SOAz（1,3,3,5,5 - 五（氮丙啶基）-1λ⁶,2,4,6,3λ⁵,5λ⁵ - 硫杂三氮杂二磷腈 - 1 - 氧化物）每周给药方案的I期评估。

Phase I evaluation of SOAz (1,3,3,5,5 pentakis(aziridino)-1 lambda 6, 2,4,6,3 lambda 5, 5 lambda 5 thiatriaza-diphosphorine-1-oxide) in a weekly schedule.

作者信息

Rodenhuis S, Mulder N H, Sleijfer D T, Schraffordt Koops H, Van de Grampel J C

出版信息

Eur J Cancer Clin Oncol. 1984 May;20(5):645-9. doi: 10.1016/0277-5379(84)90011-7.

Abstract

Eleven patients with advanced cancer were treated with SOAz, the first aziridino substituted inorganic heterocyclic compound to undergo phase I clinical trials. The agent was administered as a rapid i.v. infusion once a week in a dose of 50, 75 or 100 mg/m2. Severe myelotoxicity, which was prolonged and delayed in onset, precluded continuing treatment for more than three courses in 9 of 11 patients. In two patients thrombocytopenia showed no signs of recovery 9 and 11 weeks after the last infusion. Two minor responses were noted and there was one therapy-related death. Because of severe myelotoxicity, which is cumulative and may be irreversible, this treatment schedule seems unsuitable for phase II studies.

摘要

11名晚期癌症患者接受了SOAz治疗，SOAz是首个进入I期临床试验的氮丙啶取代无机杂环化合物。该药物通过静脉快速输注给药，每周一次，剂量为50、75或100mg/m²。严重的骨髓毒性起病延迟且持续时间长，导致11名患者中的9名无法接受超过三个疗程的持续治疗。两名患者在最后一次输注后9周和11周血小板减少未见恢复迹象。观察到两例轻微缓解，并有一例与治疗相关的死亡。由于严重的骨髓毒性具有累积性且可能不可逆转，该治疗方案似乎不适用于II期研究。