550 CRITICAL ASSESSMENT OF CRITERIA USED TO IDENTIFY MEN ELIGIBLE FOR ACTIVE SURVEILLANCE OF...
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Table 1: Predictors of re-classification at B2 Grade re-classification (GS7) Volume re-classification (PCore 3 and/or 50% single core involved) external biopsy OR 2.86 (1.37-5.88), p0.001 external biopsy OR 2.08 (1.09-4.0), p0.03 PSA density OR 2.91 (1.66-5.08), p0.001 PSA density OR 2.15 (1.33-3.47), p0.002 age OR 1.09 (1.04-1.15), p0.001 maximum % core involvement OR 1.05 (1.01-1.09), for every unit increase, p0.009 * Number of cores at baseline biopsy was not predictive of reclassification. Source of Funding: None 550 CRITICAL ASSESSMENT OF CRITERIA USED TO IDENTIFY MEN ELIGIBLE FOR ACTIVE SURVEILLANCE OF LOW-RISK PROSTATE CANCER Adam Reese*, Patricia Landis, Misop Han, Jonathan Epstein, Ballentine Carter, Baltimore, MD INTRODUCTION AND OBJECTIVES: Active surveillance (AS) is an accepted management modality for men with low-risk prostate cancer. At Johns Hopkins, men eligible for AS are those who are very low-risk as defined by their clinical stage (cT1), PSA density (0.15), biopsy Gleason score (Gleason 6), percent of positive biopsy cores (2), and maximum core positivity (50%). We hypothesized that these eligibility criteria may be excessively strict, and thus unnecessar- ily preclude many men from AS. METHODS: We identified men in the Johns Hopkins radical prostatectomy (RP) database who underwent RP between 1995 and 2012. We analyzed pathological outcomes after RP in men who met all AS criteria, and compared these outcomes to men who met all but one AS criterion. The following pathological outcomes were analyzed: ex- tracapsular tumor extension, surgical margin positivity, seminal vesicle invasion, lack of organ confinement, and pathological Gleason score 6. Differences in rates of pathological outcomes were compared among groups using the chi-squared test. RESULTS: In our RP database, 8282 patients had complete data on AS eligibility criteria. Of these, 1891 (22.8%) met all AS criteria. An additional 1234 men met all but one AS criteria; 253 (20.5%) had cT2a tumors, 153 (12.4%) had PSA density between 0.15 and 0.175, 323 (26.2%) had a biopsy Gleason score of 7, 360 (29.2%) had 3 positive biopsy cores, and 145 (11.7%) had 50-70% maximum core positivity. The table shows pathological outcomes after RP compared among these groups of men. CONCLUSIONS: Men who met all AS criteria but did not meet the PSA density or biopsy Gleason score criteria had higher rates of adverse pathology when compared to those that met all AS criteria for nearly all outcomes studied. In comparison, men with clinical T2a disease or 3 positive biopsy cores had comparable pathology to men who met all AS criteria. These favorable pathological outcomes argue that men with clinical T2a tumors or 3 positive biopsy cores should not be excluded from AS programs. Men Meeting All ASv Criteria Met All Criteria but with cT2a Tumors Met All Criteria but with PSAD 0.15-0.175 Met All Criteria but with Biopsy Gleason 7 Met All Criteria but with 3 Positive Biopsy Cores Met All Criteria but with 50-70% Core Involved Extracapsular Extension N (%) 78 (4.1%) 13 (5.2%) 17 (11.2%) 28 (8.7%) 21 (5.8%) 8 (5.5%) p-value Reference 0.45 0.01 0.01 0.15 0.43 Positive Surgical Margins N (%) 126 (6.7%) 17 (6.7%) 22 (14.6%) 25 (7.7%) 31 (8.6%) 7 (4.9%) p-value Reference 0.98 0.01 0.48 0.18 0.40 Seminal Vesicle Invasion N (%) 10 (0.5%) 2 (0.8%) 3 (2.0%) 6 (1.9%) 4 (1.1%) 1 (0.7%) p-value Reference 0.6 0.03 0.01 0.20 0.80 Men Meeting All ASv Criteria Met All Criteria but with cT2a Tumors Met All Criteria but with PSAD 0.15-0.175 Met All Criteria but with Biopsy Gleason 7 Met All Criteria but with 3 Positive Biopsy Cores Met All Criteria but with 50-70% Core Involved Non-Organ Confined Disease N (%) 182 (9.7) 30 (11.9) 30 (19.7%) 64 (19.8%) 43 (11.9%) 21 (14.5%) p-value Reference 0.26 0.01 0.01 0.18 0.06 Pathological Gleason 7 N (%) 323 (17.1%) 44 (17.5%) 41 (26.8%) 221 (69.1%) 68 (18.9%) 33 (22.8%) p-value Reference 0.88 0.01 0.01 0.41 0.08 Non-Organ Confined or Pathological Gleason 7 N (%) 420 (22.3%) 61 (24.3%) 57 (37.5%) 233 (72.8%) 92 (25.6%) 45 (31.0%) p-value Reference 0.47 0.01 0.01 0.17 0.02 Source of Funding: None 551 D’AMICO RISK STRATIFICATION OUTPERFORMS PUBLISHED ACTIVE SURVEILLANCE SELECTION CRITERIA FROM THE USA AS A WAY TO IDENTIFY PATIENTS WITH INDOLENT PROSTATE CANCER IN A RELATIVELY UNSCREENED UK POPULATION Greg Shaw*, Ben Thomas, Dawson Sarah, Sarah Vowler, Vincent Gnanapragasam, Nimish Shah, David Neal, Cambridge, United Kingdom INTRODUCTION AND OBJECTIVES: Eligibility criteria for ac- tive surveillance (AS) are based on analysis of data from screened populations. We aim to evaluate the suitability of 6 different methods to identify indolent disease in a relatively unscreened UK cohort. METHODS: 848 patients (445 patients with Gleason 33 pros- tate cancer on biopsy) underwent robotic radical prostatectomy be- tween July 2007 and October 2011. F/U data was available for 841 of these. 5 published criteria designed to identify insignificant disease and therefore candidates for AS were identified and the ability to predict insignificant disease and low grade organ confined disease compared with D’Amico risk stratification (Gleason score 6, no grade 4/5, PSA10, cT1/T2a) using univariable Cox regression. AIC (Akaike information criterion) and BIC (Bayesian information criterion) were used to compare the six non-nested models. RESULTS: AIC and BIC are two methods for comparing rela- tive goodness of fit. Given a set of models, the one with the lowest value for AIC and/or BIC is preferred (table 1). Area under the curve (AUC) of the receiver operator characteristic curve is shown in table 2. CONCLUSIONS: D’Amico outperforms the other methods for predicting insignificant (modified definition) or Gleason 6 organ con- fined disease according to AIC, BIC and AUC, however, all 6 methods have a poor PPV. Our dataset included only 2 classically defined insignificant tumours of less than 0.5cm3 rendering further analysis impossible and this reflects differences between our UK cohort and screened USA and European cohorts in which these criteria were developed and validated. These patients were all diagnosed by TRUS biopsy. Low AUR values underline the need for a better biomarker of indolent prostate cancer, and justify further investigation with confirma- tory transrectal biopsy, transperineal biopsy or MRI prior to embarking on an active surveillance program. Approach AIC BIC Tosoian 2011 817.04 821.78 Adamy 2011 812.88 817.61 Van den Bergh 2009 816.37 821.11 Whitson 2011 810.51 815.25 Soloway 2010 817.26 821.99 D’Amico 1998 805.58 810.32 e226 THE JOURNAL OF UROLOGY Vol. 189, No. 4S, Supplement, Sunday, May 5, 2013
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Transcript of 550 CRITICAL ASSESSMENT OF CRITERIA USED TO IDENTIFY MEN ELIGIBLE FOR ACTIVE SURVEILLANCE OF...
