Furusawa Kyoko, Furuta Mitsuhiro, Onishi Misa, Hama Takanori, Ishikawa Shuntaro, Hayashi Kei, Nakanoma Hiroshi, Shiotsuki Kazuo, Takizawa Kohei, Machida Nozomu, Furuse Junji, Maeda Shin
Department of Gastroenterology, Kanagawa Cancer Center, Yokohama, Japan.
Department of Gastroenterology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.
Anticancer Res. 2025 Apr;45(4):1583-1592. doi: 10.21873/anticanres.17539.
BACKGROUND/AIM: Based on the CheckMate 649 study, nivolumab plus chemotherapy is the first-line treatment for human epidermal growth factor receptor 2-negative advanced gastric cancer (AGC). 5-fluorouracil/leucovorin+oxaliplatin (FOLFOX) is often used for patients with AGC with severe peritoneal metastasis (PM) who cannot tolerate oral intake. Nivolumab monotherapy has shown efficacy against PM. However, the efficacy and safety of nivolumab plus FOLFOX (NIVO+FOLFOX) remain unclear.
We retrospectively examined 15 patients with AGC with severe peritoneal metastasis who received NIVO+FOLFOX between January 2022 and December 2023 at our institution. Severe PM was defined as massive ascites and/or inadequate oral intake.
Patients had a median age of 68 years, with 73.3% being male. Eastern Cooperative Oncology Group Performance Status 2 was observed in 20% of patients. Massive ascites was present in 86.7%, and 26.7% had inadequate oral intake. Combined positive score ≥5 was observed in 60%, and no patient had microsatellite instability-high. Median progression-free survival was 4.2 months [95% confidence interval (CI)=0.62-10.6], and median overall survival was 4.5 months (95%CI=1.48-22.5). Despite poor overall prognosis, 20.0% achieved disease control beyond 1 year. Of 13 patients with massive ascites, 38.5% responded, and 30.7% achieved complete ascites resolution. Grade ≥3 immune-related adverse events included sialadenitis, myocarditis, and hepatitis (n=1 each). No treatment-related deaths occurred.
NIVO+FOLFOX was feasible for patients with AGC with severe PM, providing potential for long-term survival and ascites reduction.
背景/目的：基于CheckMate 649研究，纳武利尤单抗联合化疗是表皮生长因子受体2阴性晚期胃癌（AGC）的一线治疗方案。5-氟尿嘧啶/亚叶酸钙+奥沙利铂（FOLFOX）常用于无法耐受口服给药的重度腹膜转移（PM）AGC患者。纳武利尤单抗单药治疗已显示出对PM的疗效。然而，纳武利尤单抗联合FOLFOX（NIVO+FOLFOX）的疗效和安全性仍不明确。
我们回顾性研究了2022年1月至2023年12月期间在我院接受NIVO+FOLFOX治疗的15例重度腹膜转移AGC患者。重度PM定义为大量腹水和/或口服摄入不足。
患者的中位年龄为68岁，73.3%为男性。20%的患者东部肿瘤协作组体能状态为2。86.7%的患者存在大量腹水，26.7%的患者口服摄入不足。60%的患者联合阳性评分≥5，无患者为微卫星高度不稳定。中位无进展生存期为4.2个月[95%置信区间（CI）=0.62-10.6]，中位总生存期为4.5个月（95%CI=1.48-22.5）。尽管总体预后较差，但20.0%的患者疾病控制超过1年。在13例大量腹水患者中，38.5%有反应，30.7%腹水完全消退。≥3级免疫相关不良事件包括涎腺炎、心肌炎和肝炎（各1例）。未发生与治疗相关的死亡。
NIVO+FOLFOX对重度PM的AGC患者可行，为长期生存和减少腹水提供了可能。
