【摘要】 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。更多还原

【Abstract】 Objective To evaluate the efficacy and safety of recombinant adenovirus-p53 gene (Gendicine) therapy combined with radiotherapy for head and neck squamous-cell carcinoma (HNSCC). Methods 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 1×10 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. Results 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. Conclusion 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.更多还原