Skip to main content
Journal cover image

Clinical trial end points for high-grade glioma: the evolving landscape.

Publication ,  Journal Article
Reardon, DA; Galanis, E; DeGroot, JF; Cloughesy, TF; Wefel, JS; Lamborn, KR; Lassman, AB; Gilbert, MR; Sampson, JH; Wick, W; Chamberlain, MC ...
Published in: Neuro Oncol
March 2011

To review the strengths and weaknesses of primary and auxiliary end points for clinical trials among patients with high-grade glioma (HGG). Recent advances in outcome for patients with newly diagnosed and recurrent HGG, coupled with the development of multiple promising therapeutics with myriad antitumor actions, have led to significant growth in the number of clinical trials for patients with HGG. Appropriate clinical trial design and the incorporation of optimal end points are imperative to efficiently and effectively evaluate such agents and continue to advance outcome. Growing recognition of limitations weakening the reliability of traditional clinical trial primary end points has generated increasing uncertainty of how best to evaluate promising therapeutics for patients with HGG. The phenomena of pseudoprogression and pseudoresponse have made imaging-based end points, including overall radiographic response and progression-free survival, problematic. Although overall survival is considered the "gold-standard" end point, recently identified active salvage therapies such as bevacizumab may diminish the association between presalvage therapy and overall survival. Finally, advances in imaging as well as the assessment of patient function and well being have strengthened interest in auxiliary end points assessing these aspects of patient care and outcome. Better appreciation of the strengths and limitations of primary end points will lead to more effective clinical trial strategies. Technical advances in imaging as well as improved survival for patients with HGG support the further development of auxiliary end points evaluating novel imaging approaches as well as measures of patient function and well being.

Duke Scholars

Altmetric Attention Stats
Dimensions Citation Stats

Published In

Neuro Oncol

DOI

EISSN

1523-5866

Publication Date

March 2011

Volume

13

Issue

3

Start / End Page

353 / 361

Location

England

Related Subject Headings

  • Survival Rate
  • Salvage Therapy
  • Oncology & Carcinogenesis
  • Humans
  • Glioma
  • Clinical Trials as Topic
  • Brain Neoplasms
  • 3211 Oncology and carcinogenesis
  • 1112 Oncology and Carcinogenesis
  • 1109 Neurosciences
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Reardon, D. A., Galanis, E., DeGroot, J. F., Cloughesy, T. F., Wefel, J. S., Lamborn, K. R., … Wen, P. Y. (2011). Clinical trial end points for high-grade glioma: the evolving landscape. Neuro Oncol, 13(3), 353–361. https://doi.org/10.1093/neuonc/noq203
Reardon, David A., Evanthia Galanis, John F. DeGroot, Timothy F. Cloughesy, Jeffrey S. Wefel, Kathleen R. Lamborn, Andrew B. Lassman, et al. “Clinical trial end points for high-grade glioma: the evolving landscape.Neuro Oncol 13, no. 3 (March 2011): 353–61. https://doi.org/10.1093/neuonc/noq203.
Reardon DA, Galanis E, DeGroot JF, Cloughesy TF, Wefel JS, Lamborn KR, et al. Clinical trial end points for high-grade glioma: the evolving landscape. Neuro Oncol. 2011 Mar;13(3):353–61.
Reardon, David A., et al. “Clinical trial end points for high-grade glioma: the evolving landscape.Neuro Oncol, vol. 13, no. 3, Mar. 2011, pp. 353–61. Pubmed, doi:10.1093/neuonc/noq203.
Reardon DA, Galanis E, DeGroot JF, Cloughesy TF, Wefel JS, Lamborn KR, Lassman AB, Gilbert MR, Sampson JH, Wick W, Chamberlain MC, Macdonald DR, Mehta MP, Vogelbaum MA, Chang SM, Van den Bent MJ, Wen PY. Clinical trial end points for high-grade glioma: the evolving landscape. Neuro Oncol. 2011 Mar;13(3):353–361.
Journal cover image

Published In

Neuro Oncol

DOI

EISSN

1523-5866

Publication Date

March 2011

Volume

13

Issue

3

Start / End Page

353 / 361

Location

England

Related Subject Headings

  • Survival Rate
  • Salvage Therapy
  • Oncology & Carcinogenesis
  • Humans
  • Glioma
  • Clinical Trials as Topic
  • Brain Neoplasms
  • 3211 Oncology and carcinogenesis
  • 1112 Oncology and Carcinogenesis
  • 1109 Neurosciences