Tabernero Josep, Pfeiffer Per, Cervantes Andrés
Medical Oncology Department, Vall d'Hebron University Hospital, P. Vall d'Hebron, 119-129, 08035, Barcelona, Spain.
Oncologist. 2008 Feb;13(2):113-9. doi: 10.1634/theoncologist.2007-0201.
The primary purpose of this paper is to present the available evidence for the administration of cetuximab on an every-2-weeks basis in combination with irinotecan in metastatic colorectal cancer (mCRC). Cetuximab is an epidermal growth factor receptor-targeted IgG(1) monoclonal antibody that is approved for use in combination with irinotecan or as monotherapy in the treatment of mCRC. The currently approved dosing regimen for cetuximab is a 400-mg/m(2) initial dose followed by 250 mg/m(2) weekly. Many commonly used chemotherapy agents for mCRC (including irinotecan alone or in combination with 5-fluorouracil [5-FU]/folinic acid [FA] and oxaliplatin plus 5-FU/FA) are administered on an every-2-weeks basis. The ability to synchronize the administration of cetuximab and concomitant chemotherapy is desirable for both patients and health care workers. A cetuximab dose of 500 mg/m(2) every 2 weeks exhibited predictable pharmacokinetics, which were similar to those of the approved weekly dosing regimen. Active serum concentrations of cetuximab were maintained throughout the 2-week dosing period with this regimen. There was no difference between the dosing regimens on pharmacodynamic parameters in skin. The efficacy and safety of the every-2-weeks dosing regimen were similar to those reported for the approved weekly dosing regimen. The indication from these preliminary findings is that every-2-weeks administration of cetuximab (500 mg/m(2)) may be a potentially convenient alternative to the approved weekly dosing regimen of 250 mg/m(2) (following an initial dose of 400 mg/m(2)) in the treatment of mCRC.
本文的主要目的是展示关于西妥昔单抗每2周一次与伊立替康联合用于转移性结直肠癌(mCRC)治疗的现有证据。西妥昔单抗是一种靶向表皮生长因子受体的IgG(1)单克隆抗体,已获批与伊立替康联合使用或作为单药用于mCRC治疗。目前批准的西妥昔单抗给药方案是初始剂量400mg/m²,随后每周250mg/m²。许多常用于mCRC的化疗药物(包括单独使用伊立替康或与5-氟尿嘧啶[5-FU]/亚叶酸[FA]联合使用,以及奥沙利铂加5-FU/FA)都是每2周给药一次。对于患者和医护人员而言,使西妥昔单抗与同步进行的化疗给药时间保持一致是很有必要的。每2周一次给予500mg/m²西妥昔单抗呈现出可预测的药代动力学,这与批准的每周给药方案相似。采用该方案时,在整个2周给药期内均可维持西妥昔单抗的有效血清浓度。两种给药方案在皮肤药效学参数方面并无差异。每2周给药方案的疗效和安全性与批准的每周给药方案所报告的相似。这些初步研究结果表明,在mCRC治疗中,每2周一次给予西妥昔单抗(500mg/m²)可能是一种潜在便利的替代方案,可替代批准的每周250mg/m²(初始剂量为400mg/m²之后)给药方案。