接受程序性死亡蛋白-1 靶向免疫治疗的晚期肝内胆管癌患者的真实世界结局。

Real-world outcomes of patients with advanced intrahepatic cholangiocarcinoma treated with programmed cell death protein-1-targeted immunotherapy.

机构信息

Department of Liver Surgery, Sun Yat-sen University Cancer Center, Guangzhou, China.

State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.

出版信息

Ann Med. 2022 Dec;54(1):803-811. doi: 10.1080/07853890.2022.2048416.

DOI:10.1080/07853890.2022.2048416

PMID:35272564

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8920361/

Abstract

OBJECTIVE

There is a lack of effective treatment to improve the prognosis of intrahepatic cholangiocarcinoma (ICC). Programmed cell death protein-1 (PD-1)-targeted immunotherapy has shown promising results in a variety of malignant tumours. However, in patients with advanced ICC, the safety and efficacy of anti-PD-1 agents remain unclear.

METHODS

Forty-two advanced ICC patients treated with anti-PD-1 agents from August 2018 to December 2020 were retrospectively analyzed. Tumour response, overall survival (OS), progression-free survival (PFS), and time to tumour progression (TTP) were evaluated. Adverse events were also recorded.

RESULTS

The median duration of follow-up was 12.1 months, and the median time of treatment was 6.7 months for all patients. The median OS, median PFS, and median TTP for the whole cohort were 19.3 months, 11.6 months, and 11.6 months, respectively. The overall response rate (ORR) and disease control rate (DCR) for the whole cohort were 23.8% and 85.7%, respectively. Of the 42 evaluable individuals, two (4.8%) had hyperprogressive disease. The most common adverse events (AEs) were pain ( = 6; 14.3%), anorexia ( = 4; 9.5%), hypertension ( = 4; 9.5%), pyrexia ( = 3; 7.1%), cough ( = 3; 7.1%), and hypothyroidism ( = 3; 7.1%). The median OS of patients with albumin-bilirubin (ALBI) grade 1 was longer than that of patients with ALBI grade 2 (19.3 months vs. 14.7 months). The median PFS did not show a significant difference between ALBI grade 1 and grade 2 patients (13.6 months vs. 6.9 months).

CONCLUSIONS

PD-1-targeted immunotherapy showed promising efficacy and safety in advanced ICC patients.Key messagesPD-1-targeted immunotherapy is a safe and effective treatment for advanced ICC patients.This study provides therapeutic strategy for advanced ICC patients.

摘要

目的

目前缺乏有效的治疗方法来改善肝内胆管癌（ICC）患者的预后。程序性死亡蛋白-1（PD-1）靶向免疫疗法在多种恶性肿瘤中显示出良好的效果。然而，对于晚期 ICC 患者，抗 PD-1 药物的安全性和疗效尚不清楚。

方法

回顾性分析了 2018 年 8 月至 2020 年 12 月期间接受抗 PD-1 药物治疗的 42 例晚期 ICC 患者。评估了肿瘤反应、总生存期（OS）、无进展生存期（PFS）和肿瘤进展时间（TTP）。还记录了不良反应事件。

结果

中位随访时间为 12.1 个月，所有患者的中位治疗时间为 6.7 个月。全队列的中位 OS、中位 PFS 和中位 TTP 分别为 19.3 个月、11.6 个月和 11.6 个月。全队列的总缓解率（ORR）和疾病控制率（DCR）分别为 23.8%和 85.7%。在 42 例可评估患者中，有 2 例（4.8%）出现超进展性疾病。最常见的不良反应（AEs）是疼痛（ = 6；14.3%）、厌食（ = 4；9.5%）、高血压（ = 4；9.5%）、发热（ = 3；7.1%）、咳嗽（ = 3；7.1%）和甲状腺功能减退症（ = 3；7.1%）。ALBI 分级 1 患者的中位 OS 长于 ALBI 分级 2 患者（19.3 个月比 14.7 个月）。ALBI 分级 1 患者和分级 2 患者的中位 PFS 无显著差异（13.6 个月比 6.9 个月）。