重组人p53腺病毒在晚期卵巢癌治疗中临床疗效及安全性评价

Efficacy and safety of recombinant human adenovirus p53 in patients with advanced ovarian cancer

目的:探讨重组人p53腺病毒注射液(rAd p53)联合TP/TC静脉化疗方案在晚期卵巢癌患者中的应用价值。方法:47例晚期卵巢癌术后患者,25例对照组患者单纯接受3周一次的TP/TC静脉化疗,共6-8疗程;22例实验组患者在化疗基础上加用2疗程rAd p53,比较2组患者近期、远期疗效及药物的安全性。结果:实验组CA125下降曲线显于对照组(P=0.037);实验组无瘤生存期优于对照组(30.4个月vs 21.5个月,P=0.012);临床缓解率两组无差异(68.2%vs 48.0%,P=0.135);总生存期无差异(39.6个月vs 32.5个月,P=0.13)。未发现rAd p53的严重不良反应。结论:rAd p53对于晚期卵巢癌患者的治疗有积极的作用,可以被很好的耐受,但结果尚需要进一步在临床应用中得以验证。

Objective： To evaluate the efficacy and safety of recombinant human adenovirus p53 injection （rAd p53 ） in patients with advanced ovarian cancer. Methods：All 47 cases with advanced ovarian cancer were randomly assigned into 2 groups ：25 cases in the control group received 6 -8 cycles of combination chemotherapy（ TP/TC, Carboplatin 0.4 -0.6/AUC or cisplatin 75mg/m^2 plus paclitaxel 175mg/m^2 or docetaxel 75mg/m^2 ） ,22 cases in the experimental group received chemotherapy plus 2 cycles rAd 1353 （ once a week for 8 weeks ）. The clinical response, CA125 decline trends, PFS and OS were compared between two groups. Results：The experimental group was associated with obvious decrease in CA125 level after 2 cycles chemotherapy（ P = 0. 037 ）, and significant improvements in median progression free survival（PFS） （ 30.4 versus 21.5months, P = 0. 012 ） compared to the control group. There was no significantly difference in clinical complete responses（CR） （68.2% versus 48.0% , P=0. 135 ）, overall survival（OS） （39.6 versus 32.5 months,P = 0.13 ） between the two groups. No serious adverse reactions of rAd p53 were found. Conclusion： Combination treatment with chemotherapy and rAd p53 has activity in advanced ovarian cancer and is well tolerated. Prospective trials are needed to further characterize the role of this regimen in the treatment of advanced ovarian cancer.