Abstract: 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 unresectable stage Ⅲ non-small cell lung cancer is a safe,effective therapy.

Key words: carcinoma, non-small-cell lung, tumor suppressor protein p53, chemoradiotherapy, adjuvant