First-Line Anlotinib Treatment for Soft-Tissue Sarcoma in Chemotherapy-Ineligible Patients: An Open-Label,...

Area of Science:

• Oncology
• Medical Research
• Clinical Trials

Background:

• Standard treatment for unresectable locally advanced or metastatic soft-tissue sarcoma (LA/M STS) involves anthracycline-based chemotherapy, which has limited patient tolerance.
• Investigating novel therapeutic agents is crucial for improving outcomes in advanced STS.

Purpose of the Study:

• To evaluate anlotinib as a first-line treatment for patients with advanced soft-tissue sarcoma (STS), with a specific focus on liposarcoma.
• To assess the efficacy and safety of anlotinib in patients with unresectable LA/M STS who are not candidates for traditional chemotherapy.

Main Methods:

• A clinical trial (NCT03792542) enrolled 40 previously untreated patients with unresectable LA/M STS.
• Anlotinib was administered orally at 12 mg once daily (days 1-14 every 3 weeks) until disease progression or intolerable adverse events.
• Primary endpoint was progression-free survival (PFS); secondary endpoints included overall survival (OS), objective response rate, and disease control rate (DCR).

Main Results:

• The median PFS was 6.83 months and median OS was 27.40 months.
• A disease control rate (DCR) of 67.5% was observed, with 1 partial response and 26 cases of stable disease.
• For the liposarcoma subgroup, median PFS was 8.71 months and median OS was 16.23 months. Grade 3+ treatment-related adverse events occurred in 25% of patients, notably hypertension and proteinuria.

Conclusions:

• Front-line anlotinib demonstrates potential benefit for patients with advanced STS ineligible for cytotoxic chemotherapy.
• The encouraging clinical outcomes in the liposarcoma subgroup warrant further investigation.
• Anlotinib offers a potential alternative treatment option with a manageable safety profile for advanced STS.