尽管一些靶向治疗已被证明对治疗HER2变异非小细胞肺癌（NSCLC）有效，但由于高成本和有限供应，生存需求尚未得到满足。本研究旨在评估在先前接受治疗的HER2变异非小细胞肺癌患者中，吡咯替尼与包括阿帕替尼、安罗替尼和贝伐单抗在内的抗血管生成剂的疗效和安全性。 本回顾性实际世界研究回顾了在2015年11月至2022年1月期间接受吡咯替尼联合抗血管生成剂作为二线或更晚线治疗的HER2变异NSCLC患者。分析了患者的客观缓解率（ORR）、疾病控制率（DCR）、无进展生存期（PFS）、总生存期（OS）以及安全性。 共有107名患者纳入分析，其中59名患者（55.1%）至少接受过两种化疗或酪氨酸激酶抑制剂。其中大多数（87.9%）被确定为携带HER2外显子20插入突变。数据截至日期为2022年5月13日，ORR、DCR、中位PFS和中位OS分别为19.6%（21/107）、94.4%（101/107）、7.13个月（95%置信区间[CI]：6.26-8.01）和19.50个月（95% CI：12.83-26.17）。在接受阿帕替尼或安罗替尼/贝伐单抗的患者中，PFS没有差异（中位PFS为7.13 vs. 6.27个月，危险比[HR] = 1.49，95% CI：0.87-2.54，p = 0.15）。最常见的3级或更高级别治疗相关不良事件是腹泻（17.6%），其次是高血压（11.0%）和恶心（3.3%）。没有治疗相关死亡事件发生。 本研究表明，吡咯替尼与抗血管生成剂在HER2变异NSCLC患者中显示出良好的疗效和耐受性。 © 2023 中国肺癌学会和约翰威利澳大利亚有限公司出版的《胸部肿瘤学》出版。

Although some targeted therapies have been shown to be effective in treating HER2-altered non-small cell lung cancer (NSCLC), the survival demands have not yet been met due to the high cost and limited availability. This study aimed to assess the effectiveness and safety of pyrotinib plus antiangiogenic agents, including apatinib, anlotinib, and bevacizumab, in previously treated patients with HER2-altered advanced NSCLC.In this retrospective real-world study, patients with HER2-altered NSCLC who received pyrotinib plus antiangiogenic agents as a second- or later-line treatment between November 2015 and January 2022 were reviewed. The objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety profiles of patients were analyzed.A total of 107 patients were included in the analysis, of which 59 patients (55.1%) had received at least two lines of prior chemotherapy or tyrosine kinase inhibitors. Most of them (87.9%) were identified as harboring HER2 exon 20 insertions. At the data cutoff date (May 13, 2022), the ORR, DCR, median PFS, and median OS were 19.6% (21/107), 94.4% (101/107), 7.13 months (95% confidence interval [CI]: 6.26-8.01), and 19.50 months (95% CI: 12.83-26.17), respectively. There was no difference in the PFS between patients receiving apatinib or anlotinib/bevacizumab (median PFS, 7.13 vs. 6.27 months, hazard ratio [HR] = 1.49, 95% CI: 0.87-2.54, p = 0.15). The most frequent grade 3 or higher treatment-related adverse events was diarrhea (17.6%), followed by hypertension (11.0%) and nausea (3.3%). No treatment-related death occurred.In this study, pyrotinib plus antiangiogenic agents demonstrated promising efficacy and were tolerable in HER2-altered NSCLC patients.© 2023 The Authors. Thoracic Cancer published by China Lung Oncology Group and John Wiley & Sons Australia, Ltd.