阿帕替尼治疗晚期软组织肉瘤的临床疗效和安全性

The clinical efficacy and safety of apatinib in the treatment of advanced soft tissue sarcoma

目的分析阿帕替尼治疗晚期软组织肉瘤(STS)的临床疗效和安全性。方法回顾性分析31例一线及以上化疗失败的晚期STS患者的临床资料。所有患者口服阿帕替尼250 mg/d、425 mg/d或500 mg/d,持续用药至疾病进展或出现不可耐受的不良反应,分析STS患者的近远期临床疗效。结果 31例晚期STS患者的客观有效率(ORR)为16.1%,疾病控制率(DCR)为77.4%,中位无进展生存时间(PFS)为4.6个月(95%CI:1.5～12.0),12周疾病无进展率为64.5%,中位总生存时间(OS)为8.0个月(95%CI:3.0～12.0)。常见的1～2级不良反应为高血压、蛋白尿、手足综合征、白细胞减少、口腔溃疡和出血。3级非血液学不良反应为出血、蛋白尿和声音嘶哑。结论阿帕替尼治疗一线及以上化疗失败的晚期STS患者,有一定的临床疗效,不良反应可耐受。

Objective To investigate the clinical efficacy and safety of apatinib in the treatment of advanced soft tissue sarcoma (STS). Method The clinical data of 31 patients with advanced soft tissue sarcoma who had received but failed firstline standard chemotherapy and subsequent chemotherapies were retrospectively analyzed. Apatinib was administered in all patients with the daily oral dose of 250 mg/d, 425 mg/d, and 500 mg/d till tumor progression or presence of intolerable adverse reactions. The short and long-term clinical efficacy of these STS patients were investigated. Result Of the 31 advanced STS patients, the objective response rate (ORR) was 16.1%, the disease control rate (DCR) was 77.4%, their median progression-free survival (PFS) was 4.6 months (95%CI: 1.5-12.0), and the progression-free rate at 12 weeks was 64.5%, and the median overall survival (OS) time was 8.0 months (95%CI: 3.0-12.0). Common adverse reactions of grade 1 to 2 were hypertension, proteinuria, hand-foot syndrome, leukocytopenia, oral ulcer, and hemorrhage. Grade 3 nonhematological toxicities included hemorrhage, proteinuria, and hoarseness. Conclusion Apatinib is effective in the treatment of advanced soft tissue sarcoma after failure of first-line and subsequent chemotherapy, and the adverse reactions can be tolerated.