When progressive disease does not mean treatment failure: Reconsidering the criteria for progression Journal Article


Authors: Oxnard, G. R.; Morris, M. J.; Hodi, F. S.; Baker, L. H.; Kris, M. G.; Venook, A. P.; Schwartz, L. H.
Article Title: When progressive disease does not mean treatment failure: Reconsidering the criteria for progression
Abstract: Although progression-based endpoints, such as progression-free survival, are often key clinical trial endpoints for anticancer agents, the clinical meaning of "objective progression" is much less certain. As scrutiny of progression-based endpoints in clinical trials increases, it should be remembered that the Response Evaluation Criteria In Solid Tumors (RECIST) progression criteria were not developed as a surrogate for survival. Now that progression-free survival has come to be an increasingly important trial endpoint, the criteria that define progression deserve critical evaluation to determine whether alternate definitions of progression might facilitate the development of stronger surrogate endpoints and more meaningful trial results. In this commentary, we review the genesis of the criteria for progression, highlight recent data that question their value as a marker of treatment failure, and advocate for several research strategies that could lay the groundwork for a clinically validated definition of disease progression in solid tumor oncology. © 2012 The Author.
Keywords: epidermal growth factor; cancer survival; treatment outcome; treatment response; disease-free survival; treatment failure; disease course; review; cancer growth; antineoplastic agents; clinical trials as topic; research design; neoplasms; prostate specific antigen; ipilimumab; melanoma; metastasis; progression free survival; lung neoplasms; lung cancer; practice guideline; receptor, epidermal growth factor; oncology; prostate cancer; prostate-specific antigen; prostatic neoplasms; antibodies, monoclonal; immunotherapy; disease progression; drug treatment failure; anaplastic lymphoma kinase; cabozantinib
Journal Title: JNCI: Journal of the National Cancer Institute
Volume: 104
Issue: 20
ISSN: 0027-8874
Publisher: Oxford University Press  
Date Published: 2012-10-17
Start Page: 1534
End Page: 1541
Language: English
DOI: 10.1093/jnci/djs353
PROVIDER: scopus
PUBMED: 22927506
PMCID: PMC3708548
DOI/URL:
Notes: --- - "Export Date: 2 November 2012" - "CODEN: JNCIA" - "Source: Scopus"
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  1. Michael Morris
    577 Morris
  2. Mark Kris
    869 Kris