Clinical Observation Of Recombinant Human Vascular Endostatin Combined With Chemoradiotherapy In The Treatment Of Locally Advanced Nasopharyngeal Carcinoma

Objective:This study aimed to reduce the rate of distant metastasis and improve the survival by study the feasibility and safety of addition of recombinant human endostatin injection to standard chemoradiotherapy for the locally advanced nasopharyngeal carcinoma.Methods:1)Between August 2018 and October 2019,we enrolled 32 patients that are stageⅢ-Ⅳa nasopharyngeal carcinoma from Xiangxi Autonomous Prefecture People’s Hospital.2)32 patients were divided into two groups according to 1:1,16patients who received standard chemoradiotherapy combined with recombinant human endostatin injection were included in the Endostar group.Another 16 patients were assigned to the control group without using Endostar.3)Radiotherapy:Patients in both groups received IMRT.PGTVnx is5mm external expansion of GTVnx received 73.92 Gy in 2.24 Gy/fraction,PGTVnd is 5mm external expansion of GTVnd received 69.96 Gy in2.12Gy/fraction and PTV1 received 60.06 Gy in 1.82Gy/fraction,for 33fraction,respectively and PTV2 received 50.96 Gy in 1.82Gy/fraction,for28 fraction.Concurrent chemotherapy:Patients in both groups received the same concurrent chemotherapy with cisplatin(DDP;100mg/m2 in three days,every 3 weeks,for 2 cycles)during radiotherapy.4)Adjuvant chemotherapy:Patients in both groups received the same 2cycles PF(DDP:80mg/m~2in three days,5-FU:750mg/m~2,d1-d5,every 3weeks,for 2 cycles)adjuvant chemotherapy after concurrent chemoradiotherapy.5)Therapy of Endostar:The patients in the Endostar group received 2cycles Endostar during concurrent chemoradiotherapy(30mg/d,24 hours venous pumping,d3-d9,d26-d32).6)Observation indicators:RECIST1.1 was used for efficacy Evaluation,whichwasdividedintoCR,PR,SD,PD,andORR,after concurrent chemotherapy 3 months later.Toxic and side effects were evaluated by NCI-CTC(4rd edition).The regular follow-up was used for PFS,DMFS,LRFS.7)Statistical approach:Survival curves for the time-to-event endpoints were analyzed by the Kaplan-Meier method and compared using the log-rank test,P<0.05 was statistically significant.Toxic effects and short-term efficacy were compared using Fisher’s exact test,P<0.05 was statistically significant.Results:1)There was comparable in general information between the two groups(P>0.05).2)After 3 months to the completion of chemoradiotherapy,there was no significant difference in the complete remission rate of nasopharyngeal lesions,the complete remission rate of cervical lymph node metastasis,the complete remission rate of overall and objective remission rate(68%VS68%,P=1;75%VS 68%,P=1;19%VS 44%,P=0.252;93.8%VS 100%,P=1).3)The most common grade 3-4 toxicity in the study was radioactive mucositis and gastrointestinal reaction.There were no significant differences of toxicities between the 2 groups(P>0.05).There was no grade4 or above toxic and side effects of chemoradiotherapy in the two groups,and no grade 3 or above blood side effects.4)The follow-up time was from August 2018 to November 2020,and the median follow-up time was 15 months.the 1-year PFS,DMFS,and LRFS in the 2 groups were 87.5%,87.5%,and 100%,respectively,for the Endostar group,these rates were 81.3%,81.3%,and100%,respectively,and for the control group,no significant difference was found(P>0.05).Conclusion:Patients did not show more side effects to the regimen of concurrent chemoradiotherapy plus Endostar than concurrent chemoradiotherapy only.Patients did not show more effective profile to the regimen of concurrent chemoradiotherapy plus Endostar than concurrent chemoradiotherapy only in our study.