Efficacy And Safety Of Nimotuzumab In The Treatment Of Locally Advanced Nasopharyngeal Carcinoma

ObjectiveThis study intends to explore the efficacy and safety of long course of nimotuzumab combined with induction chemotherapy sequential chemoradiothe-rapy in the treatment of locally advanced nasopharyngeal carcinoma.Methods:Clinical data of 331 patients with nasopharyngeal carcinoma diagnosed in the First Affiliated Hospital of Nanchang University from February 1,2018 to February 1,2020 were collected.After screening according to certain inclusion criteria and exclusion criteria,patients receiving induction chemotherapy and concurrent chemoradiotherapy were classified as the control group,while those receiving long course(9-12 cycles)of nimotuzumab combined with induction chemotherapy and concurrent chemoradiotherapy were classified as the observation group.Objective response rate(ORR)and disease control rate(DCR)were assessed based on RECIST1.1,and adverse reactions were assessed based on CTCA 5.0.The rank-sum test of two paired samples,the rank-sum test of two independent samples and the Chi-square test were used to analyze the differences between the groups.The progression-free survival(PFS)and overall survival(OS)curves were plotted by Kaplan-Meier method.Single-factor and multi-factor Cox regression models were used to analyze the prognostic factors of locally advanced nasopharyngeal carcinoma.No patients withdrew from the study due to adverse events.Result:1.The ORR of the observation group was significantly higher than that of the control group(80.33% vs 63.33%,p=0.038),but there was no significant difference in DCR between the two groups(98.36% vs 95.00%,p=0.365).2.The 3-year 0S rate of the control group and the observation group was75.00%vs81.97%,p=0.337,and the 3-year PFS rate was 56.67% vs77.05%,p=0.018,respectively.Further subgroup analysis revealed 3-year OS rates in the control and observation groups in Stage III patients(78.13% vs 94.29%,p=0.051)and 3-year PFS rate(65.63% vs 91.43%,p=0.010).3.Univariate and multivariate cox regression model analysis showed that clinical stage,induction chemotherapy cycle and treatment regimen were independent factors affecting 3-year PFS in patients with locally advanced nasopharyn-geal carcinoma(p<0.05).Clinical stage and Epstein-Barr virus status at baseline were independent factors for 3-year OS.4.The statistical results of adverse reactions between the control group and the observation group showed that only rash(10.0% vs24.6%,p=0.034)and dry mouth(75.0% vs 96.7%,p=0.001)had significant differences.There was no significant difference between grade 3 and above.Conclusion:1.Compared with chemoradiotherapy alone,combined with a long course of nimotuzumab can improve ORR and 3-year PFS in patients with locally advanced nasopharyngeal carcinoma.2.The safety of a long course of nimotuzumab for patients with locally advanced nasopharyngeal carcinoma was controllable,and there was no statistical difference in grade 3 or above adverse reactions in the observation group compared with the control group.