Phase III comparison of two irinotecan dosing regimens in second-line therapy of metastatic colorectal cancer
Phase III comparison of two irinotecan dosing regimens in second-line therapy of metastatic colorectal cancer
复制标题
DOI：
10.1200/jco.2003.08.058
复制
发表时间：
2003-03-01
影响因子：
45.3
通讯作者：
Hecht, JR
中科院分区：
文献类型：
--
作者：
Fuchs, CS;Moore, MR;Hecht, JR
目的：氟尿嘧啶(FU)难治性结直肠癌的随机试验显示，接受伊立替康治疗的患者有显著的生存优势。我们前瞻性地比较了两种伊立替康方案的疗效和耐受性(每周一次，共4周，然后每3周休息一次)。患者和方法：这项多中心、开放、III期研究按1：2比例随机分配患者，每周(125 mg/m(2))或每3周(350 mg/m(2))或每3周一次(350 mg/m(2)或300 mg/m(2))的患者，年龄70岁，东方合作肿瘤组表现状态等于2，结果：中位随访期15.8个月，两组1年生存率分别为46%和41%；P=.42)、中位生存期(分别为9.9和9.9个月，P=.43)或中位进展时间(分别为4.0和3.0个月，P=.54)。每周治疗一次的患者中有36%的患者出现3/4级腹泻，每3周治疗一次的患者中有19%的患者出现3/4级腹泻(P=0.002)。每周治疗一次的患者中有29%出现3/4级中性粒细胞减少，每3周治疗一次的患者中有34%出现3/4级中性粒细胞减少(P=.35)。每周接受伊立替康治疗的5名患者(5.3%)和每3周接受一次治疗的3名患者(1.6%)发生了与治疗相关的死亡(P=.12)。总体生活质量在治疗组之间无统计学差异。结论：伊立替康每周和每3周一次的方案在FU难治性、转移性结直肠癌患者中显示出相似的疗效和生活质量。每3周一次的方案与严重腹泻的发生率显著降低有关。(C)2003年，由美国临床肿瘤学会提供。
Purpose: Randomized trials in fluorouracil (FU)-refractory colorectal cancer demonstrate significant survival advantages for patients receiving irinotecan. We prospectively compared the efficacy and tolerability of two irinotecan regimens (once a week for 4 weeks followed by a 2-week rest period [weekly] v once every 3 weeks) in such patients.Patients and Methods: This multicenter, open-label, phase III study randomly assigned patients in a 1:2 ratio to irinotecan given either weekly (125 mg/m(2)) or once every 3 weeks (350 mg/m(2), or 300 mg/m(2) in patients who were : 70 years of age, who had Eastern Cooperative Oncology Group performance status equal to 2, or who had prior pelvic irradiation).Results: With median follow-up of 15.8 months, there was no significant difference in 1-year survival (46% v 41%, respectively; P = .42), median survival (9.9 v 9.9 months, respectively, P = .43), or median time to progression (4.0 v 3.0 months, respectively, P = .54) between the two regimens. Grade 3/4 diarrhea occurred in 36% of patients treated weekly and in 19% of those treated once every 3 weeks (P = .002). Grade 3/4 neutropenia occurred in 29% of patients treated weekly and 34% of those treated once every 3 weeks (P = .35). Treatment-related mortality occurred in five patients (5.3%) receiving irinotecan weekly and three patients (1.6%) given therapy once every 3 weeks (P = .12). Global quality of life was not statistically different between treatment groups.Conclusion: Irinotecan schedules of weekly and of once every 3 weeks demonstrated similar efficacy and quality of life in patients with FU-refractory, metastatic colorectal cancer. The regimen of once every 3 weeks was associated with a significantly lower incidence of severe diarrhea. (C) 2003 by American Society of Clinical Oncology.