Survival benefit and biomarker of PD‐1 inhibitor combination therapy in first‐line of advanced biliary tract cancer: A retrospective study

作者：Jingyi Guo, Qun Zhou, Mingzhen Zhou, Hengheng Dai, Lin Li, Yudong Qiu, Liang Mao, Baorui Liu, Jie Shen · 发表于：Cancer Medicine · 年份：2023 · DOI：10.1002/cam4.6628 · 被引用次数：5 · 研究领域：Cholangiocarcinoma and Gallbladder Cancer Studies、Liver Diseases and Immunity、Cancer Immunotherapy and Biomarkers

BACKGROUND: Immune checkpoint inhibitor (ICI) combination therapies have shown promise in the first-line treatment of advanced biliary tract cancer (BTC). However, the best partner remains to be validated. Moreover, progress on biomarkers predicting the efficacy of ICI in BTC is slow. This study aimed to assess the efficacy and investigate reliable predictive biomarkers of programmed cell death protein-1 (PD-1) antibody combination therapy in the first-line treatment of advanced BTC. METHODS: Clinical data from patients with advanced BTC who received chemotherapy or anti-PD-1 combination therapy as first-line were collected. The primary outcome was overall survival (OS). Biomarkers, including peripheral blood inflammation scores, genetic alterations, and tumor microenvironment were investigated. FINDINGS: Sixty-four patients were recruited and divided into four treatment groups: chemotherapy, anti-PD-1 plus chemotherapy, anti-PD-1 plus targeted therapy, and triple group (anti-PD-1 plus chemotherapy and targeted therapy). The median OS was 7.9, 11.3, 12.8, and 28.7 months, respectively. Compared to chemotherapy, mOS significantly prolonged in the triple group (p = 0.031). It showed that patients with five different peripheral blood inflammation scores had significantly prolonged mOS (p < 0.05). Genetic testing results suggested that patients with poor survival all had TP53 mutations and higher levels of KRAS and ERBB2 mutations. Low FOXP3/CD8 ratio was associated with prolonge...