RESUMO
<p><b>OBJECTIVE</b>To evaluate the efficacy and safety of recombinant adenovirus-p53 gene (Gendicine) therapy combined with radiotherapy for head and neck squamous-cell carcinoma (HNSCC).</p><p><b>METHODS</b>From Oct. 2001 to May 2003, a randomized controlled clinical trial on Gendicine combined with radiation in 36 patients (gene therapy + radiotherapy, GTRT) vs. radiotherapy alone in 33 patients (RT) with HNSCC was completed. In the GTRT group, Gendicine 1 x 10(12) VP (virus particle) was injected intratumorally once a week for eight weeks, and concurrently followed by irradiation. For both groups, the conventional fractionation 2 Gy/f, five fractions a week to a total dose of 70 Gy, was given to either primary tumor or neck lymph nodes. Tumor response was assessed by CT image at 40 Gy, 70 Gy, 2 months after treatment to evaluate the response rate of CR, PR, SD and PD.</p><p><b>RESULTS</b>Wild-type p53 gene significantly enhanced radiotherapeutic effectiveness in patients with HNSCC (P < 0.05). The CR rate of tumors treated by GTRT was increased by nearly 2.31 times more than that of tumors treated by RT alone. No dose-limiting toxicity and adverse events were noted, except transient fever after Gendicine administration.</p><p><b>CONCLUSION</b>Intratumoral injection of Gendicine to HNSCC patients is safe and effective. The apparent improved results of combined therapy with Gendicine and radiation suggest that p53 gene therapy has promising therapeutic potential in cancer treatment.</p>