Table 1: Predictors of re-classification at B2
Gradere-classification (GS��7)
Volumere-classification
(PCore �3and/or �50%single coreinvolved)
externalbiopsy
OR 2.86 (1.37-5.88),p�0.001
externalbiopsy
OR 2.08 (1.09-4.0),p�0.03
PSAdensity
OR 2.91 (1.66-5.08),p�0.001 PSA density
OR 2.15 (1.33-3.47),p�0.002
ageOR 1.09 (1.04-1.15),p�0.001
maximum% coreinvolvement
OR 1.05 (1.01-1.09),for every unitincrease,p�0.009
* Number of cores at baseline biopsy was not predictive of reclassification.
Source of Funding: None
550CRITICAL ASSESSMENT OF CRITERIA USED TO IDENTIFY MENELIGIBLE FOR ACTIVE SURVEILLANCE OF LOW-RISKPROSTATE CANCER
Adam Reese*, Patricia Landis, Misop Han, Jonathan Epstein,Ballentine Carter, Baltimore, MD
INTRODUCTION AND OBJECTIVES: Active surveillance (AS)is an accepted management modality for men with low-risk prostatecancer. At Johns Hopkins, men eligible for AS are those who are verylow-risk as defined by their clinical stage (cT1), PSA density (�0.15),biopsy Gleason score (Gleason 6), percent of positive biopsy cores(�2), and maximum core positivity (�50%). We hypothesized thatthese eligibility criteria may be excessively strict, and thus unnecessar-ily preclude many men from AS.
METHODS: We identified men in the Johns Hopkins radicalprostatectomy (RP) database who underwent RP between 1995 and2012. We analyzed pathological outcomes after RP in men who met allAS criteria, and compared these outcomes to men who met all but oneAS criterion. The following pathological outcomes were analyzed: ex-tracapsular tumor extension, surgical margin positivity, seminal vesicleinvasion, lack of organ confinement, and pathological Gleason score�6. Differences in rates of pathological outcomes were comparedamong groups using the chi-squared test.
RESULTS: In our RP database, 8282 patients had completedata on AS eligibility criteria. Of these, 1891 (22.8%) met all AS criteria.An additional 1234 men met all but one AS criteria; 253 (20.5%) hadcT2a tumors, 153 (12.4%) had PSA density between 0.15 and 0.175,323 (26.2%) had a biopsy Gleason score of 7, 360 (29.2%) had 3positive biopsy cores, and 145 (11.7%) had 50-70% maximum corepositivity. The table shows pathological outcomes after RP comparedamong these groups of men.
CONCLUSIONS: Men who met all AS criteria but did not meetthe PSA density or biopsy Gleason score criteria had higher rates ofadverse pathology when compared to those that met all AS criteria fornearly all outcomes studied. In comparison, men with clinical T2adisease or 3 positive biopsy cores had comparable pathology to menwho met all AS criteria. These favorable pathological outcomes arguethat men with clinical T2a tumors or 3 positive biopsy cores should notbe excluded from AS programs.
