Safety and Efficacy of Anlotinib-based Regimen in Patients with Unresectable or Metastatic Bone and Soft-tissue Sarcomas: A Retrospective Institutional Study.

Background: Anlotinib has demonstrated durable clinical benefits in patients with unresectable or metastatic bone and soft-tissue sarcomas.

Methods: 92 patients treated with chemotherapy combined with or without anlotinib were collected and analyzed. The objective response rate (ORR) and disease control rate (DCR) were analyzed. Long-term survival was assessed using the Kaplan-Meier method, including median progression-free survival (mPFS) and overall survival (mOS).

Results: Liposarcoma, synovial sarcoma, and rhabdomyosarcoma were the primary pathological subtypes of the 92 patients. The median age was 46 (range, 11-75) years. The ORR and DCR of the anlotinib-chemotherapy combination used as first-line therapy were 31.9% and 85.1%, respectively. However, the ORR and DCR were only 6.7% and 57.8% in the chemotherapy alone, respectively. Compared with the chemotherapy group, improvements were observed in the mPFS and mOS with anlotinib-based regimen (mPFS, 8.3 vs. 3.0 months; mOS, 59.0 vs. 22.0 months). Anlotinib-associated adverse events were well tolerated and mainly occurred in grades I and II. New anlotinib-related adverse reactions were not noted.

Conclusion: Anlotinib-based regimen as a first-line therapy showed a positive effect on the treatment of unresectable or metastatic BSTSs. The anlotinib-associated adverse events were minor and well tolerated.