Liu Weigeng, Xue Huhu, Lei Qian, Jia Ziyuan, He Shuang, Ma Guorui
Department of Proctology II, Xi'an Daxing Hospital Xi'an 710082, Shaanxi, China.
Department of Anorectal Surgery in Central Digestive Disease Ward, Baoji High-Tech Hospital Baoji 721000, Shaanxi, China.
Am J Transl Res. 2025 Aug 15;17(8):6180-6190. doi: 10.62347/KZDR9031. eCollection 2025.
To evaluate the therapeutic efficacy of adding cindilizumab to the Xeloda-Irinotecan (XELIRI) regimen in patients with advanced colorectal cancer and to identify clinical and molecular biomarkers predictive of treatment response.
A retrospective analysis was conducted on 197 patients with advanced colorectal carcinoma treated between January 2019 and June 2023. Patients were divided into two cohorts: the standard treatment group receiving XELIRI alone (n=103) and the combined treatment group receiving XELIRI with cindilizumab (n=94). Treatment response was assessed according to RECIST criteria and classified as responsive (complete response [CR] or partial response [PR]) or non-responsive (stable disease [SD] or progressive disease [PD]). Logistic regression analysis was performed to identify independent predictors of treatment response. Adverse events were recorded throughout the treatment course.
The experimental cohort demonstrated statistically higher objective response rate (ORR) and disease control rate (DCR) compared to the standard treatment cohort (ORR: 38.30% versus 22.33%, P=0.015; DCR: 80.85% versus 66.02%, P=0.019). The incidence of hypothyroidism and renal impairment was significantly higher in the combination group (P=0.002). Logistic regression identified carcinoembryonic antigen (CEA) (OR=1.336, P<0.001), tumor diameter (OR=2.818, P=0.001), KRAS/NRAS gene status (OR=6.229, P=0.001), and treatment regimen (OR=0.079, P<0.001) as independent predictors of treatment response. Receiver operating characteristic (ROC) curve analysis showed that their combined prediction significantly improved predictive efficacy (AUC=0.881), with high sensitivity and specificity.
Cindilizumab combined with XELIRI regimen improves ORR and DCR in patients with advanced colorectal cancer but may increase the risk of hypothyroidism and renal impairment. CEA, tumor diameter, KRAS/NRAS gene, and treatment regimen are independent predictors of treatment response. The combined predictive model demonstrates robust diagnostic performance.
评估在晚期结直肠癌患者中，西妥昔单抗联合希罗达-伊立替康（XELIRI）方案的治疗效果，并确定预测治疗反应的临床和分子生物标志物。
对2019年1月至2023年6月期间接受治疗的197例晚期结直肠癌患者进行回顾性分析。患者分为两个队列：单纯接受XELIRI治疗的标准治疗组（n = 103）和接受XELIRI联合西妥昔单抗治疗的联合治疗组（n = 94）。根据RECIST标准评估治疗反应，并分为有反应（完全缓解[CR]或部分缓解[PR]）或无反应（疾病稳定[SD]或疾病进展[PD]）。进行逻辑回归分析以确定治疗反应的独立预测因素。在整个治疗过程中记录不良事件。
与标准治疗队列相比，试验队列显示出统计学上更高的客观缓解率（ORR）和疾病控制率（DCR）（ORR：38.30%对22.33%，P = 0.015；DCR：80.85%对66.02%，P = 0.019）。联合治疗组甲状腺功能减退和肾功能损害的发生率显著更高（P = 0.002）。逻辑回归确定癌胚抗原（CEA）（OR = 1.336，P < 0.001）、肿瘤直径（OR = 2.818，P = 0.001）、KRAS/NRAS基因状态（OR = 6.229，P = 0.001）和治疗方案（OR = 0.079，P < 0.001）为治疗反应的独立预测因素。受试者工作特征（ROC）曲线分析表明，它们的联合预测显著提高了预测效能（AUC = 0.881），具有高敏感性和特异性。
西妥昔单抗联合XELIRI方案可提高晚期结直肠癌患者的ORR和DCR，但可能增加甲状腺功能减退和肾功能损害的风险。CEA、肿瘤直径、KRAS/NRAS基因和治疗方案是治疗反应的独立预测因素。联合预测模型显示出强大的诊断性能。
