信迪利单抗联合TP化疗方案对晚期食管癌患者免疫功能和预后生存的影响

doi:10.3969/j.issn.1006-5725.2025.18.018

摘要/Abstract

摘要：

目的探讨信迪利单抗联合TP化疗方案对晚期食管癌患者免疫功能和预后生存的影响。方法 2022年1月至2023年10月在医院接受治疗的晚期食管癌患者，共82例，随机数字表法分组，每组41例。对照组接受TP化疗方案，观察组在对照组的基础上联合应用信迪利单抗，21 d为1个周期，两组均治疗4个周期，随后观察组信迪利单抗单药维持至少1年。记录患者的疾病控制率和客观缓解率，比较治疗前后的免疫功能、炎性因子水平和肿瘤标志物水平，并通过吞咽功能评定量表（SSA）和食管癌生命质量测定量表（QLICP-ES）评估患者治疗前后的吞咽功能和生活质量，记录不良反应发生情况。治疗开始后随访18月，记录总生存期（OS）和生存率。结果观察组部分缓解和疾病控制率分别为53.66%和87.80%，均高于对照组，且治疗后观察组CD3^＋、CD4^＋分别为（50.48 ± 5.61）%、（37.96 ± 4.69）%，高于对照组的（44.73 ± 5.12）%、（33.15 ± 4.21）%，免疫功能比对照组提高，炎性因子水平和肿瘤标志物水平比对照组降低，吞咽功能和生活质量比对照组明显改善（P < 0.05）；18月随访结果显示，观察组平均OS为14.40（12.94，15.85）月，PFS为10（7，14）月，对照组平均OS为11.95（10.39，13.51）月，PFS为7（5，10）月，观察组OS和PFS均高于对照组。观察组和对照组生存率分别为60.98%（25/41）和36.59%（15/41），观察组高于对照组（χ² = 5.259，P = 0.022）。结论信迪利单抗联合TP化疗方案有助于提高晚期食管癌患者免疫功能，改善患者生存状况。

关键词: 信迪利单抗, TP化疗方案, 晚期食管癌, 免疫功能, 生活质量, 预后

Abstract:

Objective To investigate the impact of sintilimab combined with TP chemotherapy regimen on immune function and prognostic survival in patients with advanced esophageal cancer. Methods A total of 82 patients with advanced esophageal cancer who received treatment in the hospital from January 2022 to October 2023 were enrolled. They were divided into two groups with 41 cases in each group using the random number table method. The control group was given the TP chemotherapy regimen， while the observation group was treated with sintilimab in addition to the TP chemotherapy regimen used in the control group. The treatment cycle was 21 days， and both groups received 4 cycles of treatment. After that， the observation group received sintilimab monotherapy for maintenance treatment for at least 1 year. The disease control rate （DCR） and objective response rate （ORR） of the patients were recorded. The immune function， levels of inflammatory factors and tumor markers before and after treatment were compared between the two groups. The swallowing function and quality of life of the patients before and after treatment were evaluated using the Swallowing Safety Assessment （SSA） and the Quality of Life Instruments for Cancer Patients - Esophageal Cancer （QLICP-ES）. The occurrence of adverse reactions was also recorded. After the start of treatment， the patients were followed up for 18 months， and the overall survival （OS） and survival rate were recorded. Results In the observation group， the partial remission rate and disease control rate were 53.66% and 87.80% respectively， both higher than those in the control group. After treatment， the levels of CD3⁺ and CD4⁺ in the observation group were （50.48 ± 5.61）% and （37.96 ± 4.69）% respectively， which were higher than （44.73 ± 5.12）% and （33.15 ± 4.21）% in the control group. The immune function of the observation group was improved compared with the control group， while the levels of inflammatory factors and tumor markers were lower than those in the control group. The swallowing function and quality of life were significantly improved compared with the control group （P < 0.05）.The 18-month follow-up results showed that the median overall survival （OS） in the observation group was 16 （9， 17） months， and that in the control group was 9 （7， 14） months. The OS in the observation group was longer than that in the control group （χ2 = 13.394， P < 0.001）. The 18months survival rates in the observation group and the control group were 60.98% （25/41） and 36.59% （15/41） respectively， with the observation group being higher than the control group （χ2 = 4.881， P = 0.027）. Conclusion The sintilimab combined with TP chemotherapy regimen is beneficial for improving immune function and enhancing the survival status of patients with advanced esophageal cancer.

