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

摘要/Abstract

摘要： 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(T_3或T_4)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/m~2,120h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/m~2组;Ⅱ度12例200mg/m~2组中5例,300mg/m~2岔组5例,350mg/m~2组2例;Ⅲ度11例300mg/m~2组中1例,350mg/m~2组3例,400mg/m~2组5例,450mg/m~2组2例;Ⅳ度5例450mg/m~2组中3例,500mg/m~2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/m~2。

关键词: 鼻咽癌, 5-FU, 动脉化疗, 最大耐受剂量

Abstract: 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/m~2 /d,d1-5) for all the patients.Results 5-FU induced oral mucositis in all patients.Of the 29 patients,1 patient experienced gradeⅠmucositis in group 200mg/m~2;12 patients experienced gradeⅡmucositis which included 5 in group 200mg/m~2,5 in group 300mg/m~2 and 2 in group 350mg/ m~2; 11 patients experienced gradeⅢmucositis which included 1 in group 300mg/m~2,3 in group 350mg/m~2,5 in group 400mg/m~2 and 2 in group 450mg/m~2;5 patients experienced gradeⅣmucositis which included 3 in group 450mg/m~2 and 2 in group 500mg/m~2.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%.Conclusions Superficial temporal arterial infusion with 5-FU for T_3/T_4 nasopharyngeal carcinoma is well tolerated.The maximum tolerated dose of 5-FU is 350mg/m~2.

Key words: Nasopharyngeal carcinoma, 5-fluorouracil, Intra-arterial chemotherapy, Maximum tolerated dose

任培蓉;吴敬波;何丽佳;吴天革;张建文;尚昌玲;. 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[J]. 中国癌症防治杂志, 2009, 1(02): 142-144.

REN Pei-rong,WU Jing-bo,HE Li-jia,et al.. Phase I clinical trial of nasopharyngeal carcinoma at high T stage treated with 5-FU continued infusion for 120 hours through superficial temporal artery[J]. Chinese Journal of Oncology Prevention and Treatment, 2009, 1(02): 142-144.

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