Anti-PD-1 therapy combined with chemotherapy in patients with advanced biliary tract cancer

作者：Danyang Sun, Junxun Ma, Jinliang Wang, Chun Han, Yuanyu Qian, Guang‐Ying Chen, Xiaoyan Li, Juan Zhang, Pengfei Cui, Wushuang Du, Zhaozhen Wu, Shixue Chen, Xuan Zheng, Zhichao Yue, Jia Song, Chan Gao, Xiaochen Zhao, Shangli Cai, Yi Hu · 发表于：Cancer Immunology Immunotherapy · 年份：2019 · DOI：10.1007/s00262-019-02386-w · 被引用次数：45 · 研究领域：Cholangiocarcinoma and Gallbladder Cancer Studies、Cancer Immunotherapy and Biomarkers、Liver Diseases and Immunity

BACKGROUND: Evidence for the efficacy of immunotherapy in biliary tract cancer (BTC) is limited and unsatisfactory. METHODS: Chinese BTC patients receiving a PD-1 inhibitor with chemotherapy, PD-1 inhibitor monotherapy or chemotherapy alone were retrospectively analyzed. The primary outcome was overall survival (OS). The key secondary outcomes were progression-free survival (PFS) and safety. Patients previously treated with any agent targeting T cell costimulation or immune checkpoints were excluded. RESULTS: The study included 77 patients (a PD-1 inhibitor plus chemotherapy, n = 38; PD-1 inhibitor monotherapy, n = 20; chemotherapy alone, n = 19). The median OS was 14.9 months with a PD-1 inhibitor plus chemotherapy, significantly longer than the 4.1 months with PD-1 inhibitor monotherapy (HR 0.37, 95% CI 0.17-0.80, P = 0.001) and the 6.0 months with chemotherapy alone (HR 0.63, 95% CI 0.42-0.94, P = 0.011). The median PFS was 5.1 months with a PD-1 inhibitor plus chemotherapy, significantly longer than the 2.2 months with PD-1 inhibitor monotherapy (HR 0.59, 95% CI 0.31-1.10, P = 0.014) and the 2.4 months with chemotherapy alone (HR 0.61, 95% CI 0.45-0.83, P = 0.003). Grade 3 or 4 treatment-related adverse events were similar between the anti-PD-1 combination group and the chemotherapy alone group (34.2% and 36.8%, respectively). CONCLUSIONS: Anti-PD-1 therapy plus chemotherapy is an effective and tolerable approach for advanced BTC.