PT  - JOURNAL ARTICLE
AU  - Nanlin Hu
AU  - Yiran Si
AU  - Jian Yue
AU  - Tingting Sun
AU  - Xue Wang
AU  - Zhuqing Jia
AU  - Songlin Gao
AU  - Qiao Li
AU  - Yang Shao
AU  - Jiayu Wang
AU  - Yang Luo
AU  - Fei Ma
AU  - Binghe Xu
AU  - Peng Yuan
TI  - Anlotinib has good efficacy and low toxicity: a phase II study of anlotinib in pre-treated HER-2 negative metastatic breast cancer
AID  - 10.20892/j.issn.2095-3941.2020.0463
DP  - 2021 Aug 01
TA  - Cancer Biology and Medicine
PG  - 849--859
VI  - 18
IP  - 3
4099  - http://www.cancerbiomed.org/content/18/3/849.short
4100  - http://www.cancerbiomed.org/content/18/3/849.full
SO  - Cancer Biol Med2021 Aug 01; 18
AB  - Objective: Anlotinib is a novel tyrosine kinase inhibitor blocking angiogenesis. This study was performed to assess the efficacy and safety of anlotinib in patients with metastatic breast cancer.Methods: Patients with HER2-negative breast cancer, who were pre-treated with anthracycline or taxanes in a neoadjuvant, adjuvant, or metastatic setting, and had treatment failure after at least one prior chemotherapy regimen in the metastatic setting were enrolled. Anlotinib was administered at 12 mg daily for 14 days in a 21-day cycle until disease progression or unacceptable toxicity occurred. Simultaneously, 5–10 mL of venous blood was collected to perform circulating tumor DNA (ctDNA) testing every 2 treatment cycles. The primary endpoint was the objective response rate (ORR). Secondary endpoints included the disease control rate (DCR), progression-free survival (PFS), overall survival, safety, and biomarkers.Results: Twenty-six eligible patients were enrolled, with a median age of 56 (30–75) years. The median follow-up time was 10.5 months. The ORR was 15.4%, the DCR was 80.8%, and the median PFS was 5.22 months (95% confidence interval 2.86–6.24). Fourteen (53.8%) patients survived for more than 10 months. The changes in the detectable ctDNA variant allele frequency were consistent with the tumor response. The most common treatment-related adverse events were hypertension (57.7%), thyroid-stimulating hormone elevation (34.6%), and hand-foot syndrome (23.1%).Conclusion: Anlotinib showed objective efficacy with tolerable toxicity in heavily pre-treated, metastatic HER2-negative breast cancer. The dynamic changes in the ctDNA variant allele fraction may be predictive of the tumor response.