■探讨吡唑替尼联合不同放疗方式在人表皮生长因子受体2（HER2）阳性乳腺癌（BC）脑转移（BM）患者中的疗效和安全性。
■本研究是对2018年11月至2023年4月期间接受吡罗替尼治疗的BM患者的回顾性分析。共有66例患者接受放疗联合吡唑替尼（A组），26例患者接受了吡唑替尼作为独立治疗（B组）。A组内,18例患者行常规分割放疗(2Gy/F),48例患者接受超分割放疗（HFRT）（≥3Gy/F）。主要终点是颅内无进展生存期（IC-PFS）和总生存期（OS）。次要终点是客观缓解率（ORR）和临床获益率（CBR）。
■A组的ORR为54.5%（36/66），B组ORR为34.6%(9/26)(P=0.047)。A组CBR为89.4%(59/66),B组为69.2%(18/26)(P=0.041)。A组和B组的IC-PFS分别为12个月和8个月,分别为(P<0.001)，OS分别为20个月和16个月，分别为(P=0.065)。A组,常规分割放疗组与HFRT组的IC-PFS和OS分别为10个月和12个月,分别为(P=0.001)、16个月和24个月，分别(P<0.001)。A组和B组未观察到严重不良反应。
■对于患有BM的HER2阳性BC患者，建议采用HFRT联合吡唑替尼的治疗模式，能提高患者的局部控制力和生存率。
UNASSIGNED: To explore the efficacy and safety of pyrotinib combined with different radiotherapy modes in human epidermal growth factor receptor 2 (HER2)-positive breast cancer (BC) patients with brain metastasis (BM).
UNASSIGNED: This study is a retrospective analysis of patients diagnosed with BM who underwent treatment with pyrotinib between November 2018 and April 2023. A total of 66 patients were administered radiotherapy in conjunction with pyrotinib (Group A), while 26 patients received pyrotinib as a standalone treatment (Group B). Within Group A, 18 patients underwent conventional fractionated radiotherapy (2Gy/F), while 48 patients received hyperfractionated radiotherapy (HFRT) (≥3Gy/F). The primary endpoints were intracranial progression-free survival (IC-PFS) and overall survival (OS). The secondary endpoints were objective response rate (ORR) and clinical benefit rate (CBR).
UNASSIGNED: The ORR of Group A was 54.5% (36/66), while the ORR of Group B was 34.6% (9/26) (P= 0.047). The CBR of Group A was 89.4% (59/66) and that of Group B was 69.2% (18/26) (P= 0.041). The IC-PFS between Group A and Group B were 12 months and 8 months, respectively (P< 0.001), and the OS were 20 months and 16 months, respectively (P= 0.065). In Group A, the IC-PFS and OS between the conventional fractionation radiotherapy group and the HFRT group were 10 months and 12 months, respectively (P= 0.001) and 16 months and 24 months, respectively (P< 0.001). No serious adverse reactions were observed in Group A and Group B.
UNASSIGNED: For HER2-positive BC patients with BM, it is recommended to adopt the treatment mode of HFRT combined with pyrotinib, which can improve the local control and survival of patients.
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