Department of Internal Medicine III with Haematology, Medical Oncology, Haemostaseology, Infectiology and Rheumatology, Oncologic Center, Salzburg Cancer Research Institute - Laboratory for Immunological and Molecular Cancer Research (SCRI-LIMCR), Center for Clinical Cancer and Immunology Trials (CCCIT), Paracelsus Medical University, Salzburg, Austria.
Department of Internal Medicine II, Academic Teaching Hospital Feldkirch, Feldkirch, Austria.
BMC Cancer. 2022 Jan 10;22(1):51. doi: 10.1186/s12885-021-09115-6.
Safety and efficacy of immune checkpoint inhibitors in advanced gastric or gastroesophageal junction (GEJ) cancer could be demonstrated in predominantly Asian cohorts, whereas data in Western patients outside of clinical trials are vastly missing.
In this multi-institutional retrospective analysis conducted at nine oncologic centers in Austria, we tried to assess feasibility of checkpoint inhibitors in advanced gastric/GEJ cancer in a real-world Western cohort.
In total, data from 50 patients with metastatic gastric/GEJ cancer who received nivolumab or pembrolizumab in a palliative setting between November 2015 and April 2020 have been evaluated. The median number of previous palliative therapy lines was two. The median progression-free survival (PFS) and overall survival (OS) were 2.1 (95% CI: 1.4-2.8) and 6.3 (95% CI: 3.3-9.3) months, respectively. There was no statistically significant difference in median OS according to microsatellite or PD-L1 status. However, a trend towards prolonged PFS and OS for the microsatellite instability high subgroup could be observed. Patients with an ECOG Performance Status (PS) ≥ 2 displayed a significantly worse outcome than those with an ECOG PS ≤ 1 (p = .03). Only one patient discontinued immunotherapy due to treatment-related toxicity.
Our results support feasibility of nivolumab and pembrolizumab in pre-treated patients with metastatic gastric and GEJ cancer in a Western real-world cohort. Further phase II/III studies are needed to confirm clinical efficacy.
免疫检查点抑制剂在晚期胃癌或胃食管结合部（GEJ）癌中的安全性和疗效在主要为亚洲人群的研究中得到了证实，而在临床试验之外的西方患者中，相关数据则非常缺乏。
本项在奥地利 9 家肿瘤中心进行的多机构回顾性分析，旨在评估免疫检查点抑制剂在晚期胃癌/GEJ 癌的西方真实世界队列中的可行性。
共评估了 50 例接受nivolumab 或 pembrolizumab 姑息治疗的转移性胃/GEJ 癌患者的数据。这些患者的治疗线中位数为 2 条。中位无进展生存期（PFS）和总生存期（OS）分别为 2.1（95%CI：1.4-2.8）和 6.3（95%CI：3.3-9.3）个月。微卫星状态或 PD-L1 状态与中位 OS 无统计学差异。然而，微卫星不稳定性高亚组的 PFS 和 OS 有延长趋势。ECOG 体能状态（PS）≥2 的患者的结局明显差于 PS≤1 的患者（p=0.03）。仅有 1 例患者因治疗相关毒性而停止免疫治疗。
我们的结果支持 nivolumab 和 pembrolizumab 在晚期胃和 GEJ 癌的西方真实世界队列中具有可行性。需要进一步的 II/III 期研究来确认临床疗效。
