二线纳武单抗单药治疗和随后的三线治疗对于不可切除或转移性食管癌的真实疗效、预后因素和不良事件尚未得到充分评估。这项多机构回顾性队列研究评估了 184 名连续接受第二次治疗的患者。 2021年3月至2022年12月期间对食管癌进行一线纳武单抗单药治疗。我们评估了肿瘤反应、不良事件、长期生存和预后因素。在128名具有可测量病变的患者中，有效率为23%，疾病控制率为所有入组患者的比例为 45%。 3 级或以上不良事件的发生率为 14%，但没有出现与治疗相关的死亡。中位无进展生存期分别为 5.1 个月，总生存期为 14 个月。通过 Cox 比例风险分析，C 反应蛋白水平和体能状态被确定为总体生存的重要预后因素。具有两个有利预后因素的组比具有 1 个或零个预后因素的组表现出更好的总生存期（中位总生存期分别为 22、15 和 4.4 个月）。在接受三线紫杉烷抗癌药物的 69 名患者中，无进展生存期为 6.7 个月。我们的研究表明，二线纳武单抗单药治疗的真实世界结果在肿瘤反应方面与之前的随机临床试验结果相当、安全、长期生存。此外，良好的体能状态和低 C 反应蛋白水平可能会识别出可能从治疗中受益的患者。纳武单抗治疗后进行三线化疗可能会增强疗效；然而，需要进一步的前瞻性研究来证实这一发现。© 2024。日本胃肠病学会。

The real-world efficacy, prognostic factors, and adverse events of second-line nivolumab monotherapy and subsequent third-line therapy for unresectable or metastatic esophageal cancer have not been fully evaluated.This multi-institutional retrospective cohort study evaluated 184 consecutive patients treated with second-line nivolumab monotherapy for esophageal cancer between March 2021 and December 2022. We assessed tumor response, adverse events, long-term survival, and prognostic factors.Among 128 patients with measurable lesions, the response rate was 23% and the disease control rate for all enrolled patients was 45%. The incidence of grade 3 or higher adverse events was 14%, but no treatment-related deaths presented. Median progression-free survival was 5.1 months and overall survival was 14 months, respectively. C-reactive protein level and performance status were identified as significant prognostic factors of overall survival through Cox proportional hazards analysis. The group with two favorable prognostic factors showed better overall survival than the groups with either one or zero prognostic factors (median overall survival: 22, 15, and 4.4 months, respectively). Among 69 patients who received third-line taxane anticancer agents, the progression-free survival was 6.7 months.Our study demonstrated that the real-world outcomes of second-line nivolumab monotherapy were comparable to those of previous randomized clinical trials in terms of tumor response, safety, and long-term survival. Furthermore, a good performance status and low C-reactive protein levels may identify patients who are likely to benefit from therapy. Third-line chemotherapy after nivolumab treatment may have an enhanced effect; however, further prospective studies are required to confirm this finding.© 2024. Japanese Society of Gastroenterology.