Purpose <p>Sarcomas are rare, aggressive and unpredictable tumors that arise from mesenchymal tissues. Despite treatment, outcomes for advanced or metastatic cases remain poor. Anlotinib is a new oral tyrosine kinase inhibitor that blocks multiple angiogenic pathways and has shown encouraging results in solid tumors. This review aims to summarize and clarify the current evidence on anlotinib’s role in treating sarcoma.</p> Methods <p>A systematic search across five major databases up to February 2025 identified clinical studies that evaluate anlotinib in sarcoma patients. Eligible studies included randomized controlled trials and observational studies evaluating anlotinib in advanced or metastatic sarcoma. Pooled estimates for median progression-free survival (mPFS) and overall survival (mOS) were calculated using random-effects models.</p> Results <p>Twenty-one studies involving 1,230 patients were included. The pooled mPFS was 6.7 months and the mOS was 19.3 months. Results varied widely due to differences in sarcoma subtype, disease stage, and prior therapies, yet most studies showed meaningful tumor control and manageable toxicity.</p> Conclusions <p>Anlotinib appears to be a promising therapy for refractory or metastatic sarcomas. It offers modest yet real improvements in survival and quality of life. Larger, multicenter and biomarker-guided studies are needed to define which patients benefit most and how this drug can be best integrated into future treatment strategies.</p>

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Clinical efficacy and safety outcomes of anlotinib therapy in sarcoma: a systematic review and meta-analysis

  • Hasan Matar,
  • Ahmad Melhem,
  • Abdallah Shawwa,
  • Taleen Yousef,
  • Mohammad Alananbeh,
  • Enad Alsalim,
  • Eman Al-refai,
  • Malaak Abuhwaij,
  • Dina Elayan

摘要

Purpose

Sarcomas are rare, aggressive and unpredictable tumors that arise from mesenchymal tissues. Despite treatment, outcomes for advanced or metastatic cases remain poor. Anlotinib is a new oral tyrosine kinase inhibitor that blocks multiple angiogenic pathways and has shown encouraging results in solid tumors. This review aims to summarize and clarify the current evidence on anlotinib’s role in treating sarcoma.

Methods

A systematic search across five major databases up to February 2025 identified clinical studies that evaluate anlotinib in sarcoma patients. Eligible studies included randomized controlled trials and observational studies evaluating anlotinib in advanced or metastatic sarcoma. Pooled estimates for median progression-free survival (mPFS) and overall survival (mOS) were calculated using random-effects models.

Results

Twenty-one studies involving 1,230 patients were included. The pooled mPFS was 6.7 months and the mOS was 19.3 months. Results varied widely due to differences in sarcoma subtype, disease stage, and prior therapies, yet most studies showed meaningful tumor control and manageable toxicity.

Conclusions

Anlotinib appears to be a promising therapy for refractory or metastatic sarcomas. It offers modest yet real improvements in survival and quality of life. Larger, multicenter and biomarker-guided studies are needed to define which patients benefit most and how this drug can be best integrated into future treatment strategies.