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