Pavlakis Nick, Vogelzang Nicholas J
Royal North Shore Hospital, Department of Medical Oncology, St Leonards, NSW 2065, Australia.
Expert Opin Biol Ther. 2006 Apr;6(4):391-9. doi: 10.1517/14712598.6.4.391.
Ranpirnase (Onconase) is a novel cytotoxic ribonuclease. In clinical development as a single agent in patients with malignant mesothelioma (MM), at 480 microg/m2 intravenously weekly, analysis of survival indicated prolonged periods of stable disease in Phase II trials and a potential survival benefit, compared with doxorubicin, in a small unpublished Phase III trial. In all clinical studies it has generally demonstrated a favourable safety profile except for easily controlled allergic reactions and dose modifications for renal impairment. Standard first-line treatment for MM has recently been established with an antifolate and cisplatin. At present, a Phase III trial of doxorubicin with or without ranpirnase is nearing completion in MM patients without prior chemotherapy or one prior chemotherapy regimen.
兰吡奈酶(昂科纳酶)是一种新型细胞毒性核糖核酸酶。在作为单一药物用于恶性间皮瘤(MM)患者的临床开发中,静脉注射剂量为每周480微克/平方米,生存分析表明,在II期试验中疾病稳定期延长,在一项未发表的小型III期试验中,与阿霉素相比有潜在的生存获益。在所有临床研究中,除了易于控制的过敏反应和因肾功能损害而调整剂量外,它总体上显示出良好的安全性。MM的标准一线治疗最近已确定为使用抗叶酸剂和顺铂。目前,一项关于阿霉素联合或不联合兰吡奈酶的III期试验在未接受过化疗或仅接受过一种化疗方案的MM患者中即将完成。