The Efficacy and Safety of <scp>AI</scp> With Anlotinib Versus <scp>AI</scp> for Treating Synovial Sarcoma Patients With Lung Metastasis: A Retrospective Cohort Study

Synovial sarcoma (SS) is a rare and aggressive soft tissue sarcoma frequently associated with lung metastases. While anthracycline plus ifosfamide (AI) remains a standard first-line regimen, its benefit in SS patients with lung metastases is unknown. Anlotinib, a multi-target tyrosine kinase inhibitor (TKI), has shown promising effects in sarcoma treatment, but its combination with AI has not been well studied in this setting. This retrospective, single-center study included 108 SS patients with lung metastases treated between 2007 and 2024, receiving either AI alone (n = 59) or AI combined with anlotinib (n = 49). Survival outcomes were assessed using Kaplan-Meier analysis, and adverse events (AEs) were reviewed from clinical records. The results indicated that the combination therapy demonstrated statistically significant improvements in clinical outcomes compared to AI monotherapy, with a median PFS of 8.1 months versus 6.2 months (p = 0.0250), and a median OS of 14.8 months versus 6.8 months (p = 0.0033). Most AEs were Grades 1-2 according to common terminology criteria for adverse events (CTCAE) criteria, with manageable toxicity profiles. The combination group exhibited modest but clinically insignificant elevations in hypertension and proteinuria, with no reported treatment-related mortality. In conclusion, the anlotinib and AI chemotherapy combination regimen shows promising efficacy in prolonging survival duration for SS patients with lung metastases while maintaining an acceptable safety profile. These findings suggest that this combination therapy could be considered as a viable first-line treatment option for this patient population, warranting further validation through phase III randomized controlled trials.