首页|德曲妥珠单抗治疗乳腺癌有效性和安全性的Meta分析

德曲妥珠单抗治疗乳腺癌有效性和安全性的Meta分析

扫码查看
目的 系统评价德曲妥珠单抗(T-Dxd)治疗乳腺癌的有效性和安全性。方法 计算机检索 PubMed、Cochrane Library、Embase、Web of Science、SinoMed、CNKI、WanFang Data、VIP数据库,搜集T-Dxd(试验组)对比化疗药物或其他抗肿瘤药物(对照组)的随机对照试验(RCT),检索时限均从建库至2024年2月15日。由2名研究者独立筛选文献、提取资料并评价纳入研究的偏倚风险后,采用RevMan 5。3。1软件进行Meta分析。结果 共纳入3个RCT,包括1 689例患者。Meta分析结果显示,试验组患者的无进展生存期(PFS)[HR=0。37,95%CI(0。27,0。51),P<0。001]、总生存期(OS)[HR=0。63,95%CI(0。53,0。75),P<0。001]以及客观缓解率(ORR)[RR=2。52,95%CI(2。21,2。88),P<0。001]均显著长于或高于对照组。试验组药物相关间质性肺病[RR=10。82,95%CI(4。83,24。23),P<0。001]及射血分数降低[RR=5。05,95%CI(1。91,13。33),P=0。001]的发生率均显著高于对照组。进一步依据激素受体表达(阳性和阴性)、脑转移发生情况(发生和未发生)的不同进行亚组分析,结果显示,试验组患者的PFS均显著长于对照组(P<0。001)。敏感性分析结果显示,以PFS、OS、ORR为指标时,所得结果均较稳健。结论 当前证据表明,与化疗药物或其他抗肿瘤药物相比,T-Dxd治疗乳腺癌可延长的PFS和OS、提高ORR,但可能会增加间质性肺病及射血分数降低的发生风险。受纳入研究数量和质量的限制,上述结论尚需开展更多高质量的研究予以验证。
Efficacy and safety of trastuzumab deruxtecan in the treatment of breast cancer:a Meta-analysis
Objective To systematically evaluate the efficacy and safety of trastuzumab deruxtecan(T-Dxd)in the treatment of breast cancer.Methods PubMed,Cochrane Library,Embase,Web of Science,SinoMed,CNKI,WanFang Data,and VIP databases were electronically searched to collect randomized controlled trials(RCTs)of T-Dxd(test group)versus chemotherapeutic agents or other antineoplastic agents(control group)from inception to February 15,2024.Two reviewers independently screened the literature,extracted data,and assessed the risk of bias in the included studies.Meta-analysis was performed by using RevMan 5.3.1 software.Results A total of 3 RCTs involving 1 689 patients were included.The results of the Meta-analysis indicated that the progression-free survival(PFS)(HR=0.37,95%CI 0.27 to 0.51,P<0.001),overall survival(OS)(HR=0.63,95%CI 0.53 to 0.75,P<0.001),and objective response rate(ORR)(RR=2.52,95%CI 2.21 to 2.88,P<0.001)in the test group were significantly superior to or higher than those of the control group.The incidence of drug-related interstitial lung disease(RR=10.82,95%CI 4.83 to 24.23,P<0.001)and reduced ejection fraction(RR=5.05,95%CI 1.91 to 13.33,P=0.001)was significantly higher in patients in the test group than in the control group.Subgroup analysis showed that hormone receptor-positive and hormone receptor-negativity,brain metastasis,and no brain metastasis patients who received T-Dxd had longer PFS(P<0.001).The results of sensitivity analysis showed that the results obtained were more robust when PFS,OS,and ORR were used as indicators.Conclusion Current evidence suggests that T-Dxd can prolong PFS and OS and improve ORR in breast cancer than chemotherapeutic agents or other antineoplastic agents,however,it may increase the risk of interstitial lung disease and reduce ejection fraction.Due to the limited quality and quantity of the included studies,more high-quality studies are needed to verify the above conclusion.

Trastuzumab deruxtecanAntibody drug conjugatesBreast cancerEfficacySafetyMeta-analysisRandomized controlled trial

张晓青、刘帅、张凯、栾巍

展开 >

内蒙古医科大学研究生院(呼和浩特 010050)

内蒙古自治区人民医院肿瘤内科(呼和浩特 010017)

德曲妥珠单抗 抗体药物偶联物 乳腺癌 有效性 安全性 Meta分析 随机对照试验

2024

药物流行病学杂志
中国药学会 武汉医药(集团)股份有限公司

药物流行病学杂志

CSTPCD
影响因子:0.746
ISSN:1005-0698
年,卷(期):2024.33(5)