Gou Miaomiao, Zhang Yong, Liu Tiee, Si Haiyan, Wang Zhikuan, Yan Huan, Qian Niansong, Dai Guanghai
Medical Oncology Department, The First Medical Center, Chinese People's Liberation Army General Hospital, Beijing, China.
Medical Oncology Department, The Second Medical Center, Chinese People's Liberation Army General Hospital, Beijing, China.
Front Oncol. 2021 Jun 17;11:648068. doi: 10.3389/fonc.2021.648068. eCollection 2021.
There are limited treatment options for advanced biliary tract cancers (BTCs), including intrahepatic cholangiocarcinoma, extrahepatic bile duct cancer, gallbladder cancer. We compared the efficacy and safety of PD-1 inhibitors plus chemotherapy and chemotherapy alone as first-line treatment in patients with advanced BTC.
We retrospectively reviewed patients with BTC treated at the oncology department of the Chinese PLA general hospital receiving PD-1 inhibitor with chemotherapy (anti-PD-1+C group) or chemotherapy alone (C group). Propensity Score Matching (PSM) (1:1) was performed to balance potential baseline confounding factors. Progression-free survival (PFS) was analyzed using Kaplan-Meier survival curves with log-rank tests. Objective response rate (ORR), disease control rate (DCR), and safety were also analyzed.
This study included 75 patients who received PD-1 inhibitors (including Pembrolizumab, Nivolumab, Sintilimab, Toripalimab) plus chemotherapy and 59 patients who received chemotherapy alone. After matching, there were no significant differences between the two groups for baseline characteristics. Within the matched cohort, the median PFS was 5.8m in the anti-PD-1+C group, which was significantly longer than the C group, at 3.2m (HR: 0.47, 95% CI 0.29 to 0.76, P = 0.004). The ORR was 21.7% and DCR was 80.4% in the anti-PD-1+C group, while the ORR was 15.2% and DCR was 69.6% in the C group. No significant differences were found in the ORR and DCR between the two groups (P=0.423, P=0.231). Grade 3 or 4 treatment was related to adverse events (AEs) that occurred in the anti-PD-1+C group, namely hypothyroidism (n=3, 6.5%), rash (n=2, 4.2%), and hepatitis (n=1, 2.2%). There was no AE-related death. The grade 3-4 leukopenia rate was similar in the two groups (4.3% vs. 6.5%).
Anti-PD-1 therapy plus chemotherapy prolonged the PFS compared with chemotherapy alone in advanced BTC with controllable AEs. Further clinical trials are needed to confirm this result.
对于晚期胆管癌（BTC），包括肝内胆管癌、肝外胆管癌、胆囊癌，治疗选择有限。我们比较了PD-1抑制剂联合化疗与单纯化疗作为晚期BTC患者一线治疗的疗效和安全性。
我们回顾性分析了在中国人民解放军总医院肿瘤科接受治疗的BTC患者，这些患者接受了PD-1抑制剂联合化疗（抗PD-1+C组）或单纯化疗（C组）。进行倾向评分匹配（PSM）（1:1）以平衡潜在的基线混杂因素。使用Kaplan-Meier生存曲线和对数秩检验分析无进展生存期（PFS）。还分析了客观缓解率（ORR）、疾病控制率（DCR）和安全性。
本研究纳入了75例接受PD-1抑制剂（包括帕博利珠单抗、纳武利尤单抗、信迪利单抗、特瑞普利单抗）联合化疗的患者和59例接受单纯化疗的患者。匹配后，两组的基线特征无显著差异。在匹配队列中，抗PD-1+C组的中位PFS为5.8个月，显著长于C组的3.2个月（HR：0.47，95%CI 0.29至0.76，P = 0.004）。抗PD-1+C组的ORR为21.7%，DCR为80.4%，而C组的ORR为15.2%，DCR为69.6%。两组的ORR和DCR无显著差异（P = 0.423，P = 0.231）。3级或4级治疗相关不良事件（AE）发生在抗PD-1+C组，即甲状腺功能减退（n = 3，6.5%）、皮疹（n = 2，4.2%）和肝炎（n = 1，2.2%）。无AE相关死亡。两组的3-4级白细胞减少率相似（4.3%对6.5%）。
与单纯化疗相比，抗PD-1治疗联合化疗可延长晚期BTC患者的PFS，且AE可控。需要进一步的临床试验来证实这一结果。
