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帕妥珠单抗在实体瘤患者中的安全性和疗效评估。

Safety and efficacy evaluation of pertuzumab in patients with solid tumors.

作者信息

Zhu Chenjing, Ling Wenwu, Zhang Jing, Gao Hui, Shen Kai, Ma Xuelei

机构信息

State Key Laboratory of Biotherapy and Cancer Center, West China Hospital, Sichuan University, and Collaborative Innovation Center for Biotherapy West China Hospital, Sichuan University, Chengdu, Sichuan, China.

出版信息

Medicine (Baltimore). 2017 May;96(20):e6870. doi: 10.1097/MD.0000000000006870.

Abstract

BACKGROUND

The development of targeted therapies benefits patients with certain markers in the treatment of breast cancer. Pertuzumab is a novel humanized monoclonal antibody that blocks human epidermal growth factor receptor 2 (HER2) dimerization. The Food and Drug Administration has approved pertuzumab in combination with trastuzumab and docetaxel for the treatment of patients with HER2-positive metastatic breast cancer.

METHODS

To assess the safety and efficacy profile of pertuzumab, we searched PubMed and Embase (articles from January 1966 to January 2015) using the keyword "pertuzumab".

RESULTS

Fourteen eligible studies were included in our final analysis. From the results of our analysis, diarrhea (56.9%, 95% confidence interval [CI] 49.6%-63.9%), nausea (34.0%, 95% CI 27.7%-40.8%), and rash (25.6%, 95% CI 20.8%-31.0%) were the most common adverse effects in pertuzumab alone and pertuzumab-based therapies. Based on randomized controlled clinical trials, diarrhea (odds ratio [OR] 2.310, 95% CI 1.818-2.936), rash (OR 1.848, 95% CI 1.094-3.122), and febrile neutropenia (OR 1.672, 95% CI 1.130-2.474) were of statistical significance, which meant that pertuzumab played a prominent role in the incidence of diarrhea. Meanwhile, pertuzumab showed its effective role in cancer control and lifetime prolongation.

CONCLUSION

In conclusion, considering that the common adverse effects for pertuzumab are gastrointestinal and skin toxicities, which are easier to handle than other toxicities, pertuzumab is a safe and effective drug for patients with solid tumors.

摘要

背景

靶向治疗的发展使乳腺癌治疗中有特定标志物的患者受益。帕妥珠单抗是一种新型人源化单克隆抗体,可阻断人表皮生长因子受体2(HER2)二聚化。美国食品药品监督管理局已批准帕妥珠单抗联合曲妥珠单抗和多西他赛用于治疗HER2阳性转移性乳腺癌患者。

方法

为评估帕妥珠单抗的安全性和疗效,我们使用关键词“帕妥珠单抗”在PubMed和Embase数据库(1966年1月至2015年1月的文章)中进行检索。

结果

我们的最终分析纳入了14项符合条件的研究。从分析结果来看,腹泻(56.9%,95%置信区间[CI] 49.6%-63.9%)、恶心(34.0%,95% CI 27.7%-40.8%)和皮疹(25.6%,95% CI 20.8%-31.0%)是单独使用帕妥珠单抗及基于帕妥珠单抗的治疗中最常见的不良反应。基于随机对照临床试验,腹泻(优势比[OR] 2.310,95% CI 1.818-2.936)、皮疹(OR 1.848,95% CI 1.094-3.122)和发热性中性粒细胞减少(OR 1.672,95% CI 1.130-2.474)具有统计学意义,这意味着帕妥珠单抗在腹泻发生率中起显著作用。同时,帕妥珠单抗在癌症控制和延长生存期方面显示出有效作用。

结论

总之,考虑到帕妥珠单抗常见的不良反应为胃肠道和皮肤毒性,相较于其他毒性更容易处理,帕妥珠单抗对实体瘤患者而言是一种安全有效的药物。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/43a5/5440139/2178ccd3774f/medi-96-e6870-g001.jpg

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