摘要
目的：根据５ＦＵ、ＣＦ药代动力学特点，设计５ＦＵ连续８小时静滴，ＣＦ１００ｍｇ，在５ＦＵ静滴第０、４、８小时３次静推的ＣＦ／５ＦＵ给药方案，联合卡铂对晚期鼻咽癌患者进行临床研究，重点摸索该联合化疗方案的剂量限制性毒性及５ＦＵ的最大耐受剂量（ＭＴＤ）。方法：将符合入选条件的病例分组，每组３５例。５ＦＵ剂量从５００ｍｇ／（ｍ２·ｄ）开始，以１２５ｍｇ／（ｍ２·ｄ）逐渐递增，直至最大耐受剂量，ＣＦ３００ｍｇ、卡铂３００～３５０ｍｇ／ｍ２剂量固定不变。结果：共２１例晚期鼻咽癌患者进入该临床试验，５ＦＵ的最大耐受剂量为１０００ｍｇ／（ｍ２·ｄ），口腔粘膜炎是该联合化疗方案的主要剂量限制性毒性。初步观察该方案有较率为７６２％。结论：５ＦＵ连续８小时静滴与ＣＦ、卡铂联合化疗可提高５ＦＵ剂量强度，推荐Ⅱ期临床试用时５ＦＵ剂量为７５０～８７５ｍｇ／（ｍ２·ｄ），共５天，３～４周重复一次。该方案对晚期鼻咽癌有较高缓解率，但确切疗效尚待进一步证实。
bjective: Based on the background of pharmacokinetics of 5FU and leucovorin
(CF),we designed a new CF/5FU and carboplatin regimen,which consisted of 5FU by 8 hours
continuous infusion for 5 days (d15),CF 100 mg iv in bolus at 0,4,8 hour throughout the duration
of 5FU infusion,together with fixed dose of carbopiatin 300350 mg/m2 administered ivd on d6 to
perform dosefinding clinical trail in patients with advanced NPC to establis the adequate dose
of 5FU. Methods: 21 eligible patients were divided into five groups,each including 35
cases.5FU initial dose was 500 mg/(m2d) escalation of each groups by 125 mg/(m2d) until
maximum tolerated dose (MTD). Results: MTD of 5FU in this combination regimen was
1000mg/(m2d)with toxicity of oral mucositis being dose limiting. Overall response rate of
762%were observed. Conclusion: The dose of 5FU at 750875 mg/(m2d) was recommended in
this combination phase clinical trail.However,the high response of rate this combination
regimen was needed to be confirmed in further control study.
出处
《癌症》
SCIE
CAS
CSCD
北大核心
1999年第3期295-296,317,共3页
Chinese Journal of Cancer
