Anlotinib was confirmed to be safe and effective for soft tissue sarcoma patients who have progressed after first-line chemotherapy, based on results of a randomized, placebo-controlled, multicenter trial of patients in China.
“Anlotinib is a new treatment option for patients with advanced STS after failure of standard chemotherapy,” Yihebali Chi, MD, of the National Cancer Center/Cancer Hospital in Beijing, China, reported at the annual meeting of the American Society of Clinical Oncology.
In a study of patients with disease progression after first-line therapy, the median progression-free survival (PFS) was 6.3 months (95% CI: 4.3-8.4) with anlotinib and 1.5 months (95% CI: 1.43-1.57) with placebo (HR=0.33, P less than 0.0001). The objective response rate was 10.13% for anlotinib and 1.33% for placebo (P = 0.0145); disease control rate was 55.7% versus 22.67% (P less than 0.0001).
For 57 patients with synovial sarcomas, the median PFS was 5.73 months versus 1.43 months (HR = 0.2, P less than 0.0001). For 56 patients with alveolar soft part sarcomas, the median PFS was 18.23 months versus 3 months (HR = 0.14, P less than 0.0001). For 41 patients with leiomyosarcomas, the median PFS was 5.83 months versus 1.43 months (HR = 0.19, P less than 0.0001).
The most common grade 3 or higher adverse events were hypertension (19% with anlotinib versus 0 with placebo), gamma glutamyl transferase elevation (4.4% versus 1.3%), triglyceride increase (4.4% versus 0), low density lipoprotein elevation (3.2% versus 2.7%), hyponatremia (3.2% versus 1.3%) and neutrophil count reduction (3.2% versus 0).
The study included 233 patients aged 18 years and older with angiogenesis inhibitor naive, histologically proven advanced soft tissue sarcomas, intolerance or failure to respond to anthracycline-based chemotherapy, and at least one measurable lesion according to RECIST 1.1. Subjects were randomly assigned (2:1) to receive anlotinib (12 mg per day, 2 weeks on and 1 week off) or to placebo. Anlotinib was given to 158 patients and placebo to 75.
The authors disclosed having no relevant financial relationships. Clinical trial information: NCT02449343
SOURCE: Chi Y et al. ASCO 2018 (annual meeting of the American Society of Clinical Oncology, Abstract 11503.