Phase II study of SPI-77 (sterically stabilised liposomal cisplatin) in advanced non-small-cell lung cancer.
Phase II study of SPI-77 (sterically stabilised liposomal cisplatin) in advanced non-small-cell lung cancer.
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DOI：
10.1038/sj.bjc.6603345
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发表时间：
2006-10-09
影响因子：
8.8
通讯作者：
Ranson, M.
中科院分区：
文献类型：
--
作者：
White, S. C.;Lorigan, P.;Margison, G. P.;Margison, J. M.;Martin, F.;Thatcher, N.;Anderson, H.;Ranson, M.
确定三种剂量水平的SPI-77（空间稳定的顺铂脂质体）在晚期非小细胞肺癌（NSCLC）患者中的疗效和耐受性。患者患有IIIB或IV期NSCLC，未经化疗，东部肿瘤协作组0-2。第一个队列接受100 mg m−2的SPI-77，第二个队列接受200 mg m−2，最后一个队列接受260 mg m−2。还对患者进行了药代动力学和白细胞铂（Pt）-DNA加合物分析。26例患者接受了治疗，其中22例患者可评价缓解。在200 mg m−2剂量水平下仅发生1例缓解，总体缓解率为4.5%（在≥ 200 mg m−2时为7.1%）。除2例患者发生3级恶心外，未观察到显著毒性，包括肾毒性或耳毒性。未使用常规止吐药或水化。SPI-77的药代动力学特征对于脂质体配制的药物是典型的，并且AUC似乎与SPI-77的剂量成比例。血浆Pt水平和白细胞DNA加合物水平似乎未随连续给药而升高。SPI-77在NSCLC患者中仅表现出中等活性。
To determine the efficacy and tolerability of SPI-77 (sterically stabilised liposomal cisplatin) at three dose levels in patients with advanced non-small-cell lung cancer (NSCLC). Patients had Stage IIIB or IV NSCLC and were chemo-naïve, and Eastern Oncology Cooperative Group 0–2. The first cohort received SPI-77 at 100 mg m−2, the second 200 mg m−2 and the final cohort 260 mg m−2. Patients had also pharmacokinetics and analysis of leucocyte platinum (Pt)-DNA adducts performed. Twenty-six patients were treated, with 22 patients being evaluable for response. Only one response occurred at the 200 mg m−2 dose level for an overall response rate of 4.5% (7.1% at ⩾200 mg m−2). No significant toxicity was noted including nephrotoxicity or ototoxicity aside from two patients with Grade 3 nausea. No routine antiemetics or hydration was used. The pharmacokinetic profile of SPI-77 was typical for a liposomally formulated drug, and the AUC appeared to be proportional to the dose of SPI-77. Plasma Pt levels and leucocyte DNA adduct levels did not appear to rise with successive doses. SPI-77 demonstrates only modest activity in patients with NSCLC.
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影响因子：
45.3
作者：
Sandler, AB;Nemunaitis, J;Einhorn, LH
通讯作者：
Einhorn, LH
影响因子：
8.4
作者：
Fosså, SD;Aass, N;Parö, G
通讯作者：
Parö, G
DOI：
10.1177/106002808501900505
发表时间：
1985-01-01
期刊：
DRUG INTELLIGENCE & CLINICAL PHARMACY
影响因子：
--
作者：
FINLEY, RS;FORTNER, CL;GROVE, WR
通讯作者：
GROVE, WR
影响因子：
8.4
作者：
Kim, DH;Lee, SH;Kim, KH
通讯作者：
Kim, KH
影响因子：
3
作者：
Newman, MS;Colbern, GT;Amantea, MA
通讯作者：
Amantea, MA