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

Abstract

BackgroundAntiangiogenic agents provides an optional treatment strategy for patients with metastatic breast cancer. The present study was conducted to evaluate the efficacy and safety of anlotinib as third-line or above therapy for patients with HER-2 negative metastatic breast cancer.MethodsPatients with HER-2 negative metastatic breast cancer who have failed from prior therapy and treated with anlotinib monotherapy or combined with chemotherapy or immunotherapy from June 2018 to December 2020 were retrospectively analyzed based on real-world clinical practice. The primary end point was progression free survival (PFS). Secondary end points included objective response rate (ORR), disease control rate (DCR), overall survival (OS) and safety.Results47 patients with HER-2 negative metastatic breast cancer received anlotinib monotherapy or combination therapy as third-line or above therapy. In the general population, 10 patients achieved PR, 25 patients had SD and 12 patients had PD. The overall ORR and DCR were 21.3% and 74.5%, respectively. Subgroup analysis suggested that there were no statistically significant differences in ORR and DCR with respect to HR status (positive vs. negative), treatment programs (monotherapy vs. combination) and treatment type in combination group (chemotherapy vs. immunotherapy). The patients who did not received previously anti-angiogenesis therapy had superior DCR (84.8% vs. 50.0%, P=0.012). Median PFS and OS were 5.0 months (95% CI=4.3-5.7) and 21.0 (95% CI=14.9-27.1) months, respectively. The PFS (6.5m vs. 3.5m, P=0.042)and OS (28.2m vs. 12.6m, P=0.040) were better in HR positive patients than HR negative patients. And simultaneously, patients who received anlotinib combination therapy obtained better PFS (5.5m vs. 3.0m, P=0.045). The incidence of Grade 3-4 adverse events(AEs) was 31.9%.ConclusionsAnlotinib monotherapy or combination therapy provide a viable third-line or above therapeutic strategy in patients with HER-2 negative metastatic breast cancer, a median PFS of 5.0 months was obtained with well tolerated toxicity.

A single-arm phase II clinical trial of anlotinib combined with chemotherapy for the treatment of metastatic triple-negative breast cancer

“…was similar to that in previous relevant clinical trials (34,35). Antiangiogenic drugs likely to increase the probability of hemorrhage.…”

“…In a real-world study of anlotinib monotherapy or combined with chemotherapy in multi-line therapy in patients with advanced breast cancer, the median PFS of monotherapy was 3.0 months, and that of combined treatment was 5.5 months. In subgroup analysis, the median PFS of TNBC patients was 3.5 months ( 35 ). In our study, the median PFS of TNBC patients who had previously received at least two lines of treatment in the metastatic setting was 5.0 months, which was longer than that of patients with metastatic TNBC reported by Hu et al.…”

“…In subgroup analysis, the median PFS of TNBC patients was 3.5 months (35). In our study, the median PFS of TNBC patients who had previously received at least two lines of treatment in the metastatic setting was 5.0 months, which was longer than that of patients with metastatic TNBC reported by Hu et al (35). In addition, the median PFS of anlotinib combined with chemotherapy as first-line or secondline treatment was 10.5 months, indicating that it was better than the existing reports on metastatic TNBC.…”

“…A phase II clinical trial shows that anlotinib alone is effective for advanced breast cancer ( 34 ). A real-world study shows that single or combined treatment of anlotinib is effective for heavily pretreated HER2 negative metastatic breast cancer, with low toxicity ( 35 ).. These studies showed that anlotinib is effective in metastatic breast cancer, especially in HER2-negative subtypes or TNBC.…”

Posterior reversible encephalopathy syndrome after anlotinib treatment for small cell lung cancer: A case report and literature review

“…The most common AEs related to nervous system disorder was reported to be headache (33 [11.2%]) in the ALTER0303 trial ( Han et al, 2018 ). In addition, there were a few rare AEs reported such as insomnia, sensory neurotoxicity, and seizure ( Huang et al, 2021 ; Liu et al, 2021 ; Lu et al, 2022 ; Nie et al, 2022 ; Shao et al, 2022 ; Zou et al, 2022 ). Although a few cases of posterior reversible encephalopathy syndrome (PRES) caused by some anti-angiogenic drugs were reported in the literature ( Koopman et al, 2008 ; Chelis et al, 2012 ; Myint et al, 2014 ; Sharma et al, 2016 ; Saraceno et al, 2017 ; Miaris et al, 2019 ; Van Pelt et al, 2020 ), no PRES has been previously reported in SCLC patients treated with anlotinib.…”