A phase II study of DaunoXome® in advanced urothelial transitional cell carcinoma
A phase II study of DaunoXome® in advanced urothelial transitional cell carcinoma
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DOI：
10.1016/s0959-8049(97)10156-3
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发表时间：
1998-06-01
影响因子：
8.4
通讯作者：
Parö, G
中科院分区：
文献类型：
--
作者：
Fosså, SD;Aass, N;Parö, G
据称蒽环类药物的脂质体包封可降低毒性并改善药代动力学。因此，15名患有局部晚期或转移性尿路移行细胞癌（TCC）的患者进入了一项II期研究，评估DaunoXome（R）100 mg/m2每三周输注1小时的反应率（WHO标准）和毒性。治疗期间，6例患者病情稳定，8例患者病情进展。1例患者在第一个周期后死于肺栓塞，无法评价缓解。无患者发生4级骨髓毒性。5例患者发生3级白细胞减少症，1例患者发生1级血小板减少症，生化肝肾功能检查无治疗相关变化。4例患者在第一次或第二次输注的初始阶段主诉心绞痛样胸痛。该事件与1例患者的收缩压降低20- 30 mm相关，导致永久停药。在其他3名和所有随后的患者中，在DaunoXome（R）输注前1小时肌内应用100 mg氢化可的松防止了类似的肿胀反应。在本研究中，静脉内（i. v.）DaunoXome（R）100 mg/m2每3周1次对晚期TCC无抗癌活性。(C)1998爱思唯尔科技有限公司版权所有。
Liposomal encapsulation of anthracyclines is claimed to reduce toxicity and to improve pharmacokinetics. Therefore, 15 patients with locally advanced or metastatic transitional cell cancer (TCC) of the urinary tract were entered into a phase II study assessing the response rate (WHO criteria) and toxicity of DaunoXome(R) 100 mg/m(2) given as a 1 h infusion every third week. During treatment, 6 patients remained stable and 8 had progressive disease. 1 patient died of pulmonary embolism after the first cycle and was not evaluable for response. No patient developed grade 4 myelotoxicity. Grade 3 leucopenia was seen in 5 patients and grade 1 thrombocytopenia in 1 patient, with no treatment-related changes of biochemical liver and kidney function tests. 4 patients complained of angina pectoris-like chest pain during the initial phase of the first or second infusion. The event was associated with a decrease in systolic blood pressure by 20-30mm in I patient leading to permanent treatment discontinuation. In the other 3 and all subsequent patients, intramuscular application of 100 mg hydrocortisone 1 h prior to DaunoXome(R) infusion prevented similar hypotensive reactions. In this study, intravenous (i.v.) DaunoXome(R) 100 mg/m(2) every third week showed no anticancer activity in advanced TCC. (C) 1998 Elsevier Science Ltd. All rights reserved.