First line anlotinib plus liposomal doxorubicin for locally advanced or metastatic soft tissue sarcoma: A prospective, single-arm trial.

Objective: To examine the efficacy and safety of anlotinib as firstline therapy to treat locally advanced or metastatic soft-tissue sarcoma. Methods: This is a single-arm trial. Treatment-naïve patients (≥14 years) with locally advanced or metastatic soft tissue sarcoma were eligible. Each treatment cycle lasted for 3 weeks, and included liposomal doxorubicin (40-50 mg/m²) on day 1 and anlotinib (12 mg) on days 8-21. Starting from the 9th cycle, treatment consisted of only anlotinib. Treatment continued until disease progression or intolerable toxicities. The primary efficacy end point was progression-free survival (PFS). Results: Eight patients were enrolled between July 25, 2019 and January 8, 2020. The median number of treatment cycles was 5.5. Within 5.9 months median follow-up, PFS events occurred in 4 (4/8, 50%) patients. The median PFS was 11.3 months and the 6-month PFS rate was 56%. No patients attained complete response and 2 patients (fibrosarcoma, 1 patient and undifferentiated pleomorphic sarcoma, 1 patient) achieved partial response. Three patients (fibrosarcoma, 2 patients and synovial sarcoma, 1 patient) had stable disease. The objective response rate was 25% (2/8) for the study population, and the disease control rate was 75% (6/8). No new safety concerns emerged. Conclusions: Anlotinib plus liposomal doxorubicin demonstrated antitumor activities in previously untreated locally advanced or metastatic soft tissue sarcomas. Due to the small sample size, further investigations with a larger population should be undertaken to confirm the study findings. [ABSTRACT FROM AUTHOR]