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344 PREOPERATIVE STATIN THERAPY (ST) IS NOT ASSOCIATED WITH PROLONGED BIOCHEMICAL FREE SURVIVAL (BCFS) AFTER RADICAL PROSTATECTOMY (RP) A META-ANALYSIS OF FIVE RETROSPECTIVE STUDIES
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THE JOURNAL OF UROLOGY姞
does not have a significant effect. Further high quality prospective studies of the topic are still needed to clarify these associations.
Vol. 187, No. 4S, Supplement, Sunday, May 20, 2012
Hazard Ratios (HR) and 95% C.I. for Prostate Cancer Recurrence by statin use for all patients as well as patients stratified by risk. # of # of All Patients BCR Patients HR (95% C.I.) p-value Non-Statin Users 111 1,009 1.00 Statin Uers
55
437
Non-Statin Users
31
586
Statin Users
10
216
1.19 (0.85-1.66)
0.32
Low Risk Patients 1.00 0.99 (0.48-2.04)
0.98
Intermediate/High Risk Patients Non-Statin Users
80
423
Statin Users
45
221
1.00 1.20 (0.82-1.75)
0.35
HR, 95% C.I. and p-values were estimated from Cox models adjusted for age, post-op Gleason score, path tumor stage and pre-operative PSA.
Source of Funding: None
344 PREOPERATIVE STATIN THERAPY (ST) IS NOT ASSOCIATED WITH PROLONGED BIOCHEMICAL FREE SURVIVAL (BCFS) AFTER RADICAL PROSTATECTOMY (RP): A META-ANALYSIS OF FIVE RETROSPECTIVE STUDIES Alon Mass*, New York, NY; Ilir Agalliu, Bronx, NY; Juliana Laze, Herbert Lepor, New York, NY INTRODUCTION AND OBJECTIVES: The effect of statin therapy on prostate cancer development, screening, and biochemical progression has recently been investigated with inconsistent conclusions. Our objectives were to investigate the influence of ST on biochemical recurrence in a well-characterized cohort of men following RP and to perform a meta-analysis using data from our institution and 4 other peer-reviewed studies. METHODS: 1,446 men undergoing open RP by the same surgeon met criteria to participate in our study. Demographic, relevant co-morbidities and disease specific characteristics were compared between statin and non-statin users. A Kaplan-Meier survival analysis was performed by examining the primary end point of biochemical recurrence, which was defined as a PSA level of ⬎0.2 ng/mL with a confirmatory reading or initiation of salvage therapy. The meta-analysis was performed by searching the following terms in PubMed: “Statin” ⫹ “Biochemical Recurrence” ⫹ “Prostate Cancer” ⫹ “Prostatectomy”. The meta-analysis was performed using data from four published studies and the cohort described above, using the random-effects model in STATA, which generated a forest plot. Additionally, heterogeneity and publication bias were examined. RESULTS: 30.2% of men in our cohort were on ST at the time of RP. Statin users were older (p ⬍0.05), and more likely to have diabetes (p ⬍0.01), but were similar in terms of race, BMI, pre-op PSA level, pre-op Gleason score, and clinical/pathological staging. BCFS was not associated with preoperative statin use, even when stratified according to D’Amico low-risk and intermediate/high-risk (see table). Of the 5 studies, ours had the fewest number of censored subjects and the longest follow-up time. The meta-analysis showed no association between ST and BCFS; there was some evidence for heterogeneity among studies (see forest plot). CONCLUSIONS: The preponderance of evidence indicates that ST does not impact BCFS. While all of the published studies are limited by their retrospective design, we feel that the yield of a randomized double blind study evaluating ST in men who are at high risk for prostate cancer progression following RP is too low to justify its expense.
Source of Funding: None
345 CHARACTERISTICS OF PATIENTS WITH HIGH GRADE PROSTATE CANCER WHO UNDERWENT RADICAL PROSTATECTOMY IN THE SEER-MEDICARE DATABASE. Sean McAdams*, Oluwakayode Adejero, Sean Elliott, Joel Slaton, Minneapolis, MN INTRODUCTION AND OBJECTIVES: Initial results from the PIVOT trial reported last year suggest the patients benefiting most from radical prostatectomy (RP) are those with high grade prostate cancer when performed in a multi-modality setting. A series of single institutional studies have confirmed good outcomes in carefully selected patients with high risk disease who undergo radical prostatectomy alone. We interrogated the SEER-Medicare database in order to characterize which high grade patients are being treated aggressively with use of radical prostatectomy. METHODS: We identified 9,346 patients diagnosed with nonmetastatic high grade (Gleason sum 8-10) adenocarcinoma of the prostate between 2004 and 2007. Multivariate Cox proportional hazards analysis was used to determine parameters that significantly predicted patients who underwent RP. RESULTS: 58% of all high grade patients were Gleason sum 8, and 37% and 5% were Gleason sum 9 and 10 respectively. Median follow-up was 19 months. 1,170 patients (12.5%) underwent initial treatment with RP, and 543 (5.5%) had RP as the only treatment during the study duration. In a multivariate model, PSA less than 20ng/ml (PSA ⬍10ng/ml OR 3.6, p⬍.0001; PSA 10-20ng/ml OR 1.8, p⬍.0001), age 66-70 years (vs. ⬎70 years OR 6.5, p⬍.0001), lower clinical tumor stage (T1 vs. T4 OR 3.4, p⫽.006; T2 vs. T4 OR 2.5, p⫽.04), and lower Charlson comorbidity score were significant predictors of patients more likely to undergo RP for treatment of prostate cancer. Patients of black race were less likely to have an RP (OR 0.6, p⬍.01). CONCLUSIONS: Radical prostatectomy is rare in men with high grade prostate cancer. Its use was significantly predicted by lower PSA, age, clinical tumor stage, Charlson score, and race. Source of Funding: None
THE JOURNAL OF UROLOGY姞
does not have a significant effect. Further high quality prospective studies of the topic are still needed to clarify these associations.
