作者
Axel Hauschild, Sanjiv S Agarwala, Uwe Trefzer, David Hogg, Caroline Robert, Peter Hersey, Alexander Eggermont, Stephan Grabbe, Rene Gonzalez, Jens Gille, Christian Peschel, Dirk Schadendorf, Claus Garbe, Steven O'Day, Adil Daud, J Michael White, Chenghua Xia, Kiran Patel, John M Kirkwood, Ulrich Keilholz
发表日期
2009/6/10
期刊
Journal of Clinical Oncology
卷号
27
期号
17
页码范围
2823-2830
出版商
American Society of Clinical Oncology
简介
Purpose
This phase III, randomized, double-blind, placebo-controlled study was conducted to evaluate the efficacy and safety of sorafenib with carboplatin and paclitaxel (CP) in patients with advanced melanoma who had progressed on a dacarbazine- or temozolomide-containing regimen.
Patients and Methods
A total of 270 patients were randomly assigned to receive intravenous paclitaxel 225 mg/m2 plus intravenous carboplatin at area under curve 6 (AUC 6) on day 1 of a 21-day cycle followed by either placebo (n = 135) or oral sorafenib 400 mg (n = 135) twice daily on days 2 to 19. The primary efficacy end point was progression-free survival (PFS); secondary and tertiary end points included overall survival and incidence of best response, respectively.
Results
The median PFS was 17.9 weeks for the placebo plus CP arm and 17.4 weeks for the sorafenib plus CP arm (hazard ratio, 0.91; 99% CI, 0.63 to 1 …
引用总数
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A Hauschild, SS Agarwala, U Trefzer, D Hogg… - Journal of Clinical Oncology, 2009