Prospective Randomized Clinical Trail Of Combination With Concurrent Chemoradiotherapy And Adjuvant Chemotherapy For Local Regionally Advanced Nasopharyngeal Carcinoma

Prospective randomized clinical trail of combination with concurrent chemoradiotherapy and adjuvant chemotherapy for local regionally advanced nasopharyngeal carcinoma[Background and Purpose]Nowadays concurrent chemoradiotherapy is widely used as the main treatment for advanced nasopharyngeal carcinoma(NPC) because it is proved that concurrent chemoradiotherapy can significantly increase the progression-free surviva1(PFS) and overall surviva1(OS),and it also can decrease the distant metastasis rate.The toxicity was tolerable.The main side effects of the therapy include mucositis,nausea,vomiting and leukopenia.Adjuvant chemotherapy is promising to increase the therapeutic effect of nasopharyngeal carcinoma (NPC) and has a tolerable toxicity.This randomizedâ…¢trial compared the respose rate and toxicity of concurrent chemoradiotherapy versus combination with concurrent chemoradiotherapy and adjuvant chemotherapy.[Materials and Methods]Patients with nasopharyngeal carcinoma(NPC) aging from 18 to 70,WHOâ…¡orâ…¢type,N2-3 or T3-4 and MO(6^th Edtion AJCC/UICC) were included from April 2007 to November 2007. Radiotherapy(conventional radiotherapy or IMRT) was administered in both arms.The conventional radiotherapy was 2.0Gy per fractions daily,5 fraction per week,with 35 to 38fractions for a total dose of 70～76Gy. IMRT was 2.2Gy/fractions daily from Monday to Friday for 32 fractions, the total dose is 70.46y.Concurrent chemotherapy regimen:DDP 40mg/m² was adminisiterd weekly for 7 courses.And the adjuvant chemotherapy was given DDP 80mg/m² d1+5-Fu 800mg/m² d1-5 every 4 weeks for 3 courses 1 month postradiotherapy.[Results]58 patients(28 in concurrent chemoradiotherapygroup and 30 in combination group(combined with concurrent chemoradiotherapy and adjuvant chemotherapy))were eligible for the study.The Male to female ratio was 2.2:1;The KPS score was 70～100.Conventional radiotherapy was given to 57 patients,and IMRT for 1 patient.The total dose was 70～76Gy.Only 16(27.6%) patients completed 7 courses concurrent chemotherapy,the main reason for uncompleted concurrent chemotherapy was hematologic toxicity(48.3%).No treatment related death was found.The main acute toxicities were leukopenia,anemia,mucositis,dry mouth, dysphagia and skin action.14.8%patients completed 100%dose of adjuvant chemotherapy,22 patients received dose modification of adjuvant chemotherapy and 73.3%patients completed the adjuvant chemotherapy at last.The response rate between two arms were not statistically significant(x² test,P＞0.05).[Conclusions]1.27.6%patients finished the 7 courses of concurrent chemotherapy and 84.5%patients finished 5 courses.The main toxicities for treatment was hematologic toxicity(48.3%).2.Only 14.8%patients completed 100%dose of adjuvant chemotherapy because ofⅣ°myelosuppression.73.3%patients completed the adjuvant chemotherapy after the dose modification.3.There was non treatment related death.The main grade 3/4 side effects of chemotherapy were mucositis,leukopenia,dry mouth,anemia,etc.And the neurologic and neutropenia fever didn't appear in any case.The hearing impairment,alopecia,phlebitis,weight loss may become serious in patients who had adjuvant chemotherapy.4.Adjuvant chemotherapy didn't increase the tumor response rate.