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

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