Preliminary evaluate the safety and efficacy of anlotinib in advanced sarcoma patients in multi-line therapy.

11526 Background: Patients with advanced bone and soft tissue sarcoma are mostly treated with chemotherapy, but the effect is poor. Anlotinib hydrochloride is a multi-targeted receptor of tyrosine kinase inhibitors (TKI), which has demonstrated therapeutic effects on a variety of sarcoma subtypes, and is approved for the treatment of advanced soft tissue sarcomas in China. Methods: This is a single-arm, prospective, single-center clinical study. The included criteria were patients with pathological diagnose of bone and soft tissue sarcoma, at least one measurable lesion (according to RECIST 1.1), failed of more than first-line therapy (except for alveolar soft tissue sarcoma) in the last 6 months, with the normal function of main organs. All patients received anlotinib for more than 1 month. The primary study endpoint was objective response rate (ORR). Disease control rate (DCR) and side effects was also calculated. Results: At the latest follow up in Jan. 20th, 2020, a total of 31 patients were enrolled. The median age of the patients was 38 (8-79) years. The main subtypes included osteosarcoma (25.8%), undifferentiated pleomorphic sarcoma (19.4%), synovial sarcoma (16.1%), fibrosarcoma (12.9%). 83.9% of patients received for at least third-line therapy of anlotinib. The oral administration time was 1.5-15 months, with the average of 4.34 months. The ORR was 29%. The DCR was 77.4%. Patients who had received other TKI drugs had an ORR of 20% and a DCR of 70% in 10 cases (32.2%) in this group. mPFS and mOS have not been reached. Adverse events were mainly in grades I and II, including 6 (19.4%) of anorexia or diarrhea, 5 (16.1%) of pain, 4 (12.9%) of hand-foot syndrome, 3 (9.7%)of hypertension, fatigue and mucosa ulcer each. One case had hypertension in grades III. Conclusions: Anlotinib has shown a definite effect in the treatment of advanced sarcomas. Effectiveness can also be observed in patients who have failed in other targeted therapy. The adverse events are minor and can be tolerated. Clinical trial information: NCT04223583 .