Overall survival of relapsed and refractory multiple myeloma patients after adjusting for crossover in the MM-003 trial for pomalidomide plus low-dose dexamethasone

被引:21
作者
Morgan, Gareth [1 ]
Palumbo, Antonio [2 ]
Dhanasiri, Sujith [3 ]
Lee, Dawn [4 ]
Weisel, Katja [5 ]
Facon, Thierry [6 ]
Delforge, Michel [7 ]
Oriol, Albert [8 ]
Zaki, Mohamed [9 ]
Yu, Xin [9 ]
Sternas, Lars [9 ]
Jacques, Christian [9 ]
Akehurst, Ron [4 ,10 ]
Offner, Fritz [11 ]
Dimopoulos, Meletios A. [12 ]
机构
[1] Univ Arkansas Med Sci, Myeloma Inst Res & Therapy, Little Rock, AR 72205 USA
[2] Via Univ Torino, Turin, Italy
[3] Celgene Ltd, London, England
[4] Bres Med, Sheffield, S Yorkshire, England
[5] Univ Tubingen, Tubingen, Germany
[6] CHU Lille, Serv Malad Sang, F-59037 Lille, France
[7] Univ Hosp Leuven, Leuven, Belgium
[8] Hosp Badalona Germans Trias & Pujol, Barcelona, Spain
[9] Celgene Corp, Summit, NJ USA
[10] Univ Sheffield, Sheffield, S Yorkshire, England
[11] Univ Ziekenhuis Gent, Ghent, Belgium
[12] Univ Athens, Alexandra Hosp, Sch Med, Athens 11528, Greece
关键词
multiple myeloma; pomalidomide; survival; crossover; bias;
D O I
10.1111/bjh.13227
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
In the phase III MM-003 trial, pomalidomide plus low-dose dexamethasone (POM+LoDEX) improved overall survival (OS) versus high-dose dexamethasone (HiDEX) in 455 patients with relapsed and refractory multiple myeloma (RRMM) after treatment with bortezomib and lenalidomide. Here, a two-stage Weibull method was used to adjust for the crossover of patients in the HiDEX arm to pomalidomide-based therapy. The adjusted difference in median OS between patients in the POM+LoDEX and HiDEX arms was 70months (127 vs. 57months, respectively). These findings provide important evidence for understanding the clinical efficacy of pomalidomide on OS benefits seen in RRMM patients.
引用
收藏
页码:820 / 823
页数:4
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