Multicenter randomized phase 2 trial of anlotinib versus placebo after complete resesction of localized high-grade soft-tissue sarcoma

A multicenter randomized phase 2 trial in China evaluated six 3-week cycles of adjuvant anlotinib (n=44) versus placebo (n-44) after complete resection of localized, high-grade soft-tissue sarcoma (STS). With a median follow-up of 30.95 months, the 1-year and 2- year disease-free survival rates were 88% and 77% in the anlotinib group compared with 64% and 58% in the placebo group, respectively. Compared with patients treated with surgery alone, patients receiving adjuvant anlotinib after surgery had a reduced risk of disease recurrence (HR 0.47; p=0.0455). Four patients (9%) discontinued anlotinib: two for proteinuria/hematuria and two for poor healing of the surgical wound. The authors conclude that adjuvant anlotinib compared with placebo reduces the incidence of disease relapse in localized high-grade STS, with acceptable toxicity.