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

Immunotherapy
Susan F Slovin

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.

References

Dec 1, 2000·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·E J SmallF H Valone
Mar 29, 2003·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Susan HalabiNicholas J Vogelzang
Dec 3, 2003·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Susan F SlovinHoward I Scher
Mar 30, 2004·Clinical Prostate Cancer·Philip M ArlenWilliam Dahut
Jul 1, 2006·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Eric J SmallRobert M Hershberg
Aug 21, 2007·The Journal of Urology·Philip M ArlenJames L Gulley
Jun 17, 2009·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·June M ChanPhilip W Kantoff
Oct 3, 2009·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology

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