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1.大连理工大学附属肿瘤医院/辽宁省肿瘤医院药学部,沈阳 110042
2.沈阳药科大学生命科学与生物制药学院,沈阳 110016
副主任药师,硕士。研究方向:临床药学、抗肿瘤药系统评价。E-mail:keliyuan1990@126.com
副主任药师,硕士。研究方向:抗肿瘤药系统评价、临床药品综合评价。E-mail:huangdanxue@163.com
收稿:2025-07-17,
修回:2025-08-13,
录用:2025-10-11,
纸质出版:2025-11-15
移动端阅览
柯力援,吕欣,黎苏,等.HER2阳性晚期胃癌一线干预方案的网状Meta分析[J].中国药房,2025,36(21):2727-2732.
KE Liyuan,LYU Xin,LI Su,et al.Network meta-analysis of first-line treatment regimens for HER2-positive advanced gastric cancer[J].ZHONGGUO YAOFANG,2025,36(21):2727-2732.
柯力援,吕欣,黎苏,等.HER2阳性晚期胃癌一线干预方案的网状Meta分析[J].中国药房,2025,36(21):2727-2732. DOI: 10.6039/j.issn.1001-0408.2025.21.19.
KE Liyuan,LYU Xin,LI Su,et al.Network meta-analysis of first-line treatment regimens for HER2-positive advanced gastric cancer[J].ZHONGGUO YAOFANG,2025,36(21):2727-2732. DOI: 10.6039/j.issn.1001-0408.2025.21.19.
目的
2
评价人表皮生长因子受体2(HER2)阳性晚期胃癌一线干预方案的有效性及安全性。
方法
2
计算机检索Web of Science、Embase、中国知网、维普等中英文数据库,并筛选欧洲肿瘤内科学会和美国临床肿瘤学会年会论文摘要,收集有关HER2阳性晚期不可切除或转移性胃癌或胃食管交界处腺癌患者一线干预的随机对照试验(RCT),检索时限从建库起至2025年4月1日。由2名研究者独立筛选文献、提取资料并评价研究的偏倚风险后进行网状Meta分析。
结果
2
最终纳入5篇RCT,共2 797例患者,涉及6种干预方案。在总生存期评估中,曲妥珠单抗联合化疗(Tra_chemo)、帕妥珠单抗联合曲妥珠单抗联合化疗(Per_Tra_chemo)、高剂量曲妥珠单抗联合化疗(TraHD_chemo)、拉帕替尼联合化疗(Lap_chemo)、帕博利珠单抗联合曲妥珠单抗联合化疗(Pem_Tra_chemo)与单纯化疗(chemo)相比较有生存获益趋势,但差异无统计学意义(
P
>0.05),累积排名曲线下面积的百分比(SUCRA)排名前2位的是Pem_Tra_chemo(77.8%)、TraHD_chemo(74.2%)。在无进展生存期方面,Per_Tra_chemo和Pem_Tra_chemo与chemo相比差异有统计学意义(
P
<0.05
)
,SUCRA排名前2位的是Per_Tra_chemo(83.0%)和Pem_Tra_chemo(82.8%)。在客观缓解率方面,Pem_Tra_chemo与chemo相比差异有统计学意义(
P
<0.05),SUCRA排名前2位的是Pem_Tra_chemo(87.4%)、Per_Tra_chemo(72.2%)。在安全性方面,Lap_chemo与chemo相比,任意级别不良事件发生率差异有统计
学意义(
P
<0.05),SUCRA排名前2位的是chemo(87.1%)、Pem_Tra_chemo(53.8%);Lap_chemo较chemo、Per_Tra_chemo较Tra_chemo具有更高的≥3级不良事件发生率(
P
<0.05),SUCRA排名前2位的是Tra_chemo(79.0%)、chemo(77.6%)。
结论
2
在HER2阳性晚期胃癌一线干预方案中,Pem_Tra_chemo和Per_Tra_chemo方案的疗效相对较好,但是安全性风险较高,需要密切关注和全程化管理。
OBJECTIVE
2
To evaluate the efficacy and safety of first-line treatments regimens for human epidermal growth factor receptor 2 (HER2)-positive advanced gastric cancer.
METHODS
2
Computer searches were conducted on databases such as Web of Science, Embase, CNKI, and VIP in both Chinese and English, and abstracts of papers from the annual meetings of the European Society of Oncology and the American Society of Clinical Oncology were screened. Collected randomized controlled trials (RCTs) on first-line treatment for HER2-positive advanced unresectable or metastatic gastric cancer or gastroesophageal junction adenocarcinoma patients, with a retrieval period from database establishment until April 1, 2025. A network meta-analysis was conducted by two researchers who independently screened literature, extracted data, and evaluated the risk of bias in the study.
RESULTS
2
A total of 5 RCTs involving 2 797 patients and encompassing 6 treatment regimens were ultimately included. In the assessment of overall survival, there was a trend towards survival benefit for trastuzumab combined with chemotherapy (Tra_chemo), pertuzumab combined with trastuzumab and chemotherapy (Per_Tra_chemo), high-dose trastuzumab combined with chemotherapy (TraHD_chemo), lapatinib combined with chemotherapy (Lap_chemo), and pembrolizumab combined with trastuzumab and chemotherapy (Pem_Tra_chemo) compared to chemotherapy alone (chemo); however, the differences were not statistically significant (
P
>0.05); the top two treatment regimens in terms of the surface under the cumu
lative ranking curve (SUCRA) were Pem_Tra_chemo (77.8%) and TraHD_chemo (74.2%). For progression-free survival, there was statistical significance between Per_Tra_chemo and chemo, Pem_Tra_chemo and chemo (
P
<0.05); the top two treatment regimens in terms of SUCRA were Per_Tra_chemo (83.0%) and Pem_Tra_chemo (82.8%). Regarding objective response rate, there was statistical significance between Pem_Tra_chemo and chemo (
P
<0.05); the top two treatment regimens in terms of SUCRA were Pem_Tra_chemo(87.4%)and Per_Tra_chemo(72.2%). In terms of safety, there was statistical significance in the incidence of any level of adverse events between Lap_chemo and chemo (
P
<0.05); the top two treatment regimens in terms of SUCRA were chemo(87.1%)and Pem_Tra_chemo(53.8%). Lap_chemo exhibited a higher incidence of grade ≥3 adverse events compared to chemo, and Per_Tra_chemo showed a higher incidence compared to Tra_chemo (
P
<0.05); the top two treatment regimens in terms of SUCRA were Tra_chemo (79.0%) and chemo (77.6%).
CONCLUSIONS
2
In the first-line treatment of HER2-positive advanced gastric cancer, Pem_Tra_chemo and Per_Tra_chemo regimens have relatively good efficacy, but the safety risks are relatively high, requiring close attention and whole-process management.
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