%A Zhang,Lili
%A Wu,Xiaohong
%A Zhou,Jun
%A Zhu,Mingzhen
%A Yu,Hao
%A Zhang,Yusong
%A Zhao,Yutian
%A Han,Zhengxiang
%A Guo,Yujiang
%A Guan,Xiaoqing
%A Wang,Xufen
%A Xu,Hong
%A Sun,Li
%A Zhang,Jiaxin
%A Zhuang,Min
%A Xie,Li
%A Yu,Shiyou
%A Chen,Ping
%A Feng,Jifeng
%D 2021
%J Frontiers in Oncology
%C
%F
%G English
%K Pyrotinib,breast cancer,Human epidermal growth factor receptor 2,brain metastasis,Real-world
%Q
%R 10.3389/fonc.2021.699323
%W
%L
%M
%P
%7
%8 2021-July-16
%9 Original Research
%+ Jifeng Feng,Department of Oncology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital of Nanjing Medical University,China,fengJF_NJ@163.com
%#
%! Real-world data of pyrotinib for HER2+ advanced BC
%*
%<
%T Pyrotinib in the Treatment of Women With HER2-Positive Advanced Breast Cancer: A Multicenter, Prospective, Real-World Study
%U https://www.frontiersin.org/articles/10.3389/fonc.2021.699323
%V 11
%0 JOURNAL ARTICLE
%@ 2234-943X
%X BackgroundHER2-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.MethodsA 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).ResultsThe 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) vs. 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%).ConclusionPyrotinib-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.