Division of General Surgery, Department of Surgery, Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Kaohsiung, 833, Taiwan.
Department of Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Kaohsiung, 833, Taiwan.
BMC Cancer. 2024 Oct 28;24(1):1325. doi: 10.1186/s12885-024-13066-z.
The aim of this study is to investigate the real-world efficacy and safety of nivolumab in combination with chemotherapy for patients with advanced human epidermal growth factor receptor 2 (HER2)-negative gastric cancer (GC).
We enrolled patients diagnosed with unresectable advanced or metastatic GC who received nivolumab plus chemotherapy as first-line systemic treatment. The combined positive score (CPS), indicating the number of programmed cell death-ligand 1 (PD-L1)-stained cells, was utilized. Progression-free survival (PFS) and overall survival (OS) were analyzed using the Kaplan-Meier method. Adverse events (AEs) were graded, and treatment was ceased upon disease progression or intolerance.
A total of 27 patients were included in the study, comprising 15 patients with CPS ≥ 5 and 12 patients with CPS < 5. The objective response rate (ORR) was 55.6%, with a disease control rate (DCR) of 74.1%. Patients in the CPS ≥ 5 group exhibited higher ORR and DCR compared to those in the CPS < 5 group. Median PFS and OS were 6.1 months and 14.6 months, respectively; patients with CPS ≥ 5 showed a trend towards better PFS and OS than those with CPS < 5. Most AEs were grade 1-2, with a few instances of grade 3-4 toxicities reported, including neutropenia, thrombocytopenia, diarrhea, and anemia. There were no grade 5 AEs reported in our cohort. Furthermore, 64.7% of patients received subsequent anticancer treatment following disease progression on nivolumab plus chemotherapy.
The results of our study demonstrate the efficacy and safety of nivolumab plus chemotherapy in real-world practice support its adoption as a new standard first-line treatment for patients with advanced HER2-negative GC, particularly those with CPS ≥ 5.
本研究旨在探讨纳武利尤单抗联合化疗治疗晚期人表皮生长因子受体 2（HER2）阴性胃癌（GC）患者的真实世界疗效和安全性。
我们纳入了接受纳武利尤单抗联合化疗作为一线全身治疗的不可切除的晚期或转移性 GC 患者。采用联合阳性评分（CPS），即程序性死亡配体 1（PD-L1）染色细胞的数量。采用 Kaplan-Meier 法分析无进展生存期（PFS）和总生存期（OS）。根据不良反应（AE）分级标准，在疾病进展或不耐受时停止治疗。
本研究共纳入 27 例患者，其中 CPS≥5 者 15 例，CPS<5 者 12 例。客观缓解率（ORR）为 55.6%，疾病控制率（DCR）为 74.1%。CPS≥5 组的 ORR 和 DCR 均高于 CPS<5 组。中位 PFS 和 OS 分别为 6.1 个月和 14.6 个月；CPS≥5 组的 PFS 和 OS 有改善趋势。大多数 AE 为 1-2 级，少数报告 3-4 级毒性，包括中性粒细胞减少、血小板减少、腹泻和贫血。本队列未报告 5 级 AE。此外，64.7%的患者在纳武利尤单抗联合化疗后疾病进展时接受了后续抗癌治疗。
本研究结果表明，纳武利尤单抗联合化疗在真实世界实践中的疗效和安全性良好，支持其作为晚期 HER2 阴性 GC 患者的新一线治疗标准，尤其是 CPS≥5 的患者。
