食管癌内镜下注射重组人p53腺病毒联合化疗的临床疗效观察

The efficacy of a therapeutic modality combining human recombinant p53 adenovirus with chemo therapy against middle or late stage esophageal cancer

目的评价重组人p53(rAd-p53)腺病毒注射液联合化疗治疗中晚期食管癌的疗效观察。方法对30例食管癌患者进行了rAd-p53内镜下注射联合化疗(基因治疗联合化疗,GTCT组)与30例食管癌单纯化疗(单纯化疗,CT组)的对照临床观察。在GTCT组,每周1次行内镜下注射rAd-p53制剂1×1012 VP/支共4次,同时结合化疗,口服替吉奥胶囊50mg,口服,2次/d,d1-14×4。两组所用的化疗方案相同。结果 GTCT组和CT组治疗4、8、12周后有效率(完全缓解+部分缓解)分别63%、77%、80%和33%、37%、39%,差异有统计学意义(P<0.01)。GTCT组在治疗过程中有24例出现自限性发热,其他无明显不良反应。结论 rAd-p53联合化疗治疗食管癌有较好疗效,临床使用安全,不良反应轻微。

Objective To assess the efficacy of a therapeutic modality combining human recombinant p53 adenovirus （rAd- p53） with chemo-therapy against middle or late stage esophageal cancer. Methods Sixty patients with esophageal cancer were re- cruited and randomly treated with endoscopic rAd-p53 gene therapy and chemo therapy （GTCT group, 30 participants）, or only chemo therapy （CT group, 30 ones）. The CT patients were treated with S 1 capsule 50 mg, twice a day （dl-14 ×4）. The GTCT pa- tients were given endoscopic intratumor injection of 1 × 10^12 VP/single rAd p53 for four weeks （once a week） as well as the same schedule of chemo therapy. Results The response rates （including complete response and partial response） were 63%, 77%, and 80% for GTCT patients,and 33% ,37%,and 39% for CT ones at 4th,8th,or 12th weeks respectively. Although self limiting fever was observed in 24 GTCT patients,no other significant side effect was observed in this group. Conclusion Combination therapy u- sing rAd-p53 and chemo therapy is effective,safe and has minimal side effect for patients with esophageal cancers.