Phase I dose escalation and pharmacokinetic study of pluronic polymer-bound doxorubicin (SP1049C) in patients with advanced cancer.
Phase I dose escalation and pharmacokinetic study of pluronic polymer-bound doxorubicin (SP1049C) in patients with advanced cancer.
复制标题
I阶段剂量升级和药代动力学研究对晚期癌症患者的pluronic聚合物结合的阿霉素（SP1049C）。
DOI：
10.1038/sj.bjc.6601856
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发表时间：
2004-06-01
影响因子：
8.8
通讯作者：
中科院分区：
文献类型：
--
作者：
SP1049C是一种新型抗癌药物，包含阿霉素和两种非离子型普朗尼克嵌段共聚物。在临床前研究中，SP1049C显示出比阿霉素更高的疗效。这项首次I期研究的目的是确定SP1049C的毒性特征、剂量限制性毒性、最大耐受剂量和药代动力学特征，并记录任何抗肿瘤活性。起始剂量为5毫克/平方米（阿霉素含量），每3周静脉输注一次，最多6个周期。共有26名患者在7个剂量水平接受了78个疗程。剂量限制性毒性为骨髓抑制，在90毫克/平方米时达到剂量限制性毒性。最大耐受剂量为70毫克/平方米，推荐用于未来的试验。SP1049C的药代动力学特征显示其清除速度比传统阿霉素报道的更慢。在一些晚期耐药实体瘤患者中观察到了抗肿瘤活性的证据。现在有必要用这种药物进行II期试验，以进一步明确其抗肿瘤活性和安全性特征。
SP1049C is a novel anticancer agent containing doxorubicin and two nonionic pluronic block copolymers. In preclinical studies, SP1049C demonstrated increased efficacy compared to doxorubicin. The objectives of this first phase I study were to determine the toxicity profile, dose-limiting toxicity, maximum tolerated dose and pharmacokinetic profile of SP1049C, and to document any antitumour activity. The starting dose was 5 mg m−2 (doxorubicin content) as an intravenous infusion once every 3 weeks for up to six cycles. A total of 26 patients received 78 courses at seven dose levels. The dose-limiting toxicity was myelosuppression and DLT was reached at 90 mg m−2. The maximum tolerated dose was 70 mg m−2 and is recommended for future trials. The pharmacokinetic profile of SP1049C showed a slower clearance than has been reported for conventional doxorubicin. Evidence of antitumour activity was seen in some patients with advanced resistant solid tumours. Phase II trials with this agent are now warranted to further define its antitumour activity and safety profile.
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