比较 IVB 期食管鳞癌联合化疗免疫治疗与单纯化疗免疫治疗的疗效和安全性：多中心倾向评分匹配分析。

Comparison of Efficacy and Safety of Combined Chemoimmunotherapy With or Without Radiation Therapy for Stage IVB Esophageal Squamous Cell Carcinoma: A Multicenter Propensity Score Matching Analysis.

机构信息

Department of Radiation Oncology, State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, Guangzhou, People's Republic of China; Guangdong Esophageal Cancer Research Institute, Guangzhou, People's Republic of China; Department of Oncology, The First Affiliated Hospital, Hengyang Medical School, University of South China, Hengyang, People's Republic of China.

出版信息

Int J Radiat Oncol Biol Phys. 2024 Nov 15;120(4):1084-1095. doi: 10.1016/j.ijrobp.2024.06.008. Epub 2024 Jun 26.

DOI:10.1016/j.ijrobp.2024.06.008

PMID:38936631

Abstract

PURPOSE

This study aimed to compare the efficacy and safety of combining first-line chemoimmunotherapy with radiation therapy versus chemoimmunotherapy alone in patients with stage IVB esophageal squamous cell carcinoma (ESCC).

METHODS AND MATERIALS

We retrospectively examined 409 patients with stage IVB ESCC who received first-line chemotherapy and anti-PD-1 antibody, with or without radiation therapy of ≥40 Gy radiation dose to primary lesion, from 4 academic cancer centers between October 2018 and December 2022. Propensity score matching was conducted to minimize the potential confounding effects.

RESULTS

In the overall cohort of 409 patients, the group that received additional radiation therapy had superior overall survival (OS) (hazard ratio [HR], 0.51; 95% CI, 0.39-0.66; P < .001) and progression-free survival (PFS) (HR, 0.52; 95% CI, 0.40-0.66; P < .001) compared to the group that received chemoimmunotherapy alone. After 1:1 propensity score matching, matching age, tumor location, and metastatic sites, a total of 250 patients were selected for further analysis. The results remained consistent and showed that the addition of radiation therapy significantly improved OS and PFS (median OS, 24.9 vs 14.6 months; P = .003; median PFS, 14.2 vs 10.6 months; P = .002). Multivariate Cox analysis including tumor location, T stage, metastatic sites, and treatment modality, revealed that radiation therapy was an independent prognostic factor for both OS (HR, 0.57; 95% CI, 0.41-0.81) and PFS (HR, 0.63, 95% CI, 0.47-0.86). Subgroup analyses revealed significant OS prolongation in patients with nonregional lymph node metastases only who received radiation therapy (HR, 0.49; 95% CI, 0.34-0.70). No OS survival benefit was observed in those with distant organ metastases (HR, 0.72; 95% CI, 0.46-1.13). Regarding safety, the group receiving additional radiation therapy had higher incidences of grade 3 to 4 lymphopenia (74.4% vs 17.7%, P < .001) and esophagitis (11.2% vs 2.4%, P = .006).

CONCLUSIONS

The addition of radiation therapy to chemoimmunotherapy improved the survival of stage IVB ESCC patients with nonregional lymph node metastasis.

摘要

目的

本研究旨在比较在 IVB 期食管鳞癌（ESCC）患者中，一线化疗联合免疫治疗与单纯化疗联合免疫治疗联合放疗的疗效和安全性。

方法和材料

我们回顾性分析了 2018 年 10 月至 2022 年 12 月期间 4 家学术癌症中心的 409 名接受一线化疗和抗 PD-1 抗体治疗的 IVB 期 ESCC 患者，其中部分患者接受了≥40Gy 剂量的原发灶放疗。采用倾向评分匹配法以最小化潜在混杂因素的影响。

结果

在 409 例患者的总体队列中，与单纯化疗联合免疫治疗组相比，接受额外放疗的患者总生存期（OS）（风险比[HR]，0.51；95%置信区间[CI]，0.39-0.66；P<0.001）和无进展生存期（PFS）（HR，0.52；95%CI，0.40-0.66；P<0.001）均显著改善。经过 1:1 倾向评分匹配，匹配年龄、肿瘤位置和转移部位后，共选择 250 例患者进行进一步分析。结果仍然一致，表明放疗显著改善了 OS 和 PFS（中位 OS，24.9 与 14.6 个月；P=0.003；中位 PFS，14.2 与 10.6 个月；P=0.002）。包括肿瘤位置、T 分期、转移部位和治疗方式在内的多因素 Cox 分析显示，放疗是 OS（HR，0.57；95%CI，0.41-0.81）和 PFS（HR，0.63，95%CI，0.47-0.86）的独立预后因素。亚组分析显示，仅接受放疗的无区域淋巴结转移患者的 OS 显著延长（HR，0.49；95%CI，0.34-0.70）。远处器官转移患者未观察到 OS 生存获益（HR，0.72；95%CI，0.46-1.13）。关于安全性，接受额外放疗的患者中 3-4 级淋巴细胞减少症（74.4%比 17.7%，P<0.001）和食管炎（11.2%比 2.4%，P=0.006）的发生率更高。