Abstract: AIM: Recombinant human adenovirusp53 injection (rAd-p53) is the first marketed gene therapeutic drug worldwide.This study aimed to evaluate the safety and primary efficacy of rAd-p53 administrated on advanced solid tumors.METHODS: 24 patients with advanced solid tumor treated with rAd-p53 were reviewed, including 5 cases of renal carcinoma, 4 of nasopharyngeal carcinoma, 4 of colorectal carcinoma, 2 of melanoma, 1 of non-small-celllung cancer, 1 of esophageal carcinoma, 1 of gastric cardia carcinoma, 1 of thymic carcinoma, 1 of duodenal carcinoma, 1 of thyroid carcinoma, 1 of pancreatic carcinoma, 1 of endometrial carcinoma and 1 of rhabdomyosarcoma.RAd-p53 was weekly administrated at the dose of 1 ×1012 VP, and 4 times of administration was defined as one cycle.Administration approach included intratumoral injection, intrabronchial drop in, intraperitoneal injection, intra-arterial infusion and intravenous drip.Combined therapy was given with chemotherapy in 18 cases, radiotherapy in 2, concomitant chemotherapy and radiotherapy in 1, abdomi-nal thermotherapy and orally gefitinib in 1, cytokine immunotherapy in 1 and without combination therapy in 1.RESULTS: 23 cases underwent 35 cycles of therapy except for 1 case discontinued because of early progression. Among the 21 evaluable cases 5 PR, 5 SD and 11 PD were observed.Overall response rate was 23.8%(5/21) and disease control rate was 47.6%(10/21).Grade I-II injection site pain, chill, fever and myalgiawere the most frequent side effects.Grade III fever developed in 2 cases and grade III-IV myelosuppression in 4 cases combined with chemotherapy.Furthermore, severe ostealgia occurred in 2 cases and transient hypotension in 1.CONCLUSION: RAd-p53 is tolerable in patients with advanced solid tumor.A further randomized clinical trial is necessary to confirm the antitumor activity of rAd-p53 combined with conventional strategies.

Key words: p53, adenovirus, gene therapy, tumor, chemotherapy, side effect, efficacy, clinical trial