Li Ningning, Bai Chunmei, Zhang Ruixing, Ma Liwen, Ren Xiubao, Zhang Junping, Fu Zhanzhao, Zhao Lin
Department of Oncology, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing 100730, China.
Department of Gastroenterology, The Fourth Hospital of Hebei Medical University, Shijiazhuang 050071, China.
Transl Oncol. 2021 Feb;14(2):101004. doi: 10.1016/j.tranon.2020.101004. Epub 2020 Dec 28.
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.
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).
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%).
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.
AHEAD-G202 (NCT02668380).
甲胎蛋白产生型胃癌（AFPGC）因其预后较差，在全球范围内构成了治疗挑战。本研究旨在评估抗血管生成药物阿帕替尼在真实世界中治疗晚期AFPGC的疗效和安全性。
从2015年9月至2017年12月，从临床试验AHEAD-G202中确定的21例AFPGC患者被纳入本分析，AHEAD-G202是一项关于阿帕替尼治疗晚期转移性胃癌的开放标签、前瞻性、多中心、非干预性研究。患者接受口服阿帕替尼单药治疗或联合治疗。一个治疗周期定义为28天。主要结局为无进展生存期（PFS）和总生存期（OS），次要结局包括安全性、客观缓解率（ORR）和疾病控制率（DCR）。
20例患者接受了阿帕替尼疗效分析。阿帕替尼的ORR为10%，而DCR为70%。中位PFS为3.5个月[95%置信区间（CI）：2.34 - 4.66]。中位OS为4.5个月（95%CI：3.49 - 5.51）。癌胚抗原（CEA）未升高的AFPGC患者的中位OS达到30.8个月。通过多因素分析，CEA升高被认为是OS（P = 0.030）和PFS（P = 0.047）的潜在独立预测因素。最常见的3至4级不良事件（AE）为高血压（4.8%）、手足综合征（4.8%）、厌食（4.8%）以及呕吐和恶心（4.8%）。
阿帕替尼在晚期AFPGC患者中显示出有前景的疗效和可接受的安全性。抗血管生成治疗可能是作为胃癌罕见亚型的AFPGC治疗的一种良好策略。
AHEAD-G202（NCT02668380）。
