Xu Ting, Xiong Weili, Zhang Lili, Yuan Yuan
Department of Oncology The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China.
Department of Chemotherapy Jiangsu Cancer Hospital Jiangsu Institute of Cancer Research The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China.
Breast J. 2024 Aug 2;2024:5396107. doi: 10.1155/2024/5396107. eCollection 2024.
Endocrine therapy combined with cyclin-dependent kinase (CDK) 4/6 inhibitors (CDK4/6i) is the preferred treatment for hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (MBC). However, there are currently no recommendations for therapeutic strategies after progression on CDK4/6i-based treatment. This study aimed to examine the efficacy and safety of anlotinib plus chemotherapy in HR+/HER2- MBC after progression on CDK4/6 inhibitors.
We collected data from 32 patients with HR+/HER2- MBC treated with anlotinib plus chemotherapy after progressing on CDK4/6i at Jiangsu Cancer Hospital from March 2020 to October 2023. The median follow-up was 9.1 months (range, 2.0-19.7 months) as of the data cutoff date in October 2023. The primary endpoint was median progression-free survival (PFS); secondary endpoints included objective response rate (ORR), disease control rate (DCR), and adverse events.
The median PFS (mPFS) of all patients was 7.6 months (95% confidence interval (CI), 5.75-9.45). There was no significant difference in mPFS between patients who responded to prior CDK4/6i treatment and those who did not (8.3 months vs. 6.8 months, =0.580). Besides, the ORR was 34.4% and DCR was 93.8%. The most frequently observed adverse events were anemia (50.0%), neutropenia (40.6%), thrombocytopenia (34.4%), and epistaxis (34.4%). Dose interruption or reductions due to adverse events occurred in 2 (6.3%) and 5 (15.6%) patients, respectively.
The study preliminarily demonstrates that anlotinib combined with chemotherapy may be an optional recommendation for patients with HR+/HER2- metastatic breast cancer who have progressed after CDK4/6i.
内分泌治疗联合细胞周期蛋白依赖性激酶（CDK）4/6抑制剂（CDK4/6i）是激素受体阳性（HR+）/人表皮生长因子受体2阴性（HER2-）转移性乳腺癌（MBC）的首选治疗方法。然而，目前对于基于CDK4/6i治疗进展后的治疗策略尚无推荐。本研究旨在探讨安罗替尼联合化疗在HR+/HER2-MBC患者CDK4/6抑制剂治疗进展后的疗效和安全性。
我们收集了2020年3月至2023年10月在江苏省肿瘤医院接受CDK4/6i治疗进展后接受安罗替尼联合化疗的32例HR+/HER2-MBC患者的数据。截至2023年10月的数据截止日期，中位随访时间为9.1个月（范围2.0-19.7个月）。主要终点是中位无进展生存期（PFS）；次要终点包括客观缓解率（ORR）、疾病控制率（DCR）和不良事件。
所有患者的中位PFS（mPFS）为7.6个月（95%置信区间（CI），5.75-9.45）。对先前CDK4/6i治疗有反应的患者和无反应的患者之间的mPFS无显著差异（8.3个月对6.8个月，=0.580）。此外，ORR为34.4%，DCR为93.8%。最常观察到的不良事件是贫血（50.0%）、中性粒细胞减少（40.6%）、血小板减少（34.4%）和鼻出血（34.4%）。分别有2例（6.3%）和5例（15.6%）患者因不良事件导致剂量中断或减少。
该研究初步表明，安罗替尼联合化疗可能是HR+/HER2-转移性乳腺癌患者在CDK4/6i治疗进展后的一种可选推荐。
