The real‐world clinical outcomes and treatment patterns of patients with unresectable locally advanced or metastatic soft tissue sarcoma treated with anlotinib in the post‐ALTER0203 trial era

BACKGROUND: The ALTER0203 clinical trial showed that anlotinib, a multitargeted tyrosine kinase inhibitor, had antitumor effects on advanced soft tissue sarcoma (STS) after the failure of standard chemotherapy. We aimed to evaluate the real‐world efficacy and explore prognostic factors and treatment patterns of anlotinib in patients with advanced STS. METHODS: We retrospectively analyzed the data of patients with unresectable locally advanced or metastatic STS who received at least one dose of anlotinib from June 2018 to March 2021. The survival data were analyzed using the Kaplan–Meier method and compared using the log‐rank test. The Cox proportional hazards model was performed for multivariate analysis. RESULTS: A total of 209 patients were included. The median age was 48 (range 11–85) years. The median follow‐up, progression‐free survival, and overall survival were 18.7 months, 6.1 months [95% confidence interval (CI): 4.9–7.2], and 16.4 months (95% CI: 13.6–19.1), respectively. The objective response rate was 13.4%. Nutritional status, Eastern Cooperative Oncology Group (ECOG) performance status, and anlotinib treatment patterns (combination therapy or switch maintenance therapy vs. monotherapy) were significantly associated with progression‐free survival. Besides, pathological grade, nutritional status, ECOG performance status, and anlotinib treatment patterns were predictive of overall survival. Due to anlotinib‐related toxicity, 31 (14.8%) patients, and 25 (12.0%) patients experienced dose reduction and treatment discontinuation, respectively. CONCLUSION: These findings confirmed the efficacy of anlotinib in patients with advanced STS in a real‐world setting. The patterns of anlotinib treatment deserve further exploration.