Verweij J, Planting A, van der Burg M, Stoter G
Department of Medical Oncology, Rotterdam Cancer Institute/Daniel den Hoed Kliniek, The Netherlands.
J Cancer Res Clin Oncol. 1992;118(8):606-8. doi: 10.1007/BF01211805.
The ether lipid miltefosine (hexadecylphosphocholine) was orally given to patients with various tumours in a dose-finding study. All patients initially received a daily total dose of 100 mg, which in the absence of side-effects was increased to 150 mg and further to 200 mg. A total of 54 patients were entered and were evaluable for gastrointestinal toxicity. Nausea and vomiting were found to be dose-limiting; 22% of patients ultimately tolerated a dose of 100 mg, 59% tolerated a dose of 150 mg and 19% tolerated a dose of 200 mg. In addition 30% of patients developed renal dysfunction, which was thought to be related to the drug. No other toxicities were observed. For further phase II studies it is recommended that one starts with a dose of 150 mg daily, divided over three administrations.
在一项剂量探索研究中，给患有各种肿瘤的患者口服醚脂米托蒽醌（十六烷基磷酰胆碱）。所有患者最初每日总剂量为100mg，若无副作用则增至150mg，进而增至200mg。共有54例患者入组并可评估胃肠道毒性。发现恶心和呕吐为剂量限制性毒性；最终22%的患者耐受100mg剂量，59%的患者耐受150mg剂量，19%的患者耐受200mg剂量。此外，30%的患者出现肾功能障碍，认为与该药物有关。未观察到其他毒性。对于进一步的II期研究，建议起始剂量为每日150mg，分三次给药。
