Abstract
BACKGROUND: The prognosis of persistent, recurrent or metastatic cervical and endometrial cancer is poor. Anlotinib is a novel multitarget tyrosine kinase inhibitor (TKI). The efficacy and safety of anlotinib in patients with cervical and endometrial cancer need to be evaluated. METHODS: We retrospectively analyzed the efficacy and safety of anlotinib in patients with persistent, recurrent or metastatic cervical and endometrial cancers between March 2020 and June 2023. The objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and adverse events (AEs) were analyzed. RESULTS: The overall ORR and DCR were 24.14% and 55.17% respectively. The ORR and DCR in patients with cervical cancer were 25.00% and 56.25%; the ORR and DCR in patients with endometrial cancer were 23.08% and 53.85%. The patients received anlotinib plus immunotherapy had significantly higher rate of clinical benefit than those receiving anlotinnb alone (P=0.04). The DCR was significantly higher in patients receiving anlotinib combined with immunotherapy (DCR: 75.00% vs. 30.76%) than those without immunotherapy. The overall median PFS and OS were 12.2 months [95% confidence interval (CI): 6.6-17.8] and 22.3 months (95% CI: 20.9-23.7), respectively. The patients receiving anlotinib plus immunotherapy had significantly longer OS than those without immunotherapy [not reached vs. 12.5 months; hazard ratio (HR): 0.32 (95% CI: 0.1-0.99); P=0.04]. The most common AEs was fatigue (41.4%). CONCLUSIONS: Anlotinib might be a promising agent for persistent, recurrent or metastatic cervical and endometrial cancers with good tolerability. Moreover, anlotinib combined with immunotherapy showed synergistic antitumor effect.