多柔比星脂质体单药和联合洛铂方案治疗复发卵巢癌的临床研究

目的:评价盐酸多柔比星脂质体单药(PLD)与盐酸多柔比星脂质体联合洛铂治疗复发性卵巢癌的安全性和临床疗效。方法:收集2012年4月至2015年10月我科收治的31例复发晚期上皮性卵巢癌患者,根据患者是否存在铂类耐药分为多柔比星组(单药组)15例及多柔比星+洛铂组(对照组)16例。单药组给盐酸多柔比星脂质体50 mg/m~2,静滴;对照组给盐酸多柔比星脂质体20-30 mg/m~2,洛铂30-50 mg/m~2,静脉滴注,两组每21-28天重复一次,观察和比较两组的临床疗效和毒性反应的发生情况。结果:所有患者完成3-8周期,客观有效率(ORR)为38.7%。单药组为33.3%,对照组为占43.8%,两组ORR比较差异无统计学意义(P=0.411)。单药组骨髓抑制的毒副作用较对照组发生率显著升高高(P=0.019),两组其他毒副反应的发生情况比较差异无统计学意义(P0.05)。单药组和对照组中位生存时间(MST)分别为10个月(95%CI:1.242-18.758)、18个月(95%CI:8.261-27.739),中位无进展生存期(PFS)分别为7个月(95%CI:2.210-13.797)、13个月(95%CI:4.368-21.632),两组MST、PFS比较差异均无统计学意义(P0.277)。结论:聚乙二醇脂质体阿霉素单体或聚乙二醇脂质体阿霉素联合洛铂治疗复发性卵巢癌的疗效相当,而聚乙二醇脂质体阿霉素单体的安全性更高。

A Clinical Study on the Efficacy of Pegylated Liposomal Doxorubicin or Combination of Liposomes and Lobaplatin in the Treatment of Recurrent Ovarian Cancer

ABSTRACT Objective: To evaluate the safety and clinical efficacy of pegylated liposomal doxorubicin(PLD) and lobaplatin in the treatment of patients with recurrent ovarian cancer. Methods: According to platinum resistance level, 31 cases of patients with recurrent advance epithelial ovarian cancer admitted from April 2012 to October 2015 in our department were divided into two groups: 15 patients in the doxorubicin group (single drug group) and 16 patients in the doxorubicin combined with lobaplatin group (control group). The pa- tients in single drug group were given 50 mg/m² pegylated liposomal doxorubicin by intravenous drip. The patients in control group were given 20-30 mg/m² pegylated liposomal doxorubicin and 30-50 mg/m² lobaplatin by intravenous drip. All patients were repeated every 21-28 days. Besides, the clinical efficacy and toxicity of two groups were observed and compared. Results: After 3-8 cycles treatment, the total objective response rate (ORR) was 33.3%, which were 38.7 % and 43.8 % in the single drug group and control group respectively. There was no statistically significant difference in the ORR between two groups (P=0.411). The incidence of myelosuppression in single drug group was significantly higher than that of the control group (P=0.019), and there was no statistically significant difference in the in- cidence of other adverse reactions between two groups (P>0.05). The median survival time (MST) of single drug group and the control group were 10 months (95% CI: 1.242-18.758), 18 months (95% CI: 8.261-27.739), and the median progression free surial (PFS) were 7 months (95% CI: 2.210-13.797), 13 months (95% CI: 4.368-21.632) respectively. The MST, PFS had no statistically significance differ- ence between the two groups (P>0.277). Conclusion: Pegylated Liposomal Azithromycin had equivalent efficacy to combination of Li- posomes with Lobaplatin in the treatment of recurrent ovarian cancer, while the safety of Pegylated Liposomal Azithromycin was higher.