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Overdetection of prostate cancer ESMO Brussel 2007

Overdetection of prostate cancer ESMO Brussel 2007. Chris H.Bangma Erasmus University Medical Centre Rotterdam, The Netherlands. Increasing Pca incidence with age. 225.000 in Europe annually. Proportion Prostate Cancer. PSA and cancer incidence in men aged 50-75.

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Overdetection of prostate cancer ESMO Brussel 2007

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  1. Overdetection of prostate cancerESMO Brussel 2007 Chris H.Bangma Erasmus University Medical Centre Rotterdam, The Netherlands

  2. Increasing Pca incidence with age 225.000 in Europe annually

  3. Proportion Prostate Cancer PSA and cancer incidence in men aged 50-75

  4. Clinical incidence over time increases (Netherlands)

  5. The diagnosis of low risk prostate cancer is increasing 100 80 60 % of patients 40 20 0 ‘90 ‘94 ‘92 ‘96 ‘98 ‘00 Year Cooperberg et al, J Urol 2003

  6. Natural course of Pca • Albertsen tables JAMA ‘97 • N=767 • Clinical stage ≤ T2 • Palliative treatment • Dark grey = PCa † • Light grey = nonPCa † • White = survival

  7. There is more cancer than we can detect currently • Autopsy data (Gosselaer 2005) • Cystoprostatectomy data (Damiano R, Eur Urol 2007) Sakr 1993

  8. 2.6 2.4 5.1 2.5 3.2 1.1 1.6 1.7 Pca detection frequency in screeningERSPC first round 260.000 participants aged 50-75 in 8 EC countries

  9. Tumor volumes in 550 radical prostatectomy specimens per PSA range detected in round 1 and 2 (ERSPC Rotterdam)minimal tumours: <0.5 ml, Gleason <7 Overdiagnosis estimated to be 54 % in screening(Draisma 2003)

  10. Conclusion 1: Big wave of small cancers…big threat of overdiagnosis (and subsequent overtreatment!) Hokusai 1830

  11. Can we recognise indolent tumours upfront? (Steyerberg, Kattan, Roobol, et al. J Urol 2007) • 247 patients Pca T1-2 >> radical prostatectomy>> step section histology • 121 (48 % !) indolent disease (<0.5 ml, no Gleason 4) • Statistic analysis identifies relevant prognostic factors • Age • PSA • Prostate volume • Micturition complaints • Stage • Grade • Cancer volume in biopsies • Number of positive cancer biopsies

  12. Predicted probability of indolent cancer according to sum of scores

  13. Watchful Waiting Active Surveillance Active surveillance: strategy to deminish overtreatment of minimal cancers Active surveillance: regular monitoring, and delayed invasive treatment on signs of tumour progression Watchful Waiting Watchful Waiting Watchful Waiting Watchful Waiting

  14. PRIAS: free access www.prias-project.org • PRIAS means Prostate cancer Research International: Active Surveillance • It is a web-based tool used to include and follow-up patients considered to have indolent disease • International observational study based on experience in watchful waiting and guided by experts to optimise active surveillance • http://www.urosource.com/congress-television/berlin-2007/

  15. PRIAS inclusion: conservative approach • Criteria for inclusion in PRIAS:1. Histologically proven adenocarcinoma of the prostate2. Men should be fit for curative treatment3. PSA-level at diagnosis ≤ 10 ng/mL4. PSA density (PSA D) less than 0,25. Clinical stage T1C or T2 6. Adequate biopsy sampling (see 'biopsy protocol')7. Gleason score 3+3=68. One or 2 biopsy cores invaded with prostate cancer9. Participants must be willing to attend the follow-up visits Exclusion-criteria:1. Men who can not or do not want to be irradiated or operated2. A former therapy for prostate cancer

