抗程序性死亡蛋白1（PD-1）抗体联合放化疗治疗局部晚期食管鳞癌的疗效与安全性
Efficacy and safety of anti-PD-1 antibody plus chemoradiotherapy in locally advanced esophageal squamous cancer.
作者信息
Ma Ji, Yao Nan, Lu Jiaying, Qu Wanxi, Cui Li, Yuan Shiwang, Li Na, Tong Shaodong, Qin Zhaohui, Yao Yuanhu
机构信息
Department of Radiation Oncology, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, China.
Department of Radiation Oncology, Xuzhou Central Hospital, Xuzhou, Jiangsu, China.
出版信息
Front Oncol. 2023 Feb 9;13:1005856. doi: 10.3389/fonc.2023.1005856. eCollection 2023.
OBJECTIVE
To compare effects and adverse events of anti-programmed cell death protein 1 (anti-PD-1) antibody combined with chemoradiotherapy (CRT) and CRT alone as the initial treatment in locally advanced esophageal squamous cell carcinoma (ESCC).
METHODS
We retrospectively reviewed locally advanced ESCC patients who received Anti-PD-1+CRT as initial treatment at 3 institutions. Primary outcomes of interest were progression-free survival (PFS) and overall survival (OS); secondary outcomes were objective response rate (ORR), disease control rate (DCR), duration of response (DoR), and treatment-related adverse events (AEs) including immune-related adverse events (irAEs).
RESULTS
At data cutoff, 81 patients were included (30 Anti-PD-1+CRT, 51 CRT). Median follow-up was 31.4 months. Anti-PD-1+CRT resulted in significant improvements in PFS (median, 18.6 11.8 months, HR 0.48 [95% CI, 0.29-0.80], P = 0.008), and OS (median, 27.7 17.4 months, HR 0.37 [95% CI, 0.22-0.63], P = 0.002), compared with CRT in ESCC. The ORR and DCR of patients treated with Anti-PD-1+CRT were also significantly higher than those treated with CRT (80.0% 56.9%, P = 0.034), (100% 82.4%, P = 0.023), respectively. Anti-PD-1+CRT had better durable response compared with CRT, with DoR (median,17.3 11.1 months, P = 0.022). Treatment-related adverse event incidence was similar between the two groups (any Grade, 93.3% 92.2%; ≥Grade 3, 50.0% 33.3%).
CONCLUSION
Anti-PD-1 plus chemoradiotherapy demonstrated promising antitumor activity and was well tolerated in locally advanced ESCC.
目的
比较抗程序性死亡蛋白1（抗PD-1）抗体联合放化疗（CRT）与单纯CRT作为局部晚期食管鳞状细胞癌（ESCC）初始治疗的疗效和不良事件。
方法
我们回顾性分析了3家机构接受抗PD-1+CRT作为初始治疗的局部晚期ESCC患者。主要观察指标为无进展生存期（PFS）和总生存期（OS）；次要观察指标为客观缓解率（ORR）、疾病控制率（DCR）、缓解持续时间（DoR）以及包括免疫相关不良事件（irAEs）在内的治疗相关不良事件（AEs）。
结果
在数据截止时，纳入81例患者（30例抗PD-1+CRT，51例CRT）。中位随访时间为31.4个月。与ESCC单纯CRT相比，抗PD-1+CRT使PFS（中位值，18.6对11.8个月，HR 0.48[95%CI，0.29 - 0.80]，P = 0.008）和OS（中位值，27.7对17.4个月，HR 0.37[95%CI，0.22 - 0.63]，P = 0.002）有显著改善。抗PD-1+CRT治疗患者的ORR和DCR也显著高于CRT治疗患者（分别为80.0%对56.9%，P = 0.034），（100%对82.4%，P = 0.023）。与CRT相比，抗PD-1+CRT具有更好的持久缓解，DoR（中位值，17.3对11.1个月，P = 0.022）。两组治疗相关不良事件发生率相似（任何级别，93.3%对92.2%；≥3级，50.0%对33.3%）。
结论
抗PD-1联合放化疗在局部晚期ESCC中显示出有前景的抗肿瘤活性且耐受性良好。
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