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曲妥珠单抗联合帕妥珠单抗与化疗用于转移性HER2阳性乳腺癌:一项中国的回顾性单臂队列研究

Trastuzumab plus pertuzumab in combination with chemotherapy in metastatic HER2-positive breast cancer: a retrospective single-armed cohort study in China.

作者信息

Qian Yu, Peng Ying, Zhou Hao, Zhang Lili, Yuan Yuan

机构信息

Department of Oncology, The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China.

Department of Chemotherapy, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China.

出版信息

Ann Transl Med. 2022 Aug;10(16):877. doi: 10.21037/atm-22-3592.

Abstract

BACKGROUND

There are currently few studies on the efficacy and safety of the dual human epidermal growth factor receptor 2 (HER2)-targeted combination of trastuzumab and pertuzumab in second-line or subsequent therapy of metastatic breast cancer (MBC). This study retrospectively demonstrated the clinical efficacy and side effects of trastuzumab plus pertuzumab in combination with chemotherapy in HER2-positive MBC.

METHODS

Patients with HER2-positive MBC and treated with trastuzumab plus pertuzumab combined with chemotherapy at our hospital between August 2013 and October 2021 were included. The primary endpoint was progression-free survival (PFS), and the secondary endpoints were disease control rate (DCR), objective response rate (ORR), clinical benefit rate (CBR), and side effects. PFS was calculated using the Kaplan-Meier method and side effects were assessed according to Common Terminology Criteria for Adverse Events 5.0.

RESULTS

A total of 55 women were included and the median PFS for trastuzumab plus pertuzumab combined with chemotherapy was 10 months. For the different treatment lines, the median PFS was 19, 8, and 5 months in first, second, and third and beyond, respectively. The DCR, ORR, and CBR were 81.8%, 47.3%, and 56.4%, respectively. The median PFS of patients with primary trastuzumab resistance was significantly shorter than trastuzumab-sensitive patients (5 12 months, P=0.011). The most common adverse reactions were neutropenia (40.0%), leukopenia (34.5%), thrombocytopenia (32.7%), and diarrhea (29.1%). The most common grade 3-4 adverse reactions were leukopenia (12.7%), thrombocytopenia (9.1%), and diarrhea (9.1%).

CONCLUSIONS

For patients with HER2-positive MBC, treatment with trastuzumab plus pertuzumab combined with chemotherapy appeared efficacious and safe.

摘要

背景

目前关于曲妥珠单抗和帕妥珠单抗双重靶向人表皮生长因子受体2(HER2)联合用药在转移性乳腺癌(MBC)二线或后续治疗中的疗效和安全性的研究较少。本研究回顾性地证明了曲妥珠单抗联合帕妥珠单抗与化疗在HER2阳性MBC中的临床疗效和副作用。

方法

纳入2013年8月至2021年10月在我院接受曲妥珠单抗联合帕妥珠单抗与化疗治疗的HER2阳性MBC患者。主要终点为无进展生存期(PFS),次要终点为疾病控制率(DCR)、客观缓解率(ORR)、临床获益率(CBR)和副作用。采用Kaplan-Meier方法计算PFS,并根据不良事件通用术语标准5.0评估副作用。

结果

共纳入55名女性,曲妥珠单抗联合帕妥珠单抗与化疗的中位PFS为10个月。对于不同治疗线,一线、二线、三线及以上的中位PFS分别为19个月、8个月和5个月。DCR、ORR和CBR分别为81.8%、47.3%和56.4%。原发性曲妥珠单抗耐药患者的中位PFS明显短于曲妥珠单抗敏感患者(5对12个月,P = 0.011)。最常见的不良反应为中性粒细胞减少(40.0%)、白细胞减少(34.5%)、血小板减少(32.7%)和腹泻(29.1%)。最常见的3-4级不良反应为白细胞减少(12.7%)、血小板减少(9.1%)和腹泻(9.1%)。

结论

对于HER2阳性MBC患者,曲妥珠单抗联合帕妥珠单抗与化疗治疗似乎有效且安全。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8899/9469119/451b39e8b18b/atm-10-16-877-f1.jpg

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