ObjectiveNasopharyngeal carcinoma(NPC)is a kind of common tumor of head and neck in Guangdong province and coastal areas of China.Cisplatin concurrent concurrent chemoradiotherapy(CCRT)is a standard treatment for locally advanced nasopharyngeal carcinoma(LA-NPC).But nausea and vomiting,Oral mucositis and other side effects caused by cisplatin is significant,it may lead to interruption of treatment and affecting the efficacy.Studies have found that a new generation of chemotherapy drugs docetaxel as a concurrent chemotherapy program,the effect is not inferior to cisplatin and have less side effects.But these results are from small sample and retrospective studies,and lack of prospective research currently.The oral mucositis is one of the most important side effects of NPC during concurrent chemotherapy.There are no effective treatments and drugs for radioactive oral mucositis.Recently,traditional Chinese medicine,especially nourishing yin and clearing heat medicine has an advantage of in reducing the side effects of radiotherapy and chemotherapy.Fluid-increasing decoction is one of the representatives of nourishing yin and clearing heat prescription.Some studies have shown that fluid-increasing decoction can reduce oral mucosal response,but there have little studies,whether the fluid-increasing decoction can reduce the process of oral mucosal response remains to be studied.Based on the above problems,this study was designed.This study used prospective randomized method,compared the efficacy and toxicity between docetaxel(TXT)and cisplatin(DDP)in concurrent chemoradiotherapy of LA-NPC.To investigate whether TXT can be used as an alternative for DDP in order to provide more efficient and low toxicity chemotherapy regimen for patients with NPC.At the same time,Some patients taking the addition of fluid-increasing decoction during radiotherapy,in order to clarify the effect of it in mucositis,and to provide effective traditional Chinese medicine prescriptions for reducing the side effects of radiotherapy and chemotherapy and improving the compliance of treatment.MethodsThere were 81 patients with LA-NPC from March 3,2015 to February 15,2017 in oncology department of General Hospital of Guangzhou Military Command of PLA.The patients received 3 courses induction chemotherapy followed by concurrent chemoradiotherpy.The induction chemotherapy regimen was docetaxel(TXT,75mg/m2),cisplatin(DDP,80mg/m2).Chemotherapy was repeated every 3 weeks according to the performance status.The patients received three dimensional conformal radiationtherapy(3D-CRT)with total dose(DT)of 70Gy/35f.Patients enrolled randomly into trial group(TXT 75mg/m2/3w)or control group(40mg/m2/w or 80mg/m2/3w)during concurrent chemoradiothe'rapy therapy.The patients,randomly selected from the two groups,were given modified fluid-increasing decoction during radiotherapy,All patients were evaluated of toxicity and efficacy 3 months after the end of treatment.ResultsAll patients completed radiotherpy and chemotherapy.1 patients appeared distant metastasis during thearpy.80 patients can evaluated curative efficacy.There was no significant difference in complete remission rate between two groups(incidence of CR 73.3%vs.72.0%;incidence of PR 26.7%vs.28.0%,P>0.05)).The incidence of grade 1-3 mucositis in TXT group were 10.0%?56?7%?33.3%,Respectively;The incidence of grade 1-3 mucositis in DDP group were 2.0%?37.3%?60.8%,Respectively.There were no grade 4 mucositis appeared in two arms.The levels of mucositis was significantly lower in TXT group as compared with DDP group(P=0.011).The occurrence of mucositis in TXT group was later than in DDP group([11.63 ± 3.68]d vs.[9.76 ±3.57]d,t=2.249,P=0.027).In multivariate analysis,concurrent chemotherapy regimens was an independent impact factor of the incidence of grade 3 mucositis(OR=0.324,P=0.034).Gender,age,T stage,N stage,clinical stage,Chinese medicine,regimens of were not associated with the incidence of grade 3 mucositis(P>0.05).The incidence of grade 1-3 radiodermatitis in TXT group were 56.7%,30.0%,13.3%,Respectively;The incidence of grade 1-3 radiodermatitis in DDP group were 49.0%,43.1%,7.8%,Respectively.There was no difference in the incidence of radiodermatitis between two groups(P=0.723).The incidence of nausea or vomiting was statistically significantly lower with TXT than DDP arm(91.2%vs.56.7%,P=0.001).There was no difference in the incidence of myelosuppression between two groups.In multivariate analysis,the kind of drug in Concurrent chemoradiotherapy was an independent impact factor of the incidence of grade 2-3 nausea or vomiting(OR=0.272,P=0.026).There was no significant difference in the incidence of myelosuppression between the two groups(P>0.05).In multivariate analysis,Concurrent chemotherapy regimens(P=0.016),gender(P=0.029)were associated with the incidence of anemia.The incidence of grade 1-3 mucositis in western medicine group were 1.9%?38.5%?59.6%,Respectively;The incidence of grade 1-3 mucositis in chinese medicine group were 10.3%?55.2%?34.5%,Respectively.The levels of oral mucositis in Chinese medicine group was lower than that in western medicine group(P=0.019).ConclusionsThere was the similar recently curative effect with docetaxel and cisplatin during concurrent chemotherapy in LA-NPC.TXT arm had lighter mucositis and gastrointestinal reaction.Patients were well toterated with TXT.Docetaxel can be used to replace cisplatin as one of the chemotherapy drugs for NPC.Modified fluid-increasing decoction can alleviated mucositis,and improve patients tolerance and treatment compliance. |