Abstract
BackgroundAlpha-fetoprotein-producing gastric cancer (AFPGC) poses a therapeutic challenge worldwide because of its poor prognosis. This study aimed to systematically evaluate the efficacy and safety of apatinib targeted therapy in advanced AFPGC and investigate the predictive factors of apatinib treatment. MethodsThree hundred thirty-seven patients were enrolled in the clinical trial AHEAD-G202, an open-label, prospective, multicenter, non-interventional study of apatinib for advanced metastatic gastric cancer. Among them, we recruited all the patients identified with AFPGC for this study. The clinical features, efficacy, adverse events, and survival were assessed. ResultsWe enrolled 21 patients with AFPGC into this study. The objective response rate (ORR) of apatinib in patients with AFPGC was 10%, whereas the disease control rate (DCR) was 70%. The median progression-free survival (PFS) was 3.5 months [95%confidence interval (CI): 2.34-4.66]. The median overall survival (OS) was 4.5 months (95%CI: 3.49-5.51). The common grade adverse events (AEs) were hypertension (33.3%), fatigue (23.8%), and myelosuppression (19.0%). The most common grade 3 to 4 AEs were hypertension (4.8%), hand-foot syndrome (4.8%), anorexia (4.8%), and vomiting and nausea (4.8%). Carcinoembryonic antigen (CEA) elevation was considered to be a potential independent predictive factor (P=0.030). ConclusionsApatinib 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. Clinical trial identificationAHEAD-G202 (NCT02668380). Editorial acknowledgementElsevier Language Editing Services. Legal entity responsible for the studyThe author. FundingJiangsu HengRui Medcine Co., Ltd.; 2016 PUMCH Science Fund for Junior Faculty (Pumch-2016-1.13); Chinese Anti-cancer Association (CORP-143-09). DisclosureThe author has declared no conflicts of interest.
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