Prospectively randomized North Central Cancer Treatment Group trial of intensive-course fluorouracil combined with the l-isomer of intravenous leucovorin, oral leucovorin, or intravenous leucovorin for the treatment of advanced colorectal cancer
Prospectively randomized North Central Cancer Treatment Group trial of intensive-course fluorouracil combined with the l-isomer of intravenous leucovorin, oral leucovorin, or intravenous leucovorin for the treatment of advanced colorectal cancer
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DOI：
10.1200/jco.1997.15.11.3320
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发表时间：
1997-11-01
影响因子：
45.3
通讯作者：
Moertel, CG
中科院分区：
文献类型：
--
作者：
Goldberg, RM;Hatfield, AK;Moertel, CG
目的：在晚期结直肠癌患者中进行的三臂随机III期试验被设计为测试等效剂量的（1）L-甲酰四氢叶酸或（2）口服甲酰四氢叶酸的替代是否比标准静脉内（IV）（d，l）-甲酰四氢叶酸更有效地增强氟尿嘧啶（5-FU）。（a）强化疗程5-FU加l-甲酰四氢叶酸与IV甲酰四氢叶酸（Immunex Corp，西雅图，华盛顿州）100 mg/m（2）和IV 5-FU 370 mg/m（2）（B）强化疗程5-FU加口服（d，l）-亚叶酸，口服亚叶酸125 mg/m（2）在第0、1、2和3小时（总剂量，500 mg/m2），随后在第4小时给予5-FU 370 mg/m2;或（C）强化疗程5-FU + IV（d，l）-亚叶酸，IV亚叶酸200 mg/m2和5-FU 370 mg/m2。每天给药，连续5天，疗程在第4周和第1周重复，此后每5周重复一次。结果：926例患者中，756例死亡，总有效率为32%（514例中的165例），不同治疗方案的缓解率无差异（A组，28% [47/140]; B组，34% [60/174]; C组，34% [58/170]）或存活率，有9例可能与化疗相关的死亡，III级Po IV Por，ic效应在各组之间没有明显差异，包括口腔炎（12%~ 14%）、腹泻（15%~ 19%）、恶心（7%~ 9%）和呕吐（6%~ 8%）。结论：这三种不同的甲酰四氢叶酸制剂与5-FU联合应用在反应、生存或毒性方面没有差异。(C)1997年，美国临床肿瘤学会。
Purpose: A three-arm randomized phase III trial in advanced colorectal cancer patients was designed to test whether substitution of an equivalent dose of (1) l-leucovorin or (2) oral leucovorin would more effectively potentiate fluorouracil (5-FU) than standard intravenous (IV) (d,l)-leucovarin.Patients and Methods: A total of 926 chemotherapy-naive patients participated, patients received one of three treatments: (a) intensive-course 5-FU plus l-leucovorin with IV leucovorin (Immunex Corp, Seattle, WA) at 100 mg/m(2) and IV 5-FU at 370 mg/m(2) (B) intensive-course 5-FU plus oral (d,l)-leucovorin with oral leucovorin at 125 mg/m(2) on hours 0, 1, 2, and 3 (total dose, 500 mg/m(2)) followed by 5-FU 370 mg/m(2) on hour 4; or (C) intensive-course 5-FU plus IV (d,l)-leucovorin with IV leucovorin 200 mg/m(2) and 5-FU 370 mg/m(2). Drugs were administered daily for 5 consecutive days, Courses were repeated at 4 and a weeks, and every 5 weeks thereafter. Dosage was reduced for neutropenia, thrombocytopenia, diarrhea, stomatitis, and dermatitis.Results: Of 926 eligible patients, 756 have died, The overall response rate for patients with measurable disease was 32% (165 of 514), There were no differences between regimens in response rates (arm A, 28% [47 of 140]; arm B, 34% [60 of 174]; and arm C, 34% [58 of 170]) or in survival, There have been nine possible chemotherapy-related fatalities, Grade III Po IV Por,ic effects did nor differ appreciably by arm and included stomatitis (12% to 14%), diarrhea (15% to 19%), nausea (7% to 9%), and vomiting (6% to 8%).Conclusion: There was no difference in response, survival, or toxicity between these three different leucovorin formulations combined with 5-FU. (C) 1997 by American Society of Clinical Oncology.