Department of Radiation Oncology, Shandong Cancer Hospital, Cheeloo College of Medicine, Shandong University; Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, Shandong, China.
Department of Radiation Oncology, Shandong Cancer Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China.
J Cancer Res Ther. 2022 Apr;18(2):545-552. doi: 10.4103/jcrt.jcrt_125_22.
Although programmed death 1 (PD-1) inhibitors are a standard second-line treatment for esophageal squamous cell carcinoma (ESCC), their efficacy when used in combination with chemotherapy or anti-angiogenesis targeted therapy is unclear.
To compare the efficacy and safety of PD-1 inhibitor monotherapy with that of combination therapy.
A retrospective study was conducted at the Shandong Cancer Hospital.
Based on records, patients with advanced ESCC, treated with second-line or above PD-1 inhibitor-containing regimens from August 15, 2019 to April 12, 2021 were divided into combination (PD-1 inhibitors plus chemotherapy or anti-angiogenesis targeted therapy) and monotherapy groups. The primary endpoints were progression-free survival (PFS) and overall survival (OS).
The baseline differences between subgroups were assessed using the χ-test, Fisher's exact test, or Student's t-test. Follow-up period, PFS, OS, median survival, and 95% confidence intervals (CIs) were estimated using Kaplan‒Meier analysis. The log-rank test was used to compare subgroups.
In the 169 patients included, clinical features were well balanced between both groups. The median PFS of the combination group was better than that of the monotherapy group (8.5 months [95%CI 6.3-10.7] vs. 3.2 months [95%CI 0.0-6.5]; hazard ratio (HR) = 0.34 [95%CI 0.13-0.92]; P < 0.001). The median OS showed the same trend (18.9 months [95%CI 14.4-23.3] vs. 9.8 months [95%CI 6.3-13.2]; HR = 0.47 [95%CI 0.21-1.04]; P = 0.010).
Using PD-1 inhibitors in a combination treatment may improve PFS and OS, with acceptable toxicities.
尽管程序性死亡受体 1（PD-1）抑制剂是治疗食管鳞状细胞癌（ESCC）的标准二线治疗药物，但它们与化疗或抗血管生成靶向治疗联合使用的疗效尚不清楚。
比较 PD-1 抑制剂单药治疗与联合治疗的疗效和安全性。
这是一项在山东省肿瘤医院进行的回顾性研究。
根据记录，将 2019 年 8 月 15 日至 2021 年 4 月 12 日接受二线或以上含 PD-1 抑制剂方案治疗的晚期 ESCC 患者分为联合治疗组（PD-1 抑制剂联合化疗或抗血管生成靶向治疗）和单药治疗组。主要终点为无进展生存期（PFS）和总生存期（OS）。
采用 χ 检验、Fisher 确切检验或 Student t 检验比较亚组间的基线差异。采用 Kaplan-Meier 分析估计随访期、PFS、OS、中位生存期和 95%置信区间（CI）。采用对数秩检验比较亚组。
在纳入的 169 例患者中，两组的临床特征均具有良好的均衡性。联合治疗组的中位 PFS 优于单药治疗组（8.5 个月[95%CI 6.3-10.7]比 3.2 个月[95%CI 0.0-6.5]；风险比（HR）=0.34[95%CI 0.13-0.92]；P<0.001）。中位 OS 也呈现出相同的趋势（18.9 个月[95%CI 14.4-23.3]比 9.8 个月[95%CI 6.3-13.2]；HR=0.47[95%CI 0.21-1.04]；P=0.010）。
PD-1 抑制剂联合治疗可能会提高 PFS 和 OS，且毒性可接受。
