PMID- 31786466 OWN - NLM STAT- MEDLINE DCOM- 20200929 LR - 20200929 IS - 1950-6007 (Electronic) IS - 0753-3322 (Linking) VI - 122 DP - 2020 Feb TI - Efficacy and safety of the VEGFR2 inhibitor Apatinib for metastatic soft tissue sarcoma: Chinese cohort data from NCT03121846. PG - 109587 LID - S0753-3322(19)35209-6 [pii] LID - 10.1016/j.biopha.2019.109587 [doi] AB - 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. CI - Copyright (c) 2019 The Author(s). Published by Elsevier Masson SAS.. All rights reserved. FAU - Liu, Xinyue AU - Liu X AD - Departments of Bone and Soft Tissue Tumor, Tianjin Medical University Cancer Institute & Hospital, Tianjin, 300060, People's Republic of China; National Clinical Research Center of Cancer, Tianjin Medical University Cancer Institute & Hospital, Tianjin, 300060, People's Republic of China; Key Laboratory of Molecular Cancer Epidemiology, Tianjin, 300060, People's Republic of China. FAU - Xu, Jin AU - Xu J AD - Department of Anesthesiology, Tianjin Hospital, Tianjin, Tianjin, 300000, People's Republic of China. FAU - Li, Feng AU - Li F AD - Departments of Bone and Soft Tissue Tumor, Tianjin Medical University Cancer Institute & Hospital, Tianjin, 300060, People's Republic of China; National Clinical Research Center of Cancer, Tianjin Medical University Cancer Institute & Hospital, Tianjin, 300060, People's Republic of China; Key Laboratory of Molecular Cancer Epidemiology, Tianjin, 300060, People's Republic of China. FAU - Liao, Zhichao AU - Liao Z AD - Departments of Bone and Soft Tissue Tumor, Tianjin Medical University Cancer Institute & Hospital, Tianjin, 300060, People's Republic of China; National Clinical Research Center of Cancer, Tianjin Medical University Cancer Institute & Hospital, Tianjin, 300060, People's Republic of China. FAU - Ren, Zhiwu AU - Ren Z AD - Departments of Bone and Soft Tissue Tumor, Tianjin Medical University Cancer Institute & Hospital, Tianjin, 300060, People's Republic of China; National Clinical Research Center of Cancer, Tianjin Medical University Cancer Institute & Hospital, Tianjin, 300060, People's Republic of China. FAU - Zhu, Lei AU - Zhu L AD - National Clinical Research Center of Cancer, Tianjin Medical University Cancer Institute & Hospital, Tianjin, 300060, People's Republic of China; Molecular Imaging, Tianjin Medical University Cancer Institute & Hospital, Tianjin, 300060, People's Republic of China. FAU - Shi, Yehui AU - Shi Y AD - National Clinical Research Center of Cancer, Tianjin Medical University Cancer Institute & Hospital, Tianjin, 300060, People's Republic of China; Pharmacological Research Center, Tianjin Medical University Cancer Institute & Hospital, Tianjin, 300060, People's Republic of China. FAU - Zhao, Gang AU - Zhao G AD - National Clinical Research Center of Cancer, Tianjin Medical University Cancer Institute & Hospital, Tianjin, 300060, People's Republic of China; Pathology, Tianjin Medical University Cancer Institute & Hospital, Tianjin, 300060, People's Republic of China. FAU - Bai, Xu AU - Bai X AD - National Clinical Research Center of Cancer, Tianjin Medical University Cancer Institute & Hospital, Tianjin, 300060, People's Republic of China; Radiation Oncology, Tianjin Medical University Cancer Institute & Hospital, Tianjin, 300060, People's Republic of China. FAU - Zhao, Jun AU - Zhao J AD - Departments of Bone and Soft Tissue Tumor, Tianjin Medical University Cancer Institute & Hospital, Tianjin, 300060, People's Republic of China; National Clinical Research Center of Cancer, Tianjin Medical University Cancer Institute & Hospital, Tianjin, 300060, People's Republic of China. FAU - Xing, Ruwei AU - Xing R AD - Departments of Bone and Soft Tissue Tumor, Tianjin Medical University Cancer Institute & Hospital, Tianjin, 300060, People's Republic of China; National Clinical Research Center of Cancer, Tianjin Medical University Cancer Institute & Hospital, Tianjin, 300060, People's Republic of China. FAU - Teng, Sheng AU - Teng S AD - Departments of Bone and Soft Tissue Tumor, Tianjin Medical University Cancer Institute & Hospital, Tianjin, 300060, People's Republic of China; National Clinical Research Center of Cancer, Tianjin Medical University Cancer Institute & Hospital, Tianjin, 300060, People's Republic of China. FAU - Yang, Yun AU - Yang Y AD - Departments of Bone and Soft Tissue Tumor, Tianjin Medical University Cancer Institute & Hospital, Tianjin, 300060, People's Republic of China; National Clinical Research Center of Cancer, Tianjin Medical University Cancer Institute & Hospital, Tianjin, 300060, People's Republic of China. FAU - Yang, Jilong AU - Yang J AD - Departments of Bone and Soft Tissue Tumor, Tianjin Medical University Cancer Institute & Hospital, Tianjin, 300060, People's Republic of China; National Clinical Research Center of Cancer, Tianjin Medical University Cancer Institute & Hospital, Tianjin, 300060, People's Republic of China; Key Laboratory of Molecular Cancer Epidemiology, Tianjin, 300060, People's Republic of China. Electronic address: yangjilong@tjmuch.com. LA - eng PT - Clinical Trial, Phase IV PT - Journal Article PT - Randomized Controlled Trial DEP - 20191128 PL - France TA - Biomed Pharmacother JT - Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie JID - 8213295 RN - 0 (Antineoplastic Agents) RN - 0 (Pyridines) RN - 5S371K6132 (apatinib) RN - EC 2.7.10.1 (Vascular Endothelial Growth Factor Receptor-2) SB - IM MH - Adolescent MH - Adult MH - Aged MH - Aged, 80 and over MH - Antineoplastic Agents/*therapeutic use MH - China MH - Cohort Studies MH - Female MH - Humans MH - Male MH - Middle Aged MH - Pyridines/adverse effects/*therapeutic use MH - Sarcoma/*drug therapy MH - Survival Rate MH - Treatment Outcome MH - Vascular Endothelial Growth Factor Receptor-2/*antagonists & inhibitors OTO - NOTNLM OT - Apatinib OT - Efficacy OT - Progression-free survival OT - Soft tissue sarcoma OT - Toxicity EDAT- 2019/12/02 06:00 MHDA- 2020/09/30 06:00 CRDT- 2019/12/02 06:00 PHST- 2019/08/29 00:00 [received] PHST- 2019/10/22 00:00 [revised] PHST- 2019/10/26 00:00 [accepted] PHST- 2019/12/02 06:00 [pubmed] PHST- 2020/09/30 06:00 [medline] PHST- 2019/12/02 06:00 [entrez] AID - S0753-3322(19)35209-6 [pii] AID - 10.1016/j.biopha.2019.109587 [doi] PST - ppublish SO - Biomed Pharmacother. 2020 Feb;122:109587. doi: 10.1016/j.biopha.2019.109587. Epub 2019 Nov 28.