EURURO Vol. 71 No. 4

511 692

Platinum Priority – Brief Correspondence
Editorial by Scott Eggener on pp. 515–516 of this issue
Generalizability of the Prostate Cancer Intervention Versus
Observation Trial (PIVOT) Results to Contemporary North
American Men with Prostate Cancer
Deepansh Dalela Patrick Karabon Jesse Sammon Akshay Sood Bjo¨rn Lo¨ppenberg
Quoc-Dien Trinh Mani Menon Firas Abdollah
a VUI Center for Outcomes Research, Analytics and Evaluation, Vattikuti Urology Institute, Henry Ford Health System, Detroit, MI, USA; bPublic Health
Sciences, Henry Ford Health System, Detroit, MI, USA; c Division of Urological Surgery, Center for Surgery and Public Health, Brigham and Women’s Hospital,
Harvard Medical School, Boston, MA, USA
ava ilable at
journal homepage:
Article info
Article history:
Accepted August 22, 2016
Associate Editor:
Giacomo Novara
Keywords:
Prostate cancer
Radical prostatectomy
Observation
PIVOT
National Cancer Database
Abstract
The Prostate Cancer Intervention Versus Observation Trial (PIVOT) concluded that
radical prostatectomy (RP) offered no survival benefit compared with observation in
men with clinically localized prostate cancer (PCa). We identified patients within the
National Cancer Database (NCDB) for the period 2004-2012 who met the inclusion
criteria of PIVOT (ie, histologically confirmed PCa, clinical stage T1–2NxM0, prostate-
specific antigen <50 ng/ml, age <75 yr, estimated life expectancy >10 yr, and undergo-
ing RP or observation as initial treatment within 12 mo of diagnosis) to confirm the
generalizability of the PIVOT results to the US population. Life expectancy was calculated
using the US Social Security Administration life tables and was adjusted for comorbid-
ities at diagnosis. Compared with PIVOT, men in the NCDB were younger (mean age
60.3 vs 67.0 yr) and healthier (Charlson-Deyo comorbidity index of 0: 93% vs 56%; both
p < 0.001). Furthermore, 42% of men randomized to receive RP in PIVOT harbored
D’Amico low-risk PCa, whereas 32% of men undergoing RP in the NCDB had low-risk
disease. Our findings were confirmed in a sensitivity analysis including men regardless
of life expectancy but satisfying all other inclusion criteria of PIVOT. Given that the NCDB
represents nearly 70% of all incident cancers diagnosed in the United States, our data
provide further evidence that PIVOT results may not be generalizable to contemporary
clinical practice.
Patient summary: We observed that men diagnosed with clinically localized prostate
cancer within the National Cancer Database (2004–2012) were younger, healthier, and
more likely to have radical prostatectomy for higher risk disease than men in the
Prostate Cancer Intervention Versus Observation Trial (PIVOT), raising questions about
the applicability of PIVOT conclusions to the contemporary US population.
# 2016 European Association of Urology. Published by Elsevier B.V. All rights reserved.
* Corresponding author. VUI Center for Outcomes Research, Analytics and Evaluation, Vattikuti
Urology Institute, Henry Ford Health System, 2799 West Grand Boulevard K-9, Detroit, MI 48202,
USA. Tel. +1 313 916 7129; Fax: +1 313 916 4352.
E-mail address: (F. Abdollah).
0302-2838/# 2016 European Association of Urology. Published by Elsevier B.V. All rights reserved.