同步放化疗联合rhAd-p53治疗局部进展期宫颈癌的疗效观察

目的 探讨放化疗联合腺病毒重组人p53注射液在局部进展期宫颈癌（LACC）中的近远期疗效。方法 采用简单随机分组方法将51例LACC（ⅡA~ⅣA期）患者分为实验组（RCT-p53）24例和对照组（RCT）27例。实验组患者接受rhAd-p53注射液同步放化疗，对照组患者未接受rhAd-p53注射液治疗，放化疗方法同实验组。疗效评价包括近期疗效、远期疗效和早期不良反应。结果 RCT-p53组的客观缓解率（ORR）为91.7%，RCT组的ORR为62.9%（P=0.037）；两组的完全缓解（CR）率分别为66.7%和40.7%。两组的早期血液学毒性、消化道反应和肝肾功能损伤等不良反应率的差异均无统计学意义。RCT-p53和RCT组的5年无进展生存率（PFS）分别为79.8%和51.3%（P=0.028）。5年生存率（OS）分别为81.6%和60.3%（P=0.061）。结论 与同步放化疗相比，加入rhAd-p53治疗有更高的近期疗效和良好的远期生存获益，且不会增加早期不良反应。

Efficacy of Concurrent Chemoradiotherapy Combined with rhAd-p53 on LocallyAdvanced Cervical Cancer

Objective To analyze the short- and long-term effect of chemoradiotherapy combined with rhAd-p53 on locally advanced cervical cancer (LACC). Methods A total of 51 patients with stage ⅡA-ⅣA LACC were divided into experimental group (chemoradiotherapy+rhAd-p53 gene therapy, RCT-p53) and control group (chemoradiotherapy, RCT). Short-term effect, long-term effect and early side-effect were evaluated. Results ORR of RCT-p53 group and RCT group were 91.7% and 62.9%, respectively (P=0.037); CR rates were 66.7% and 40.7%, respectively. There was no significant difference of early side-effects between two groups, in terms of hematologic toxicity, digestive toxicity, hepatotoxicity or renal toxicity. Fiveyear PFS of RCT-p53 group and RCT group were 79.8% and 51.3%, respectively (P=0.028); 5-year OS were 81.6% and 60.3%, respectively (P=0.061). Conclusion rhAd-p53 treatment has better short-term effect and long-term effect than concurrent chemoradiotherapy, without increasing early side effects.