 5, d29 - 33 ivgtt, tAd - p53 was administered through bronchial artery infusion via a catheter access 3 days before once each chemotherapy at a dose level of 4 ×10^12 viral particles（VP）. Patients were followed up, with safety evaluated by the National Cancer Institute＇s Common Toxicity Criteria and tumor response evaluated with thoracic CT scans performed 4 weeks after completion of treatment in accordance with response evaluation criteria in solid tumor （RECIST）, re- spectively. Survival rates were analyzed by Kaplan- Meier method. Results All patients completed treatment and evaluation of toxicities and efficacy. The overall response rates was 76.9%. One - year overall survival rate was 73.1% ,and one- year progression- free survival rate was 57.7%. Grade 3 acute radia- tion esophagitis and radiation pneumonitis were observed in 15.4% and 11.5%, respectively. There were no serious adverse events except for self - limiting fever and transient influenza- like symptom was repo- ted. Conclusion Trans- catheter bronchial arterial infusion Gendicine combined with concurrent radio - chemothrepy in patients with stage of T4N0 - 2 non- small cell lung cancer in elderly is a safe, effective therapy.