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曲妥珠单抗联合或不联合治疗对 HER2 阳性乳腺癌的疗效和安全性:一项荟萃分析。

Efficacy and safety of treatment with or without pertuzumab for HER2-positive breast cancer: A meta-analysis.

机构信息

Department of Thoracic Surgery, The People's Hospital of Wenchang, Hainan, China.

Department of Orthopaedic Surgery, Graduate School of Medicine, Tohoku University, Sendai, Japan.

出版信息

Medicine (Baltimore). 2023 Jun 2;102(22):e33925. doi: 10.1097/MD.0000000000033925.

Abstract

BACKGROUND

We conducted a meta-analysis to systematically evaluate the efficacy and safety of treatment with or without pertuzumab for human epidermal growth factor receptor-2 -positive (HER2)-positive breast cancer and provided evidence-based reference for clinical use.

METHODS

The Cochrane Library, PubMed, EMbase, Clinical Trials and Web of Science databases were searched for studies published up to July 2022, which reported clinical randomized controlled trials of treatment in combination with pertuzumab (experimental group) and without pertuzumab (control group) for HER2-positive breast cancer. Meta-analysis was performed using R 4.2.1 based on the extraction of the data and the risk of bias assessment under the supervision of the Cochrane Handbook for Systematic Reviews of Interventions 5.1.0.

RESULTS

The results from this study showed that, the patients in the experimental group showed prolonged progression-free survival [hazard ratio = 0.72, 95% confidence interval (CI) (0.65,0.80), P < .01] and overall survival [hazard ratio = 0.80, 95% CI (0.66,0.96), P = .02] than those in the control group. In terms of safety, the incidence of grade ≥ 3 adverse events including diarrhea [risk ratio (RR) = 2.36, 95% CI (1.98,2.81), P < .01] and anemia [RR = 1.43, 95% CI (1.17,1.75), P < .01] in the experimental group were significantly higher than those in the control group. The incidence of common adverse events, that is rash in the experimental group was significantly higher than that in the control group [RR = 1.62, 95% CI (1.38,1.90), P < .01].

CONCLUSION

These results support that the treatment in combination with pertuzumab is superior to the treatment in combination without pertuzumab in the treatment of HER2-positive breast cancer, but there are some adverse effects such as diarrhea, anemia, and rash, which should be carefully monitored in clinical practice.

摘要

背景

我们进行了一项荟萃分析,系统地评估了曲妥珠单抗联合或不联合治疗对人表皮生长因子受体-2 阳性(HER2 阳性)乳腺癌的疗效和安全性,并为临床应用提供了循证参考。

方法

检索 Cochrane 图书馆、PubMed、EMbase、临床试验和 Web of Science 数据库,检索截至 2022 年 7 月发表的报告曲妥珠单抗联合(实验组)和不联合(对照组)治疗 HER2 阳性乳腺癌的临床随机对照试验的研究。在 Cochrane 干预系统评价手册 5.1.0 的监督下,基于数据提取和偏倚风险评估,使用 R 4.2.1 进行荟萃分析。

结果

本研究结果表明,实验组患者无进展生存期[风险比=0.72,95%置信区间(CI)(0.65,0.80),P<.01]和总生存期[风险比=0.80,95%CI(0.66,0.96),P=0.02]均长于对照组。安全性方面,实验组中腹泻[风险比(RR)=2.36,95%CI(1.98,2.81),P<.01]和贫血[RR=1.43,95%CI(1.17,1.75),P<.01]等≥3 级不良事件发生率明显高于对照组。实验组常见不良事件,即皮疹发生率明显高于对照组[RR=1.62,95%CI(1.38,1.90),P<.01]。

结论

这些结果支持曲妥珠单抗联合治疗在治疗 HER2 阳性乳腺癌方面优于曲妥珠单抗联合治疗,但存在腹泻、贫血、皮疹等不良反应,临床实践中应密切监测。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2ac3/10237690/1f158bd76806/medi-102-e33925-g001.jpg

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