Department of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.
Cancer Chemotherapy Center, Osaka Medical and Pharmaceutical University, Takatsuki, Osaka, Japan.
Cancer Med. 2024 Jun;13(12):e7401. doi: 10.1002/cam4.7401.
Nivolumab was approved for the treatment of advanced gastric cancer in 2017 in Japan. The aim of this study was to assess the impact of nivolumab in a real-world clinical setting.
This single-institutional retrospective study included patients with advanced gastric or esophagogastric junction adenocarcinoma and a history of first-line chemotherapy with platinum-based doublet or triplet regimens between 2010 and 2020. To assess the impact of nivolumab on survival, the patients were divided based on the year of nivolumab approval into a pre-2017 (2010-2016) group and a post-2017 (2017-2020) group.
From a total of 1918 patients, 1093 were excluded. There were 533 patients in the pre-2017 group and 292 in the post-2017 group. Immune checkpoint inhibitors were used significantly more often in the post-2017 group than in the pre-2017 group (8.6% vs. 47.9%). Median overall survival was significantly longer in the post-2017 group (16.9 vs. 13.9 months; hazard ratio [HR] 0.75, 95% confidence interval [CI] 0.63-0.90; p < 0.01). The proportion of patients transitioning to third-line treatment was higher in the post-2017 group than in the pre-2017 group (56.3% vs. 43.8%, p < 0.01). Median survival outcomes following progression on second-line treatment were significantly longer in the post-2017 group (4.3 vs. 3.2 months; HR 0.70, 95% CI 0.57-0.86; p < 0.01).
The proportion of patients transitioning to third-line treatment and survival outcomes following progression on second-line treatment have improved since the approval of nivolumab. This drug might help to prolong overall survival in real-world practice.
纳武利尤单抗于 2017 年在日本被批准用于治疗晚期胃癌。本研究的目的是评估纳武利尤单抗在真实临床环境中的影响。
这是一项单机构回顾性研究,纳入了 2010 年至 2020 年间接受过一线含铂双药或三药方案化疗的晚期胃或胃食管交界处腺癌患者。为了评估纳武利尤单抗对生存的影响,根据纳武利尤单抗批准年份将患者分为 2017 年前(2010-2016 年)组和 2017 年后(2017-2020 年)组。
共纳入 1918 例患者,其中 1093 例被排除。2017 年前组 533 例,2017 年后组 292 例。2017 年后组免疫检查点抑制剂的使用率明显高于 2017 年前组(8.6%比 47.9%)。2017 年后组中位总生存期明显长于 2017 年前组(16.9 比 13.9 个月;风险比 [HR]0.75,95%置信区间 [CI]0.63-0.90;p<0.01)。2017 年后组进展后转用三线治疗的患者比例高于 2017 年前组(56.3%比 43.8%;p<0.01)。2017 年后组二线治疗进展后的中位生存时间明显长于 2017 年前组(4.3 比 3.2 个月;HR0.70,95%CI0.57-0.86;p<0.01)。
自纳武利尤单抗批准以来,转用三线治疗的患者比例和二线治疗进展后的生存结果有所改善。该药物可能有助于延长真实世界中的总生存期。