特瑞普利单抗联合卡培他滨、放疗治疗中晚期鼻咽癌的临床研究

Clinical study on the combination of toripalimab,capecitabine,and radiotherapy in treating advanced nasopharyngeal carcinoma

目的探讨特瑞普利单抗联合卡培他滨、放疗治疗中晚期鼻咽癌的临床效果。方法前瞻性选取2021年6月至2023年6月海南省人民医院收治的中晚期鼻咽癌患者80例。按照随机数字表法将其分为放化疗组和联合组,每组各40例。放化疗组给予卡培他滨、放疗进行治疗,联合组在放化疗组的基础上联合特瑞普利单抗进行治疗,比较两组客观缓解率(ORR)以及治疗前、后患者血清肿瘤标志物[鳞状细胞癌抗原(SCC-Ag)、高迁移率族蛋白B1(HMGB1)与细胞角蛋白19片段抗原21-1(CYFRA21-1)]水平、免疫功能(CD4^(+),CD8^(+)、CD4^(+)/CD8^(+))变化情况,并统计观察两组不良反应及复发、转移情况。结果联合组ORR为90.00%,显著高于放化疗组(70.00%),差异有统计学意义(P<0.05)。治疗3个月后,两组患者SCC-AG、HMGB1、CYFRA21-1水平均较治疗前降低,且联合组SCC-AG、HMGB1、CYFRA21-1水平分别为(1.45±0.37)ng/mL、(108.04±14.46)ng/mL、(3.56±1.04)μg/L,均低于放化疗组[(4.43±0.95)ng/mL、(136.52±16.72)ng/mL、(7.29±1.81)μg/L],差异均有统计学意义(P<0.05)。治疗3个月后,两组患者CD4^(+)、CD4^(+)/CD8^(+)水平均较治疗前升高,联合组CD8^(+)水平较治疗前降低,且联合组的CD4^(+)、CD4^(+)/CD8^(+)水平分别为(38.25±4.92)%、1.65±0.26,均高于放化疗组[(35.14±4.68)%、1.34±0.22],CD8^(+)水平为(23.22±2.89)%,低于放化疗组[(25.36±2.93)%],差异均有统计学意义(P<0.05)。治疗期间,两组不良反应总发生率比较,差异无统计学意义(P>0.05)。治疗后,联合组局部复发率为10.00%,显著低于放化疗组(27.50%),差异有统计学意义(P<0.05)。治疗后,联合组转移率为7.50%,放化疗组转移率为15.00%,两组比较差异无统计学意义(P>0.05)。结论采用特瑞普利单抗联合卡培他滨、放疗治疗中晚期鼻咽癌可提高患者临床疗效,降低肿瘤标志物水平,改善免疫功能,且安全性可靠。

Objective To explore the clinical efficacy of combination with toripalimab,capecitabine,and radiotherapy on advanced nasopharyngeal carcinoma.Methods Eighty patients with advanced nasopharyngeal carcinoma admitted to Hainan General Hospital from June 2021 to June 2023 were prospectively selected.According to the random number table method,they were divided into the radiotherapy and chemotherapy group and the combination group,with 40 cases in each group.The radiotherapy and chemotherapy group received treatment with capecitabine and radiation therapy,while the combination group received treatment with toripalimab in addition to the radiotherapy and chemotherapy group.The objective remission rate(ORR),serum tumor marker[squamous cell carcinoma antigen(SCC-Ag),high mobility group protein B1(HMGB1),cytokeratin 19 Fragment Antigen 21-1(CYFRA21-1)]levels and immune function(CD4^(+),CD8^(+)and CD4^(+)/CD8^(+))changes of the two groups were compared before and after treatment,adverse reactions,recurrence and transfer were statistically observed.Results The ORR of the combination group was 90.00%,which was significantly higher than that of the radiotherapy and chemotherapy group(70.00%),and the difference was statistically significant(P<0.05).After 3 months of treatment,the levels of SCC-AG,HMGB1,and CYFRA21-1 in two groups of patients were lower than those before treatment,and the levels of SCC-AG,HMGB1,and CYFRA21-1 in the combination group were(1.45±0.37)ng/mL,(108.04±14.46)ng/mL,and(3.56±1.04)μg/L,respectively,which were lower than those in the radiotherapy and chemotherapy group[(4.43±0.95)ng/mL,(136.52±16.72)ng/mL,and(7.29±1.81)μg/L],the differences were statistically significant(P<0.05).After 3 months of treatment,the levels of CD4^(+)and CD4^(+)/CD8^(+)in two groups of patients were higher than those before treatment,while the levels of CD8^(+)in the combination group was lower than that before treatment,the levels of CD4^(+)and CD4^(+)/CD8^(+)in the combination group were(38.25±4.92)%and 1.65±0.26,respectively,which were higher than those in the radiotherapy and chemotherapy group[(35.14±4.68)%and 1.34±0.22],and the level of CD8^(+)was(23.22±2.89)%,which was lower than that in the radiotherapy and chemotherapy group[(25.36±2.93)%],the differences were statistically significant(P<0.05).During the treatment period,there was no statistically significant difference in the total incidence of adverse reactions between the two groups(P>0.05).After treatment,the local recurrence rate of the combined group was 10.00%,which was lower than that in the radiotherapy and chemotherapy group(27.50%),the difference was statistically significant(P<0.05).After treatment,the transfer rate of the combination group was 7.50%,and the transfer rate of the radiotherapy and chemotherapy group was 15.00%.There was no statistically significant difference between the two groups.Conclusion The toripalimab combined with capecitabine and radiotherapy for middle to late stage nasopharyngeal carcinoma can improve clinical efficacy,reduce tumor marker levels,improve immune function,and is safe and reliable.