Benefits of cytoreductive nephrectomy:
reflection of surgery or surgeon’s bias?
Gennady Bratslavsky, M.D.
Professor and Chairman
Department of Urology
Upstate Medical University
Syracuse, NY
Disclosures
No financial disclosures
Alternate title: The surgeon’s confession
Outline
Two concepts
What we know
How what we know makes us do something what we know
1988
Culp et al, Cancer. 2010
WE CAN SEECT ALL RIGHT!
Patient selection?
YES
YES
YES
We are trained to select!
Conti et al., Int J Cancer,
2013.
CN + ( n =6 9 1 5 ) CN - ( n =1 3 , 1 8 9 ) P va l u e
Ag e (m e a n ± SD ) 60.8 ± 11.30 67.8 ± 12.77 <0 . 0001
Ag e G ro u p (% ): <6 4 65 - 69 70 - 74 75 - 79 >8 0
4,319 ( 62.5 %)
981 ( 14.2 %) 792 ( 11.4 %) 513 ( 7.4 %) 310 ( 4.5 %)
5,231 ( 39.7 %) 1,738 ( 13.2 %) 1,783 (1 3 . 5 %) 1,795 ( 13.6 %) 2,642 ( 20.0 %)
<0 . 0001
Se x (% ): Male Fem ale
4 , 7 8 6 (6 9 . 2 % ) 2 , 1 2 9 (3 0 . 8 % )
8 , 4 6 5 (6 4 . 2 % ) 4 , 7 2 4 (3 5 . 8 % )
<0 . 0001
R a ce / Et h n i ci t y (% ): Whit e Bl a ck O t h e r o r U n kn o w n R a ce
5 , 9 3 5 (8 5 . 8 % )
5 5 4 (8 . 0 % ) 4 2 6 (6 . 2 % )
1 0 , 8 9 0 (8 2 . 6 % ) 1 , 4 9 7 (1 1 . 3 % )
8 0 2 (6 . 1 % )
<0 . 0001
M a ri t a l St a t u s (% ): Si n g l e M a rri e d D i v o rce d / W i d o w e d U n kn o w n
7 7 8 (1 1 . 3 % )
4 , 6 6 4 (6 7 . 4 % ) 1 , 2 9 5 (1 8 . 7 % )
1 8 0 (2 . 6 % )
1 , 8 2 6 (1 3 . 8 % ) 7 , 1 2 1 (5 4 . 0 % ) 3 , 7 4 9 (2 8 . 4 % )
4 9 3 (3 . 7 % )
<0 . 0001
R e g i o n (% ): W e st M i d w e st N o rt h e a st So u t h
3 , 9 7 9 (5 7 . 5 % )
8 5 2 (1 2 . 3 % ) 9 1 9 (1 3 . 2 % )
1 , 1 6 5 (1 6 . 8 % )
7 , 3 2 7 (5 5 . 6 % ) 1 , 8 7 4 (1 4 . 2 % ) 1 , 8 2 3 (1 3 . 8 % ) 2 , 1 6 5 (1 6 . 4 % )
0 . 0002
Vi t a l St a t u s (% ) Al i v e Dead
1 , 6 4 0 (2 3 . 7 % ) 5,275 (7 6 . 3 % )
9 6 9 (7 . 3 % )
1 2 , 2 2 0 (9 2 . 7 % )
<0 . 0001
WHY?
Many reasons suggested
US vs non-US
VA vs non-VA
Difference in cohorts, etc
Or investigator’s bias?
Therapeutic equipoise
CARMENA TRIAL
2018
HYPOTHETICAL TRIAL
DIALYSIS IS PATIENTS WITH ANURIA
If you do it in terminally ill patients in their last 3 days
you will NOT find any benefit to survival
Does it mean that dialysis does not help in renal
failure?
The population studied and patients randomised
often dictate the outcome
Slow enrollment (why?)
CARMENA – 43% poor-risk disease
NO ROLE OF CN IN POOR RISK (and likely
intermediate risk)
ENACT TRIAL
ENZALUTAMIDE vs AS in GLEASON 6 and 7
I have 5 patients from my site in the past 1 year
I have performed about 100 RALPs for Gleason 7
in the past 1 year
I discuss this trial with everyone (with different
intensity)
A FEW THOUGHTS
NO STATISTICAL METHODS CAN
OVERCOME SELECTION BIAS
WE ARE GOOD IN SELECTION!
WE ARE ALSO VICTIMS OF OUR
KNOWLEDGE AND SKILLS
OUR THERAPEUTIC EQUIPOISE IS
CLOUDED
MY QUESTION
CAN WE LEAVE THE BIASES?
CAN WE OFFER THE TRIAL WITHOUT OUR OWN
INPUT?
IF NOT, CAN WE HONESTLY PUSH WITH THE
SAME DEGREE?
SUNY Upstate Medical University
Department of Urology