Key words: sintilimab, TP chemotherapy regimen, advanced esophageal cancer, immune function, quality of life, prognosis

中图分类号:

R735.1

李敬国,刘艳,汪超,李承慧. 信迪利单抗联合TP化疗方案对晚期食管癌患者免疫功能和预后生存的影响[J]. 实用医学杂志, 2025, 41(18): 2906-2912.

Jingguo LI,Yan LIU,Chao WANG,Chenghui LI. Impact of sintilimab combined with TP chemotherapy regimen on immune function and prognostic survival in patients with advanced esophageal cancer[J]. The Journal of Practical Medicine, 2025, 41(18): 2906-2912.

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组别	例数	性别 (男/女）/例	年龄/岁	体质量指数/（kg/m²）	病变长度/cm	病理分期/例		病变部位/例
组别	例数	性别 (男/女）/例	年龄/岁	体质量指数/（kg/m²）	病变长度/cm	Ⅲb期	Ⅳ期	胸上段	胸中段	胸下段
对照组	41	23/18	60.78 ± 7.23	22.28 ± 3.40	6.47 ± 1.15	18	23	12	19	10
观察组	41	19/22	61.12 ± 7.45	22.52 ± 3.65	6.35 ± 1.07	20	21	14	18	9
t/χ² 值		0.781	0.210	0.308	0.489	0.196		0.234
P值		0.377	0.834	0.759	0.626	0.658		0.890

组别	例数	CR	PR	SD	PD	ORR	DCR
对照组	41	0（0.00）	12（29.27）	16（39.02）	13（24.39）	12（29.27）	28（68.29）
观察组	41	1（2.44）	21（51.22）	14（34.15）	5（7.32）	22（53.66）	36（87.80）
χ² 值						5.025	4.556
P值						0.025	0.033

组别	例数	CD3^＋		CD4^＋		CD8^＋
组别	例数	治疗前	治疗后	治疗前	治疗后	治疗前	治疗后
对照组	41	55.79 ± 6.40	44.73 ± 5.12^?	40.93 ± 5.42	33.15 ± 4.21^?	30.19 ± 4.06	35.99 ± 4.42^*
观察组	41	56.12 ± 6.63	50.48 ± 5.61^?	41.21 ± 5.76	37.96 ± 4.69^?	30.44 ± 4.11	33.13 ± 4.10^?
t值		0.229	4.848	0.227	4.887	0.227	3.038
P值		0.819	< 0.05	0.821	< 0.05	0.783	< 0.05

组别	例数	IL-6/（ng/L）		TNF-α/（g/L）		IL-8/（ng/mL）
组别	例数	治疗前	治疗后	治疗前	治疗后	治疗前	治疗后
对照组	41	178.12 ± 23.62	132.84 ± 16.46^?	15.01 ± 2.46	10.01 ± 1.34^?	4.59 ± 0.68	3.13 ± 0.52^?
观察组	41	176.91 ± 21.35	96.75 ± 10.39^?	14.76 ± 2.29	6.98 ± 1.02^?	4.65 ± 0.71	2.03 ± 0.40^?
t值		0.243	11.872	0.476	11.521	0.391	10.736
P值		0.808	< 0.05	0.635	< 0.05	0.697	< 0.05

组别	例数	CEA/ (ng/mL)		CA199 /(U/mL)		SCC/（μg/L）
组别	例数	治疗前	治疗后	治疗前	治疗后	治疗前	治疗后
对照组	41	11.64 ± 2.32	7.16 ± 1.23^?	52.74 ± 6.63	42.92 ± 5.67^?	9.25 ± 1.36	4.48 ± 0.59^?
观察组	41	12.16 ± 2.48	5.11 ± 1.18^?	52.32 ± 6.42	35.09 ± 5.20^?	9.18 ± 1.31	3.51 ± 0.40^?
t值		0.980	7.701	0.291	6.517	0.237	8.713
P值		0.330	< 0.05	0.771	< 0.05	0.813	< 0.05