CORRECTING OVERALL SURVIVAL FOR THE IMPACT OF CROSSOVER VIA A RANK-PRESERVING STRUCTURAL FAILURE TIME (RPSFT) MODEL IN THE RECORD-1 TRIAL OF EVEROLIMUS IN METASTATIC RENAL-CELL CARCINOMA

被引：30

作者：

Korhonen, P. ^{[1
]}

Zuber, E. ^{[2
]}

Branson, M. ^{[2
]}

Hollaender, N. ^{[2
]}

Yateman, N. ^{[3
]}

Katiskalahti, T. ^{[1
]}

Lebwohl, D. ^{[4
]}

Haas, T. ^{[2
]}

机构：

[1] StatFinn Oy, FI-02150 Espoo, Finland

[2] Novartis Pharma AG, Basel, Switzerland

[3] SDE Serv AG, Pratteln, Switzerland

[4] Novartis Pharmaceut, E Hanover, NJ USA

来源：

JOURNAL OF BIOPHARMACEUTICAL STATISTICS | 2012年 / 22卷 / 06期

关键词：

Everolimus; Rank-preserving accelerated failure time model; Treatment crossover; RANDOMIZED-TRIALS; NONCOMPLIANCE; INFERENCE;

D O I：

10.1080/10543406.2011.592233

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

Clinical trials in oncology often allow patients randomized to placebo to cross over to the active treatment arm after disease progression, leading to underestimation of the treatment effect on overall survival as per the intention-to-treat analysis. We illustrate the statistical aspects and practical use of the rank-preserving structural failure time (RPSFT) model with the Fleming-Harrington family of tests to estimate the crossover-corrected treatment effect, and to assess its sensitivity to various weighting schemes in the RECORD-1 trial. The results suggest that the benefit demonstrated in progression-free survival is likely to translate into a robust overall survival benefit.

引用

页码：1258 / 1271

页数：14

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