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曲妥珠单抗-美坦新共轭复合物治疗HER-2阳性乳腺癌有效性和安全性的系统评价 被引量:4

Efficacy and safety of tratuzumab-emtansine in treatment of HER-2 positive breast cancer: a systematic review
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摘要 目的系统评价曲妥珠单抗-美坦新共轭复合物(T-DM1)治疗人表皮生长因子受体2(HER-2)阳性乳腺癌的有效性和安全性。方法计算机检索PubMed、Embase、Cochrane Library、中国生物医学文献数据库、中国知网、万方数字化期刊全文数据库、维普数据库于2019年4月10日前发表的关于T-DM1的文献。两名研究者根据纳入排除标准独立筛选文献后提取资料并评价质量。使用RevMan 5.1进行Meta分析。结果共纳入7项随机对照研究,合计4310例患者,治疗组2439例,对照组1871例。分析结果显示,与对照组相比,T-DM1组总生存期(OS)显著延长(HR=0.70,95%CI:0.65~0.76,P<0.00001);亚组分析显示T-DM1在用作一线治疗(HR=0.87,95%CI:0.77~0.98,P=0.03)或非一线治疗(HR=0.60,95%CI:0.53~0.69,P<0.00001)时无进展生存期(PFS)均显著延长。安全性方面,2组总不良事件发生率无显著差异(RR=1.00,95%CI:0.98~1.02,P=0.97),但≥3级不良事件发生率T-DM1组显著低于对照组(RR=0.78,95%CI:0.68~0.89,P=0.0002)。结论与其他抗HER-2治疗相比,T-DM1可显著改善HER-2阳性乳腺癌患者的预后,严重不良事件发生率低,可作为替代治疗方案用于HER-2阳性晚期乳腺癌患者。 AIM To systematically evaluate the efficacy and safety of tratuzumab-emtansine(T-DM1) in treatment of human epidermal growth factor receptor 2(HER-2)-positive breast cancer. METHODS The database including PubMed, Embase, Cochrane Library, CBM, CNKI, Wanfang and VIP database were electronically searched from their inception to April 10, 2019 to collect the studies about T-DM1. According to the inclusion and exclusion criteria, two reviewers screened the literatures independently, extracted data and assessed methodological quality. The meta-analysis was performed using RevMan 5.1 software. RESULTS A total of 7 randomized controlled trials involving 4 310 patients were included, 2 439 patients in the T-DM1 group and 1 871 patients in the control group. The meta-analysis showed that compared with control group, the overall survival(OS) of T-DM1 group was significantly prolonged(HR = 0.70, 95%CI: 0.65 to 0.76, P < 0.000 01). Subgroup analysis indicated that T-DM1 significantly improved progression-free survival(PFS) when it was used as first-line(HR = 0.87, 95%CI: 0.77 to 0.98, P = 0.03) or non-first-line treatment(HR = 0.60, 95%CI: 0.53 to 0.69, P < 0.000 01). In terms of safety, there was no statistical difference in the incidence of all-grade adverse events(RR = 1.00, 95%CI: 0.98 to 1.02, P = 0.97) between the T-DM1 group and the control group, whereas the incidence of adverse events grade ≥ 3 was marked lower in TDM1 group(RR = 0.78, 95%CI: 0.68 to 0.89, P = 0.000 2). CONCLUSION Compared with other anti-HER-2 therapies, T-DM1 can significantly improve the prognosis in patients with HER-2 positive breast cancer and reduce the incidence of severe adverse events, and it can be used as an alternate treatment option in patients with HER2 positive advanced breast cancer.
作者 郭一萌 杨静 严虹霞 郝志英 GUO Yi-meng;YANG Jing;YAN Hong-xia;HAO Zhi-ying(Department of Pharmacy,Shanxi Cancer Hospital,Taiyuan SHANXI 030013,China)
出处 《中国新药与临床杂志》 CAS CSCD 北大核心 2020年第4期247-252,共6页 Chinese Journal of New Drugs and Clinical Remedies
基金 山西省重点研发计划(指南)项目(201603D321105)。
关键词 曲妥珠单抗-美坦新共轭复合物 受体 表皮生长因子 乳腺肿瘤 Meta分析 tratuzumab-emtansine receptor,epidermal growth factor breast neoplasms meta-analysis
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