Evaluating and Adjusting for Premature Censoring of Progression-Free Survival

被引:2
作者
Rothmann, Mark [1 ]
Koti, Kallappa [1 ]
Lee, Kyung Yul [1 ]
Lu, Hong Laura [1 ]
Shen, Yuan Li [1 ]
Zhang, Jenny J. [1 ]
Jin, Mei [1 ]
Zhou, Haojin [1 ]
机构
[1] US FDA, Ctr Drug Evaluat & Res, Div Biometr 5, Silver Spring, MD 20993 USA
关键词
Loss to follow-up; Overall survival; Progression-free survival;
D O I
10.1080/10543406.2013.813526
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
The intent-to-treat principle, grouping subjects as they were randomized and following all subjects to the endpoint or the end of study, allows valid statistical comparisons. Progression-free survival (PFS) has been used as a decision-making endpoint in oncology. It can be difficult to have a meaningful intent-to-treat analysis of PFS as some studies have extensive loss to follow-up for PFS. In the analysis, subjects lost to follow-up for PFS have their PFS times censored, with the censoring treated as noninformative. We use remaining overall survival to investigate whether premature censoring for PFS is informative and the potential bias in treating such censoring as noninformative.
引用
收藏
页码:1091 / 1105
页数:15
相关论文
共 8 条
[1]  
Buyse M, 2000, Biostatistics, V1, P49, DOI 10.1093/biostatistics/1.1.49
[2]   Progression-free survival is a surrogate for survival in advanced colorectal cancer [J].
Buyse, Marc ;
Burzykowski, Tomasz ;
Carroll, Kevin ;
Michiels, Stefan ;
Sargent, Daniel J. ;
Miller, Langdon L. ;
Elfring, Gary L. ;
Pignon, Jean-Pierre ;
Piedbois, Pascal .
JOURNAL OF CLINICAL ONCOLOGY, 2007, 25 (33) :5218-5224
[3]  
*EUR MED AG, 2008, METH CONS US PROGR F
[4]  
European Medicines Agency, 2005, GUID EV ANT MED PROD
[5]   Issues in Using Progression-Free Survival When Evaluating Oncology Products [J].
Fleming, Thomas R. ;
Rothmann, Mark D. ;
Lu, Hong Laura .
JOURNAL OF CLINICAL ONCOLOGY, 2009, 27 (17) :2874-2880
[6]  
Health Canada, 2007, US FOOD DRUG ADM GUI
[7]   Estimation of survival distributions of treatment policies in two-stage randomization designs in clinical trials [J].
Lunceford, JK ;
Davidian, M ;
Tsiatis, AA .
BIOMETRICS, 2002, 58 (01) :48-57
[8]  
U.S. Food and Drug Administration, 2007, US FOOD DRUG ADM GUI