Clinical Research Papers:
Efficacy and safety of Apatinib in stage IV sarcomas: experience of a major sarcoma center in China
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Feng Li1,2, Zhichao Liao1,2, Jun Zhao1,2, Gang Zhao2,3, Xubin Li2,4, Xiaoling Du5, Yun Yang1,2 and Jilong Yang1,2
1 Department of Bone and Soft Tissue Tumor, Tianjin Medical University Cancer Institute & Hospital, Tianjin, People’s Republic of China
2 National Clinical Research Center of Cancer, Tianjin Medical University Cancer Institute & Hospital, Tianjin, People’s Republic of China
3 Department of Pathology, Tianjin Medical University Cancer Institute & Hospital, Tianjin, People’s Republic of China
4 Department of Radiology, Tianjin Medical University Cancer Institute & Hospital, Tianjin, People’s Republic of China
5 Department of Diagnostics, Tianjin Medical University, Tianjin, People’s Republic of China
Jilong Yang, email:
Keywords: sarcoma; Apatinib; efficacy; progression free survival; clinical benefit response
Received: October 06, 2016 Accepted: March 01, 2017 Published: March 16, 2017
Purpose: This study was conducted to review the efficacy and safety of Apatinib in stage IV sarcoma patients who failed previous chemotherapy.
Materials and Methods: The 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.
Results: Patients 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.
Conclusion: Apatinib 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.
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