Calvert A H, Harland S J, Newell D R, Siddik Z H, Harrap K R
Cancer Treat Rev. 1985 Sep;12 Suppl A:51-7. doi: 10.1016/0305-7372(85)90018-0.
Carboplatin was evaluated in a Phase I and pharmacokinetic study at the Royal Marsden Hospital between April 1981 and November 1981. Sixty patients were entered of whom 16 had impaired renal function. No evidence of ototoxicity or nephrotoxicity was found. Nausea and vomiting were much reduced compared to cisplatin. The dose limiting toxicity was delayed myelosuppression with thrombocytopenia being more severe than leucopenia. A number of clinical responses were seen, particularly in patients with ovarian carcinoma. Pharmacokinetic studies suggested that the dose of JM8 should be adjusted according to the glomerular filtration rate.
1981年4月至1981年11月期间,在皇家马斯登医院对卡铂进行了一项I期药代动力学研究。共有60名患者入组,其中16名患者肾功能受损。未发现耳毒性或肾毒性证据。与顺铂相比,恶心和呕吐明显减轻。剂量限制性毒性为延迟性骨髓抑制,血小板减少比白细胞减少更严重。观察到一些临床反应,特别是在卵巢癌患者中。药代动力学研究表明,JM8的剂量应根据肾小球滤过率进行调整。