Biomarker-based adaptive trials for patients With glioblastoma-lessons from I-SPY 2

被引：31

作者：

Alexander, Brian M. ^{[1
,2
]}

Wen, Patrick Y. ^{[2
]}

Trippa, Lorenzo ^{[3
]}

Reardon, David A. ^{[2
]}

Yung, Wai-Kwan Alfred ^{[4
]}

Parmigiani, Giovanni ^{[3
]}

Berry, Donald A. ^{[5
]}

机构：

[1] Harvard Univ, Sch Med, Dept Radiat Oncol, Dana Farber Brigham & Womens Canc Ctr, Boston, MA USA

[2] Harvard Univ, Sch Med, Ctr Neurooncol, Dana Farber Brigham & Womens Canc Ctr, Boston, MA USA

[3] Harvard Univ, Sch Publ Hlth, Dana Farber Canc Inst, Dept Biostat & Computat Biol, Boston, MA 02115 USA

[4] Univ Texas MD Anderson Canc Ctr, Dept Neurooncol, Houston, TX 77030 USA

[5] Univ Texas MD Anderson Canc Ctr, Dept Biostat, Houston, TX 77030 USA

来源：

NEURO-ONCOLOGY | 2013年 / 15卷 / 08期

关键词：

adaptive; Bayesian; biomarker; clinical trials; glioblastoma; PROGRESSION-FREE SURVIVAL; INTEGRATED GENOMIC ANALYSIS; CLINICAL-TRIALS; PHASE-II; END-POINT; DESIGN; TEMOZOLOMIDE; THERAPY; PREDICT; IDH1;

D O I：

10.1093/neuonc/not088

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

The traditional clinical trials infrastructure may not be ideally suited to evaluate the numerous therapeutic hypotheses that result from the increasing number of available targeted agents combined with the various methodologies to molecularly subclassify patients with glioblastoma. Additionally, results from smaller screening studies are rarely translated to successful larger confirmatory studies, potentially related to a lack of efficient control arms or the use of unvalidated surrogate end-points. Streamlining clinical trials and providing a flexible infrastructure for biomarker development is clearly needed for patients with glioblastoma. The experience developing and implementing the I-SPY studies in breast cancer may serve as a guide to developing such trials in neuro-oncology.

引用

页码：972 / 978

页数：7

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