5-FU经颞浅动脉120小时持续灌注治疗高T分期鼻咽癌的Ⅰ期临床试验

目的 研究5-FU经颞浅动脉120h持续化疗高T分期鼻咽癌的最大耐受剂量(MTD).方法 对29例病理确诊为鼻咽癌的初治高T分期(T3或T4)患者采用颞浅动脉插管化疗.化疗方案:5-FU+顺铂,观察5-FU持续120h动脉灌注化疗的不良反应以及最大的耐受剂量.5-FU的剂量分别为200、300、350、400、450、500mg/m2,120h持续动脉滴注;顺铂20mg,第1～5天动脉快速滴注;21d为1疗程,共2个疗程.结果 不良反应: 29例病人均出现口腔黏膜反应,其中Ⅰ度1例为200mg/m2组;Ⅱ度12例200mg/m2组中5例,300mg/m2组5例,350mg/m2组2例;Ⅲ度11例300mg/m2组中1例,350mg/m2组3例,400mg/m2组5例,450mg/m2组2例;Ⅳ度5例450mg/m2组中3例,500mg/m2组2例;5例出现局部疼痛,对症治疗后好转.29例病人出现的骨髓抑制、消化道反应以及肝肾功能损害均在Ⅰ度和Ⅱ度.疗后原发灶CR 2例,PR 25例,SD 2例;有效率(CR+PR)为93%.颈部淋巴结CR 1例,PR 16例,SD 0例,余12例患者颈淋巴结为阴性,有效率(CR+PR)为100%.结论 5-FU经颞浅动脉持续化疗高T分期鼻咽癌,患者耐受尚可,最大耐受剂量为350mg/m2.

Phase I clinical trial of nasopharyngeal carcinoma at high T stage treated with 5-FU continued infusion for 120 hours through superficial temporal artery

Objective To determine the maximum tolerated dose of 5-Flouruorail (5-FU) via superficial temporal arterial infusion for the patients with T3/T4 nasopharyngeal carcinoma.Methods A total of 29 patients were enrolled in this study.They were treated with 5-FU plus Cisplatin.A chemotherapy cycle was designed as 21 days and all patients were treated for 2 cycles.5-FU was administrated by pump infusion for continuous 120-hour via superficial temporal arterial.The maximum tolerated dose of 5-FU was determined by testing increasing doses on different groups of patient until the highest dose with acceptable side effects was found.Cisplatin was infused via superficial temporal artery (20mg/m2/d,d1-5) for all the patients.Results 5-FU induced oral mucositis in all patients.Of the 29 patients,1 patient experienced grade I mucositis in group 200mg/m2; 12 patients experienced grade II mucositis which included 5 in group 200mg/m2,5 in group 300mg/m2 and 2 in group 350mg/ m2; 11 patients experienced grade III mucositis which included 1 in group 300mg/m2,3 in group 350mg/m2,5 in group 400mg/m2 and 2 in group 450mg/m2; 5 patients experienced grade IV mucositis which included 3 in group 450mg/m2 and 2 in group 500mg/m2.Five patients experienced oral mucosal pain.For the primary tumor,2 cases achieved complete remission (CR),25 achieved partial remission (PR) and 2 presented stable disease (SD),in which the overall response rate (CR+PR) was 93%.For the neck lymph nodes,the cases of CR,PR and SD were 1,16 and 0 respectively,the rest 12 were neck-node-negative,in which the CR+PR was 100%.Conclusion s Superficial temporal arterial infusion with 5-FU for T3/T4 nasopharyngeal carcinoma is well tolerated.The maximum tolerated dose of 5-FU is 350mg/m2.