Published in:
Open Access
01-09-2019 | Cytostatic Therapy | Original Article
Anti-PD-1 therapy combined with chemotherapy in patients with advanced biliary tract cancer
Authors:
Danyang Sun, Junxun Ma, Jinliang Wang, Chun Han, Yuanyu Qian, Guangying 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
Published in:
Cancer Immunology, Immunotherapy
|
Issue 9/2019
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Abstract
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.