Phase 2 trial of first-line anlotinib plus anthracyclines and ifosfamide followed by anlotinib maintenance in advanced soft tissue sarcoma

A phase 2 trial at Shandong First Medical University (Shandong, China) evaluated first-line anlotinib plus anthracyclines (4 to 6 cycles) for patients with advanced soft tissue sarcoma (STS), followed by anlotinib maintenance therapy in patients without disease progression after induction therapy. Maintenance therapy was given until progression, unacceptable toxicity, or death. The objective response rate (primary endpoint) was 30.8% (95% CI 18.7-45.1) and the disease control rate was 82.7% (69.7-91.8). With a median follow-up of 29.9 months, the median progression-free survival was 6.2 months (95% CI 2.6-11.2) and the median overall survival was not reached (14.4-NE). Treatment-related adverse events of any grade occurred in all patients, while most common grade 3 or 4 TRAEs were anemia (23.1% of patients), leukopenia (17.3), and thrombocytopenia (9.6%). No treatment-related deaths occurred. The authors conclude that first-line anlotinib plus chemotherapy, followed by anlotinib maintenance, demonstrated encouraging efficacy with acceptable toxicity in patients with advanced STS.