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Anlotinib plus Epirubicin Followed by Anlotinib Maintenance as First-line Treatment for Advanced Soft-tissue Sarcoma: An Open-label, Single-arm, Phase II Trial

医学 白细胞减少症 表阿霉素 内科学 中性粒细胞减少症 软组织肉瘤 临床终点 贫血 不利影响 临床研究阶段 粘膜炎 外科 胃肠病学 肿瘤科 化疗 临床试验 软组织 环磷酰胺
作者
Zhi-ming Wang,Rongyuan Zhuang,Xi Guo,Chen-lu Zhang,Yang You,Li-sha Chen,Wen-shuai Liu,Yong Zhang,Rongkui Luo,Yingyong Hou,Weiqi Lu,Yuhong Zhou
出处
期刊:Clinical Cancer Research [American Association for Cancer Research]
卷期号:28 (24): 5290-5296 被引量:14
标识
DOI:10.1158/1078-0432.ccr-22-1903
摘要

Abstract Purpose: The treatment outcome for locally advanced or metastatic soft-tissue sarcoma (STS) remains unsatisfactory. Anlotinib had demonstrated impressive activity in the subsequent-line treatment of STS. This study investigated the combination of anlotinib and epirubicin followed by anlotinib maintenance as first-line treatment for patients with advanced STS. Patients and Methods: This prospective, open-label, single-arm, phase II trial was conducted in Zhongshan Hospital, Fudan University. Eligible patients were ages 18 years or older and had previously untreated, pathologically confirmed, unresectable locally advanced or metastatic STS. All patients received up to six cycles of anlotinib plus epirubicin followed by anlotinib maintenance until disease progression, unacceptable toxicity, or death. The primary endpoint was the progression-free survival (PFS) rate at 6 months. The study was registered on chictr.org (identifier ChiCTR1900024928). Results: From June 2019 to August 2020, 30 patients were enrolled. By December 2021, the median PFS was 11.5 months [95% confidence interval (CI): 8.6–14.4 months], while the median overall survival was not reached (95% CI: NE–NE). The objective response rate was 13.33% and the disease control rate was 80.0%. The most common adverse events (AE) included anemia (43.3%), nausea/vomiting (40.0%), fatigue (36.7%), leukopenia (30.0%), and proteinuria (10.0%), which were mainly of grade 1 or 2. The most frequent grade 3 or 4 AEs were anemia (10.0%), febrile neutropenia (33.3%), hypothyroidism (3.3%), and leukopenia (3.3%). No treatment-related death occurred. Conclusions: The combination of anlotinib and epirubicin followed by anlotinib maintenance demonstrated promising efficacy with a favorable safety profile.
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