Huang Jia-Yi, Zhang Yan, Du Cai-Wen
Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Shenzhen, Guangdong, 518116, People's Republic of China.
Department of Emergency, Shenzhen Longhua District People's Hospital, Shenzhen, Guangdong, 518109, People's Republic of China.
Breast Cancer (Dove Med Press). 2025 Jun 28;17:545-555. doi: 10.2147/BCTT.S534082. eCollection 2025.
To explore the efficacy and safety of continuous administration of anlotinib combined with oral vinorelbine in refractory human epidermal growth factor-2 (HER2) negative advanced breast cancer (ABC).
This retrospective study included 41 HER2 negative ABC patients who received anlotinib (8mg orally per day without interruption) plus oral vinorelbine during November 2019 and February 2023. These patients have received at least two treatments in the past. The efficacy and adverse events (AEs) of these patients need to be evaluated.
The median follow-up time for this study was 35.6 months. Among 41 patients with HER2 negative ABC, 16 were HR positive/HER2 negative and 25 were triple negative breast cancer (TNBC). The median progression free survival (PFS) and overall survival (OS) were 6.7 months (95% CI, 4.9-8.5 months) and 28.3 months (95% CI, 10.6-46.0 months). There were no statistical differences in PFS (p=0.200) and OS (p=0.494) between the HR positive/HER2 negative and TNBC subgroups. The objective response rate (ORR), clinical benefit rate (CBR) and disease control rate (DCR) were 22.0%, 61.0% and 82.9%, respectively. Forty patients (97.6%) experienced varying grades of AEs and 31.7% of patients for grades 3-4. The most common grade 3-4 AEs that we observed were neutropenia (17.1%), leukopenia (9.8%) and diarrhea (9.8%).
Continuous administration of anlotinib combined with oral vinorelbine demonstrates to be efficacious and well tolerated for refractory HER2 negative ABC.
探讨连续使用安罗替尼联合口服长春瑞滨治疗难治性人表皮生长因子2（HER2）阴性晚期乳腺癌（ABC）的疗效和安全性。
这项回顾性研究纳入了2019年11月至2023年2月期间接受安罗替尼（每日口服8mg不间断）加口服长春瑞滨治疗的41例HER2阴性ABC患者。这些患者过去至少接受过两种治疗。需要评估这些患者的疗效和不良事件（AE）。
本研究的中位随访时间为35.6个月。在41例HER2阴性ABC患者中，16例为激素受体（HR）阳性/HER2阴性，25例为三阴性乳腺癌（TNBC）。中位无进展生存期（PFS）和总生存期（OS）分别为6.7个月（95%CI，4.9 - 8.5个月）和28.3个月（95%CI，10.6 - 46.0个月）。HR阳性/HER2阴性亚组和TNBC亚组之间的PFS（p = 0.200）和OS（p = 0.494）无统计学差异。客观缓解率（ORR）、临床获益率（CBR）和疾病控制率（DCR）分别为22.0%、61.0%和82.9%。40例患者（97.6%）经历了不同程度的AE，31.7%的患者为3 - 4级。我们观察到最常见的3 - 4级AE为中性粒细胞减少（17.1%）、白细胞减少（9.8%）和腹泻（9.8%）。
连续使用安罗替尼联合口服长春瑞滨治疗难治性HER2阴性ABC显示出有效且耐受性良好。
