Anlotinib versus Placebo as Adjuvant Therapy for Localized High-Grade Soft-Tissue Sarcomas: A Phase II,...

Area of Science:

• Oncology
• Pharmacology
• Surgical Oncology

Background:

• Soft-tissue sarcomas (STS) are rare cancers requiring effective adjuvant therapies post-resection.
• High-grade localized STS have a significant risk of recurrence after complete surgical removal.
• Targeted therapies offer potential for improved outcomes in adjuvant settings.

Purpose of the Study:

• To evaluate the efficacy and safety of anlotinib as an adjuvant targeted therapy for completely resected localized high-grade STS.
• To compare disease-free survival and recurrence rates between anlotinib and placebo groups.
• To assess the safety profile and toxicity of anlotinib in this patient population.

Main Methods:

• A randomized, double-blind, placebo-controlled trial (NCT03951571) involving 88 patients with localized high-grade STS.
• Patients received either oral anlotinib (12 mg once daily) or placebo for 14 days every 21 days, up to six cycles.
• Efficacy endpoints included disease-free survival and recurrence risk; safety was monitored throughout the study.

Main Results:

• Anlotinib group showed higher 1- and 2-year disease-free survival rates (88% and 77%) compared to placebo (64% and 58%).
• Adjuvant anlotinib significantly reduced the risk of disease recurrence (HR, 0.47; P = 0.0445).
• Adverse events included proteinuria/hematuria and poor wound healing, leading to discontinuation in 5% of patients.

Conclusions:

• Adjuvant anlotinib following surgery is effective in reducing disease relapse for localized high-grade STS.
• Anlotinib demonstrates an acceptable safety profile in the adjuvant setting for STS.
• This study supports anlotinib as a potential targeted therapy option for improving outcomes in resected localized high-grade STS.