免疫化疗联合放疗与单纯免疫化疗作为初治晚期食管鳞状细胞癌一线治疗方案的比较（AEC-ICR-1st）：一项多中心队列研究
Immunochemotherapy plus radiotherapy versus immunochemotherapy alone as first-line treatment for treatment-naïve, advanced esophageal squamous cell carcinoma (AEC-ICR-1st): A multi-center cohort study.
作者信息
Li Jiacheng, Wang Xiaofeng, Cao Jianzhong, Fan Chengcheng, Xiao Qin, Zheng Zhunhao, Gao Wenyan, Liu Xiao, Feng Peixin, Liu Fang, Ouyang Shuyu, Zhang Tian, Chen Xi, Yuan Zhiyong, Pang Qingsong, Wang Ping, Wang Qifeng, Zhang Wencheng
机构信息
Department of Radiation Oncology, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin's Clinical Research Center for Cancer, Tianjin, 300060, China.
Department of Radiotherapy, Shanxi Province Cancer Hospital, Shanxi Hospital Affiliated to Cancer Hospital, Chinese Academy of Medical Sciences, Cancer Hospital Affiliated to Shanxi Medical University, Taiyuan, 030013, China.
出版信息
Cancer Lett. 2024 Dec 28;611:217411. doi: 10.1016/j.canlet.2024.217411.
Immunochemotherapy is Currently the standard first-line treatment for advanced esophageal squamous cell carcinoma (ESCC). However, its prognosis remains unsatisfactory. We aimed to evaluate the efficacy and safety of immunochemotherapy plus radiotherapy (ICR) compared with immunochemotherapy (IC) alone as a first-line treatment for advanced ESCC. This multicenter cohort study was conducted across five cancer centers (NCT06190652). We evaluated the outcomes in patients with advanced ESCC who received first-line therapy of IC, with or without radiotherapy (RT), between 2018 and 2023. Propensity score matching (PSM) was performed to control for potential confounders. Sensitivity analysis was conducted to evaluate the robustness of the results. Overall, 23,641 patients were screened, and 702 patients were finally eligible. 270 patients included in ICR cohort, and 432 patients in IC alone cohort. Both before and after PSM, the ICR cohort had a longer median OS compared to IC alone cohort (20.4 versus 16.8 months, P = 0.001; 21.3 versus 17.5 months, P = 0.008; respectively); multivariate analysis further supported that RT was associated with a better OS (HR: 0.695, 95%CI: 0.558-0.867, P = 0.001; HR: 0.729, 95%CI: 0.561-0.947, P = 0.018; respectively). Exploratory analysis revealed that the survival benefits were most pronounced in the subgroup that received IC concurrently combined with definitive dose RT to the primary tumor, with a median OS of 23.6 months (HR: 0.515, 95%CI: 0.308-0.862, P = 0.011) and PFS of 14.4 months (HR: 0.567, 95%CI: 0.370-0.870, P = 0.009). The grade ≥3 treatment-related adverse events (TRAEs) were esophagitis (4.10 % versus 0.41 %; P = 0.006), anemia (6.97 % versus 1.64 %; P = 0.004), leukopenia (12.70 % versus 6.56 %; P = 0.021) and lymphopenia (38.52 % versus 4.92 %, P < 0.001) in the ICR and IC cohorts. The addition of RT to IC as a first-line treatment for advanced ESCC could bring benefits, and was well-tolerated.
免疫化疗目前是晚期食管鳞状细胞癌（ESCC）的标准一线治疗方法。然而，其预后仍不尽人意。我们旨在评估免疫化疗联合放疗（ICR）与单纯免疫化疗（IC）作为晚期ESCC一线治疗的疗效和安全性。这项多中心队列研究在五个癌症中心进行（NCT06190652）。我们评估了2018年至2023年间接受IC一线治疗（无论是否接受放疗[RT]）的晚期ESCC患者的结局。进行倾向评分匹配（PSM）以控制潜在的混杂因素。进行敏感性分析以评估结果的稳健性。总体而言，共筛查了23641例患者，最终702例患者符合条件。ICR队列中有270例患者，单纯IC队列中有432例患者。在PSM前后，ICR队列的中位总生存期均长于单纯IC队列（分别为20.4个月对16.8个月，P = 0.001；21.3个月对17.5个月，P = 0.008）；多因素分析进一步支持放疗与更好的总生存期相关（风险比：0.695，95%置信区间：0.558 - 0.867，P = 0.001；风险比：0.729，95%置信区间：0.561 - 0.947，P = 0.018；分别）。探索性分析显示，在接受IC同时联合对原发肿瘤进行根治性剂量放疗的亚组中生存获益最为显著，中位总生存期为23.6个月（风险比：0.515，95%置信区间：0.308 - 0.862，P = 0.011），无进展生存期为14.4个月（风险比：0.567，95%置信区间：0.370 - 0.870，P = 0.009）。ICR和IC队列中≥3级治疗相关不良事件（TRAEs）分别为食管炎（4.10%对0.41%；P = 0.006）、贫血（6.97%对1.64%；P = 0.004）、白细胞减少（12.70%对6.56%；P = 0.021）和淋巴细胞减少（38.52%对4.92%，P < 0.001）。IC联合RT作为晚期ESCC的一线治疗可带来益处，且耐受性良好。
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