作者
F Stephen Hodi, Steven J O'day, David F McDermott, Robert W Weber, Jeffrey A Sosman, John B Haanen, Rene Gonzalez, Caroline Robert, Dirk Schadendorf, Jessica C Hassel, Wallace Akerley, Alfons JM Van Den Eertwegh, Jose Lutzky, Paul Lorigan, Julia M Vaubel, Gerald P Linette, David Hogg, Christian H Ottensmeier, Celeste Lebbé, Christian Peschel, Ian Quirt, Joseph I Clark, Jedd D Wolchok, Jeffrey S Weber, Jason Tian, Michael J Yellin, Geoffrey M Nichol, Axel Hoos, Walter J Urba
发表日期
2010/8/19
期刊
New England Journal of Medicine
卷号
363
期号
8
页码范围
711-723
出版商
Massachusetts Medical Society
简介
Background
An improvement in overall survival among patients with metastatic melanoma has been an elusive goal. In this phase 3 study, ipilimumab — which blocks cytotoxic T-lymphocyte–associated antigen 4 to potentiate an antitumor T-cell response — administered with or without a glycoprotein 100 (gp100) peptide vaccine was compared with gp100 alone in patients with previously treated metastatic melanoma.
Methods
A total of 676 HLA-A*0201–positive patients with unresectable stage III or IV melanoma, whose disease had progressed while they were receiving therapy for metastatic disease, were randomly assigned, in a 3:1:1 ratio, to receive ipilimumab plus gp100 (403 patients), ipilimumab alone (137), or gp100 alone (136). Ipilimumab, at a dose of 3 mg per kilogram of body weight, was administered with or without gp100 every 3 weeks for up to four treatments (induction). Eligible patients could …
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FS Hodi, SJ O'day, DF McDermott, RW Weber… - New England Journal of Medicine, 2010