Efficacy and safety analysis of sintilimab combined with regofenib in the treatment of advanced colorectal cancer

doi:10.3877/cma.j.issn.2095-2015.2023.06.009

Abstract

Abstract:

Objective

To explore the efficacy and safety of immune checkpoint inhibitor sintilimab combined with regofenib in the treatment of advanced colorectal cancer(CRC).

Methods

A total of 90 advanced CRC patients who were treated in Guangzhou First People′s Hospital from January 2020 to January 2022 were prospective selected, and were divided into observation group and control group according to the random number table, with 45 patients in each group.The control group received oral regofini, and the observation group received sintilimab injection on the basis of the control group.The clinical efficacy, tumor markers, immune function, survival time and adverse reaction were compared between the two groups.

Results

After treatment, objective response rate and disease control rate of the observation group were 53.33% and 80.00%, those of the control group were 20.00% and 60.00%(P<0.05). After treatment, carbohydrate antigen 199(CA199), cytokeratin 19 fragment antigen 21-1(CYFRA21-1), carcinoembryonic antigen(CEA)decreased in both groups, and the indicators of the observed group were lower than those of the control group(P<0.05). The proportion of cytotoxic T cells(CD8⁺ )decreased in both groups, while the proportion of helper T cells(CD4⁺ )and CD4⁺ /CD8⁺ ratio increased in both groups.Moreover, the proportion of CD4⁺ and CD4⁺ /CD8⁺ in the observed group were higher than those in the control group(P<0.05), while the proportion of CD8⁺ was lower than that in the control group(P>0.05). The overall survival(P=0.040)and progression-free survival(P=0.046)of the observation group were longer than those of the control group.The incidence of adverse reactions in the observation group was lower than that in the control group(64.44% vs.62.22%, P>0.05).

Conclusion

Immune checkpoint inhibitors sintilimab combined with regofenib has good efficacy and safety in the treatment of the patients with advanced CRC, prolonging survival time and alleviating the pain caused by cancer.

Key words: Colorectal cancer, Immune checkpoint inhibitors, Clinical efficacy, Survival analysis, Safety

Wenlong Liang, Jie Cao, Qing Huang, Yong Lin, Hongli Huang, Ping Yang, Guanwei Li, He Hu. Efficacy and safety analysis of sintilimab combined with regofenib in the treatment of advanced colorectal cancer[J]. Chinese Journal of Digestion and Medical Imageology(Electronic Edition), 2023, 13(06): 409-413.

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Figures/Tables 6

References 18

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组别	例数	完全缓解	部分缓解	病情稳定	病情进展	客观缓解率	疾病控制率
对照组	45	0	9(20.00)	18(40.00)	18(40.00)	9(20.00)	27(60.00)
观察组	45	0	24(53.33)	12(26.67)	9(20.00)	24(53.33)	36(80.00)
χ²值						10.766	4.286
P值						0.001	0.038

组别	例数	完全缓解	部分缓解	病情稳定	病情进展	客观缓解率	疾病控制率
对照组	45	0	9(20.00)	18(40.00)	18(40.00)	9(20.00)	27(60.00)
观察组	45	0	24(53.33)	12(26.67)	9(20.00)	24(53.33)	36(80.00)
χ²值						10.766	4.286
P值						0.001	0.038

组别	例数	糖类抗原199(U/mL)		癌胚抗原(μg/mL)		细胞角蛋白19片段抗原21-1(μg/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	45	102.14±11.97	77.94±8.19^#	20.64±3.14	8.45±2.81^#	8.84±1.37	3.69±0.77^#
观察组	45	104.88±12.29	65.25±7.98^#	19.58±3.25	5.68±2.74^#	8.37±1.59	3.35±0.73^#
t值		1.071	7.445	1.573	4.734	1.502	2.150
P值		0.287	0.000	0.119	0.000	0.137	0.034

组别	例数	糖类抗原199(U/mL)		癌胚抗原(μg/mL)		细胞角蛋白19片段抗原21-1(μg/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	45	102.14±11.97	77.94±8.19^#	20.64±3.14	8.45±2.81^#	8.84±1.37	3.69±0.77^#
观察组	45	104.88±12.29	65.25±7.98^#	19.58±3.25	5.68±2.74^#	8.37±1.59	3.35±0.73^#
t值		1.071	7.445	1.573	4.734	1.502	2.150
P值		0.287	0.000	0.119	0.000	0.137	0.034

组别	例数	反应性毛细血管增生	免疫性肺炎	免疫性肝炎	免疫性结肠炎	甲状腺功能减退	合计
对照组	45
1~2级		21(46.67)	1(2.22)	3(6.67)	1(2.22)	1(2.22)	27(60.00)
3~4级		1(2.22)	0(0.00)	1(2.22)	0(0.00)	0(0.00)	2(4.44)
观察组	45
1~2级		15(33.33)	3(6.67)	5(11.11)	0(0.00)	3(6.67)	26(57.78)
3~4级		0(0.00)	1(2.22)	1(2.22)	0(0.00)	0(0.00)	2(4.44)

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