Purpose: The prognosis for patients with refractory soft-tissue sarcoma (STS) is dismal. Anlotinib has previously shown antitumor activity on STS in preclinical and phase I studies. Experimental Design: Patients 18 years and older, progressing after anthracycline-based chemotherapy, naïve from angiogenesis inhibitors, with at least one measurable lesion according to RECIST 1.1, were enrolled. The main subtypes eligible were: undifferentiated pleomorphic sarcoma (UPS), liposarcoma (LPS), leiomyosarcoma (LMS), synovial sarcoma (SS), fibrosarcoma (FS), alveolar soft part sarcoma (ASPS) and clear cell sarcoma (CCS). Participants were treated with anlotinib. The primary endpoint was progression-free rate at 12 weeks (PFR 12 weeks). Results: 166 patients were included in the final analysis. Overall, the PFR 12 weeks was 68% and objective response rate was 13% (95% CI 7.6%-18%). The median progression free survival (PFS) and overall survival (OS) were 5.6 and 12 months respectively. The PFR 12 weeks, median PFS and OS were: 58%, 4.1 and 11 months for UPS (n=19); 63%, 5.6 and 13 months for LPS (n=13); 75%, 11 and 15 months for LMS (n=26); 75%, 7.7 and 12 months for SS (n=47); 81%, 5.6 and 12 months for FS (n=18); 77%, 21 and not reached for ASPS (n=13); 54%, 11 and 16 months for CCS (n=7); 44%, 2.8 and 8.8 months for other sarcoma (n=23), respectively. The most common clinically significant grade 3 or higher adverse events were hypertension (4.8%), triglyceride elevation (3.6%) and pneumothorax (2.4%). No treatment-related death occurred. Conclusions: Anlotinib showed antitumor activity in several STS entities. The toxicity was manageable.
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