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目的评价重组人p53腺病毒注射液结合放射治疗头颈鳞癌(HNSCC)的疗效及安全性。方法基因治疗加放疗(GTRT)组36例HNSCC患者,重组人p53腺病毒注射液每周1次瘤内注射1×1012病毒颗粒,共8周,并结合放射治疗;单纯放疗(RT)组33例HNSCC患者,仅行单纯放疗。两组采用同样的常规分次放疗,每次2Gy,每周5次,使原发灶和颈部转移淋巴结均达到70Gy照射剂量。治疗第5周(40Gy)、第8周(70Gy)及疗后2个月(疗效确认)时,用CT图像评定肿瘤变化,进行疗效评价。结果野生型p53基因明显提高了HNSCC放疗的疗效,疗效确认时,GTRT组瘤灶完全缓解(CR)率为64.3%,比RT组提高了2.3倍。除一过性发热外,未发现其他剂量限制性毒性和不良反应。结论HNSCC患者瘤内注射重组人p53腺病毒是安全而有效的,有明显的放射增敏作用。
Objective To evaluate the efficacy and safety of recombinant adenovirus p53 combined with radiotherapy for head and neck squamous cell carcinoma (HNSCC). Methods Thirty-six patients with HNSCC were treated with GTRT. The recombinant adenovirus was inoculated intraperitoneally with 1 × 10 12 virus particles weekly for 8 weeks in combination with radiation therapy. Radiotherapy (RT) group 33 Cases of HNSCC patients, only a simple radiotherapy. Two groups using the same conventional fractionated radiotherapy, each 2Gy, 5 times a week, so that the primary tumor and neck metastases reached 70 Gy irradiation dose. At the fifth week (40 Gy), the eighth week (70 Gy), and the second month after the treatment (confirmation of the curative effect), the CT images were used to evaluate tumor changes to evaluate the therapeutic effect. Results The wild-type p53 gene significantly improved the efficacy of HNSCC radiotherapy. The complete remission (CR) rate was 64.3% in GTRT group, which was 2.3 times higher than that in RT group. In addition to a transient fever, no other dose-limiting toxicities and adverse reactions were found. Conclusion Intratumoral injection of recombinant human p53 adenovirus in HNSCC patients is safe and effective, with obvious radiosensitization effect.