Department of Gastroenterological Chemotherapy, Cancer Institute Hospital of Japanese Foundation for Cancer Research, 3-8-31 Ariake, Koto-Ku, Tokyo, 135-8550, Japan.
Department of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.
Gastric Cancer. 2022 Jan;25(1):245-253. doi: 10.1007/s10120-021-01244-y. Epub 2021 Sep 28.
This postmarketing surveillance study evaluated the real-world safety and effectiveness of nivolumab as salvage (after ≥ 2 lines) therapy in Japanese patients with unresectable advanced or recurrent gastric/gastroesophageal junction (G/GEJ) cancer.
This multicenter, observational study was conducted at 158 centers in Japan. Patients with unresectable advanced or recurrent G/GEJ cancer were registered between Nov 1, 2017, and Oct 31, 2018, and observed for 6 months after treatment initiation with nivolumab. Correlation of background characteristics with treatment-related adverse events (TRAEs) and tumor response was explored.
Overall, 654 patients were registered (safety analysis set, n = 650; effectiveness analysis set, n = 636; response evaluation set, n = 516). The incidences of all TRAEs and grade ≥ 3 TRAEs were 31.5 and 11.2%, respectively. TRAEs significantly correlated with the absence of peritoneal metastasis; C-reactive protein level < 1; prior G/GEJ cancer surgery; and past or concomitant pulmonary, thyroid, or renal disease (each p < 0.05). The incidence of TRAEs was significantly lower in patients with higher Glasgow prognostic scores (p < 0.05). No new safety signals were observed. Complete response, partial response, stable disease, and progressive disease were observed in 1.2, 10.1, 27.1, and 58.3% of the response evaluation set, respectively. Patients aged ≥ 65 years (13.9 vs 5.3%, p = 0.0083) and ≥ 75 years (18.8 vs 9.2%, p = 0.0036) showed a higher response rate than their younger counterparts.
The real-world safety and effectiveness of nivolumab as salvage (after ≥ 2 lines) therapy in Japanese patients with unresectable advanced or recurrent G/GEJ cancer were consistent with those observed in the phase 3 ATTRACTION-2 study.
本项上市后监测研究评估了纳武利尤单抗作为挽救（二线及以上）疗法在日本不可切除的晚期或复发性胃/胃食管交界处（G/GEJ）癌患者中的真实世界安全性和有效性。
本项多中心、观察性研究在日本的 158 家中心开展。2017 年 11 月 1 日至 2018 年 10 月 31 日期间，登记不可切除的晚期或复发性 G/GEJ 癌患者，并在开始纳武利尤单抗治疗后 6 个月进行观察。对患者的背景特征与治疗相关不良事件（TRAEs）和肿瘤反应的相关性进行了探讨。
共登记了 654 例患者（安全性分析集，n=650；有效性分析集，n=636；疗效评价集，n=516）。所有 TRAEs 和≥3 级 TRAEs 的发生率分别为 31.5%和 11.2%。TRAEs 与无腹膜转移、C 反应蛋白水平<1、既往 G/GEJ 癌手术、既往或同时存在肺部、甲状腺或肾脏疾病显著相关（均 p<0.05）。格拉斯哥预后评分较高的患者 TRAEs 发生率显著降低（p<0.05）。未观察到新的安全性信号。疗效评价集分别有 1.2%、10.1%、27.1%和 58.3%的患者观察到完全缓解、部分缓解、疾病稳定和疾病进展。年龄≥65 岁（13.9%比 5.3%，p=0.0083）和≥75 岁（18.8%比 9.2%，p=0.0036）的患者比年轻患者的缓解率更高。
纳武利尤单抗作为不可切除的晚期或复发性 G/GEJ 癌日本患者的挽救（二线及以上）疗法，其真实世界安全性和有效性与 III 期 ATTRACTION-2 研究观察到的结果一致。
