The Effectivity and Toxicity of Methylsulfonic Apatinib for Extensively Pre-treated Advanced Sarcoma: a Multicentric Retrospective Study in China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- objective response rate
研究概览
简要总结
Anti-angiogenesis Tyrosine kinase inhibitors (TKIs) have been proved to show promising effects on prolonging progression-free survival (PFS) for advanced sarcoma after failure of standard multimodal Therapy. Methylsulfonic apatinib is one of those TKIs which specifically inhibits VEGFR-2. This study summarizes the experience of three Peking University affiliated hospitals in off-label use of apatinib in the treatment of extensively pre-treated sarcoma.
详细描述
The investigators retrospectively analysed files of patients with advanced sarcoma not amenable to curative treatment, who were receiving an apatinib-containing regimen between June 1, 2015 and December 1, 2016. Fifty-six patients were included: 22 osteosarcoma, 10 Ewing's sarcoma, 3 chondrosarcoma and 21 soft tissue sarcoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologically confirmed high-grade sarcoma;
- •initial treatment in the orthopedic oncology departments of the three affiliated hospitals of Peking University;
- •tumors not amenable to curative treatment or inclusion in clinical trials;
- •unresectable local advanced lesions or multiple metastatic lesions that could not be cured by local therapy;
- •measurable lesions according to Response Evaluation Criteria for Solid Tumors (RECIST1.1) [8];
- •Eastern Cooperative Oncology Group performance status 0 or 1 [9]; and 7) acceptable hematologic, hepatic, and renal function.
排除标准
- •had been previously exposed to other TKIs;
- •had central nervous system metastasis;
- •had other kinds of malignant tumors at the same time; had cardiac insufficiency or arrhythmia;
- •had uncontrolled complications such as diabetes mellitus, coagulation disorders, urine protein ≥ ++ and so on;
- •had pleural or peritoneal effusion that needs to be handled by surgical treatment;
- •combined with other infections or wounds
- •were pregnant or breastfeeding.
研究组 & 干预措施
osteosarcoma
all patients had been given apatinib alone
干预措施: Methylsulfonic apatinib (Drug)
Ewing sarcoma
Some of patients had been given apatinib alone while some of them had been given apatinib+everolimus
干预措施: Methylsulfonic apatinib (Drug)
soft tissue sarcoma
Some of the patients had been given apatinib alone while some of the patients had been given apatinib together with GT chemotherapy, which was gemcitabine 1000 mg/m2 d1,8 and docetaxel 75 mg/m2 d8 once every 21 day.
干预措施: Methylsulfonic apatinib (Drug)
Chondrosarcoma
Patients were given apatinib alone
干预措施: Methylsulfonic apatinib (Drug)
结局指标
主要结局
objective response rate
时间窗: 3 month
CR+PR accroding to RECIST 1.1
次要结局
- Overall Survival,OS(12 months)
- progression-free survival, PFS(4 months and 6 months)
- duration of response, DOR(4 months)
- toxicity(12 months)