卡瑞利珠单抗与信迪利单抗治疗晚期非小细胞肺癌的临床疗效及安全性分析

摘要/Abstract

摘要：

目的比较卡瑞利珠单抗与信迪利单抗治疗晚期非小细胞肺癌（NSCLC）的临床疗效，探究其对肿瘤标志物水平和免疫功能指标的影响并进行安全性分析。方法选取2019年5月至2021年5月在江苏省海安市人民医院治疗的87例晚期NSCLC患者作为研究对象，根据治疗方案将患者分为卡瑞利珠单抗组（n=41）和信迪利单抗组（n=46）。比较两组临床疗效、预后、肿瘤标志物水平、免疫功能指标和免疫相关不良反应。结果卡瑞利珠单抗组和信迪利单抗组客观缓解率[48.78%（20/41）比39.13%（18/46），χ²=0.82，P=0.365]、疾病控制率[78.05%（32/41）比71.74%（33/46），χ²=0.46，P=0.499]相比，差异均无统计学意义。卡瑞利珠单抗组患者中位无进展生存期（PFS）为9.1个月，中位总生存期（OS）为15.4个月；信迪利单抗组中位PFS为9.7个月，中位OS为15.7个月。两组患者中位PFS及中位OS比较，差异均无统计学意义（χ²=0.18，P=0.633；χ²=0.15，P=0.697）。治疗前卡瑞利珠单抗组和信迪利单抗组癌胚抗原（CEA）[（47.68±8.12）ng/ml比（49.03±8.70）ng/ml，t=0.75，P=0.458]、细胞角蛋白19片段抗原21-1（CYFRA21-1）[（18.06±3.41）ng/ml比（17.25±3.78）ng/ml，t=1.05，P=0.299]、糖类抗原125（CA125）[（72.26±21.06）U/ml比（74.03±22.10）U/ml，t=0.38，P=0.704]水平比较，差异均无统计学意义。治疗后两组CEA[（28.11±7.68）ng/ml比（27.63±5.71）ng/ml，t=0.33，P=0.740]、CYFRA21-1[（9.29±1.88）ng/ml比（9.06±1.80）ng/ml，t=0.15，P=0.814]、CA125[（61.39±21.22）U/ml比（60.51±11.03）U/ml，t=0.25，P=0.806]水平比较，差异均无统计学意义。但两组患者治疗后CEA、CYFRA21-1、CA125水平均较治疗前下降（均P<0.05）。治疗前两组T细胞亚群CD4⁺[（41.15±3.24）%比（41.17±2.90）%，t=0.03，P=0.976]、CD8⁺[（68.82±3.94）%比（70.06±4.08）%，t=1.44，P=0.154]和CD4⁺/CD8⁺（1.88±0.33比1.76±0.25，t=1.92，P=0.058）比较，差异均无统计学意义。治疗后两组T细胞亚群CD4⁺[（47.08±3.22）%比（48.53±5.07）%，t=1.57，P=0.120]、CD8⁺[（61.22±1.67）%比（61.45±1.66）%，t=0.64，P=0.522]和CD4⁺/CD8⁺（2.31±0.17比2.36±0.12，t=1.60，P=0.114）比较，差异均无统计学意义。两组治疗后T细胞亚群CD8⁺均低于治疗前，而CD4⁺及CD4⁺/CD8⁺均高于治疗前（均P<0.05）。信迪利单抗组不良反应总发生率[10.87%（5/46）]低于卡瑞利珠单抗组[31.71%（13/41）]，差异有统计学意义（χ²=5.74，P=0.016）。结论卡瑞利珠单抗与信迪利单抗对NSCLC患者的临床疗效基本一致，且对肿瘤标志物及免疫功能的影响相当，但信迪利单抗的安全性优于卡瑞利珠单抗。

关键词:癌,非小细胞肺,治疗结果,药物相关性副作用和不良反应,卡瑞利珠单抗,信迪利单抗

Abstract:

