Anlotinib hydrochloride capsules for advanced soft tissue sarcoma: single-center data analysis of a stageⅡmulticenter clinical trial
10.3969/j.issn.1000-8179.2018.20.632
- VernacularTitle:盐酸安罗替尼胶囊治疗晚期软组织肉瘤Ⅱb期多中心临床试验的单中心数据分析
- Author:
Jiayong LIU
1
;
Zhengfu FAN
;
Shu LI
;
Ruifeng XUE
;
Tian GAO
;
Chujie BAI
;
Lu ZHANG
;
Zhichao TAN
;
Zhiwei FANG
Author Information
1. 北京肿瘤医院暨北京市肿瘤防治研究所
- Keywords:
soft tissue sarcoma;
targeted therapy;
anlotinib;
progression free survival (PFS);
advanced soft tissue sarcoma
- From:
Chinese Journal of Clinical Oncology
2018;45(20):1066-1070
- CountryChina
- Language:Chinese
-
Abstract:
Objective: To investigate the efficacy and safety of anlotinib hydrochloride capsules for the treatment of advanced soft tissue sarcoma based on the data from Department of Bone and Soft Tissue Tumor, Peking University Cancer Hospital&Institute. Methods: Patients were randomized allocated at 2:1 ratio for the anlotinib treatment and placebo group. The treatment group received 12 mg/day of anlotinib for 14 consecutive days in a 21-day cycle. The primary end-point was progression-free survival (PFS), and the secondary end-points were disease control rate (DCR), overall survival (OS), and adverse event rate. Results: A total of 46 patients were enrolled in this study; 7 of them were excluded from per protocol set (PPS). Among the remaining 39 patients, 28 were included in the anlotinib group and 11 in the placebo group. In the anlotinib group, 4 patients had partial remission and 13 had stable disease (SD), whereas in the placebo group, 3 patients had SD. The difference in DCR between the 2 groups was statistically significant (60.7% vs . 27.3%, P=0.082). The DCR of the advanced soft tissue sarcoma in the anlotinib group was 78.6% (11/14). The median PFS in the anlotinib group was 12.4 (95% confidence interval [CI]: 7.6 to 17.2) months, which was significantly longer than 4 months in the placebo group (95% CI: 1.7 to 6.3 months, P=0.043); however, the difference in OS between the 2 groups was not significant (19.4 vs . 17.6 months, P=0.961). Regarding the safety, 2 patients had severe adverse events (7.14%) possibly related with treatment in the anlotinib group; one of them had pneumothorax. The other adverse events were grade 1 to 2. Conclusions: Soft tissue sarcoma is highly responsive to anlotinib, with prolonged PFS. Anlotinib is well tolerated and can be used as a treatment option for advanced soft tissue sarcoma.
