reflection of surgery or surgeons bias? Gennady Bratslavsky, M.D. - - PowerPoint PPT Presentation

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Apr 07, 2024 568 likes •898 views

Benefits of cytoreductive nephrectomy: reflection of surgery or surgeons bias? Gennady Bratslavsky, M.D. Professor and Chairman Department of Urology Upstate Medical University Syracuse, NY Disclosures No financial disclosures

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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

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Disclosures

 No financial disclosures  Alternate title: The surgeon’s confession

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Outline

 Two concepts

 What we know  How what we know makes us do something what we know

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1988

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Culp et al, Cancer. 2010 WE CAN SEECT ALL RIGHT!

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Patient selection?

 YES  YES  YES  We are trained to select!

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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

>8 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 . 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

U n kn

n R a ce 5 , 9 3 5 (8 5 . 8 % ) 5 5 4 (8 . % ) 4 2 6 (6 . 2 % ) 1 , 8 9 (8 2 . 6 % ) 1 , 4 9 7 (1 1 . 3 % ) 8 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

d / W i d

e d U n kn

n 7 7 8 (1 1 . 3 % ) 4 , 6 6 4 (6 7 . 4 % ) 1 , 2 9 5 (1 8 . 7 % ) 1 8 (2 . 6 % ) 1 , 8 2 6 (1 3 . 8 % ) 7 , 1 2 1 (5 4 . % ) 3 , 7 4 9 (2 8 . 4 % ) 4 9 3 (3 . 7 % ) <0 . 0001 R e g i

(% ): W e st M i d w e st N

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 % ) . 0002 Vi t a l St a t u s (% ) Al i v e Dead 1 , 6 4 (2 3 . 7 % ) 5,275 (7 6 . 3 % ) 9 6 9 (7 . 3 % ) 1 2 , 2 2 (9 2 . 7 % ) <0 . 0001

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WHY?

 Many reasons suggested

US vs non-US VA vs non-VA Difference in cohorts, etc

 Or investigator’s bias?

Therapeutic equipoise

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CARMENA TRIAL

2018

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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

ften dictate the outcome

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 Slow enrollment (why?)  CARMENA – 43% poor-risk disease  NO ROLE OF CN IN POOR RISK (and likely

intermediate risk)

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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)

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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

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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?

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