Anlotinib has good efficacy and low toxicity: a phase II study of anlotinib in pre-treated HER-2 negative metastatic breast cancer

Abstract

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%), thyroidstimulating 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.

A real-world study of anlotinib as third-line or above therapy in patients with her-2 negative metastatic breast cancer

“…A previous basic study showed that anlotinib inhibits the proliferation and induces apoptosis of MCF‐7 breast cancer cells by downregulating TFAP2C ( 28 ). At present, only one phase II clinical study with a small sample size has evaluated the clinical efficacy of anlotinib in metastatic breast cancer ( 29 ).…”

Partial Response After Toripalimab Plus Anlotinib for Advanced Metaplastic Breast Carcinoma: A Case Report

“…Meanwhile, severe adverse events (AEs, ≥G3) were hypertension (26.92%) and hand–foot syndrome (3.85%). These results showed that anlotinib had good efficacy and limited toxicity with HER2-negative breast cancer ( 26 ). Only one case of advanced MBC treated with anlotinib has been reported.…”

Anlotinib for the Treatment of Multiple Recurrent Lumbar and Sacral Cord Hemangioblastomas: A Case Report

“…Anlotinib has been approved by the Chinese Food and Drug Administration for third-line treatment for advanced NSCLC patients. Also, anlotinib has exhibited inspiring efficacy as well as low toxicity in heavily pre-treated HER2-negative metastatic breast cancer ( 21 ).…”