Kadowaki Shigenori, Otsuka Tomoyuki, Minashi Keiko, Nishina Shinichi, Yabusaki Hiroshi, Inagaki Chiaki, Nishina Tomohiro, Yasui Hisateru, Matsuoka Hiroshi, Machida Nozomu, Tsuda Masahiro, Nagashima Fumio, Hosaka Hisashi, Matsubara Junichi, Arai Hiroyuki, Ida Satoshi, Kimijima Yuya, Matsuda Yuko, Muto Manabu, Muro Kei
Department of Clinical Oncology, Aichi Cancer Center Hospital, Aichi, Japan.
Department of Medical Oncology, Osaka International Cancer Institute, Osaka, Japan.
Gastric Cancer. 2025 Jul 9. doi: 10.1007/s10120-025-01641-7.
Nivolumab plus chemotherapy has shown efficacy in clinical trials for advanced or recurrent gastric cancer (GC). However, real-world utilization data are limited. In this study, we aimed to assess the effectiveness, safety, and treatment status of first line nivolumab plus chemotherapy in Japanese patients with treatment-naïve advanced or recurrent GC.
Untreated patients with advanced or recurrent GC who initiated nivolumab plus chemotherapy as first line treatment from November 2021 to June 2023 across 23 Japanese sites were enrolled in this observational study (G-KNIGHT). This report focused on the objective response rate (ORR), real-world progression-free survival (rwPFS), and the treatment-related adverse event (TRAE) incidence. Furthermore, subgroup analyses for ORR and rwPFS were conducted for patients stratified by various factors including age and the programmed cell death ligand 1 (PD-L1) combined positive score (CPS).
Among 527 patients (median age, 70.3 years; 25.2% aged ≥ 75 years; 65.5% male; 84.3% with advanced GC), the median follow-up period was 10.4 (interquartile range, 6.7-15.2) months. The ORR was 65.6% (95% confidence interval [CI], 59.9-70.9%). The median rwPFS (months, 95% CI) was 6.9 (6.2-7.6); by subgroups: age < 75 years, 6.7 (6.0-7.5); age ≥ 75 years, 7.4 (6.2-8.6); PD-L1 CPS < 1, 7.5 (6.5-9.0); CPS 1-5, 6.2 (5.5-8.0); and CPS ≥ 5, 7.0 (6.2-8.2). TRAEs occurred in 91.3% of patients, with 40.4% experiencing grade ≥ 3 events.
This large-scale real-world study supports the effectiveness and safety of nivolumab plus chemotherapy in untreated Japanese patients with advanced or recurrent GC.
纳武利尤单抗联合化疗在晚期或复发性胃癌（GC）的临床试验中已显示出疗效。然而，真实世界的应用数据有限。在本研究中，我们旨在评估一线纳武利尤单抗联合化疗在初治的日本晚期或复发性GC患者中的有效性、安全性和治疗状况。
本观察性研究（G-KNIGHT）纳入了2021年11月至2023年6月期间在日本23个地点开始接受纳武利尤单抗联合化疗作为一线治疗的未经治疗的晚期或复发性GC患者。本报告重点关注客观缓解率（ORR）、真实世界无进展生存期（rwPFS）和治疗相关不良事件（TRAE）发生率。此外，还对按年龄和程序性细胞死亡配体1（PD-L1）联合阳性评分（CPS）等各种因素分层的患者进行了ORR和rwPFS的亚组分析。
在527例患者中（中位年龄70.3岁；25.2%年龄≥75岁；65.5%为男性；84.3%为晚期GC），中位随访期为10.4（四分位间距，6.7 - 15.2）个月。ORR为65.6%（95%置信区间[CI]，59.9 - 70.9%）。中位rwPFS（月，95%CI）为6.9（6.2 - 7.6）；按亚组划分：年龄<75岁，6.7（6.0 - 7.5）；年龄≥75岁，7.4（6.2 - 8.6）；PD-L1 CPS<1，7.5（6.5 - 9.0）；CPS 1 - 5，6.2（5.5 - 8.0）；CPS≥5，7.0（6.2 - 8.2）。91.3%的患者发生了TRAE，40.4%的患者经历了≥3级事件。
这项大规模真实世界研究支持纳武利尤单抗联合化疗在未经治疗的日本晚期或复发性GC患者中的有效性和安全性。
