Validation of treatment induced specific adverse effect as a predictor of treatment benefit: A case study of NCIC CTG BR21

被引：15

作者：

Ding, K. ^{[1
]}

Pater, J.

Whitehead, M.

Seymour, L.

Shepherd, F. A. ^{[2
,3
]}

机构：

[1] Queens Univ, Canc Res Inst, NCIC Clin Trials Grp, Kingston, ON K7L 3N6, Canada

[2] Princess Margaret Hosp Site, Univ Hlth Network, Dept Med Oncol & Hematol, Toronto, ON, Canada

[3] Univ Toronto, Toronto, ON, Canada

来源：

CONTEMPORARY CLINICAL TRIALS | 2008年 / 29卷 / 04期

基金：

加拿大自然科学与工程研究理事会;

关键词：

targeted therapies; surrogate endpoints; phase III clinical trials; time-dependent covariate; Cox regression model;

D O I：

10.1016/j.cct.2008.01.004

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

The target of novel signal transduction inhibitors may be present on normal as well as tumor cells, resulting in mechanistic adverse effects (AE) in addition to antitumor activity. As those AEs lie in the causal pathway that patients respond to the drug, may thus serve as an indicator of benefit from the drug. In this paper, we discuss issues in validating drug related AEs as predictive markers of overall survival bencfit. Based on our proposed approach, we showed that erlotinib induced skin rash appears to predict a survival benefit. (c) 2008 Elsevier Inc. All rights reserved.

引用

页码：527 / 536

页数：10

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