Department of Oncology, Eastern Hepatobiliary Surgery Hospital, Naval Medical University, Shanghai, China.
Department of Special Treatment I and Liver Transplantation, Eastern Hepatobiliary Surgery Hospital, Naval Medical University, Shanghai, China.
Cancer Sci. 2024 Jun;115(6):1979-1988. doi: 10.1111/cas.16142. Epub 2024 Mar 15.
Immune checkpoint inhibitors (ICIs) have shown promising efficacy in multiple cancers including biliary tract cancers (BTCs). However, the data focusing on the efficacy of ICIs in patients with gallbladder cancer (GBC) is still limited. In this study, we aim to assess the efficacy of ICIs in GBC and explore the clinicopathologic and molecular markers associated with ICI benefit. We retrospective analyzed 69 GBC patients who had received ICI therapy between January 2016 and December 2020. Tumor samples were obtained for genomic sequencing and immunohistochemical analysis. The median progression-free survival (PFS) and overall survival (OS) was 4.4 months and 8.5 months, respectively. Multivariate analysis indicated that alcohol intake history, carcinoma embryonic antigen (CEA) level ≥100 U/mL, and cutaneous immune-related adverse events (irAEs) were independent prognostic factors for PFS. CEA level ≥100 U/mL and cutaneous irAEs were independent prognostic factors for OS. The objective response rate and disease control rate (DCR) were 15.9% and 37.7%, respectively. Patients with cutaneous irAEs, high CD8 T cell infiltrated or immune inflamed GBCs had higher DCR. Patients with high CD8 T cell infiltrated or immune inflamed GBCs also had a notably improved prognosis. These results suggest that ICIs were effective in patients with GBC. High CEA level, cutaneous irAEs, high CD8 T cell infiltration, and immune inflamed phenotype could be useful for predicting the efficacy of ICIs in GBC.
免疫检查点抑制剂（ICIs）在多种癌症中显示出了有希望的疗效，包括胆道癌（BTCs）。然而，关于 ICI 在胆囊癌（GBC）患者中的疗效的数据仍然有限。在这项研究中，我们旨在评估 ICI 在 GBC 中的疗效，并探讨与 ICI 获益相关的临床病理和分子标志物。我们回顾性分析了 2016 年 1 月至 2020 年 12 月期间接受 ICI 治疗的 69 例 GBC 患者。获取肿瘤样本进行基因组测序和免疫组化分析。中位无进展生存期（PFS）和总生存期（OS）分别为 4.4 个月和 8.5 个月。多变量分析表明，饮酒史、癌胚抗原（CEA）水平≥100 U/mL 和皮肤免疫相关不良事件（irAEs）是 PFS 的独立预后因素。CEA 水平≥100 U/mL 和皮肤 irAEs 是 OS 的独立预后因素。客观缓解率和疾病控制率（DCR）分别为 15.9%和 37.7%。发生皮肤 irAEs、高 CD8 T 细胞浸润或免疫浸润性 GBC 的患者 DCR 更高。高 CD8 T 细胞浸润或免疫浸润性 GBC 的患者预后也显著改善。这些结果表明 ICI 对 GBC 患者有效。高 CEA 水平、皮肤 irAEs、高 CD8 T 细胞浸润和免疫浸润表型可能有助于预测 ICI 在 GBC 中的疗效。
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