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
WE CAN SEECT ALL RIGHT! Culp et al, Cancer. 2010
Patient selection? YES YES YES We are trained to select!
CN + ( n =6 9 1 5 ) CN - ( n =1 3 , 1 8 9 ) P va l u e ± 60.8 ± 11.30 67.8 ± 12.77 <0 . 0001 Ag e (m e a n SD ) Ag e G ro u p (% ): <0 . 0001 <6 4 4,319 ( 62.5 %) 5,231 ( 39.7 %) 65 - 69 981 ( 14.2 %) 1,738 ( 13.2 %) 70 - 74 792 ( 11.4 %) 1,783 (1 3 . 5 %) 75 - 79 513 ( 7.4 %) 1,795 ( 13.6 %) >8 0 310 ( 4.5 %) 2,642 ( 20.0 %) Se x (% ): <0 . 0001 Male 4 , 7 8 6 (6 9 . 2 % ) 8 , 4 6 5 (6 4 . 2 % ) Fem ale 2 , 1 2 9 (3 0 . 8 % ) 4 , 7 2 4 (3 5 . 8 % ) R a ce / Et h n i ci t y (% ): <0 . 0001 Whit e 5 , 9 3 5 (8 5 . 8 % ) 1 0 , 8 9 0 (8 2 . 6 % ) Bl a ck 5 5 4 (8 . 0 % ) 1 , 4 9 7 (1 1 . 3 % ) O t h e r o r U n kn o w n R a ce 4 2 6 (6 . 2 % ) 8 0 2 (6 . 1 % ) M a ri t a l St a t u s (% ): <0 . 0001 Si n g l e 7 7 8 (1 1 . 3 % ) 1 , 8 2 6 (1 3 . 8 % ) M a rri e d 4 , 6 6 4 (6 7 . 4 % ) 7 , 1 2 1 (5 4 . 0 % ) D i v o rce d / W i d o w e d 1 , 2 9 5 (1 8 . 7 % ) 3 , 7 4 9 (2 8 . 4 % ) U n kn o w n 1 8 0 (2 . 6 % ) 4 9 3 (3 . 7 % ) R e g i o n (% ): 0 . 0002 W e st 3 , 9 7 9 (5 7 . 5 % ) 7 , 3 2 7 (5 5 . 6 % ) M i d w e st 8 5 2 (1 2 . 3 % ) 1 , 8 7 4 (1 4 . 2 % ) N o rt h e a st 9 1 9 (1 3 . 2 % ) 1 , 8 2 3 (1 3 . 8 % ) So u t h 1 , 1 6 5 (1 6 . 8 % ) 2 , 1 6 5 (1 6 . 4 % ) Vi t a l St a t u s (% ) <0 . 0001 Al i v e 1 , 6 4 0 (2 3 . 7 % ) 9 6 9 (7 . 3 % ) Dead 5,275 (7 6 . 3 % ) 1 2 , 2 2 0 (9 2 . 7 % ) Conti et al ., Int J Cancer, 2013.
WHY? Many reasons suggested US vs non-US VA vs non-VA Difference in cohorts, etc Or investigator’s bias? Therapeutic equipoise
2018 CARMENA TRIAL
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
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