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食管鳞状细胞癌一线免疫治疗联合放化疗的真实世界研究

Real-world study of first-line immunotherapy combined with chemoradiotherapy in esophageal squamous cell carcinoma.

作者信息

Zhao Xiaohan, Weng Chengang, Yang Wuhan, Gao Hongmei, Wang Hesong, Deng Wenzhao, Zhu Shuchai, Shen Wenbin

机构信息

Department of Radiation Oncology, The Fourth Hospital of Hebei Medical University Cancer Institute, No. 12 Jiankan Road, Chang'an District, Shijiazhuang, 050011, China.

Department of Thoracic Surgery Department, The Fourth Hospital of Hebei Medical University Cancer Institute, Shijiazhuang, China.

出版信息

Sci Rep. 2025 Aug 4;15(1):28343. doi: 10.1038/s41598-025-12250-w.

DOI:10.1038/s41598-025-12250-w
PMID:40760130
Abstract

This study aimed to assess the effectiveness, safety, and recurrence patterns of first-line immunotherapy combined with chemoradiotherapy in esophageal squamous cell carcinoma (ESCC) patients. A retrospective analysis of 79 eligible ESCC patients was conducted. Primary outcomes included overall survival (OS) and progression-free survival (PFS), with secondary outcomes being objective response rate (ORR), disease control rate (DOR), treatment-related adverse events (trAEs), and treatment failure patterns. The median follow-up was 29.4 months, with median OS unreached and median PFS of 14.6 months (95% CI 10.7-18.5). ORR was 82.3%, and DOR was 96.2%. Factors affecting OS were clinical stage, immunotherapy cycles, immunotherapy and chemoradiotherapy sequence, radiation coverage, mid-treatment lymphocyte count, and short-term efficacy (HR = 2.254, 0.374, 2.653, 2.957, 2.309, 2.789; P = 0.030, 0.019, 0.009, 0.004, 0.001, 0.014). Factors impacting PFS were clinical stage, immunotherapy and chemoradiotherapy, and post-treatment lymphocyte count (HR = 2.135, 2.048, 1.911; P = 0.007, 0.010, 0.001). Among the cohort, 46.8% experienced treatment failure, with 33 receiving second-line treatment, resulting in a median OS of 14.17 months (95% CI 7.303-21.037) and 1- and 2-year OS rates of 56.7% and 24.3%. Notably, 36.7% experienced grade ≥ 2 trAEs, bone marrow suppression most commonly happened, and 5.1% developed esophageal fistulas. Immunotherapy combined with chemoradiotherapy demonstrates strong anti-tumor activity and tolerability in ESCC patients, The radiation for all leisions, sequential immunotherapy combined with chemoradiotherapy, and higher levels of lymph node cell counts are associated with a better prognosis. Large-scale randomized controlled trials are needed for further validation.

摘要

本研究旨在评估一线免疫治疗联合放化疗在食管鳞状细胞癌(ESCC)患者中的有效性、安全性和复发模式。对79例符合条件的ESCC患者进行了回顾性分析。主要结局包括总生存期(OS)和无进展生存期(PFS),次要结局为客观缓解率(ORR)、疾病控制率(DCR)、治疗相关不良事件(trAEs)和治疗失败模式。中位随访时间为29.4个月,中位OS未达到,中位PFS为14.6个月(95%CI 10.7-18.5)。ORR为82.3%,DCR为96.2%。影响OS的因素有临床分期、免疫治疗周期、免疫治疗与放化疗的顺序、放疗范围、治疗中期淋巴细胞计数和短期疗效(HR = 2.254、0.374、2.653、2.957、2.309、2.789;P = 0.030、0.019、0.009、0.004、0.001、0.014)。影响PFS的因素有临床分期、免疫治疗与放化疗以及治疗后淋巴细胞计数(HR = 2.135、2.048、1.911;P = 0.007、0.010、0.001)。在该队列中,46.8%的患者经历了治疗失败,33例接受了二线治疗,中位OS为14.17个月(95%CI 7.303-21.037),1年和2年OS率分别为56.7%和24.3%。值得注意的是,36.7%的患者发生了≥2级trAEs,最常见的是骨髓抑制,5.1%的患者发生了食管瘘。免疫治疗联合放化疗在ESCC患者中显示出较强的抗肿瘤活性和耐受性,对所有病灶进行放疗、序贯免疫治疗联合放化疗以及较高水平的淋巴细胞计数与较好的预后相关。需要进行大规模随机对照试验以进一步验证。

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Factors affecting prognosis in patients with locally advanced and advanced esophageal cancer receiving definitive radiotherapy in plateau regions.高原地区局部晚期和晚期食管癌患者接受根治性放疗的预后影响因素
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Oncologist. 2023 Aug 3;28(8):e645-e652. doi: 10.1093/oncolo/oyad109.
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Association Between Lymphopenia and Survival Outcomes in Esophageal Carcinoma Patients Receiving Combined Immunotherapy and Chemoradiotherapy.接受免疫联合放化疗的食管癌患者淋巴细胞减少与生存结局的关系。
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