A clinical trials outcome paradox: Should survival prevail in the absence of clinical benefit? Journal Article


Author: Slovin, S. F.
Article Title: A clinical trials outcome paradox: Should survival prevail in the absence of clinical benefit?
Abstract: Evaluation of: Gulley JL, Arlen PM, Madan RA et al.: Immunologic and prognostic factors associated with overall survival employing a poxviral-based PSA vaccine in metastatic castrate-resistant prostate cancer. Cancer Immunol. Immunother. 1, 27-29 (2009). A comparison was made using an established prognostic nomogram to determine the impact of survival on patients with castration-resistant prostate cancer using a pox-based vaccine. Survival in the treated cohort of 32 patients had improved compared with what was anticipated for the same group using an established nomogram. With a median follow-up of 44.6 months, the median overall survival for all 32 patients in the study was 26.6 months compared with a median nomogram-predicted survival of 17.4 months. The data suggested that there may be measures by which patients may be preselected and therefore may be more responsive candidates to a vaccine treatment approach. This study brings to light improved survival for patients, but the issue of how to reconcile a survival advantage in the absence of significant clinical anti-tumor response remains unsettled. © 2010 Future Medicine Ltd.
Keywords: survival; unclassified drug; overall survival; prednisone; clinical trial; note; follow up; prostate specific antigen; dacarbazine; cancer immunotherapy; melanoma; antineoplastic activity; cancer resistance; docetaxel; prostate cancer; cancer vaccine; castration; provenge; granulocyte macrophage colony stimulating factor vaccine; metronidazole; vaccine; poxvirus; tricom; viral vector; b7 antigen plus intercellular adhesion molecule 1 plus lymphocyte function associated antigen 3; cytotoxic lymphocyte antigen 4 monoclonal antibody; programmed death antigen monoclonal antibody; prostvac vf
Journal Title: Immunotherapy
Volume: 2
Issue: 2
ISSN: 1750-743X
Publisher: Future Medicine  
Date Published: 2010-03-01
Start Page: 155
End Page: 158
Language: English
DOI: 10.2217/imt.10.5
PROVIDER: scopus
PUBMED: 20635924
DOI/URL:
Notes: --- - "Export Date: 20 April 2011" - "Source: Scopus"
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  1. Susan Slovin
    254 Slovin