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目的 评价重组人p5 3腺病毒注射液 (rAd p5 3)联合放射线治疗头颈鳞癌的疗效及安全性。方法 自 2 0 0 1年 10月至 2 0 0 2年 9月 ,对 4 2例头颈鳞癌进行了rAd p5 3制剂结合放疗 (基因治疗加放疗 ,GTRT)对比单纯放疗 (单纯放疗 ,RT)的前瞻性随机对照Ⅱ期临床试验。患者被随机地分入结合治疗的GTRT组 (共 2 0例 )和作为对照的RT组 (共 2 2例 )。在GTRT组 ,每周 1次行瘤内注射rAd p5 3制剂 1× 10 1 2 病毒颗粒共 8次 ,同时结合放疗。两组都采用同样的常规放疗方案 ,每次 2Gy ,每周 5次 ,使原发灶和颈部转移淋巴结都达到 70Gy 35f 7～ 8w。观测病人的不良反应、血清抗腺病毒抗体水平和肿瘤变化。以CT对比分析GTRT组和RT组病人在 4 0Gy、70Gy及疗效确认时 (治疗后 2月 )肿瘤即刻反应率。结果 随机对比分析或自身对比分析结果都表明 ,rAd p5 3明显地提高了头颈鳞癌患者放疗的疗效 (P <0 0 5 )。随机对比结果表明 ,rAd p5 3对 4 0Gy放疗的增效倍数为 1 72 ,疗效确认时头颈鳞癌GTRT组CR率比RT组CR率提高 1 6 8倍。自身对比结果表明 ,rAd p5 3对 4 0Gy放疗的增效倍数为 1 6 9,疗效确认时头颈鳞癌GTRT瘤灶的CR率比自身RT瘤灶CR率提高 2 5 3倍。 2 0例头颈鳞癌患者接受多次rAd p5 3瘤内注射 ,除了出现一时性?
Objective To evaluate the efficacy and safety of recombinant human p5 3 adenovirus injection (rAd p5 3) in combination with radiation for the treatment of squamous cell carcinoma of the head and neck. Methods From April 2001 to September 2002, 42 cases of head and neck squamous cell carcinoma were treated with rAd p5 3 in combination with radiotherapy (gene therapy plus radiotherapy, GTRT) compared with radiotherapy (radiotherapy alone, RT) Prospective randomized phase Ⅱ clinical trial. Patients were randomized to receive combined treatment with GTRT (20 in total) and RT (2 in 2) as control. In the GTRT group, 1 × 10 12 viral particles of rAd p5 3 were injected intratumorally once a week for 8 times in combination with radiotherapy. The same routine radiotherapy regimen was used in both groups, with 2 Gy each time, 5 times a week, so that the primary tumor and cervical lymph node metastases reached 70 Gy 35f 7-8w. Adverse reactions observed in patients, serum anti-adenovirus antibody levels and tumor changes. CT contrast analysis of patients in the GTRT group and RT group 4 0Gy, 70Gy and efficacy (2 months after treatment) tumor response rate. Results Random comparison analysis or self-contrast analysis showed that rAd p5 3 significantly improved the curative effect of radiotherapy in patients with head and neck squamous cell carcinoma (P <0.05). Random comparison results showed that the rAd p5 3 4 0Gy radiotherapy efficiency multiples of 1 72, the curative effect of head and neck squamous cell carcinoma GTRT CR rate CR group compared with RT increased by 1 6 8 times. The self-contrast results showed that the rAd p5 3 4 60Gy radiotherapy synergistic multiples of 1 6 9, the curative effect of head and neck squamous cell carcinoma GTRT tumor CR rate than their own RT tumor CR rate increased by 23.5 times. 20 cases of patients with head and neck squamous cell carcinoma received multiple rAd p5 intratumoral injection, in addition to temporary?