Multicenter phase II study to evaluate a 28-day regimen of oral fluorouracil plus eniluracil in the treatment of patients with previously untreated metastatic colorectal cancer
Multicenter phase II study to evaluate a 28-day regimen of oral fluorouracil plus eniluracil in the treatment of patients with previously untreated metastatic colorectal cancer
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DOI：
10.1200/jco.2000.18.15.2894
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发表时间：
2000-08-01
影响因子：
45.3
通讯作者：
Lokich, J
中科院分区：
文献类型：
--
作者：
Mani, S;Hochster, H;Lokich, J
目的：确定氟尿嘧啶 (5-FU) 加恩尿嘧啶对既往未经治疗的转移性结直肠癌患者给药的疗效。 患者和方法：在这项单臂 II 期研究中，既往未经治疗的转移性结直肠癌患者接受口服恩尿嘧啶加 5-FU（10:1 剂量比），5-FU 剂量为 1.00 mg/m(2) 或 1.15 mg/m(2)，每天两次（每 12 小时）连续 28 天，每 5 周重复一次（一个周期）。治疗持续进行，直至出现疾病进展或不可接受的毒性。结果：30 名和 25 名患者分别以 1.00 mg/m(2) 和 1.15 mg/m(2) 的起始剂量入组。 55 名患者中有 14 名 (25%)（95% 置信区间，15% 至 39%）有部分缓解，20 名患者 (36%) 病情稳定。部分缓解和疾病稳定的中位持续时间分别为 23.9 周（范围，12.3 至 52.1+ 周）和 24.1 周（范围，17.1 至 55.6+ 周）。无进展生存期和总生存期的中位持续时间分别为 22.6 周（范围：21.0 至 29.0 周）和 59 周（范围：4 至 84+ 周）。 1.15 mg/m(2)剂量组的反应率与1.00 mg/m(2)剂量组相似（分别为28%和23%）。严重（3/4 级）非血液学治疗相关毒性包括腹泻（9 名患者）、恶心/呕吐（各 1 名患者）、粘膜炎（2 名患者）和厌食（1 名患者）。严重的血液学毒性很少见。在 1.15 mg/m(2) 剂量水平下，两名患者出现 3 级粒细胞减少症，两名患者出现 3 级贫血。结论：口服 5-FU 加恩尿嘧啶的缓解率与输注 5-FU 或推注 5-FU 和左旋四氢叶酸观察到的缓解率相当。该口服方案的毒性特征对于在门诊家庭环境中使用是可以接受的。 J Clin Oncol 18：2894-2901，(C) 2000，美国临床肿瘤学会。
Purpose: To determine the efficacy of fluorouracil (5-FU) plus eniluracil when administered to patients with previously untreated metastatic colorectal cancer.Patients and Methods: In this single-arm phase II study, patients with previously untreated metastatic colorectal cancer received oral eniluracil plus 5-FU (10:1 dose ratio), at 5-FU doses of 1.00 mg/m(2) or 1.15 mg/m(2) twice daily (every 12 hours) for 28 consecutive days repeated every 5 weeks (one cycle). Treatment continued until there was documented disease progression or unacceptable toxicity.Results: Thirty and 25 patients were enrolled at a starting dose of 1.00 mg/m(2) and 1.15 mg/m(2), respectively. Fourteen (25%) of 55 patients (95% confidence interval, 15% to 39%) had a partial response, and 20 patients (36%) had stable disease. The median durations of the partial responses and stable disease were 23.9 weeks (range, 12.3 to 52.1+ weeks) and 24.1 weeks (range, 17.1 to 55.6+ weeks), respectively. The median durations of progression-free and overall survival were 22.6 weeks (range, 21.0 to 29.0 weeks) and 59 weeks (range, 4 to 84+ weeks), respectively. The response rate in the 1.15 mg/m(2)-dose group was similar to the 1.00 mg/m(2)-dose group (28% v 23%, respectively). Severe (grade 3/4) nonhematologic treatment-related toxicity included diarrhea (nine patients), nausea/vomiting (one patient each), mucositis (two patients), and anorexia (one patient). Severe hematologic toxicities were rare. At the 1.15 mg/m(2)-dose level, two patients exhibited grade 3 granulocytopenia, and two patients had grade 3 anemia.Conclusion: The response rate with oral 5-FU plus eniluracil is comparable with that observed with infusional 5-FU or bolus 5-FU and levcovorin. The toxicity profile of this oral regimen is acceptable for use in an outpatient home-based setting. J Clin Oncol 18:2894-2901, (C) 2000 by American Society of Clinical Oncology.