Efficacy and safety of the VEGFR2 inhibitor Apatinib for metastatic soft tissue sarcoma: Chinese cohort data from NCT03121846.

Abstract

BACKGROUND:

There is no standard treatment for stage IV soft tissue sarcoma (STS) after the failure of Adriamycin-based chemotherapy. This phase II study (NCT03121846) assessed the efficacy and safety of apatinib (YN968D1), a new tyrosine kinase inhibitor that targets VEGFR-2, for patients with stage IV STS after chemotherapy failure.

METHODS:

Forty-two subjects with stage IV STSs who had failed chemotherapy and who received Apatinib were recruited between September 2015 and February 2018. The primary endpoint was progression-free survival (PFS), and the secondary endpoints were the PFS rate (PFR), objective response rate (ORR), and disease control rate (DCR) at week 12. Treatment-related adverse effects (AEs) were evaluated.

RESULTS:

Forty-two subjects were evaluated for AEs and 38 subjects were evaluated for efficacy. At 12 weeks, the PFR, ORR, and DCR were 70%, 26.32% (10/38), and 86.84% (33/38), respectively. Regarding overall responses, the ORR and DCR were 23.68% (9/38) and 57.89% (22/38), respectively. The median PFS was 7.87 months, and the median overall survival (OS) was 17.55 months. The most common AEs included hypertension (n = 18, 42.86%), hand-foot-skin reaction (n = 15, 35.71%), apositia (n = 13, 30.95%), and proteinuria (n = 11, 26.19%). No subjects had grade 4 AEs and 11 subjects (26.19%) experienced grade 3 AEs, mainly hypertension, hand-foot-skin reaction, proteinuria, apositia, fatigue, pain, and dysgeusia. Notably, the subjects who experienced hypertension, hand-foot-skin reaction, or proteinuria had significantly longer OS than those without these AEs (P = 0.0003).

CONCLUSION:

With the largest Chinese STS cohort to date, we report that apatinib show good efficacy in advanced STS subjects with significant higher ORR and some adverse events may predict prognosis.

• Authors: Xinyue Liu, Jin Xu, Feng Li, Zhichao Liao, Zhiwu Ren, Lei Zhu, Yehui Shi, Gang Zhao, Xu Bai, Jun Zhao, Ruwei Xing, Sheng Teng, Yun Yang, Jilong Yang
• Journal: Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie (Biomed Pharmacother) Vol. 122 Pg. 109587 (Feb 2020) ISSN: 1950-6007 [Electronic] France
• PMID: 31786466 (Publication Type: Clinical Trial, Phase IV, Journal Article, Randomized Controlled Trial)
• Copyright: Copyright © 2019 The Author(s). Published by Elsevier Masson SAS.. All rights reserved.

Chemical References

• Antineoplastic Agents
• Pyridines
• apatinib
• Vascular Endothelial Growth Factor Receptor-2

Topics

• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Antineoplastic Agents (therapeutic use)
• China
• Cohort Studies
• Female
• Humans
• Male
• Middle Aged
• Pyridines (adverse effects, therapeutic use)
• Sarcoma (drug therapy)
• Survival Rate
• Treatment Outcome
• Vascular Endothelial Growth Factor Receptor-2 (antagonists & inhibitors)