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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.
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.
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.
FROM ASCO 2018