A phase II trial of nab-paclitaxel (ABI-007) and carboplatin in patients with unresectable stage IV melanoma : a North Central Cancer Treatment Group Study, N057E(1).
A phase II trial of nab-paclitaxel (ABI-007) and carboplatin in patients with unresectable stage IV melanoma : a North Central Cancer Treatment Group Study, N057E(1).
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DOI：
10.1002/cncr.25659
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发表时间：
2011-04-15
期刊：
影响因子：
6.2
通讯作者：
Markovic, Svetomir N.
中科院分区：
文献类型：
--
作者：
Kottschade, Lisa A.;Suman, Vera J.;Amatruda, Thomas, III;McWilliams, Robert R.;Mattar, Bassam I.;Nikcevich, Daniel A.;Behrens, Robert;Fitch, Tom R.;Jaslowski, Anthony J.;Markovic, Svetomir N.
越来越多的证据表明紫杉醇和卡铂在转移性黑色素瘤（MM）的治疗中具有临床活性。ABI-007是紫杉醇的白蛋白结合制剂，已证明其对转移性黑色素瘤具有单药活性。在未经化疗（CN）或既往接受过治疗（PT）的不可切除的IV期黑色素瘤患者中进行了一项平行II期试验。治疗方案包括ABI-007（100 mg/m2）和卡铂曲线下面积（AUC 2），每28天在第1、8和15天给药一次。本研究的主要目的是客观缓解率（RECIST）。2006年11月至2007年7月入组了76例患者（41例CN和35例PT）。3例患者在开始治疗前撤回知情同意书。中位治疗周期数为4个。CN队列中有10例（25.6%）缓解（1例完全缓解[CR ]和9例部分缓解[PR]）（90% CI：16.7-42.3%），PT队列中有3例（8.8%）缓解（3例PR）（90% CI：2.5-21.3%）。中位PFS为4.5个月（CN）和4.1个月（PT）。中位总生存期（OS）为11.1个月（CN）和10.9个月（PT）。两组的重度毒性[不良反应通用术语标准（CTCAE）≥ 3级]包括中性粒细胞减少症、血小板减少症、神经感觉、疲乏、恶心和呕吐。ABI-007和卡铂的每周联合治疗似乎具有中等耐受性，在CN患者中具有有希望的临床活性，在PT患者中具有适度的抗肿瘤活性
There is increasing evidence that paclitaxel and carboplatin are clinically active in the treatment of metastatic melanoma (MM). ABI-007 is an albumin bound formulation of paclitaxel which has demonstrated single agent activity against metastatic melanoma. A parallel phase II trial was conducted in patients with unresectable stage IV melanoma who were either chemotherapy naïve (CN) or were previously treated (PT). The treatment regimen consisted of ABI-007 (100 mg/m2) and carboplatin area under the curve (AUC2) administered on days 1, 8, and 15, every 28 days. The primary aim of this study was objective response rate (RECIST). 76 patients (41 CN and 35 PT) enrolled from 11/2006 – 7/2007. Three patients withdrew consent prior to starting treatment. The median number of treatment cycles was 4. There were 10 (25.6%) responses (1 complete response [CR ] and 9 partial responses [PRs]) in the CN cohort (90% CI: 16.7–42.3%) and 3 (8.8%) responses ( 3 PRs) in the PT cohort (90% CI: 2.5–21.3%). Median PFS was 4.5 months (CN) and 4.1 months (PT). Median overall survival (OS) was 11.1 months (CN) and 10.9 (PT). Severe toxicities in both groups [Common Terminology Criteria for Adverse Effects (CTCAE) ≥ grade 3] included neutropenia, thrombocytopenia, neuro-sensory, fatigue, nausea, and vomiting. The weekly combination of ABI-007 and carboplatin appears to be moderately well tolerated with promising clinical activity as therapy in patients who are CN and modest anti-tumor activity in those who had PT
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影响因子：
45.3
作者：
Chapman, PB;Einhorn, LH;Kirkwood, JM
通讯作者：
Kirkwood, JM
影响因子：
3.7
作者：
KAPLAN, EL;MEIER, P
通讯作者：
MEIER, P
影响因子：
45.3
作者：
Middleton, MR;Grob, JJ;Thatcher, N
通讯作者：
Thatcher, N
影响因子：
45.3
作者：
Hauschild, Axel;Agarwala, Sanjiv S.;Keilholz, Ulrich
通讯作者：
Keilholz, Ulrich
影响因子：
2.2
作者：
Zimpfer-Rechner, C;Hofmann, U;Schadendorf, D
通讯作者：
Schadendorf, D