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1.四川省肿瘤临床医学研究中心/四川省肿瘤医院研究所/四川省癌症防治中心/电子科技大学附属肿瘤医院药学部,成都 610041
2.哈尔滨医科大学附属肿瘤医院药学部,哈尔滨 150086
主管药师,博士。研究方向:肿瘤个体化药物治疗。电话:028-85420311。E-mail:cyfy1112@163.com
主管药师,博士。研究方向:肿瘤个体化药物治疗。电话:0451-86298399。E-mail:jdyhmu3@163.com
纸质出版日期:2023-05-15,
收稿日期:2023-01-16,
修回日期:2023-02-08,
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陈燕,姜帅.奥拉帕利辅助治疗BRCA1/2突变HER2阴性乳腺癌有效性与安全性的Meta分析 Δ[J].中国药房,2023,34(09):1109-1114.
CHEN Yan,JIANG Shuai.Efficacy and safety of olaparib in adjuvant therapy of BRCA1/2 mutated HER2-negative breast cancer: a meta-analysis[J].ZHONGGUO YAOFANG,2023,34(09):1109-1114.
陈燕,姜帅.奥拉帕利辅助治疗BRCA1/2突变HER2阴性乳腺癌有效性与安全性的Meta分析 Δ[J].中国药房,2023,34(09):1109-1114. DOI: 10.6039/j.issn.1001-0408.2023.09.16.
CHEN Yan,JIANG Shuai.Efficacy and safety of olaparib in adjuvant therapy of BRCA1/2 mutated HER2-negative breast cancer: a meta-analysis[J].ZHONGGUO YAOFANG,2023,34(09):1109-1114. DOI: 10.6039/j.issn.1001-0408.2023.09.16.
目的
2
系统评价奥拉帕利辅助治疗乳腺癌易感基因(
BRCA
)
1/2
突变人表皮生长因子受体2(HER2)阴性乳腺癌的有效性和安全性,为临床治疗提供循证参考。
方法
2
计算机检索中国知网、维普、万方、PubMed、ScienceDirect、the Cochrane Library和Embase数据库,收集奥拉帕利辅助治疗(试验组)对比其他药物辅助治疗(对照组)的随机对照试验。筛选文献、提取数据后,采用RevMan 5.4软件进行Meta分析、发表偏倚分析和敏感性分析。
结果
2
共纳入5项随机对照试验,共计2 633例患者,其中试验组1 459例,对照组1 174例。Meta分析结显示,在有效性方面,与对照组相比,试验组患者的总生存期[HR=1.02,95%CI(1.01,1.03),
P
=0.000 8]和无进展生存期[HR=1.78,95%CI(1.46,2.17),
P
<0.000 01]显著延长。在安全性方面,与对照组相比,试验组患者的任何级别不良反应发生率更高[RR=1.41,95%CI(1.12,1.78),
P
=0.004],而两组患者的3级以上不良反应发生率比较差异无统计学意义[RR=1.75,95%CI(0.82,3.74),
P
=0.15]。发表偏倚结果显示,本研究存在发表偏倚的可能性较小。敏感性分析结果显示,本研究所得结果稳健。
结论
2
与非奥拉帕利辅助治疗的患者相比,奥拉帕利辅助治疗
BRCA1/2
突变HER2阴性乳腺癌可延长患者的总生存期和无进展生存期,但不良反应发生风险相对较高。
OBJECTIVE
2
To systematically evaluate the efficacy and safety of olaparib in adjuvant therapy of breast cancer susceptibility gene (
BRCA
)
1/2
mutated human epidermal growth factor receptor 2 (HER2)-negative breast cancer, and to provide evidence-based reference for clinical treatment.
METHODS
2
Retrieved from CNKI, VIP, Wanfang data, PubMed, ScienceDirect, the Cochrane Library and Embase databases, randomized controlled trials about adjuvant therapy of olaparib (trial group) versus adjuvant therapy of other drugs (control group) were collected. After literature screening and data extraction, meta-analysis, publication bias analysis and sensitivity analysis were performed by using RevMan5.4 software.
RESULTS
2
A total of 5 randomized controlled trials were included, with a total of 2 633 patients, including 1 495 cases in trial group and 1 174 cases in control group. Meta-analysis showed that in terms of efficacy, compared with control group, overall survival [HR=1.02, 95%CI (1.01,1.03),
P
=0.000 8] and progression-free survival [HR=1.78, 95%CI(1.46,2.17),
P
<0.000 01] were longer significantly in the trial group. In terms of safety, compared with the control group, the incidence of adverse drug reactions at any level in the trial group was higher [RR=1.41, 95%CI (1.12, 1.78),
P
=0.004], while there was no statistically significant difference in the incidence of adverse drug reactions above level 3 between the two groups [RR=1.75, 95%CI (0.82, 3.74),
P
=0.15]. The results of publication bias indicated that the possibility of publication bias in this study was relatively low. The results of sensitivity analysis showed that the results obtained in this study were robust.
CONCLUSIONS
2
Compared with patients without adjuvant therapy of olaparib, adjuvant therapy of olaparib can prolong overall survival and progression-free survival of patients with
BRCA1/2
mutated HER2-negative breast cancer, but the risk of adverse drug reactions is relatively high.
奥拉帕利乳腺癌易感基因人表皮生长因子受体2乳腺癌有效性安全性
breast cancer susceptibility genehuman epidermal growth factor receptor 2breast cancerefficacysafety
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