Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Department of Medical Oncology, The First Affiliated Hospital of Xinxiang Medical University, Xinxiang, China.
Cancer Med. 2024 May;13(10):e7203. doi: 10.1002/cam4.7203.
To explore the efficacy of serplulimab plus chemotherapy in esophageal squamous cell carcinoma (ESCC) patients with liver metastases.
A post hoc exploratory analysis of ASTRUM-007 study was performed, focusing on the association between the liver metastases status and the clinical outcomes. A systematic literature search of electronic databases was conducted to identify eligible randomized controlled trials for the meta-analysis. Study-level pooled analyses of hazard ratios (HRs) for PFS according to liver metastases were performed.
The post hoc analysis of ASTRUM-007 showed that although patients with liver metastases had a worse prognosis comparing with the non-liver metastases patients in both treatment arms (serplulimab plus chemotherapy arm: median PFS, 5.7 vs. 6.6 months, HR 1.57 [95% CI, 1.15-2.13]; median OS, 13.7 vs. 15.3 months, HR 1.48 [95% CI, 1.09-1.98]; placebo plus chemotherapy arm: median PFS, 4.3 vs. 5.5 months, HR 1.58 [95% CI, 1.01-2.39]; median OS, 10.3 vs. 11.2 months, HR 1.32 [95% CI, 0.84-2.00]), OS and PFS benefits derived from serplulimab plus chemotherapy versus placebo plus chemotherapy in this study were observed in both patients with liver metastases (HR of PFS: 0.60; 95% CI, 0.37-0.97; HR of OS: 0.68; 95% CI, 0.43-1.11) and the non-liver metastases patients (HR of PFS: 0.62; 95% CI, 0.49-0.80; HR of OS: 0.69; 95% CI, 0.55-0.87) with similar magnitude. Three randomized controlled trials were included in the meta-analysis. Pooled HRs demonstrated that the addition of anti-PD-1 antibodies significantly improved PFS compared to chemotherapy alone regardless of liver metastases status.
This study reveals that the presence of liver metastases is a poor prognostic factor but does not affect the improvements in both PFS and OS brought by adding PD-1 blockade to chemotherapy in ESCC patients. Predictive biomarkers for survival in these patients warrant further investigation.
探索塞普鲁单抗联合化疗治疗食管鳞癌（ESCC）伴肝转移患者的疗效。
对 ASTRUM-007 研究进行了事后探索性分析，重点关注肝转移状态与临床结局之间的关系。对电子数据库进行了系统的文献检索，以确定荟萃分析的合格随机对照试验。根据肝转移情况对 PFS 的研究水平汇总分析进行了风险比（HR）的荟萃分析。
ASTRUM-007 的事后分析表明，与两个治疗组的非肝转移患者相比，肝转移患者的预后更差（塞普鲁单抗联合化疗组：中位 PFS，5.7 个月 vs. 6.6 个月，HR 1.57[95%CI，1.15-2.13]；中位 OS，13.7 个月 vs. 15.3 个月，HR 1.48[95%CI，1.09-1.98]；安慰剂联合化疗组：中位 PFS，4.3 个月 vs. 5.5 个月，HR 1.58[95%CI，1.01-2.39]；中位 OS，10.3 个月 vs. 11.2 个月，HR 1.32[95%CI，0.84-2.00]）；在这项研究中，与安慰剂联合化疗相比，塞普鲁单抗联合化疗在肝转移患者中观察到的 OS 和 PFS 获益（PFS 的 HR：0.60；95%CI，0.37-0.97；OS 的 HR：0.68；95%CI，0.43-1.11）和非肝转移患者（PFS 的 HR：0.62；95%CI，0.49-0.80；OS 的 HR：0.69；95%CI，0.55-0.87）相似。荟萃分析纳入了三项随机对照试验。汇总 HR 表明，与单独化疗相比，添加抗 PD-1 抗体可显著改善 PFS。
本研究表明，肝转移是预后不良的因素，但不影响 ESCC 患者联合 PD-1 阻断治疗时 PFS 和 OS 的改善。这些患者的生存预测生物标志物值得进一步研究。
