| Purpose: Nimotuzumab is a monoclonal antibody drug targeting epidermal growth factor(EGFR)with high humanization characteristics,compared with concurrent chemoradiation(CCRT),the combined use of nimotuzumab in the treatment of locally advanced nasopharyngeal carcinoma(NPC)has more obvious advantages.The2009 China edition NCCN guidelines to promote that nimotuzumab be used in concurrent radiotherapy for locally advanced nasopharyngeal carcinoma.Studies have confirmed that induction chemotherapy(IC)on the basis of concurrent chemoradiotherapy can further increase the failure-free survival rate of locally advanced nasopharyngeal carcinoma,and even can prolong overall survival time.In 2019,concurrent radiotherapy and chemotherapy after TPF induction chemotherapy were promoted by NCCN guidelines as the preferred treatment for locally advanced nasopharyngeal carcinoma,in 2020,concurrent chemoradiotherapy after induction chemotherapy with TPF and GP regimens will be recommended as grade I for locally advanced nasopharyngeal carcinoma.This study is mainly dedicated to estimate the effectiveness and safety of nimotuzumab for concurrent radiotherapy and chemotherapy after TPF induction chemotherapy for locally advanced nasopharyngeal carcinoma.Methods: A total of 72 patients with stage III-IVA nasopharyngeal carcinoma who were pathologically diagnosed as nasopharyngeal carcinoma and EGFR(+～+++)in the Department of Head and Neck Oncology of Xiangxi Autonomous Prefecture Hospital from March 1,2019 to March 1,2020 were selected.Use random number table method for random grouping,there are 36 cases in the observation group and the control group,Patients in both groups received the same TPF induction chemotherapy for 2 cycles(paclitaxel liposome 135mg/m2,intravenous drip,d1,cisplatin 25mg/m2,intravenous drip,d1-3,fluorouracil 600mg/m2 continuous intravenous pumping,d1-5,repeated every 3 weeks).All patients received radical intense-modulated radiotherapy(IMRT)2 week after 2 cycles of TPF induction chemotherapy,Prescription measurement:PGTVnx:69.96-73.92Gy/2.12-2.24Gy/33 f,PGTVnd:69.96 G y/2.12 Gy/33 f,PTV1:60.06 Gy/1.82 Gy/33 f,PTV2:50.4Gy/1.8Gy/28 f.According to the requirements of Radiation Therapy Oncology Group(RTOG)0225,the limited dose and planning of organs at risk were evaluated,the irradiation method was 1 time/day,5 times/week,33 times in total.Patients in observation group and control group received the same dose of cisplatin monotherapy at the same time of IMRT(cisplatin80mg/m2,intravenous drip,divided into 3 days,repeated every 3 weeks,2 cycles),the observation group received targeted therapy of nimotuzumab(200mg,intravenous drip,once a week *6 times)at the same time of radiotherapy.Response evaluation criteria in solid tumors(RECIST)was used to evaluate the objective efficacy,RTOG score was used to evaluate the adverse reactions of radiotherapy,adverse reactions to chemotherapy were evaluated according to national cancer institute common toxicity criteria version 4.02(NCI CTCAE 4.02)standard,the short-term efficacy was evaluated by the chi-square test,and the 1-year survival index curve was plotted by the Kaplan-Meier method,it is statistically significant to take P<0.05 as the difference.Results: 1、Baseline characteristics:The baseline characteristics such as age,KPS,gender,tumor stage(T stage),lymph node stage(N stage),clinical stage of tumor,pathological classification and degree of EGFR were comparable between the two groups(P>0.05).2、Short-term efficacy:The CR rates of the observation group and control group were(80.6% vs 66.7%,P=0.388),the ORR rates of the observation group and control group were(94.4% vs 91.7%,P=1.000),the DCR rates of the observation group and control group were(97.2% vs97.2%,P=1.000)3、Subsistence analysis:The 1-year PFS rates of the observation group and the control group were(94.4% vs 88.9%,P=0.406),the 1-year OS rates were(97.2% vs 97.2%,P= 0.992),the 1-year LRFS rates were(100%vs100%,P=1.000),the 1-year MDFS rates were(94.4% vs91.7%,P=0.649).4、Subgroup survival analysis: For T4 patients,the 1-year PFS rates of the observation group and the control group were(93.8% vs85.7%,P=0.439),the 1-year OS rates were(100% vs 95.2%,P=0.383),the1-year LRFS rates were(100% vs 100%,P=1.000),the 1-year MDFS rates were(93.8% vs 90.5%,P=0.706).For T3 patients,the 1-year PFS rates of the observation group was higher than that of the control group(92.9% vs71.4%,P=0.167),the 1-year OS rates of the two groups of patients were(92.9% vs 92.9%,P=0.979),the 1-year LRFS rates of the two groups of patients were(100% vs 100%,P= 1.000),the 1-year DMFS rates of the two groups of patients were(92.9% vs 71.4%,P=0.167).5、Adverse reactions:The observation group had no adverse reactions related to nimotuzumab,such as fever,allergies,and skin rashes.Hematological toxicity:For the reduction of grade 1-2 hemoglobin,the observation group and the control group were respectively(36.2% vs69.5%),no severe anemia occurred,and the difference was statistically significant(P=0.008);the observation group and the control group had grade 1-2 leukopenia(72.2% vs 69.4%)and grade 3 leukopenia(2.8% vs0.0%)respectively.There was no incidence of grade 4 leukopenia,and the difference was not statistically significant(P =0.275);the two groups were grade 1-2 neutropenia(5.6% vs 8.3%),grade 3-4 neutropenia were(2.8% vs 2.8%),the difference was not statistically significant(P=1.000);the two groups of grade 1-2 thrombocytopenia were(5.6% vs 11.1%),the grade 3 thrombocytopenia was(2.8% vs 0.0%),and there was no incidence of grade 4 thrombocytopenia,and the difference was not statistically significant(P=0.804).Non-hematological toxicity: The two groups had mild nausea and vomiting,the incidence rates were(100% vs100%),there was no grade 3-4 digestive tract reactions,showing no statistical difference(P=0.629);The incidence of grade 1-2 hepatotoxicity between the two groups was(27.8% vs 38.9%),there was no grade 3-4hepatotoxicity,and the difference was not statistically significant(P=0.630);Grade 1-2 radiation dermatitis in the two groups was(97.2%vs 100%),and the incidence of grade 3 radiation dermatitis in the two groups was(2.8% vs 0.0%),there was no significant difference in grade 4radiation dermatitis between the two groups(P=0.372);Grade 1-2 oral mucositis was found in the two groups(83.3% vs 86.1%),and grade 3oral mucositis was found in the two groups(16.7% vs 13.9%),there was no significant difference in grade 4 oral mucositis between the two groups(P=0.397);The incidence of grade 1-2 changes in ECG between the two groups was(19.5% vs 13.9%),no grade 3-4 occurred,and there was no statistical difference(P=0.753);For nasopharyngeal mucosa necrosis,the rates of nasopharyngeal mucosa necrosis were(5.6% vs 11.1%,P=0.674).Conclusion: For locally advanced nasopharyngeal carcinoma,after TPF induction chemotherapy,combined with nimotuzumab on the basis of concurrent chemotherapy and radiotherapy has a very good short-term effect and a higher complete remission rate.For N3 patients,there is a tendency to improve the rate of 1-year PFS and DMFS without increasing the toxic side effects,which is worthy of further expansion of data studies to track long-term survival outcomes. |
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