This study aimed to evaluate the efficacy and safety of the combination of sintilimab and apatinib for the treatment of patients with advanced or metastatic gastric cancer (GC) and gastroesophageal junction (GEJ) cancer. This retrospective study analyzed data from 34 patients who had advanced or metastatic GC/GEJ cancer and received the combination therapy of sintilimab and apatinib as a third-line or above treatment. The primary endpoint was progression-free survival (PFS), and secondary endpoints included objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety. Among the 34 patients, none achieved a complete response (CR), 3 patients (8.8%) achieved a partial response, 23 patients (67.6%) had stable disease, and 8 patients (23.5%) experienced progressive disease. The ORR and DCR were 8.8% and 76.5%, respectively. The median PFS was 6.0 months (95% CI: 3.6-8.4), and the median OS was 11.6 months (95% CI: 8.1-15.1). Subgroup analysis revealed significant differences in OS between patients with high and low Eastern Cooperative Oncology Group Performance Status scores and between patients with and without a history of gastrectomy. Common adverse events (AEs) during treatment included fatigue (52.9%), anemia (47.1%), leukopenia (26.5%), hypothyroidism (23.5%), nausea and vomiting (20.6%), neutropenia (20.6%), and thrombocytopenia (17.6%), most of which were grade 1 and 2 AEs. No deaths occurred due to AEs. These findings indicate that the combination of sintilimab and apatinib has a favorable therapeutic effect in patients with advanced GC. Moreover, the AEs associated with this therapy are generally manageable.

中文翻译：

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信迪利单抗联合阿帕替尼三线及以上治疗晚期或转移性胃癌的疗效和安全性

本研究旨在评估信迪利单抗和阿帕替尼联合治疗晚期或转移性胃癌（GC）和胃食管交界处（GEJ）癌患者的有效性和安全性。这项回顾性研究分析了 34 例晚期或转移性 GC/GEJ 癌并接受信迪利单抗和阿帕替尼联合治疗作为三线或以上治疗的患者的数据。主要终点是无进展生存期（PFS），次要终点包括客观缓解率（ORR）、疾病控制率（DCR）、总生存期（OS）和安全性。在34名患者中，没有人获得完全缓解（CR），3名患者（8.8%）获得部分缓解，23名患者（67.6%）疾病稳定，8名患者（23.5%）疾病进展。ORR 和 DCR 分别为 8.8% 和 76.5%。中位 PFS 为 6.0 个月（95% CI：3.6-8.4），中位 OS 为 11.6 个月（95% CI：8.1-15.1）。亚组分析显示，东部肿瘤合作组表现状态评分高和低的患者之间以及有或没有胃切除史的患者之间的 OS 存在显着差异。治疗期间常见的不良事件（AE）包括疲劳（52.9%）、贫血（47.1%）、白细胞减少（26.5%）、甲状腺功能减退（23.5%）、恶心和呕吐（2​​0.6%）、中性粒细胞减少（20.6%）和血小板减少。 17.6%），其中大部分为 1 级和 2 级 AE。没有发生因 AE 导致的死亡。这些结果表明信迪利单抗和阿帕替尼联合治疗晚期GC患者具有良好的治疗效果。此外，与该疗法相关的不良事件通常是可以控制的。