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:

Objective To 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. Methods A 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. Results There 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/ml vs. （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/ml vs. （17.25±3.78） ng/ml， t=1.05， P=0.299]， and carbohydrate antigen 125 （CA125） [（72.26±21.06） U/ml vs. （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/ml vs. （27.63±5.71） ng/ml， t=0.33， P=0.740]， CYFRA21-1 [（9.29±1.88） ng/ml vs. （9.06±1.80） ng/ml， t=0.15， P=0.814]， and CA125 [（61.39±21.22） U/ml vs. （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 （all P<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±0.33 vs. 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±0.17 vs. 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 （all P<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）. Conclusion The 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