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1.揭阳市人民医院药学部,广东 揭阳 522000
2.揭阳市人民医院肿瘤内科,广东 揭阳 522000
副主任药师,硕士。研究方向:临床药学。E-mail:ss8311@163.com
收稿日期:2025-02-17,
修回日期:2025-08-14,
录用日期:2025-08-14,
纸质出版日期:2025-09-15
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吴珊珊,黄晓杰,谢晓纯,等.PD-1抑制剂用于晚期食管鳞状细胞癌的疗效预测模型构建[J].中国药房,2025,36(17):2154-2159.
WU Shanshan,HUANG Xiaojie,XIE Xiaochun,et al.Construction of a prediction efficacy model for PD-1 inhibitor in advanced esophageal squamous cell carcinoma[J].ZHONGGUO YAOFANG,2025,36(17):2154-2159.
吴珊珊,黄晓杰,谢晓纯,等.PD-1抑制剂用于晚期食管鳞状细胞癌的疗效预测模型构建[J].中国药房,2025,36(17):2154-2159. DOI: 10.6039/j.issn.1001-0408.2025.17.12.
WU Shanshan,HUANG Xiaojie,XIE Xiaochun,et al.Construction of a prediction efficacy model for PD-1 inhibitor in advanced esophageal squamous cell carcinoma[J].ZHONGGUO YAOFANG,2025,36(17):2154-2159. DOI: 10.6039/j.issn.1001-0408.2025.17.12.
目的
2
构建晚期食管鳞状细胞癌(ESCC)患者接受程序性死亡受体1(PD-1)抑制剂治疗获得持久临床获益(DCB)的预测模型。
方法
2
回顾性收集2020年1月至2023年12月在揭阳市人民医院接受PD-1抑制剂治疗的晚期ESCC患者的临床资料,通过最小绝对收缩和选择算子(Lasso)回归模型筛选预测变量,建立多因素Logistic回归模型预测患者DCB,并基于该模型绘制列线图。通过Bootstrap法对预测模型进行内部验证,采用受试者操作特征曲线、校准曲线、决策曲线分析对预测模型进行评价。
结果
2
共纳入91例晚期ESCC患者。Lasso回归与Logistic回归联合分析的结果表明,基线淋巴细胞/单核细胞比值(LMR)[比值比(OR)为1.97,95%置信区间(CI)为1.15~3.36,
P
=0.013
]
、白蛋白(ALB)含量(OR=1.35,95%CI为1.1
3~1.60,
P
<0.001)、体重指数(BMI)1(正常vs.低:OR=0.28,95%CI为0.09~0.96,
P
=0.042)、BMI2(超重~肥胖vs.低:OR=0.08,95%CI为0.01~0.59,
P
=0.013)及治疗方案(免疫单药vs.免疫联合其他:OR=0.07,95%CI为0.01~0.50,
P
=0.008)是晚期ESCC患者接受PD-1抑制剂获得DCB的预测因素。基于上述指标构建预测模型,经Bootstrap法内部验证,其曲线下面积为0.831(95%CI为0.746~0.904),特异度为74.4%,灵敏度为75.0%。Hosmer-Lemeshow拟合优度检验的
χ
2
=9.930,
P
=0.270,校准曲线的斜率接近1。决策曲线分析结果显示该模型的风险阈值范围在0.1~1.0时具有良好的临床应用价值。
结论
2
通过基线LMR、ALB含量、BMI和治疗方案成功构建了预测模型,其在评估晚期ESCC患者接受PD-1抑制剂治疗效果上具有良好的预测能力和临床实用性。
OBJECTIVE
2
To develop a prediction model for durable clinical benefit (DCB) in patients with advanced esophageal squamous cell carcinoma (ESCC) receiving programmed death-1 (PD-1) inhibitor.
METHODS
2
The clinical data of patients with advanced ESCC who received PD-1 inhibitor in Jieyang People’s Hospital were retrospectively collected between January 2020 to December 2023. Predictors were screened by least absolute shrinkage and selection operator (Lasso) regression, and a multivariable Logistic regression model was developed to predict DCB. A nomogram was constructed based on the model. Internal validation of the prediction model was performed by using the Bootstrap method, and the model was evaluated by the receiver operating characteristic (ROC) curve, calibration curve, and decision curve analysis.
RESULTS
2
A total of 91 patients with advanced ESCC were included. The results of Lasso regression combined with Logistic regression analysis indicated that the baseline lymphocyte monocyte ratio (LMR) [odds ratio (OR)=1.97, 95% confidence interval (CI): 1.15-3.36,
P
=0.013
]
, albumin (ALB) content (OR=1.35, 95%CI: 1.13-1.60,
P
<0.001), body mass index (BMI) category 1 [normal vs. low: OR=0.28, 95%CI (0.09-0.96),
P
=0.042
]
, BMI category
2 [overweight-obesity vs. low: OR=0.08, 95%CI (0.01-0.59),
P
=0.013
]
, and treatment regimen [monotherapy vs. monotherapy combination therapy: OR=0.07, 95%CI (0.01-0.50),
P
=0.008
]
were predictive factors for patients with advanced ESCC to achieve DCB when treated with PD-1 inhibitor. A prediction model was constructed based on the above indicators. Internal validation of the model using the Bootstrap method showed an area under the curve of 0.831 (95%CI: 0.746-0.904), with specificity of 74.4% and sensitivity of 75.0%. The Hosmer-Lemeshow test yielded
χ
2
=9.930,
P
=0.270, and the calibration curve slope was close to 1. The decision curve analysis demonstrated that the model exhibited good clinical utility within a threshold range of 0.1 to 1.0.
CONCLUSIONS
2
The prediction model based on baseline LMR, ALB content, BMI, and treatment regimen demonstrates robust predictive performance and clinical utility for assessing therapeutic efficacy of PD-1 inhibitor in the treatment of advanced ESCC.
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