Abstract
Objective: This study aimed to assess the effectiveness and safety of anlotinib in treating advanced rhabdomyosarcoma in a real-world setting.
Methods:Clinical data were collected from patients with advanced rhabdomyosarcoma who underwent anlotinib treatment at the Eighth People’s Hospital of Shanghai between January 2018 and November 2023. The objective response rate (ORR) and disease control rate (DCR) were evaluated based on RECIST 1.1 criteria. Progression-free survival (PFS) and adverse reactions were also documented and analyzed.
Results: A total of 38 patients (23 female, 15 male) were included in the study. Three patients (8%) achieved complete response, 16 (42%) achieved partial response (PR), and 10 (26%) achieved stable disease (SD), resulting in an ORR of 50% and a DCR of 76%. The median PFS was 10 months (95% CI: 8.898-11.102). Most adverse events, such as hand-foot skin syndrome, fatigue, hypertension, and oral ulcers, were mild to moderate (grade 1/2). The most common severe adverse events were fatigue, thrombocytopenia, and neutropenia (each at 5%).
Conclusion: The findings suggest that anlotinib is a safe and effective alternative for treating advanced rhabdomyosarcoma in real-world scenarios. However, further prospective randomized controlled trials are necessary to validate these results.