AXI-STS: A UK NCRI Sarcoma Clinical Studies Group Phase 2 Trial of Axitinib in Advanced STS

CTOS 2016

This open-label phase 2 trial assessed the activity, safety, and tolerability of axitinib 5 mg orally twice daily in patients with advanced soft-tissue sarcoma (STS) who were unsuitable for or relapsed after standard chemotherapy. This report focuses on patients with angiosarcoma and synovial sarcoma. The primary outcome measure was RECIST progression-free survival (PFS) rate at 12 weeks. Patients with stable or responding disease at 12 weeks were characterized as a success. Secondary outcome measures included overall response rate (ORR), PFS, overall survival (OS), and toxicity. UK centers recruited 38 angiosarcoma and 36 synovial sarcoma patients for this study. Both strata demonstrated benefit with axitinib: 9 angiosarcoma and 10 synovial sarcoma patients achieved success. The 12-week PFS rates were 42% and 57%, respectively. ORR was 10% and 7%, respectively. Median PFS was 4.2 months and 3.8 months, respectively. Median OS was 11.6 months and 10.1 months, respectively. Similar to other studies of axitinib, the most common toxicities were diarrhea, mucositis, nausea, fatigue, anorexia, arthralgia, cough, dyspnea, voice alterations, and hypertension. Common grade 3 and 4 toxicities included hypertension and fatigue. Axitinib is active and well tolerated in patients with angiosarcoma and synovial sarcoma. The drug merits further investigation in these patients. Woll P, et al. CTOS 2016. Abstract 2554618. P2 Poster 124.