ObjectiveTo compare the clinical efficacy of camrelizumab and sintilimab in the treatment of advanced non-small cell lung cancer （NSCLC）， and to explore its impact on tumor marker levels and immune function index， as well as to perform safety analysis.MethodsA total of 87 patients with advanced NSCLC who were treated in Hai'an People's Hospital of Jiangsu Province from May 2019 to May 2021 were selected as the research objects. According to the treatment scheme， the patients were divided into camrelizumab group （n=41） and sintilimab group （n=46）. The clinical efficacy， prognosis， tumor marker levels， immune function index and immune related adverse reactions of the two groups were compared.ResultsThere were no statistically significant differences in objective response rate [48.78% （20/41）vs.39.13% （18/46），χ²=0.82，P=0.365] or disease control rate [78.05% （32/41）vs.71.74% （33/46），χ²=0.46，P=0.499] in both camrelizumab and sintilimab group. The median progression-free survival （PFS） in the camrelizumab group was 9.1 months， and the median overall survival （OS） was 15.4 months. The median PFS in the sintilimab group was 9.7 months， and the median OS was 15.7 months. There were no statistically significant differences in median PFS and median OS between the two groups （χ²=0.18，P=0.633；χ²=0.15，P=0.697）. Before treatment， there were no statistically significant differences in carcinoembryonic antigen （CEA） [（47.68±8.12） ng/mlvs.（49.03±8.70） ng/ml，t=0.75，P=0.458]， cytokeratin 19 fragment antigen 21-1 （CYFRA21-1） [（18.06±3.41） ng/mlvs.（17.25±3.78） ng/ml，t=1.05，P=0.299]， and carbohydrate antigen 125 （CA125） [（72.26±21.06） U/mlvs.（74.03±22.10） U/ml，t=0.38，P=0.704] levels between the camrelizumab group and sintilimab group. After treatment， there were no statistically significant differences in CEA [（28.11±7.68） ng/mlvs.（27.63±5.71） ng/ml，t=0.33，P=0.740]， CYFRA21-1 [（9.29±1.88） ng/mlvs.（9.06±1.80） ng/ml，t=0.15，P=0.814]， and CA125 [（61.39±21.22） U/mlvs.（60.51±11.03） U/ml，t=0.25，P=0.806] levels between the two groups， but CEA， CYFRA21-1， and CA125 levels decreased after treatment compared with those before treatment in both groups （allP<0.05）. Before treatment， there were no statistically significant differences in T cells CD4⁺[（41.15±3.24）%vs.（41.17±2.90）%，t=0.03，P=0.976]， CD8⁺[（68.82±3.94）%vs.（70.06±4.08）%，t=1.44，P=0.154]， and CD4⁺/CD8⁺（1.88±0.33vs.1.76±0.25，t=1.92，P=0.058） between the two groups. After treatment， there were no statistically significant differences in T cells CD4⁺[（47.08±3.22）%vs.（48.53±5.07）%，t=1.57，P=0.120]， CD8⁺[（61.22±1.67）%vs.（61.45±1.66）%，t=0.64，P=0.522]， and CD4⁺/CD8⁺（2.31±0.17vs.2.36±0.12，t=1.60，P=0.114） between the two groups， while T cells CD8⁺was lower than that before treatment， and CD4⁺as well as CD4⁺/CD8⁺were higher than those before treatment in both groups （allP<0.05）. The overall incidence of adverse reactions in the sintilimab group [10.87% （5/46）] was lower than that in the camrelizumab group [31.71% （13/41）]， and with a statistically significance （χ²=5.74，P=0.016）.ConclusionThe clinical efficacy of camrelizumab and sintilimab in NSCLC patients is basically the same， the impacts of which on tumor markers and immune function are comparable， but the safety of sintilimab is better than that of camrelizumab.

Key words:Carcinoma,non-small-cell lung,Treatment outcome,Drug-related side effects and adverse reactions,Camrelizumab,Sintilimab

严爱婷, 王翠竹, 刘春桂, 鲁小敏. 卡瑞利珠单抗与信迪利单抗治疗晚期非小细胞肺癌的临床疗效及安全性分析[J]. 国际肿瘤学杂志, 2024, 51(3): 137-142.

Yan Aiting, Wang Cuizhu, Liu Chungui, Lu Xiaomin. Clinical efficacy and safety of camrelizumab and sintilimab in the treatment of advanced non-small cell lung cancer[J]. Journal of International Oncology, 2024, 51(3): 137-142.

图/表5

表1

两组晚期NSCLC患者一般临床资料比较[例（%）/ $\bar{x} \pm s$]"

一般临床资料	卡瑞利珠单抗组（n=41）	信迪利单抗组（n=46）	χ²/t/ Z值	P值
性别
男	25（60.98）	27（58.70）	0.05	0.829
女	16（39.02）	19（41.30）	0.05	0.829
年龄（岁）	61.83±7.12	60.97±7.20	0.94	0.362
BMI（kg/m²）	25.40±2.02	25.21±2.21	0.96	0.329
TMB
低突变	5（12.20）	6（13.04）
中突变	11（26.83）	13（28.26）	0.21	0.830
高突变	25（60.98）	27（58.70）
PD-L1阳性表达率>1%
是	24（58.54）	28（60.87）	0.05	0.825
否	17（41.46）	18（39.13）	0.05	0.825
吸烟史
有	33（80.49）	30（65.22）	2.53	0.112
无	8（19.51）	16（34.78）	2.53	0.112

表1

图1

组别	CEA（ng/ml）			CA125（U/ml）
卡瑞利珠单抗组（n=41）	47.68±8.12	28.11±7.68^a	18.06±3.41	9.29±1.88^a	72.26±21.06	61.39±21.22^a
信迪利单抗组（n=46）	49.03±8.70	27.63±5.71^a	17.25±3.78	9.06±1.80^a	74.03±22.10	60.51±11.03^a
t值	0.75	0.33	1.05	0.15	0.38	0.25
P值	0.458	0.740	0.299	0.814	0.704	0.806

表2

组别	CD4⁺（%）			CD4⁺/CD8⁺
卡瑞利珠单抗组（n=41）	41.15±3.24	47.08±3.22^a	68.82±3.94	61.22±1.67^a	1.88±0.33	2.31±0.17^a
信迪利单抗组（n=46）	41.17±2.90	48.53±5.07^a	70.06±4.08	61.45±1.66^a	1.76±0.25	2.36±0.12^a
t值	0.03	1.57	1.44	0.64	1.92	1.60
P值	0.976	0.120	0.154	0.522	0.058	0.114

表3

组别	皮肤反应	疲劳	高血糖	原发性肾上腺功能减退	甲状腺功能异常	合计
卡瑞利珠单抗组（n=41）	3（7.32）	4（9.76）	2（4.88）	1（2.44）	3（7.32）	13（31.71）
信迪利单抗组（n=46）	1（2.17）	2（4.35）	1（2.17）	0（0）	1（2.17）	5（10.87）
χ²值						5.74
P值						0.016

表4

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