Hojo Yudai, Tomita Toshihiko, Igeta Masataka, Murakami Motoki, Kohno Shugo, Nakao Eiichiro, Kitayama Yoshitaka, Nakamura Tatsuro, Kurahashi Yasunori, Ishida Yoshinori, Hirota Seiichi, Shinzaki Shinichiro, Shinohara Hisashi
Department of Gastroenterological Surgery, Faculty of Medicine, Hyogo Medical University, Nishinomiya, Japan.
Department of Gastroenterology, Faculty of Medicine, Hyogo Medical University, Nishinomiya, Japan.
Anticancer Res. 2025 May;45(5):2091-2102. doi: 10.21873/anticanres.17583.
BACKGROUND/AIM: The approval of first-line nivolumab plus chemotherapy marks a breakthrough in treating human epidermal growth factor receptor 2 (HER2)-negative unresectable advanced gastric and gastroesophageal junction (G/GEJ) cancer. This study aimed to evaluate the impact of nivolumab plus chemotherapy on conversion therapy in clinical stage (cStage) IVB HER2-negative G/GEJ adenocarcinoma.
Patients with cStage IVB HER2-negative G/GEJ adenocarcinoma who underwent systemic chemotherapy at Hyogo Medical University Hospital from January 2017 to March 2023 were included. Nivolumab plus chemotherapy was initiated following its approval in Japan in November 2021. Conversion surgery (CS) was performed when distant metastases had disappeared, except for resectable liver metastases.
In total, 103 patients were eligible: 28 received nivolumab plus chemotherapy, and 75 received chemotherapy as first-line treatment. The conversion rate in the nivolumab plus chemotherapy group was significantly higher than that in the chemotherapy group (28.6% 8.0%, =0.011). Multivariate analysis revealed a significant association between first-line nivolumab plus chemotherapy and undergoing CS [odds ratio=3.540, 95% confidence interval (CI)=1.059-12.157]. R0 resection was achieved in all eight patients who underwent CS, and delayed immune-related adverse events did not occur perioperatively. In the nivolumab plus chemotherapy group, the median survival time in patients who underwent CS was significantly longer than that in patients treated with chemotherapy alone [not reached (95%CI=22.7-not reached) 11.8 months (95%CI=5.1-33.3), =0.035].
First-line nivolumab plus chemotherapy increased the conversion rate compared with chemotherapy in patients with cStage IVB HER2-negative G/GEJ adenocarcinoma. CS following nivolumab plus chemotherapy was safe, and patients who underwent CS survived longer than those who received chemotherapy alone.
背景/目的：一线纳武利尤单抗联合化疗的获批标志着在治疗人表皮生长因子受体2（HER2）阴性不可切除的晚期胃癌和胃食管交界（G/GEJ）癌方面取得了突破。本研究旨在评估纳武利尤单抗联合化疗对临床分期（cStage）IVB期HER2阴性G/GEJ腺癌转化治疗的影响。
纳入2017年1月至2023年3月在兵库医科大学医院接受全身化疗的cStage IVB期HER2阴性G/GEJ腺癌患者。纳武利尤单抗联合化疗于2021年11月在日本获批后开始应用。当远处转移消失（可切除的肝转移除外）时进行转化手术（CS）。
总共103例患者符合条件：28例接受纳武利尤单抗联合化疗，75例接受化疗作为一线治疗。纳武利尤单抗联合化疗组的转化率显著高于化疗组（28.6%对8.0%，P=0.011）。多因素分析显示一线纳武利尤单抗联合化疗与接受CS之间存在显著关联[比值比=3.540，95%置信区间（CI）=1.059-12.157]。所有8例接受CS的患者均实现了R0切除，围手术期未发生延迟性免疫相关不良事件。在纳武利尤单抗联合化疗组中，接受CS的患者的中位生存时间显著长于单纯接受化疗的患者[未达到（95%CI=22.7-未达到）对11.8个月（95%CI=5.1-33.3），P=0.035]。
与化疗相比，一线纳武利尤单抗联合化疗提高了cStage IVB期HER2阴性G/GEJ腺癌患者的转化率。纳武利尤单抗联合化疗后的CS是安全的，接受CS的患者比单纯接受化疗的患者存活时间更长。
