A clinical trials outcome paradox: should survival prevail in the absence of clinical benefit?

Abstract

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.