Efficacy and Safety of Treating Refractory Bone and Soft Tissue Sarcoma with Anlotinib in Different Treatment Patterns

Background and Aim. Anlotinib, a novel tyrosine kinase inhibitor, has demonstrated encouraging antitumor activity in bone and soft tissue sarcomas in several prospective clinical trials. This retrospective study is aimed at analyzing the clinical efficacy and safety of treating refractory bone and soft tissue sarcoma with anlotinib in different treatment patterns. Methods. The medical data of 47 patients with refractory bone and soft tissue sarcoma, who received anlotinib from January 2019 to December 2020, were retrospectively collected. The overall response rate (ORR) and disease control rate (DCR) were evaluated according to the solid tumor response evaluation version 1.1 standard. The progression-free survival (PFS), overall survival (OS), and adverse reactions were recorded. Results. A total of 44 patients, including 13 with osteosarcoma and 31 with soft tissue sarcoma, were enrolled in this study. Among patients with osteosarcoma, no patients achieved complete response (CR) or partial response (PR), while seven patients (54%) had stable disease (SD). Besides, the median PFS (m-PFS) was 4.4 months, and the median OS (m-OS) was 15.7 months. Among patients with soft tissue sarcoma, the ORR and DCR were 19% and 71%, respectively. The median m-PFS was 5.4 months, and m-OS was 17.9 months. Anlotinib plus chemotherapy had a higher ORR compared with anlotinib monotherapy (6% vs. 38%, P=0.047). The most common grade 3/4 adverse reactions were pneumothorax (5%) and pleural effusion (5%), and no treatment-related deaths occurred. Conclusions. Anlotinib alone showed encouraging efficacy and favorable tolerability in refractory bone and soft tissue sarcoma. Anlotinib plus chemotherapy did not show a significant clinical benefit compared with anlotinib alone. Anlotinib showed better tumor control when used as first-line drug treatment in refractory bone and soft tissue sarcoma.