  16. Schedule active surveillance study Analysing biologic tumour behavior Correcting for sampling errors

  17. PSA kinetics can indicate a biopsy or treatment shift Flowchart for follow-up

  18. Unique protected individualised entry

  19. Modification of follow-up data feasible: curves

  20. Is active surveillance safe? • Natural course of disease of Gleason 6 cancer after 20 years 85-96 % • Lead time of 12 years in screening setting • D’Amico: low risk population (PSA<10, Bx Gleason <7 and T1-2): 5 year cancer specific survival after therapy of 98% • Klotz 2005: PSADT< 2 years as an indication for active therapy after active surveillance misses few progressive tumours over 8 years (1 % metas) • ERSPC: 100% tumour specific survival in 61 patients over 4 years of active surveillance (Roemeling 2006) • Delayed radical prostatectomy does not increase tumor stages (Carter 2003, Roemeling 2007)

  21. 10 year 10 year Overall and cancer specific survivalminimal (cGleason  6, PSA  10, T1c) versus relevant cancers (> Gleason 6, cT2) Overall survival Pca specific survival months months

  22. What can we offer European men?Men want to know their risks….how can we reduce overdiagnosis? • Level 1: Man age 55 – 74: do I need to screen? • Level 2: PSA known: shall I visit a urologist? • Level 3: Levels 1+2, DRE, TRUS, and prostate volume known: do I need a biopsy? • Level 4: Biopsy result known: do I need a therapy? PRIAS? • Level 5: first biopsy shows no cancer: do I need a second screen? • Level 6: in case of cancer: what is my risk to get metastases?

  23. Future: reducing overdiagnosis will reduce overtreatment.Risk calculators • We may offer risk analysis to decrease wild screening / rescreening in low-risk groups • Avoid screening of asymptomatic cancers in the elderly: only 0.09% of men aged 70-75 in ERSPC died in six years of Pca (Roobol 2007) • Avoid rescreen within 5 years in men with PSA< 1.0 (Roobol, Prostate. 2006 , Crawford, J Urol. 2006)

  24. Conclusion 2: overdiagnosis in EuropeCan men be protected? • Overtreatment of indolent tumours can be avoided with active surveillance (www.prias-project.org) • Introduction of step-wise risc-calculation will likely reduce overdiagnosis in men aware of prostate cancer (EAU-website:www.urolog.org) • Active Surveillance policies should be improved with respect to patient inclusion and monitoring by validated markers

  25. Europe as a scaffold to integrate research for prostate cancer patients Biomarker research: P-MARK, PROCABIO Patient organisations: Europa Uomo Research programs: ERSPC , EORTC Industry Health care professionals: EAU

  26. Tailored treatment (Active Surveillance) by PROstate CAncer BIOmarkers: PROCABIO year 1 year 1 years 2 years 2 - - 4 4 outcome outcome WP1: Biorepository management WP1: Biorepository management Active surveillance Active surveillance Management serum Management serum Management prospective biomaterials from active Management prospective biomaterials from active and tissue validation set and tissue validation set biorepository biorepository surveillance study surveillance study WP2: Proteomics biomarkers & WP3: Genomics biomarkers WP2: Proteomics biomarkers & WP3: Genomics biomarkers Marker Marker Marker validation for Marker validation for Clinical implementation selected markers in active Clinical implementation selected markers in active implementation in implementation in discrimination indolent discrimination indolent surveillance study surveillance study treatment policies treatment policies and progressive PCa and progressive PCa Marker format optimisation Marker format optimisation WP4: Clinical study WP4: Clinical study Evaluation Evaluation Preparatory phase Preparatory phase European multi European multi - - centre active surveillance study centre active surveillance study intermediate intermediate participating clinical participating clinical Cohort A: entry by set parameters Cohort A: entry by set parameters endpoints endpoints centres centres Cohort B: entry by risk calculator Cohort B: entry by risk calculator WP5: Public relations WP5: Public relations Guidelines on Guidelines on Informing stakeholders Informing stakeholders Informing stakeholders on progress and outcome Informing stakeholders on progress and outcome active surveillance active surveillance on active surveillance on active surveillance active surveillance study and marker implementation active surveillance study and marker implementation

  27. Detection ofindolent cancers PSAirways …risk of flying…

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