奥拉帕尼维持疗法对复发性浆液性卵巢癌的疗效及安全性Meta分析

Therapeutic Effects and Safety of Olaparib on Treatment of Recurrent Serosity Ovarian Cancer: a Meta-analysis

目的：评价奥拉帕尼维持疗法治疗复发性浆液性卵巢癌的疗效及安全性。方法：采用计算机检索Cochrane图书馆、Pub Med、Embase、ASCO、中国生物医学文献数据库、中国期刊全文数据库、万方数据库中从建库至2015年6月30日关于奥拉帕尼维持疗法治疗复发性浆液性卵巢癌的临床随机对照试验。由两名评价者独立按Cochrane系统评价手册5.1版推荐的RCT标准评价纳入研究的质量,并采用Cochrane协作网提供的Rev Man5.3软件进行Meta分析,无进展生存期（progression free survival,PFS）及总生存期（overall survival,OS）合并统计量为风险比（hazard ratio,HR）,不良反应合并统计量为相对危险度（relative risk,RR）。结果：纳入3项Ⅱ期临床随机对照试验共523例患者。Meta分析结果显示,与对照组相比较,奥拉帕尼维持疗法能够改善患者的PFS（HR=0.50,95%CI=0.32-0.80）,尤其对于BRCA突变患者（HR=0.32,95%CI=0.11-0.94）。但在OS（HR=0.89,95%CI=0.55-1.43;HR=0.99,95%CI=0.78-1.25）上未显示明显优势。安全性分析显示,奥拉帕尼较常见的不良反应为恶心、呕吐、腹痛、便秘及贫血等,但多数为1-2级不良反应,耐受性较好。结论：目前证据表明,奥拉帕尼维持疗法能够改善复发性浆液性卵巢癌患者的无进展生存期,但是否延长总生存期,目前证据不充分,尚需进一步开展大规模、高质量的临床研究进行证实。

Objective To evaluate the efficacy and safety of Olaparib maintenance therapy in patients with recurrent serosity ovarian cancer.Methods We searched the Cochrane Library,Pub Med,Embase,ASCO,CBM,CNKI and Wanfang datebases for studies published from beginning to June 2015 that evaluated the efficacy and safety of Olaparib in patients with recurrent serosity ovarian cancer.Two reviewiers independently retrieved clinical controlled trails according to the inclusion and exclusion criteria,assessed the methodological quality of included trials,and extracted data.Meta analysis was performed by Rev Man 5.3 software.The complicated statistic of progression free survival（ PFS） and overall survival（ OS） was hazard ratio（ HR）.The complicated statistic of adverse reaction was relative risk（ RR）.Results Three phase Ⅱ random clinical trails（ RCTs） including 523 patients were ultimately included.The meta-analysis demonstrated that Olaparib maintenance therapy significantly improved progression-free survival（ HR = 0.50,95%CI = 0.32 - 0.80）,especially in patients with BRCA mutations（ HR = 0.32,95%CI = 0.11 - 0.94）,and had an acceptable and manageable tolerability profile,but had no significant advantage on OS（ HR = 0.89,95%CI = 0.55 - 1. 43; HR = 0. 99,95% CI = 0. 78 - 1. 25）. The safety study of Olaparib showed that the common adverse reactions including nausea,emesis,abdominal pain,constipation and anemia with 1 or 2 degree.Conclusion Current evidences demonstrated that Olaparib maintenance therapy could prolong the PFS of patients with recurrent serosity ovarian cancer,but whether prolong the OS had not yet been confirmed,which will need more extensive,high quality research.