PMID- 30816108 OWN - NLM STAT- MEDLINE DCOM- 20200529 LR - 20220416 IS - 2092-6413 (Electronic) IS - 1226-3613 (Print) IS - 1226-3613 (Linking) VI - 51 IP - 3 DP - 2019 Feb 28 TI - Phase II trial of VEGFR2 inhibitor apatinib for metastatic sarcoma: focus on efficacy and safety. PG - 1-11 LID - 10.1038/s12276-019-0221-7 [doi] LID - 24 AB - Apatinib (YN968D1) is a novel tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor 2 (VEGFR-2). We conducted a single-arm, nonrandomized phase II study (NCT03121846) to assess the efficacy and safety of apatinib in patients with stage IV sarcoma. We recruited 64 patients with stage IV sarcoma who had failed chemotherapy. The primary endpoint was progression-free survival (PFS), and the secondary endpoints were progression-free survival rate (PFR), objective response rate (ORR), and disease control rate (DCR) at week 12. Treatment-related adverse effects (AEs) were evaluated. Fifty-nine patients were assessed for efficacy and 64 patients for AEs. The median PFS was 7.93 months. At 12 weeks, the PFR was 74%, the ORR was 16.95% (10/59), and the DCR was 86.44% (51/59). The final ORR was 15.25% (9/59) and the DCR was 57.63% (34/59). Notably, 22 patients (34.38%) who developed hypertension, hand-foot-skin reaction, or proteinuria had significantly longer OS than those without these AEs (18.20 vs. 10.73 months; P = 0.002). We conclude that apatinib is effective and well tolerated in patients with advanced sarcoma. The development of hypertension, hand-foot-skin reaction, or proteinuria may indicate a favorable prognosis, representing a novel finding in sarcoma patients. 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. AD - National Clinical Research Center of Cancer, Tianjin Medical University Cancer Institute & Hospital, Tianjin, 300060, 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. AD - National Clinical Research Center of Cancer, Tianjin Medical University Cancer Institute & Hospital, Tianjin, 300060, People's Republic of China. FAU - Zhang, Chao AU - Zhang C AD - Departments of Bone and Soft Tissue Tumor, Tianjin Medical University Cancer Institute & Hospital, Tianjin, 300060, People's Republic of China. AD - 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. AD - Departments of 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. AD - 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. AD - Departments of 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. AD - Departments of Radiation Oncology, Tianjin Medical University Cancer Institute & Hospital, Tianjin, 300060, People's Republic of China. FAU - Hassan, Shafat AU - Hassan S AD - Departments of Bone and Soft Tissue Tumor, Tianjin Medical University Cancer Institute & Hospital, Tianjin, 300060, People's Republic of China. AD - National Clinical Research Center of Cancer, Tianjin Medical University Cancer Institute & Hospital, Tianjin, 300060, People's Republic of China. 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. AD - National Clinical Research Center of Cancer, Tianjin Medical University Cancer Institute & Hospital, Tianjin, 300060, People's Republic of China. FAU - Li, Ting AU - Li T AD - Departments of Bone and Soft Tissue Tumor, Tianjin Medical University Cancer Institute & Hospital, Tianjin, 300060, People's Republic of China. AD - National Clinical Research Center of Cancer, Tianjin Medical University Cancer Institute & Hospital, Tianjin, 300060, People's Republic of China. FAU - Xing, Peipei AU - Xing P AD - Departments of Bone and Soft Tissue Tumor, Tianjin Medical University Cancer Institute & Hospital, Tianjin, 300060, People's Republic of China. AD - National Clinical Research Center of Cancer, 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. AD - National Clinical Research Center of Cancer, Tianjin Medical University Cancer Institute & Hospital, Tianjin, 300060, People's Republic of China. FAU - Zhang, Jin AU - Zhang J AD - Departments of Bone and Soft Tissue Tumor, Tianjin Medical University Cancer Institute & Hospital, Tianjin, 300060, People's Republic of China. AD - 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. AD - 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. AD - 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. AD - National Clinical Research Center of Cancer, Tianjin Medical University Cancer Institute & Hospital, Tianjin, 300060, People's Republic of China. FAU - Chen, Kexin AU - Chen K AD - National Clinical Research Center of Cancer, Tianjin Medical University Cancer Institute & Hospital, Tianjin, 300060, People's Republic of China. AD - Departments of Epidemiology and Biostatistics, Tianjin Medical University Cancer Institute & Hospital, Tianjin, 300060, People's Republic of China. FAU - Yang, Jilong AU - Yang J AUID- ORCID: 0000-0001-5162-3740 AD - Departments of Bone and Soft Tissue Tumor, Tianjin Medical University Cancer Institute & Hospital, Tianjin, 300060, People's Republic of China. yangjilong@tjmuch.com. AD - National Clinical Research Center of Cancer, Tianjin Medical University Cancer Institute & Hospital, Tianjin, 300060, People's Republic of China. yangjilong@tjmuch.com. LA - eng PT - Clinical Trial, Phase II PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20190228 PL - United States TA - Exp Mol Med JT - Experimental & molecular medicine JID - 9607880 RN - 0 (Antineoplastic Agents) RN - 0 (Protein Kinase Inhibitors) RN - 0 (Pyridines) RN - 5S371K6132 (apatinib) RN - EC 2.7.10.1 (KDR protein, human) 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/adverse effects/*therapeutic use MH - Child MH - Female MH - Humans MH - Male MH - Middle Aged MH - Neoplasm Metastasis/drug therapy/pathology MH - Progression-Free Survival MH - Protein Kinase Inhibitors/adverse effects/*therapeutic use MH - Pyridines/adverse effects/*therapeutic use MH - Sarcoma/*drug therapy/pathology MH - Treatment Outcome MH - Vascular Endothelial Growth Factor Receptor-2/*antagonists & inhibitors MH - Young Adult PMC - PMC6395676 COIS- The authors declare that they have no conflict of interest. EDAT- 2019/03/01 06:00 MHDA- 2020/05/30 06:00 PMCR- 2019/02/28 CRDT- 2019/03/01 06:00 PHST- 2018/09/20 00:00 [received] PHST- 2018/11/22 00:00 [accepted] PHST- 2018/11/15 00:00 [revised] PHST- 2019/03/01 06:00 [entrez] PHST- 2019/03/01 06:00 [pubmed] PHST- 2020/05/30 06:00 [medline] PHST- 2019/02/28 00:00 [pmc-release] AID - 10.1038/s12276-019-0221-7 [pii] AID - 221 [pii] AID - 10.1038/s12276-019-0221-7 [doi] PST - epublish SO - Exp Mol Med. 2019 Feb 28;51(3):1-11. doi: 10.1038/s12276-019-0221-7.