PMID- 33383486 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20231110 IS - 1936-5233 (Print) IS - 1936-5233 (Electronic) IS - 1936-5233 (Linking) VI - 14 IP - 2 DP - 2021 Feb TI - Efficacy and safety of apatinib for the treatment of AFP-producing gastric cancer. PG - 101004 LID - S1936-5233(20)30496-4 [pii] LID - 10.1016/j.tranon.2020.101004 [doi] LID - 101004 AB - BACKGROUND: Alpha-fetoprotein-producing gastric cancer (AFPGC) poses a therapeutic challenge worldwide because of its poor prognosis. This study aimed to evaluate the efficacy and safety of antiangiogenic drug apatinib in advanced AFPGC in a real-world setting. METHODS: From September 2015 to December 2017, twenty-one patients identified with AFPGC from the clinical trial AHEAD-G202, an open-label, prospective, multicenter, non-interventional study of apatinib for advanced metastatic gastric cancer, were enrolled to perform this analysis. Patients received oral apatinib as monotherapy or combination therapy. A treatment cycle was defined as 28 days. The primary outcome was progression-free survival (PFS) and overall survival (OS), and the secondary outcomes included safety, objective response rate (ORR), and disease control rate (DCR). RESULTS: Twenty patients were evaluated for the apatinib efficacy analysis. The ORR of apatinib was 10%, whereas the DCR was 70%. The median PFS was 3.5 months [95%confidence interval (CI): 2.34-4.66]. The median OS was 4.5 months (95%CI: 3.49-5.51). Median OS of AFPGC patients without carcinoembryonic antigen (CEA) elevation achieved 30.8 months. CEA elevation was considered to be a potential independent predictive factor for OS (P = 0.030) and PFS (P = 0.047) by the analysis of multivariate analysis. The most common grade 3 to 4 adverse events (AEs) were hypertension (4.8%), hand-foot syndrome (4.8%), anorexia (4.8%), and vomiting and nausea (4.8%). CONCLUSION: Apatinib showed promising efficacy and an acceptable safety profile in patients with advanced AFPGC. Antiangiogenic therapy may be a good strategy for the treatment of AFPGC as a rare sub-type of gastric cancer. TRIAL REGISTRATION: AHEAD-G202 (NCT02668380). CI - Copyright (c) 2020. Published by Elsevier Inc. FAU - Li, Ningning AU - Li N AD - Department of Oncology, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing 100730, China. FAU - Bai, Chunmei AU - Bai C AD - Department of Oncology, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing 100730, China. FAU - Zhang, Ruixing AU - Zhang R AD - Department of Gastroenterology, The Fourth Hospital of Hebei Medical University, Shijiazhuang 050071, China. FAU - Ma, Liwen AU - Ma L AD - Department of Tumor Chemotherapy and Radiology, Peking University Third Hospital, Beijing 100191, China. FAU - Ren, Xiubao AU - Ren X AD - Department of Biotherapy, Tianjin Medical University Cancer Institute and Hospital, Tianjin 300060, China. FAU - Zhang, Junping AU - Zhang J AD - Department of Medical Oncology, Shanxi Academy of Medical Sciences, Shanxi Dayi Hospital, Taiyuan 030032, China. FAU - Fu, Zhanzhao AU - Fu Z AD - Department of Medical Oncology, First Hospital of Qinhuangdao, Qinhuangdao 066001, China. FAU - Zhao, Lin AU - Zhao L AD - Department of Oncology, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing 100730, China. Electronic address: wz20010727@aliyun.com. LA - eng SI - ClinicalTrials.gov/NCT02668380 PT - Journal Article DEP - 20201228 PL - United States TA - Transl Oncol JT - Translational oncology JID - 101472619 PMC - PMC7777135 OTO - NOTNLM OT - AFP-producing gastric cancer OT - Alpha-fetoprotein OT - Apatinib OT - Target therapy COIS- Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. EDAT- 2021/01/01 06:00 MHDA- 2021/01/01 06:01 PMCR- 2020/12/28 CRDT- 2020/12/31 20:16 PHST- 2020/07/26 00:00 [received] PHST- 2020/12/20 00:00 [revised] PHST- 2020/12/21 00:00 [accepted] PHST- 2021/01/01 06:00 [pubmed] PHST- 2021/01/01 06:01 [medline] PHST- 2020/12/31 20:16 [entrez] PHST- 2020/12/28 00:00 [pmc-release] AID - S1936-5233(20)30496-4 [pii] AID - 101004 [pii] AID - 10.1016/j.tranon.2020.101004 [doi] PST - ppublish SO - Transl Oncol. 2021 Feb;14(2):101004. doi: 10.1016/j.tranon.2020.101004. Epub 2020 Dec 28.