Survey
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
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 1 December 4, 2015 2 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 3 Disclosures • No Relevant Financial Relationships to • Disclose • Non FDA Approved Use of Drugs and • Products Referenced in this presentation • -none December 4, 2015 4 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 5 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 December 4, 2015 8 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 December 4, 2015 11 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 12 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 December 4, 2015 13 December 4, 2015 14 • >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) December 4, 2015 15 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 December 4, 2015 16 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 December 4, 2015 17 Conclusions • High volume hospitals and surgeons in the US were associated with improved: – Recovery (fewer complications) – Decreased long term complications December 4, 2015 18 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??? December 4, 2015 19 December 4, 2015 20 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 December 4, 2015 21 Conclusion #1 • Multitude of retrospective data suggests hospitals and surgeons performing higher volume prostate procedures have improved outcomes. December 4, 2015 22 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 December 4, 2015 23 Patient resources • Prostate Cancer Foundation of Norway • http://prostatakreftstiftelsen.no December 4, 2015 24 http://prostatakreftstiftelsen.no/pcf_nor December 4, 2015 25 How have we proactively worked to improve patient outcomes • Systematic case review – Prostate Cancer Multidisciplinary Clinic • Systematic quality improvement December 4, 2015 26 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 December 4, 2015 27 Multi-Disciplinary Team • • • • • Urology Radiation Oncology Medical Oncology Radiology Pathology December 4, 2015 28 December 4, 2015 29 Pathology Gleason grade change in MDC December 4, 2015 30 Prostate Cancer Multidisciplinary Clinic December 4, 2015 31 Examples by “risk group” December 4, 2015 32 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 December 4, 2015 33 Conclusion #2 • MDC experience – Time intensive; however, – a systematic approach can improve patient care December 4, 2015 34 December 4, 2015 35 Improved treatment can occur at multiple levels of care • Hospital level • Physician level – Systematic quality improvement • Patient level December 4, 2015 36 Proactive quality tracking • Surgeon specific, blinded outcome assessments December 4, 2015 37 Since Surgeons have no Ego… this has been easy! December 4, 2015 38 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 December 4, 2015 39 Prostatectomy Report Card December 4, 2015 40 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 December 4, 2015 41 Conclusion #3 • Proactive outcome tracking / safety dashboard – Improved short term outcome measures. – Long term functional recovery results are pending December 4, 2015 42 Improved treatment can occur at multiple levels of care • Hospital level • Physician level • Patient level December 4, 2015 43 Can “precision medicine” also improve patient outcomes by reducing morbidity? December 4, 2015 44 December 4, 2015 45 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/ December 4, 2015 46 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. December 4, 2015 47 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 48 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 49 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 50 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 51 Thanks and Questions 52 December 4, 2015 53 December 4, 2015 54 Genomic Classifier adds to predictive ability of individual pathologic features 04/12/15 55 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 56 Distribution of patients by CapraS and Genomic Classifier Non Metastatic Metastatic Nomogram risk 04/12/15 Genomic Classifier 57 Distribution of patients by CapraS and Genomic Classifier Non Metastatic Metastatic Nomogram risk 04/12/15 Genomic Classifier 58 Distribution of patients by CapraS and Genomic Classifier Non Metastatic Metastatic Nomogram 04/12/15 Genomic Classifier Risk 59 Distribution of patients by CapraS and Genomic Classifier Non Metastatic Metastatic Nomogram 04/12/15 Genomic Classifier 60 Distribution of patients by Capra/ Eggener and Genomic Classifier 04/12/15 61 Distribution of patients by Capra/ Eggener and Genomic Classifier Men don’t need Genomic test – All met 04/12/15 62 Distribution of patients by Capra/ Eggener and Genomic Classifier Men don’t need Genomic test – No Mets 04/12/15 63 Distribution of patients by Capra/ Eggener and Genomic Classifier Men benefit from Genomic test 04/12/15 64 Distribution of patients by Capra/ Eggener and Genomic Classifier 04/12/15 65 Distribution of patients by Capra/ Eggener and Genomic Classifier 04/12/15 66