MenMeetingAll ASvCriteria
Met AllCriteriabut with
cT2aTumors
Met AllCriteriabut withPSAD
0.15-0.175
Met AllCriteriabut withBiopsy
Gleason 7
Met AllCriteriabut with
3 PositiveBiopsyCores
Met AllCriteria but
with50-70%
CoreInvolved
ExtracapsularExtension
N (%) 78 (4.1%) 13 (5.2%) 17 (11.2%) 28 (8.7%) 21 (5.8%) 8 (5.5%)
p-value Reference 0.45 � 0.01 � 0.01 0.15 0.43
PositiveSurgicalMargins
N (%) 126 (6.7%) 17 (6.7%) 22 (14.6%) 25 (7.7%) 31 (8.6%) 7 (4.9%)
p-value Reference 0.98 � 0.01 0.48 0.18 0.40
SeminalVesicleInvasion
N (%) 10 (0.5%) 2 (0.8%) 3 (2.0%) 6 (1.9%) 4 (1.1%) 1 (0.7%)
p-value Reference 0.6 0.03 � 0.01 0.20 0.80
MenMeetingAll ASvCriteria
Met AllCriteriabut with
cT2aTumors
Met AllCriteriabut withPSAD
0.15-0.175
Met AllCriteriabut withBiopsy
Gleason 7
Met AllCriteriabut with
3 PositiveBiopsyCores
Met AllCriteria but
with50-70%
CoreInvolved
Non-OrganConfinedDisease
N (%) 182 (9.7) 30 (11.9) 30 (19.7%) 64 (19.8%) 43 (11.9%) 21 (14.5%)
p-value Reference 0.26 � 0.01 � 0.01 0.18 0.06
PathologicalGleason 7
N (%) 323 (17.1%) 44 (17.5%) 41 (26.8%) 221 (69.1%) 68 (18.9%) 33 (22.8%)
p-value Reference 0.88 � 0.01 � 0.01 0.41 0.08
Non-OrganConfinedorPathologicalGleason 7
N (%) 420 (22.3%) 61 (24.3%) 57 (37.5%) 233 (72.8%) 92 (25.6%) 45 (31.0%)
p-value Reference 0.47 � 0.01 � 0.01 0.17 0.02
Source of Funding: None
551D’AMICO RISK STRATIFICATION OUTPERFORMS PUBLISHEDACTIVE SURVEILLANCE SELECTION CRITERIA FROM THE USAAS A WAY TO IDENTIFY PATIENTS WITH INDOLENT PROSTATECANCER IN A RELATIVELY UNSCREENED UK POPULATION
Greg Shaw*, Ben Thomas, Dawson Sarah, Sarah Vowler,Vincent Gnanapragasam, Nimish Shah, David Neal, Cambridge,United Kingdom
INTRODUCTION AND OBJECTIVES: Eligibility criteria for ac-tive surveillance (AS) are based on analysis of data from screenedpopulations. We aim to evaluate the suitability of 6 different methods toidentify indolent disease in a relatively unscreened UK cohort.
METHODS: 848 patients (445 patients with Gleason 3�3 pros-tate cancer on biopsy) underwent robotic radical prostatectomy be-tween July 2007 and October 2011. F/U data was available for 841 ofthese. 5 published criteria designed to identify insignificant disease andtherefore candidates for AS were identified and the ability to predictinsignificant disease and low grade organ confined disease comparedwith D’Amico risk stratification (Gleason score 6, no grade 4/5,PSA��10, cT1/T2a) using univariable Cox regression. AIC (Akaikeinformation criterion) and BIC (Bayesian information criterion) wereused to compare the six non-nested models.
RESULTS: AIC and BIC are two methods for comparing rela-tive goodness of fit. Given a set of models, the one with the lowestvalue for AIC and/or BIC is preferred (table 1). Area under the curve(AUC) of the receiver operator characteristic curve is shown in table 2.
CONCLUSIONS: D’Amico outperforms the other methods forpredicting insignificant (modified definition) or Gleason 6 organ con-fined disease according to AIC, BIC and AUC, however, all 6 methodshave a poor PPV. Our dataset included only 2 classically definedinsignificant tumours of less than 0.5cm3 rendering further analysisimpossible and this reflects differences between our UK cohort andscreened USA and European cohorts in which these criteria weredeveloped and validated. These patients were all diagnosed by TRUSbiopsy. Low AUR values underline the need for a better biomarker ofindolent prostate cancer, and justify further investigation with confirma-tory transrectal biopsy, transperineal biopsy or MRI prior to embarkingon an active surveillance program.
Approach AIC BICTosoian 2011 817.04 821.78
Adamy 2011 812.88 817.61
Van den Bergh 2009 816.37 821.11
Whitson 2011 810.51 815.25
Soloway 2010 817.26 821.99
D’Amico 1998 805.58 810.32
e226 THE JOURNAL OF UROLOGY� Vol. 189, No. 4S, Supplement, Sunday, May 5, 2013
