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.

KEYWORDS::

• poxvirus
• prostate cancer
• survival
• TRICOM
• vaccine
• viral vector

Financial & competing interests disclosure

The author has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

No writing assistance was utilized in the production of this manuscript.