Department of Breast Surgery, Hubei Cancer Hospital, Tongji Medical College, Huazhong University of Science and Technology and Hubei Provincial Clinical Research Center for Breast Cancer.
Department of Neurology, Wuhan First Hospital.
Tohoku J Exp Med. 2023 May 9;260(1):13-20. doi: 10.1620/tjem.2023.J006. Epub 2023 Jan 26.
Apatinib is a tyrosine kinase inhibitor (TKI) that targets vascular endothelial growth factor receptor 2 (VEGFR2) as an effective anti-angiogenic agent. The current study intended to explore the treatment efficacy and safety profile of third-line apatinib plus chemotherapy in metastatic triple-negative breast cancer (mTNBC) patients. This multicenter, retrospective, cohort study analyzed 97 mTNBC patients who underwent third-line apatinib plus single-agent chemotherapy (N = 45) or single-agent chemotherapy (N = 52). The objective response rate (44.4% vs. 19.2%, P = 0.007) and disease control rate (77.8% vs. 48.1%, P = 0.003) were higher in the apatinib plus chemotherapy group than in the chemotherapy group. The apatinib plus chemotherapy group had a longer median progression-free survival (PFS) [6.9 (95% confidence interval, CI: 5.2-8.6) vs. 4.3 (95%CI: 3.2-5.4) months, P = 0.008] and overall survival (OS) [11.6 (95% CI: 9.3-13.9) vs. 9.0 (95% CI: 7.3-10.7) months, P = 0.012] than the chemotherapy group. Further adjustment of multivariate Cox's regression analysis verified that apatinib plus chemotherapy (vs. chemotherapy) resulted in a longer PFS (P = 0.003) and OS (P = 0.010). There was no difference in adverse events between the two groups, except that the incidence of hypertension was higher in the apatinib plus chemotherapy group than in the chemotherapy group (P = 0.018); meanwhile, the grade 3-4 adverse events in the apatinib plus chemotherapy group included hypertension (13.3%), neutropenia (8.9%), nausea and vomiting (4.4%), fatigue (4.4%), leukopenia (4.4%), thrombocytopenia (2.2%), and hand-foot syndrome (2.2%). Third-line apatinib plus chemotherapy may achieve a more satisfying survival benefit and no obvious safety concerns in mTNBC patients compared with mono-chemotherapy. However, more large-scale, randomized studies are warranted for further validation.
阿帕替尼是一种靶向血管内皮生长因子受体 2（VEGFR2）的酪氨酸激酶抑制剂（TKI），作为一种有效的抗血管生成药物。本研究旨在探讨三线阿帕替尼联合化疗治疗转移性三阴性乳腺癌（mTNBC）患者的疗效和安全性。这项多中心、回顾性队列研究分析了 97 例接受三线阿帕替尼联合单药化疗（N=45）或单药化疗（N=52）的 mTNBC 患者。与化疗组相比，阿帕替尼联合化疗组的客观缓解率（44.4% vs. 19.2%，P=0.007）和疾病控制率（77.8% vs. 48.1%，P=0.003）更高。阿帕替尼联合化疗组的中位无进展生存期（PFS）[6.9（95%置信区间，CI：5.2-8.6）vs. 4.3（95%CI：3.2-5.4）个月，P=0.008]和总生存期（OS）[11.6（95%CI：9.3-13.9）vs. 9.0（95%CI：7.3-10.7）个月，P=0.012]均长于化疗组。多变量 Cox 回归分析的进一步调整证实，与化疗组相比，阿帕替尼联合化疗（vs. 化疗）可使 PFS（P=0.003）和 OS（P=0.010）更长。两组间不良反应无差异，除阿帕替尼联合化疗组高血压发生率高于化疗组（P=0.018）外；同时，阿帕替尼联合化疗组的 3-4 级不良反应包括高血压（13.3%）、中性粒细胞减少（8.9%）、恶心呕吐（4.4%）、疲劳（4.4%）、白细胞减少（4.4%）、血小板减少（2.2%）和手足综合征（2.2%）。与单药化疗相比，三线阿帕替尼联合化疗可能为 mTNBC 患者带来更满意的生存获益，且无明显安全性担忧。但仍需更大规模、随机研究进一步验证。
