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[摘要]
目的:探讨重组人p53腺病毒注射液(rAd-p53)联合静脉化疗对复发性上皮性卵巢癌(recurrent epithelial ovarian carcinoma,REOC)的临床疗效。方法:选取甘肃省妇幼保健院妇产科2007年7月至2011年12月住院的49例REOC患者,其中25例在静脉化疗基础上加用rAd-p53治疗(联合组),24例单纯进行静脉化疗(化疗组),比较两组患者近期、远期疗效及药物的不良反应。结果:3个疗程治疗后,联合组CA125下降正常率高于化疗组(68.0% vs 33.3%,P=0.02);疾病控制率两组分别为92.0%与87.5%,差异无统计学意义(χ2=1.03,P=0.59)。随访5~41个月(中位时间26个月),两组患者总生存期无明显差异(18.8个月vs 13.9个月,P=0.051)。患者使用rAd-p53未发现严重的不良反应。结论:rAd-p53联合化疗对于复发性REOC患者似乎有一定受益,无明显的不良反应,结果尚需要进一步在临床应用中得以验证。
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[Abstract]
Objective: To evaluate the efficacy of recombinant human adenovirus p53 (rAd-p53) combined with chemotherapy in patients with recurrent epithelial ovarian carcinoma (REOC). Methods: Forty-nine patients with REOC were assigned into a combined-treatment group (n=25) or a mono-chemotherapy group (n=24). Patients in the combined-treatment group underwent chemotherapy plus 2 cycles of rAd-p53 (once a week for 8 weeks), while those in the mono-chemotherapy group received chemotherapy only. Patient outcomes and adverse events were compared between the two groups. Results:The combined-treatment resulted in a significant decrease in CA-125 levels after 3 cycles chemotherapy compared to the monotherapy (P=0.02). There was no significantly difference in the disease control rate (92.0% vs 87.5%, P=0.59), overall survival (39.6 versus 32.5 months, P=0.13) between the two treatment regimens. No serious adverse events were observed in either of the two groups. Conclusion:Patients with REOC may benefit from chemotherapy combined with administration of rAd-p53, without concerns over adverse effects. This benefit needs to be further evaluated in more prospective trials.
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