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Background  Gene therapy is a promising therapeutic approach for cancer. Targeted expression of desired therapeutic proteins within the tumor is the best approach to reduce toxicity and improve survival. This study is to establish a more effective and less toxic gene therapy of cancer.    Methods  Combined gene therapy strategy with recombinant adenovirus expressing horseradish peroxidase (HRP) mediated by human telomerase reverse transcriptase (hTERT) promoter (AdhTERTHRP) and murine interleukin-12 (mIL-12) under the control of Cytomegalovirus (CMV) promoter (AdCMVmIL-12) was developed and evaluated against Lewis lung carcinoma (LLC) both  in vivo  and  in vitro . The mechanism of action and systemic toxicities were also investigated.    Results  The combination of AdhTERTHRP/indole-3-acetic acid (IAA) treatment and AdCMVmIL-12 resulted in significant tumor growth inhibition and survival improvement compared with AdhTERTHRP/IAA alone (tumor volume, 427.4 ± 48.7 mm 3   vs  581.9 ± 46.9 mm 3 ,  p  = 0.005 on day 15; median overall survival (OS), 51 d  vs  33 d) or AdCMVmIL-12 alone (tumor volume, 362.2 ± 33.8 mm 3   vs  494.4 ± 70.2 mm 3 ,  p  = 0.046 on day 12; median OS, 51 d  vs  36 d). The combination treatment stimulated more CD4 +  and CD8 +  T lymphocyte infiltration in tumors, compared with either AdCMVmIL-12 alone (1.3-fold increase for CD4 +  T cells and 1.2-fold increase for CD8 +  T cells,  P  < 0.01) or AdhTERTHRP alone (2.1-fold increase for CD4 +  T cells and 2.2-fold increase for CD8 +  T cells,  P  < 0.01). The apoptotic cells in combination group were significantly increased in comparison with AdCMVmIL-12 alone group (2.8-fold increase,  P  < 0.01) or AdhTERTHRP alone group (1.6-fold increase,  P  < 0.01). No significant systematic toxicities were observed.    Conclusions  Combination gene therapy with AdhTERTHRP/IAA and AdCMVmIL-12 could significantly inhibit tumor growth and improve host survival in LLC model, without significant systemic adverse effects.

journal of translational medicine

Gene therapy with tumor-specific promoter mediated suicide gene plus IL-12 gene enhanced tumor inhibition and prolonged host survival in a murine model of Lewis lung carcinoma