Cetuximab and irinotecan/5-fluorouracil/folinic acid is a safe combination for the first-line treatment of patients with epidermal growth factor receptor expressing metastatic colorectal carcinoma
Cetuximab and irinotecan/5-fluorouracil/folinic acid is a safe combination for the first-line treatment of patients with epidermal growth factor receptor expressing metastatic colorectal carcinoma
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DOI：
10.1093/annonc/mdj084
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发表时间：
2006-03-01
影响因子：
50.5
通讯作者：
Köhne, CH
中科院分区：
文献类型：
--
作者：
Folprecht, G;Lutz, MP;Köhne, CH
背景资料：研究EGFR抗体西妥昔单抗联合伊立替康/5-氟尿嘧啶（5-FU）/亚叶酸（FA）一线治疗转移性结直肠癌（mCRC）患者的安全性/耐受性。患者和方法：21例未经治疗的转移性EGFR表达CRC患者接受西妥昔单抗400 mg/m2作为初始剂量，此后每周250 mg/m2。此外，患者接受2个剂量水平的5-FU（24 h）输注（1500 mg/m2，低5-FU组，n = 6或2000 mg/m2，高5-FU组，n = 15），联合FA 500 mg/m2和伊立替康80 mg/m2，每周x6 q50 d。低剂量5-FU组无剂量限制性毒性（DLT），高剂量5-FU组有3例DLT（20%）（2例患者腹泻3级，1例患者腹泻4级）。在低剂量5-FU组中，所有6名患者均接受了> 80%的计划剂量。在高剂量5-FU组，14例患者中有7例（50%）接受了
Background: To investigate the safety/tolerability of the EGFR-antibody cetuximab when added to irinotecan/5-fluorouracil (5-FU)/folinic acid (FA) for first-line treatment in patients with metastatic colorectal cancer (mCRC).Patients and methods: Twenty-one patients with untreated, metastatic, EGFR-expressing CRC received cetuximab 400 mg/m(2) as an initial dose, and thereafter 250 mg/m(2) weekly. In addition, patients received infusional 5-FU (24 h) in two dose levels (1500 mg/m(2), low 5-FU group, n = 6 or 2000 mg/m(2), high 5-FU group, n = 15), plus FA at 500 mg/m(2) and irinotecan at 80 mg/m(2), weekly x6 q50d.Results: Twenty patients were assessable for tolerability after the first cycle. There were no dose limiting toxicities (DLTs) in the low 5-FU group and three DLTs (20%) in the high 5-FU group (two patients with diarrhea grade 3 and one patient with diarrhea grade 4). In the low 5-FU group all six patients received > 80% of the planned dose. In the high 5-FU group, seven of 14 patients (50%) received