Real-world efficacy and safety of anlotinib in Chinese solid tumors patients with liver metastases: a multicenter retrospective study

Introduction Liver metastases are associated with dismal prognosis in solid tumors. This retrospective study evaluated the efficacy and safety of anlotinib in patients with solid tumors and liver metastases in the real-world setting. Methods Patient data from 5 centers in China were reviewed, and patients treated with anlotinib-based therapy were included in a single group. Tumor response was evaluated according to the Response Evaluation Criteria in Solid Tumors version 1.1. The primary outcomes were objective response rate (ORR) and progression-free survival (PFS). Secondary outcomes included hepatic ORR (hORR), hepatic PFS (hPFS), overall survival (OS), duration of response (DOR), and safety. Results Between January 2020 and February 2023, 475 patients were included. Median PFS was 5.80 months (95% confidence interval CI: 5.27-6.60). The ORR and hORR were 17.89% and 18.74%, with a median DOR of 8.63 months (95% CI: 6.57 to not reached NR) and 8.80 months (95% CI: 7.51-NR), respectively. Median hPFS and OS were 6.03 months (95% CI: 5.33-6.60) and 9.53 months (95% CI: 8.40-NR), respectively. Similar median PFS, hPFS, and OS were observed across different tumor types. Patients with body mass index (BMI) 18.5 kg/m 2 had significantly shorter median PFS and hPFS than those with BMI of 18.5-23.9 kg/m 2 and ≥24.0 kg/m 2 . The incidence of any-grade adverse events was 19.58%, with the most common being hematological toxicities (14.11%). Grade ≥3 adverse events occurred in 1.68% of the patients. Discussion These findings suggest the clinical benefits of anlotinib for the treatment of solid tumors with liver metastases, with a manageable safety profile.