Editorial Office, Henan Provincial People's Hospital, Zhengzhou University People's Hospital; Henan University People's Hospital, Zhengzhou, Henan 450003, China.
Department of Gastrointestinal Surgery, Henan Provincial People's Hospital; Zhengzhou University People's Hospital; Henan University People's Hospital, Zhengzhou, Henan 450003, China.
Dis Markers. 2022 Apr 29;2022:4322404. doi: 10.1155/2022/4322404. eCollection 2022.
BACKGROUND: Apatinib is established to be the standard of care as third-line therapy for patients with previously treated advanced gastric cancer (GC). Programmed cell death protein 1 (PD-1) blockades also exhibited promising efficacy and safety for patients with treatment-refractory advanced GC. OBJECTIVE: This study was to explore the feasibility and tolerance of apatinib plus PD-1 inhibitors for patients with previously treated advanced GC. METHODS: This study was performed as a real-world study; patients with advanced GC who were treated with previous systemic chemotherapy were screened retrospectively. Eligible patients were administered with apatinib combined with PD-1 blockade treatment. Efficacy of the patients was assessed with the change of target lesion using radiological evidence according to RECIST 1.1 criteria, and follow-up was carried out regularly. A safety profile was collected and documented during the combination treatment. Univariate analysis based on baseline characteristic subgroup was implemented in univariate analysis to identify the potential factor that might contribute to progression-free survival (PFS). RESULTS: Between August 2018 and October 2021, a total of 39 patients with advanced GC or gastroesophageal junction adenocarcinoma participated in this study consecutively and all the patients were available for efficacy and safety assessment. The best overall response during apatinib plus PD-1 blockade administration exhibited that PR was observed in 8 patients, SD was noted in 19 patients, and PD was found in 12 patients, which yielded an ORR of 20.5% (95% CI: 9.3%-36.5%), and DCR was 69.2% (95% CI: 52.4%-83.0%). Furthermore, the relatively enough follow-up had resulted in the mature PFS and overall survival (OS) data, suggesting that the median PFS of the 39 patients with advanced GC was 3.9 months (95% CI: 2.74-5.06). Additionally, the median OS of the 39 patients with advanced GC was 7.8 months (95% CI: 4.82-10.78). Furthermore, the most common adverse reactions of the 39 patients who received apatinib plus PD-1 blockades treatment were fatigue (61.5%), nausea and vomiting (56.4%), diarrhea (48.7%), hypertension (46.2%), hand-foot syndrome (38.5%), and rash (28.2%). Furthermore, performance status was independently associated with PFS of apatinib plus PD-1 inhibitor combination administration in baseline characteristic subgroup analysis. CONCLUSION: Apatinib plus PD-1 inhibitors exhibited promising effectiveness and acceptable tolerance for previously treated advanced GC preliminarily. And this conclusion should be confirmed in clinical trials in the future.
背景：阿帕替尼已被确立为三线治疗先前治疗的晚期胃癌（GC）患者的标准治疗方法。程序性死亡蛋白 1（PD-1）阻断剂也显示出对治疗难治性晚期 GC 患者的良好疗效和安全性。
目的：本研究旨在探讨阿帕替尼联合 PD-1 抑制剂治疗先前治疗的晚期 GC 患者的可行性和耐受性。
方法：本研究为真实世界研究；回顾性筛选接受过先前全身化疗的晚期 GC 患者。符合条件的患者接受阿帕替尼联合 PD-1 阻断治疗。根据 RECIST 1.1 标准，使用影像学证据评估目标病变的变化来评估患者的疗效，并定期进行随访。在联合治疗期间收集并记录安全性概况。基于基线特征亚组的单因素分析用于单因素分析，以确定可能与无进展生存期（PFS）相关的潜在因素。
结果：2018 年 8 月至 2021 年 10 月，共有 39 例晚期 GC 或胃食管交界处腺癌患者连续入组本研究，所有患者均可进行疗效和安全性评估。阿帕替尼联合 PD-1 阻断治疗期间最佳总体缓解表现为 8 例患者观察到 PR，19 例患者观察到 SD，12 例患者观察到 PD，ORR 为 20.5%（95%CI：9.3%-36.5%），DCR 为 69.2%（95%CI：52.4%-83.0%）。此外，足够的随访时间产生了成熟的 PFS 和 OS 数据，提示 39 例晚期 GC 患者的中位 PFS 为 3.9 个月（95%CI：2.74-5.06）。此外，39 例晚期 GC 患者的中位 OS 为 7.8 个月（95%CI：4.82-10.78）。此外，接受阿帕替尼联合 PD-1 阻断治疗的 39 例患者最常见的不良反应为乏力（61.5%）、恶心呕吐（56.4%）、腹泻（48.7%）、高血压（46.2%）、手足综合征（38.5%）和皮疹（28.2%）。此外，在基线特征亚组分析中，体力状况与阿帕替尼联合 PD-1 抑制剂联合治疗的 PFS 独立相关。
结论：阿帕替尼联合 PD-1 抑制剂对先前治疗的晚期 GC 具有良好的疗效和可接受的耐受性，这一结论需要在未来的临床试验中得到证实。
CA Cancer J Clin. 2021-5
Pathol Res Pract. 2021-2
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