Download How to reduce suffering and death from Prostate cancer…. Lessons

How to reduce suffering and death from
Prostate cancer….
Lessons learned from the US
Edward “Ted” Schaeffer MD PhD
R. Christian B Evensen Professor of Urology
Director of the Prostate Cancer Program
Johns Hopkins School of Medicine
December 4, 2015
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December 4, 2015
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New position
•  Edmund Andrews Professor
•  Chair of the Department of Urology
•  Director of the Urologic Oncology
Program at the Luire Comprehensive
Cancer Center
December 4, 2015
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Disclosures
•  No Relevant Financial Relationships to
•  Disclose
•  Non FDA Approved Use of Drugs and
•  Products Referenced in this
presentation
•  -none
December 4, 2015
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Contemporary approach in the US
to reduce suffering and death
from prostate cancer
Improved treatment can occur at multiple
levels of care
•  Hospital level
•  Physician level
•  Patient level
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Prostate Cancer: Second leading cause of
cancer related death in US men
From Jemal, A. et al.
CA Cancer J Clin 2008;58:71-96.
Copyright ©2008 American Cancer Society
Historical approach to reducing
prostate cancer deaths
Screen everyone + Treat everyone
=
Reduced prostate cancer deaths*
*Caveat to this approach is significant
overtreatment of the disease
Contemporary approach to
reducing prostate cancer deaths
Grade of the cancer
Stage of the cancer
PSA biomarker
+
Anticipated life expectancy
=
Treatment - Yes/No
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From: Trends in Management for Patients With Localized Prostate Cancer, 1990-2013
JAMA. 2015;314(1):80-82. doi:10.1001/jama.2015.6036
Figure Legend:
Treatment Trends for the Overall Cohort in the Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE)
RegistryError bars indicate 95% confidence intervals; CAPRA, Cancer of the Prostate Risk Assessment.
Date of download: 11/1/2015
Copyright © 2015 American Medical Association.
All rights reserved.
Prostate Cancer: Second leading cause of
cancer related death in men
From Jemal, A. et al.
CA Cancer J Clin 2008;58:71-96.
Copyright ©2008 American Cancer Society
Contemporary approach to
reducing prostate cancer deaths
Improved Prostate Cancer screening
approaches = Henrik Gronberg
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Contemporary approach in the US
to reduce suffering and death
from prostate cancer
Improved treatment can occur at multiple
levels of care
•  Hospital level
•  Physician level
•  Patient level
December 4, 2015
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Contemporary approach in the US
to reduce suffering and death
from prostate cancer
Retrospective analyses reveals an
organic approach to improve outcomes.
•  Hospital level approaches
–  Volume = Better outcome
•  Physician level approaches
–  Volume = Better outcome
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•  >11,000 patients tracked through government
billing codes
•  Health related outcomes measured in relation to:
–  Hospital volume
–  Surgeon volume
–  Volumes measures were determined by quartiles of
Prostatectomies done/ 5 years
–  Hospital volumes
•  Low (< 8 cases/yr) High (> 29 cases/yr)
–  Surgeon Volumes
•  Low (< 2.5 cases/yr) High (> 8 cases/yr)
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Health outcomes after
prostate surgery
•  Hospital
–  No Difference in Death
–  Post operative complications reduced in
high volume hospitals
–  Urinary complications reduced in high
volume hospitals
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Health outcomes after
prostate surgery
•  Surgeon
–  No Difference in Death
–  Post operative complications reduced in
high volume surgeons
–  Urinary complications reduced in high
volume surgeons
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Conclusions
•  High volume hospitals and surgeons in
the US were associated with improved:
–  Recovery (fewer complications)
–  Decreased long term complications
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Caveats to study…
•  Early in the life of Radical
Prostatectomy surgery
•  Little granularity in the data
•  High volume surgeons (>8 cases) and
hospitals (>29 cases) relatively small
volumes for the US.
•  Did not evaluate cancer control
•  Would even higher volume surgeons
and hospitals do even better???
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Wilt systematic review
•  17 studies on Volume and Outcome
•  Hospitals with >43 surgeries/yr
–  Lower mortality
–  Lower morbidity
•  Surgeon Volume
–  Decreased length of stay, complications
–  Lower rates of incontinence/strictures
–  Rates improves for each additional 10
cases
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Conclusion #1
•  Multitude of retrospective data suggests
hospitals and surgeons performing
higher volume prostate procedures
have improved outcomes.
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Conclusion #1
•  Multitude of retrospective data suggests
hospitals and surgeons performing
higher volume prostate procedures
have improved outcomes.
•  Patients should GET A SECOND
OPINION!
•  Institutions should publish their results
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Patient resources
•  Prostate Cancer Foundation
of Norway
•  http://prostatakreftstiftelsen.no
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http://prostatakreftstiftelsen.no/pcf_nor
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How have we proactively worked
to improve patient outcomes
•  Systematic case review
–  Prostate Cancer Multidisciplinary Clinic
•  Systematic quality improvement
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Improved Identification of patients
Prostate Cancer Multidisciplinary Clinic
• 
• 
• 
• 
200 patients / year
Full day multi-specialty assessment
Pathology and radiology re-review
Multi-specialty assessment and plan
•  Since 2008
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Multi-Disciplinary Team
• 
• 
• 
• 
• 
Urology
Radiation Oncology
Medical Oncology
Radiology
Pathology
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Pathology
Gleason grade change in MDC
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Prostate Cancer Multidisciplinary Clinic
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Examples by “risk group”
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Summary of MDC clinic
experience
•  29% of men had a change in their
stage and/or grade that potentially
impacted treatment choices.
