Randomized phase 2 trial of adjuvant anlotinib versus placebo for localized high-grade soft tissue sarcomas

A randomized phase 2 study at Fudan University Shanghai Cancer Center evaluated adjuvant anlotinib after complete resection of high-grade localized soft-tissue sarcoma. The study included 88 patients, who were randomized 1:1 to oral anlotinib (n=44) or placebo (n=44). With a median follow-up of 31 months, the 1-year and 2-year disease-free survival (DFS) rates were 88% and 77% in the anlotinib group, compared to 64% and 58% in the placebo group. Compared to the placebo group, the risk of recurrence was 53% lower in the anlotinib group (HR 0.47; p=0.045). Four patients (9%) discontinued anlotinib owing to toxicities. The authors conclude that after complete resection of localized high-grade STS, adjuvant anlotinib reduces the risk of recurrence, with acceptable toxicity.