Anti-PD-1 therapy combined with chemotherapy in patients with advanced biliary tract cancer
Anti-PD-1 therapy combined with chemotherapy in patients with advanced biliary tract cancer
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DOI：
10.1007/s00262-019-02386-w
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发表时间：
2019-09-01
影响因子：
5.8
通讯作者：
Hu, Yi
中科院分区：
文献类型：
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作者：
Sun, Danyang;Ma, Junxun;Hu, Yi
背景胆道癌（biliary tract cancer，BTC）免疫治疗疗效的证据有限且不令人满意。方法回顾性分析接受PD-1抑制剂联合化疗、PD-1抑制剂单药治疗或单纯化疗的中国BTC患者。主要结局为总生存期（OS）。关键的次要结局是无进展生存期（PFS）和安全性。结果本研究包括77例患者（PD-1抑制剂联合化疗，n = 38; PD-1抑制剂单药治疗，n = 20;单纯化疗，n = 19）。PD-1抑制剂联合化疗的中位OS为14.9个月，显著长于PD-1抑制剂单药治疗的4.1个月（HR 0.37，95% CI 0.17-0.80，P = 0.001）和单独化疗的6.0个月（HR 0.63，95% CI 0.42-0.94，P = 0.011）。PD-1抑制剂联合化疗的中位PFS为5.1个月，显著长于PD-1抑制剂单药治疗的2.2个月（HR 0.59，95% CI 0.31-1.10，P = 0.014）和单独化疗的2.4个月（HR 0.61，95% CI 0.45-0.83，P = 0.003）。抗PD-1联合化疗组与单纯化疗组3 ~ 4级不良反应发生率分别为34.2%和36.8%。结论抗PD-1联合化疗是治疗晚期BTC的一种有效、可耐受的方法。
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.