–  6% of men with localized disease were
found to have metastatic lesions
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Conclusion #2
•  MDC experience
–  Time intensive; however,
–  a systematic approach can improve patient
care
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Improved treatment can occur at multiple
levels of care
•  Hospital level
•  Physician level
–  Systematic quality improvement
•  Patient level
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Proactive quality tracking
•  Surgeon specific, blinded outcome
assessments
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Since Surgeons have no Ego…
this has been easy!
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Hawthorn Effect
•  Elton Mayo study on mechanisms to increase
productivity (best lighting to maximize
productivity) at a Western Electric plant
(Hawthorn Works) in Cicero IL USA
•  Productivity increased independent of lighting
(high or low)
•  Altered behavior in response to being observed
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Prostatectomy Report Card
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T2 Surgical Margin Rates - 2014.2
35
30
25
20
15
JHU
12.2
194X
6.5
10
5
0
T2 Surgical Rates - 2015.1
35
30
25
20
15
10
JHU
6.9
194X
4.7
5
0
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Conclusion #3
•  Proactive outcome tracking / safety
dashboard
–  Improved short term outcome measures.
–  Long term functional recovery results are
pending
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Improved treatment can occur at multiple
levels of care
•  Hospital level
•  Physician level
•  Patient level
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Can “precision medicine” also
improve patient outcomes by
reducing morbidity?
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Study Objective and Design
•  Explore if genomic classifier could
provide prognostic and predictive
information regarding timing of post
operative radiation in at risk cohort.
•  Genomic Classifier – Decipher was
performed on all men
•  https://genomedx.com/
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Methods
• 
Endpoint for the analysis was metastasis (regional or distant) as
evidenced by positive CT and/or bone scans
• 
Adjuvant and salvage radiation treatment (RT) were defined by PSA
levels of ≤ 0.2 and > 0.2 ng/mL prior to initiation of RT, respectively.
• 
Prognostic accuracy of the models were tested using c-index and
decision curve analysis. Cox regression tested the relationship between
GC and metastasis after adjusting for available covariates.
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Patients with high Genomic Classifier:
Improved Mets free survival with ART vs SRT
Patient with Low GC: No difference in met free survival
Decipher low-­‐risk (GC < 0.4) Decipher high-­‐risk (GC ≥ 0.4) Salvage RT
Adjuvant RT
Adjuvant RT
Salvage RT
HR Adjuvant RT
(Ref Salvage RT)
Low Risk
0.76
95% CI
p value
0.11-5.46
0.787
HR Adjuvant RT
(Ref Salvage RT)
High Risk
0.20
95% CI
p value
0.04-0.90
0.0357
•  80% reduction in hazards for high GC that got ART compared
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to SRT
Conclusions
•  Decipher test can help stratify men into risks groups
where there may be potential benefit of ART vs SRT
•  This may help guide physicians and patients deciding
on ART vs SRT
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GenomeDx Biosciences Confidential
October 14
Conclusion - Final
Contemporary approach in the US to reduce
suffering and death from prostate cancer
•  Hospital level
•  Physician level
•  Patient level
December 4, 2015
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Acknowledgements
Schaeffer Lab
Brian Simons
Deb Sundi
Farzana Faisel
Michael Johnson
JHMI
Ashley Ross
Paula Hurley
George Netto
Bruce Trock
Angelo DeMarzo
Helen Fedor
December 4, 2015
Tamara
Lotan
Felix Feng - UM
Scott Tomlins -UM
Jeff Karnes - Mayo
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Thanks and Questions
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Genomic Classifier adds to predictive
ability of individual pathologic features
04/12/15
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Cox MVA of Genomic Classifier
and validated Nomograms
CAPRA-S** 1.67 (1.54 - 1.82) <0.0001 1.60 (1.46 - 1.76) <0.0001 Decipher* 1.48 (1.30 - 1.69) <0.0001 1.32 (1.17 - 1.51) <0.0001 Eggener* 1.54 (1.36 - 1.73) <0.0001 1.50 (1.35 - 1.66) <0.0001 Decipher* 1.48 (1.30 - 1.69) <0.0001 1.39 (1.20 - 1.62) <0.0001 December 4, 2015
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Distribution of patients by CapraS
and Genomic Classifier
Non Metastatic
Metastatic
Nomogram
risk
04/12/15
Genomic Classifier
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Distribution of patients by CapraS
and Genomic Classifier
Non Metastatic
Metastatic
Nomogram
risk
04/12/15
Genomic Classifier
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Distribution of patients by CapraS
and Genomic Classifier
Non Metastatic
Metastatic
Nomogram
04/12/15
Genomic Classifier Risk
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Distribution of patients by CapraS
and Genomic Classifier
Non Metastatic
Metastatic
Nomogram
04/12/15
Genomic Classifier
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Distribution of patients by Capra/
Eggener and Genomic Classifier
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Distribution of patients by Capra/
Eggener and Genomic Classifier
Men don’t need Genomic test – All met
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Distribution of patients by Capra/
Eggener and Genomic Classifier
Men don’t need Genomic test – No Mets
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Distribution of patients by Capra/
Eggener and Genomic Classifier
Men benefit from Genomic test
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Distribution of patients by Capra/
Eggener and Genomic Classifier
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Distribution of patients by Capra/
Eggener and Genomic Classifier
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