Mitchell E P
Division of Medical Oncology, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.
Oncology (Williston Park). 2000 Dec;14(12 Suppl 11):30-2.
No adequate second- or third-line therapy is available in the United States for patients with metastatic colorectal cancer and disease progression following treatment with fluorouracil (5-FU)-based therapy and an irinotecan (CPT-11, Camptosar)-containing regimen, or a combination of the two. Oxaliplatin (Eloxatin), a new platinum analog, has demonstrated high activity in the treatment of colorectal cancer, especially when combined with 5-FU and leucovorin. The combination of oxaliplatin and 5-FU/leucovorin has been approved in Europe for the first- and second-line treatment of colorectal cancer. This compassionate-use study was initiated because of the unavailability of the agent in the United States and inadequate US safety data. The following review summarizes data from this ongoing study, the primary focus of which is to provide oxaliplatin for compassionate use until it receives US Food and Drug Administration approval and becomes available commercially.
对于接受过基于氟尿嘧啶（5-FU）的治疗以及含伊立替康（CPT-11，开普拓）方案或两者联合治疗后出现疾病进展的转移性结直肠癌患者，美国尚无足够的二线或三线治疗方案。奥沙利铂（乐沙定）是一种新型铂类类似物，已证明在结直肠癌治疗中具有高活性，尤其是与5-FU和亚叶酸联合使用时。奥沙利铂与5-FU/亚叶酸的联合用药在欧洲已被批准用于结直肠癌的一线和二线治疗。开展这项同情用药研究是因为该药物在美国无法获得且美国的安全性数据不足。以下综述总结了这项正在进行的研究的数据，其主要重点是在奥沙利铂获得美国食品药品监督管理局批准并上市之前提供同情用药。
