Department of Gastroenterology, The Second Hospital of Hebei Medical University, No. 215 Heping Road, Shiijazhuang, 050000, China.
Department of Gastroenterology, Handan Central Hospital, Handan, China.
J Cancer Res Clin Oncol. 2023 Jul;149(7):4091-4099. doi: 10.1007/s00432-022-04302-9. Epub 2022 Aug 30.
Programmed cell death protein 1 (PD-1) inhibitor and apatinib have been utilized in metastatic gastric cancer patients. The current study aimed to further investigate the efficacy and safety of neoadjuvant S-1 plus oxaliplatin combined with PD-1 inhibitor and apatinib (SOXPA) in locally advanced gastric cancer (LAGC) patients.
This two-centered, prospective, cohort study analyzed 30 resectable LAGC patients receiving SOXPA as neoadjuvant therapy.
Two (6.7%), 18 (60.0%), and 10 (33.3%) patients achieved complete response (CR), partial response (PR), and stable disease (SD), separately. The objective response rate (ORR) and disease control rate (DCR) were 66.7% and 100.0%, respectively. The R0 resection rate was 93.3%. Beyond that, 6 (20.0%), 18 (60.0%), and 6 (20.0%) patients achieved grade 1, 2, and 3 pathological responses. The pathological complete response (pCR) rate was 20%. The 1-year and 2-year disease-free survival (DFS) rates were 96.6% and 77.7% respectively; meanwhile, the 1-year and 2-year overall survival (OS) rates were 96.6% and 90.1%, separately. What's more, better clinical response (P = 0.046); achievement of ORR (P = 0.014), and better pathological response (P = 0.020) were correlated with longer DFS. Besides, ORR achievement was linked with longer OS (P = 0.040). Most adverse events were relatively mild and manageable. Grade 3 adverse events included leukopenia, anemia, neutropenia, fatigue, hand-foot syndrome, nausea and vomiting. No grade 4 adverse events were witnessed.
SOXPA as neoadjuvant therapy achieves a satisfying clinical response, pathological response, survival profile, and tolerable safety in LAGC patients.
程序性死亡蛋白 1（PD-1）抑制剂和阿帕替尼已用于转移性胃癌患者。本研究旨在进一步探讨新辅助 S-1 联合奥沙利铂联合 PD-1 抑制剂和阿帕替尼（SOXPA）在局部晚期胃癌（LAGC）患者中的疗效和安全性。
这是一项两中心、前瞻性、队列研究，分析了 30 例接受 SOXPA 作为新辅助治疗的可切除 LAGC 患者。
2 例（6.7%）、18 例（60.0%）和 10 例（33.3%）患者分别达到完全缓解（CR）、部分缓解（PR）和稳定疾病（SD）。客观缓解率（ORR）和疾病控制率（DCR）分别为 66.7%和 100.0%。R0 切除率为 93.3%。此外，6 例（20.0%）、18 例（60.0%）和 6 例（20.0%）患者的病理反应分别达到 1 级、2 级和 3 级。病理完全缓解（pCR）率为 20%。1 年和 2 年无病生存率（DFS）分别为 96.6%和 77.7%；1 年和 2 年总生存率（OS）分别为 96.6%和 90.1%。更重要的是，更好的临床反应（P=0.046）、ORR 的实现（P=0.014）和更好的病理反应（P=0.020）与更长的 DFS 相关。此外，ORR 的实现与更长的 OS 相关（P=0.040）。大多数不良事件相对较轻且可管理。3 级不良事件包括白细胞减少、贫血、中性粒细胞减少、疲劳、手足综合征、恶心和呕吐。未观察到 4 级不良事件。
SOXPA 作为新辅助治疗在 LAGC 患者中取得了令人满意的临床反应、病理反应、生存情况和可耐受的安全性。
