Zhao Xiao-Han, Gao Hong-Mei, Wen Jing-Yuan, Wang He-Song, Wu Luan-Ying, Song Chun-Yang, Deng Wen-Zhao, Zhu Shu-Chai, Shen Wen-Bin
Department of Radiation Oncology, The Forth Hospital of Hebei Medical University, No. 12 Jiankan Road, Chang'an District, Shijiazhuang, 050011, China.
Department of Radiation, Shijiazhuang People's Hospital, Shijiazhuang, China.
Discov Oncol. 2023 Sep 4;14(1):165. doi: 10.1007/s12672-023-00783-3.
This study was designed to investigate the efficacy and prognostic factors for immune checkpoint inhibitors (ICIs) combined with or without radio(chemo)therapy and to evaluate their toxicity in patients with locally advanced or recurrent/metastatic esophageal squamous cell carcinoma (LA/RM ESCC).
In this study, 198 patients with locally advanced or recurrent/metastatic (LA/RM) ESCC who received ICIs combined with or without radiotherapy/chemotherapy in the Department of Radiotherapy of the Fourth Hospital of Hebei Medical University were retrospectively analyzed. Univariate and multivariate analyses were performed to determine the prognostic factors for overall survival (OS) and progression free survival (PFS). The factors affecting treatment response and the occurrences of treatment-related adverse events (trAEs) were analyzed.
The median OS and PFS were 30.4 months (95% confidence interval [CI] 15.1-45.7 months) and 15.3 months (95% CI 12.8-17.8 months), respectively. Univariate and multivariate analysis showed that the number of ICI cycles, the intervention of radiotherapy and dysphagia were independent factors affecting OS (Hazard ratio [HR] = 0.39, 2.043 and 0.365, respectively; P = 0.018, 0.001 and 0.032, respectively). The intervention of radiotherapy was an independent factor for PFS (hazard ratio [HR] = 18.149, P = 0.013). The median OS and PFS for patients who had complete response and partial response (Objective response, ORR) were 50.8 months (95% CI 25.8-75.7 months) and 20.5 months (95% CI 14.1-27.0), respectively, which were significantly higher than those in the non-ORR group (OS:17.5 months, 95% CI 14.0-21.0; χ = 13.881, P < 0.001; PFS: 12.1 months, 95% CI 10.1-14.1, χ = 10.676, P = 0.001). The intervention of radiotherapy could improve treatment response (χ = 47.725, P = 0.000). In entire study population, 83 patients (41.9%) had ≥ grade 2 trAEs.
ICIs combined with radiotherapy/chemotherapy are safe and effective in LA/RM ESCC patients. Intervention of radiotherapy, the number of immunotherapy cycles and occurrence of dysphagia affecting the overall survival of LR/RM ESCC patients. Intervention of radiotherapy was an independent prognosis factor for OS and PFS and associated with better treatment response.
本研究旨在探讨免疫检查点抑制剂（ICI）联合或不联合放（化）疗的疗效及预后因素，并评估其在局部晚期或复发/转移性食管鳞状细胞癌（LA/RM ESCC）患者中的毒性。
本研究回顾性分析了河北医科大学第四医院放疗科198例接受ICI联合或不联合放疗/化疗的局部晚期或复发/转移性（LA/RM）ESCC患者。进行单因素和多因素分析以确定总生存期（OS）和无进展生存期（PFS）的预后因素。分析影响治疗反应和治疗相关不良事件（trAE）发生的因素。
中位OS和PFS分别为30.4个月（95%置信区间[CI] 15.1 - 45.7个月）和15.3个月（95% CI 12.8 - 17.8个月）。单因素和多因素分析显示，ICI疗程数、放疗干预和吞咽困难是影响OS的独立因素（风险比[HR]分别为0.39、2.043和0.365；P分别为0.018、0.001和0.032）。放疗干预是PFS的独立因素（风险比[HR] = 18.149，P = 0.013）。完全缓解和部分缓解（客观缓解率，ORR）患者的中位OS和PFS分别为50.8个月（95% CI 25.8 - 75.7个月）和20.5个月（95% CI 14.1 - 27.0），显著高于非ORR组（OS：17.5个月，95% CI 14.0 - 21.0；χ = 13.881，P < 0.001；PFS：12.1个月，95% CI 10.1 - 14.1，χ = 10.676，P = 0.001）。放疗干预可改善治疗反应（χ = 47.725，P = 0.000）。在整个研究人群中，83例患者（41.�%）发生≥2级trAE。
ICI联合放疗/化疗在LA/RM ESCC患者中安全有效。放疗干预、免疫治疗疗程数和吞咽困难的发生影响LR/RM ESCC患者的总生存期。放疗干预是OS和PFS的独立预后因素，且与更好的治疗反应相关。
