吡咯替尼治疗HER2阳性晚期乳腺癌女性患者：一项多中心、前瞻性、真实世界研究

Pyrotinib in the Treatment of Women With HER2-Positive Advanced Breast Cancer: A Multicenter, Prospective, Real-World Study.

作者信息

Zhang Lili, Wu Xiaohong, Zhou Jun, Zhu Mingzhen, Yu Hao, Zhang Yusong, Zhao Yutian, Han Zhengxiang, Guo Yujiang, Guan Xiaoqing, Wang Xufen, Xu Hong, Sun Li, Zhang Jiaxin, Zhuang Min, Xie Li, Yu Shiyou, Chen Ping, Feng Jifeng

机构信息

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

Department of Oncology, Affiliated Hospital of Jiangnan University, Wuxi, China.

出版信息

Front Oncol. 2021 Jul 16;11:699323. doi: 10.3389/fonc.2021.699323. eCollection 2021.

DOI:10.3389/fonc.2021.699323

PMID:34336688

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8322968/

Abstract

BACKGROUND

HER2-positive breast cancer was aggressive, resulting in a poorer prognosis. This multicenter study analyzed the real-world data of women treated with pyrotinib-based therapy, aiming to describe their characteristics, treatment regimens, and to investigate the clinical outcomes.

METHODS

A total of 141 patients with HER2-positive breast cancer were enrolled from February 2019 to April 2020. Last follow-up time was February 2021. All patients were treated with pyrotinib-based therapy in 21-day cycles. The primary endpoint was progression-free survival (PFS).

RESULTS

The median PFS (mPFS) for pyrotinib-based therapy was 12.0 months (95%CI 8.1-17.8) in all patients. Among the patients with liver metastases, mPFS was 8.7 months (95%CI, 6.3-15.4) compared to 12.3 months (95%CI, 8.8-23.3) for patients without liver metastases (P=0.172). In addition, patients receiving pyrotinib-based therapy as their >2 lines treatment had a numerically lower mPFS than those receiving pyrotinib-based therapy as their ≤2 lines treatment [8.4 (95%CI, 5.9-15.4) . 15.1 (95%CI, 9.3-22.9) months, P=0.107]. The mPFS was 12.2 months (95%CI, 7.9-18.8) in patients with previous exposure to trastuzumab and 11.8 months (95%CI, 6.8-22.9) in patients without previous exposure to trastuzumab (P=0.732). Moreover, mPFS in patients receiving regimens with and without capecitabine were 15.1 months (95%CI, 10.0-18.8) and 8.4 months (95%CI, 6.7-22.9), respectively (P=0.070). Furthermore, in patients with brain metastases, estimated 6-month PFS rate was 70.0%, and rate at 12 months was 60.0%. Seventy patients with measurable lesions were evaluable for response. The objective response rate was 38.6% and disease control rate was 85.7%. The most common adverse event was diarrhea (85.0%).

CONCLUSION

Pyrotinib-based therapy showed promising efficacy in patients with HER2-positive breast cancer and was well tolerated, especially in patients treated with pyrotinib as ≤2 lines treatment and receiving regimens with capecitabine. The results of this real-world study further confirmed the intriguing efficacy of pyrotinib.

摘要

背景

人表皮生长因子受体2（HER2）阳性乳腺癌侵袭性强，预后较差。这项多中心研究分析了接受吡咯替尼治疗的女性的真实世界数据，旨在描述其特征、治疗方案，并研究临床结局。

方法

2019年2月至2020年4月共纳入141例HER2阳性乳腺癌患者。末次随访时间为2021年2月。所有患者均接受以吡咯替尼为基础的治疗，每21天为一个周期。主要终点为无进展生存期（PFS）。

结果

所有患者接受吡咯替尼治疗的中位PFS（mPFS）为12.0个月（95%CI 8.1-17.8）。肝转移患者的mPFS为8.7个月（95%CI 6.3-15.4），无肝转移患者为12.3个月（95%CI 8.8-23.3）（P=0.172）。此外，接受吡咯替尼治疗作为二线以上治疗的患者的mPFS在数值上低于接受吡咯替尼治疗作为二线及以内治疗的患者[8.4（95%CI 5.9-15.4）. 15.1（95%CI 9.3-22.9）个月，P=0.107]。既往接受过曲妥珠单抗治疗的患者的mPFS为12.2个月（95%CI 7.9-18.8），未接受过曲妥珠单抗治疗的患者为11.8个月（95%CI 6.8-22.9）（P=0.732）。此外，接受含卡培他滨方案和不含卡培他滨方案治疗的患者的mPFS分别为15.1个月（95%CI 10.0-18.8）和8.4个月（95%CI 6.7-22.9）（P=0.070）。此外，脑转移患者的6个月PFS估计率为70.0%，12个月时为60.0%。70例有可测量病灶的患者可评估疗效。客观缓解率为38.6%，疾病控制率为85.7%。最常见的不良事件为腹泻（85.0%）。