Efficacy and safety of Apatinib in stage IV sarcomas: experience of a major sarcoma center in China.

Feng Li,Gang Zhao,Jilong Yang,Xubin Li,Xiaoling Du,Zhichao Liao,Jun Zhao,Yun Yang

doi:10.18632/oncotarget.16293

Feng Li, Gang Zhao + Show 6 more

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https://doi.org/10.18632/oncotarget.16293

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Abstract

PurposeThis study was conducted to review the efficacy and safety of Apatinib in stage IV sarcoma patients who failed previous chemotherapy.Materials and MethodsThe clinical information on 16 patients with stage IV sarcomas who failed in prior chemotherapy and subsequently received Apatinib treatment was collected. Apatinib was given 500mg/daily and 4 weeks as a cycle. All patients had at least one measurable extracranial tumor according to Response Evaluation Criteria In Solid Tumors 1.0 criteria. Progression free survival (PFS), overall survival (OS), objective response rate (ORR), disease control rate (DCR) and treatment-related adverse effects (AEs) were reviewed and evaluated.ResultsPatients was administered Apatinib for 0 to 9 cycles with the median of 3.2 cycles. Median follow-up time was 8.4 months (1 to 12 months). Ten of 16 patients received at least 1 complete cycle of Apatinib treatment were eligible for the efficacy analysis. The median PFS was 8.84 months. Two patients achieved partial response (PR) and 6 patients achieved stable disease (SD). Two patients were evaluated as progression disease (PD) and one patient died of disease progression. The ORR was 20.0% (2/10) and the DCR was 80.0% (8/10). The most common grade 3/4 treatment-related AEs were hypertension (18.7%), hand-foot syndrome (12.5%) and proteinuria (6.3%). No drug-related severe AEs occurred.ConclusionCApatinib treatment in this exploratory study exhibited objective efficacy and manageable toxicity in stage IV sarcoma patients who failed in chemotherapy. This result supports future random controlled trial to further define Apatinib activity in stage IV sarcomas.

Highlights

Sarcoma is a group of malignant tumors that is originated in mesenchymal tissue
Ten of 16 patients received at least 1 complete cycle of Apatinib treatment were eligible for the efficacy analysis
Two patients were evaluated as progression disease (PD) and one patient died of disease progression

Summary

Introduction

Sarcoma is a group of malignant tumors that is originated in mesenchymal tissue. As the most common primary malignant bone sarcoma in children and adolescents, osteosarcoma is a typical and representative malignant mesenchymal tumor [2]. 20% of the osteosarcoma patients have metastases at the time of diagnosis, and the lung is the most common site of metastasis, followed by bone [2, 3]. STSs are a heterogeneous group of rare sarcomas with distinct clinical and pathologic characteristics and www.impactjournals.com/oncotarget the most common type is pleomorphic undifferentiated sarcoma (25% ~ 35%), followed by liposarcoma (25% ~ 30%), leiomyosarcoma (12%), synovial sarcoma (10%) and malignant peripheral nerve sheath tumor (6%) [4]. In 2016, an estimated 12,310 people are diagnosed with STS in US, and approximately 4,990 would die of this disease [5]. The National Central Cancer Registry of China, composed of 72 local population-based cancer registries providing a population coverage of about 85.5 million people (6.5% of the national population), estimated that there were 28,000 new bone sarcoma cases and 20,700 bone sarcoma deaths in China in 2015 [6]

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