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Implementation of nomograms into clinical practice. Steven Joniau Filip Ameye. Clinical value of nomograms. Important role in the process of decision aid and patient counseling Predictive accuracy Statistical vs clinical significance
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Implementation of nomograms into clinical practice Steven Joniau Filip Ameye
Clinical value of nomograms • Important role in the process of decision aid and patient counseling • Predictive accuracy • Statistical vs clinical significance • Accuracy Increase of 12% = 120 out of 1000 patients are provided with accurate prediction • Medical, ethical, economical,… implications • Uplevelling by introduction of novel biomarkers
Why should we use nomograms? • Nomograms have been developed to accomodate stage migration • Not only take into account PSA, Gleason score, clinical stage • Also account for number of biopsies, prior biopsies, etc. • Use updated data sets • Should be validated, ideally by external validation
Predictive accuracy of existing nomograms Chun F et al. World J Urol 2007
Question: Are you? Question: Are you? Urologist Radiation oncologist Medical oncologist • Urologist • Radiation oncologist • Medical oncologist 86% 11% 3% You have 10 seconds
Question for Urologists: do you have access to robot-assisted surgery ? Question for Urologists: do you have access to robot-assisted surgery ? • Yes • No • Yes • No 37% 63% You have 10 seconds
Clinical case • 62 years old, married, sexually active • First PSA: 13.5 ng/ml. PSA years before 9 ng/ml • DRE: nodule of the right prostatic lobe T3a
Clinical case • Large hypoechoic zone in postero-basal right • 12 biopsies • Right side: 6/6 positives in 3 sextants Gleason 3+4 • Left side : 2/6 positives Gleason 4+4
Final stage is T3a N0 M0 Final stage is T3a N0 M0 Question: What are the chances this patient has extraprostatic extension ? • 25% • 50% • 75% • 100% • 25% • 50% • 75% • 100% 20% 38% 39% 3% You have 10 seconds
Partin Tables Partin tables are not appropriate for staging T3a cancers!!! NCCN, Practice Guidelines in Oncology, 2005
T3 pre-treatment table 200 pts with clinical unilateral T3a disease - RP and bilateral LN dissection Joniau S et al. Eur Urol 2007;51:388–96
Final stage is T3a N0 M0 Final stage is T3a N0 M0 Question:What are the chances this patient has lymph node involvement ? • < 10% • 10 – 20% • 20 – 50% • > 50% • < 10% • 10 – 20% • 20 – 50% • > 50% 11% 43% 43% 0% 3% You have 10 seconds
Nomogram: Kattan MSKCC Memorial Sloan Kettering Cancer Center Web Site
A small exercise… • Patient XY • PSA 6.4 • cT2a • Biopsy Gleason score 6 on biopsies
What is the risk of… • ECE? 20% 40% 60% 80% • SVI invasion? 5% 10% 15% 20% • pN+? 2% 4% 6% 8%
What is the risk of… • ECE? 20% 40% 60% 80% • SVI invasion? 5% 10% 15% 20% • pN+? 2% 4% 6% 8%
What is the risk of… • ECE? 20% 40% 60% 80% • SVI invasion? 5% 10% 15% 20% • pN+? 2% 4% 6% 8%
What is the risk of… • ECE? 20% 40% 60% 80% • SVI invasion? 5% 10% 15% 20% • pN+? 2% 4% 6% 8%
What is the risk of biochemical relapse after surgery… 25% 50% 75% 100%
What is the risk of biochemical relapse after surgery… 25% 50% 75% 100%
A small exercise… • Patient YY • PSA 8.6 • cT2c • Biopsy Gleason score 7 on biopsies
What is the risk of… • ECE? 20% 40% 60% 80% • SVI invasion? 5% 10% 15% 20% • pN+? 2% 4% 6% 8%
What is the risk of… • ECE? 20% 40% 60% 80% • SVI invasion? 5% 10% 15% 20% • pN+? 2% 4% 6% 8%
What is the risk of… • ECE? 20% 40% 60% 80% • SVI invasion? 5% 10% 15% 20% • pN+? 2% 4% 6% 8%
What is the risk of… • ECE? 20% 40% 60% 80% • SVI invasion? 5% 10% 15% 20% • pN+? 2% 4% 6% 8%
What is the risk of biochemical relapse after surgery… 25% 50% 75% 100%
What is the risk of biochemical relapse after surgery… 25% 50% 75% 100%
EAU prostate cancer guidelines • Use of nomograms is only included 3 times • Preoperative staging (Kattan nomogram, Partin tables (= look-up tables)) • Indication of extended lymph node dissection (Briganti nomogram) • Indication of nerve-sparing surgery (Partin tables)
So, clearly the use of nomograms has not yet been implemented sufficiently into routine urological practice!!!!! • The reason for this is that studies providing EBM on the advantage of using nomograms over clinical judgement are virtually ABSENT!!!
Why should nomograms be implemented into clinical practice? • Appropriate patient couseling and decision-making • Better disease prognostication • Follow-up scheduling • Selection of appropriate patients for clinical trials
Why should nomograms be implemented into guidelines? • Currently, the only method through which we can compare biochemical recurrence rates after alternative treatment modalities with brachytherapy, external beam radiotherapy, and radical prostatectomy are nomograms
What do we need in the future? • Update nomograms to contemporary situation • Head-to-head comparisons between nomograms to select the best-suited model in selected fields of PCa outcomes • We need nomograms that provide accurate predictions of hard clinical endpoints (clinical failure, death from the disease) • We need nomograms that accurately predict death from comorbid disease in men with localized disease selected for radical treatment • We need nomograms that predict treatment-related toxicity
What do we need in the future? • Ultimately, improved imaging studies and high-throughput genomics may replace the use of nomograms, as they will provide an real patient-specific staging and prognostication, and patient-tailored treatment decisions • In the meantime, nomograms are the best possible alternative and should be actively implemented in urological practice