Vol. 187, No. 4S, Supplement, Sunday, May 20, 2012
Hazard Ratios (HR) and 95% C.I. for Prostate Cancer Recurrence by statin use for all patients as well as patients stratified by risk. # of # of All Patients BCR Patients HR (95% C.I.) p-value Non-Statin Users 111 1,009 1.00 Statin Uers
55
437
Non-Statin Users
31
586
Statin Users
10
216
1.19 (0.85-1.66)
0.32
Low Risk Patients 1.00 0.99 (0.48-2.04)
0.98
Intermediate/High Risk Patients Non-Statin Users
80
423
Statin Users
45
221
1.00 1.20 (0.82-1.75)
0.35
HR, 95% C.I. and p-values were estimated from Cox models adjusted for age, post-op Gleason score, path tumor stage and pre-operative PSA.
Source of Funding: None
344 PREOPERATIVE STATIN THERAPY (ST) IS NOT ASSOCIATED WITH PROLONGED BIOCHEMICAL FREE SURVIVAL (BCFS) AFTER RADICAL PROSTATECTOMY (RP): A META-ANALYSIS OF FIVE RETROSPECTIVE STUDIES Alon Mass*, New York, NY; Ilir Agalliu, Bronx, NY; Juliana Laze, Herbert Lepor, New York, NY INTRODUCTION AND OBJECTIVES: The effect of statin therapy on prostate cancer development, screening, and biochemical progression has recently been investigated with inconsistent conclusions. Our objectives were to investigate the influence of ST on biochemical recurrence in a well-characterized cohort of men following RP and to perform a meta-analysis using data from our institution and 4 other peer-reviewed studies. METHODS: 1,446 men undergoing open RP by the same surgeon met criteria to participate in our study. Demographic, relevant co-morbidities and disease specific characteristics were compared between statin and non-statin users. A Kaplan-Meier survival analysis was performed by examining the primary end point of biochemical recurrence, which was defined as a PSA level of ⬎0.2 ng/mL with a confirmatory reading or initiation of salvage therapy. The meta-analysis was performed by searching the following terms in PubMed: “Statin” ⫹ “Biochemical Recurrence” ⫹ “Prostate Cancer” ⫹ “Prostatectomy”. The meta-analysis was performed using data from four published studies and the cohort described above, using the random-effects model in STATA, which generated a forest plot. Additionally, heterogeneity and publication bias were examined. RESULTS: 30.2% of men in our cohort were on ST at the time of RP. Statin users were older (p ⬍0.05), and more likely to have diabetes (p ⬍0.01), but were similar in terms of race, BMI, pre-op PSA level, pre-op Gleason score, and clinical/pathological staging. BCFS was not associated with preoperative statin use, even when stratified according to D’Amico low-risk and intermediate/high-risk (see table). Of the 5 studies, ours had the fewest number of censored subjects and the longest follow-up time. The meta-analysis showed no association between ST and BCFS; there was some evidence for heterogeneity among studies (see forest plot). CONCLUSIONS: The preponderance of evidence indicates that ST does not impact BCFS. While all of the published studies are limited by their retrospective design, we feel that the yield of a randomized double blind study evaluating ST in men who are at high risk for prostate cancer progression following RP is too low to justify its expense.
Source of Funding: None
345 CHARACTERISTICS OF PATIENTS WITH HIGH GRADE PROSTATE CANCER WHO UNDERWENT RADICAL PROSTATECTOMY IN THE SEER-MEDICARE DATABASE. Sean McAdams*, Oluwakayode Adejero, Sean Elliott, Joel Slaton, Minneapolis, MN INTRODUCTION AND OBJECTIVES: Initial results from the PIVOT trial reported last year suggest the patients benefiting most from radical prostatectomy (RP) are those with high grade prostate cancer when performed in a multi-modality setting. A series of single institutional studies have confirmed good outcomes in carefully selected patients with high risk disease who undergo radical prostatectomy alone. We interrogated the SEER-Medicare database in order to characterize which high grade patients are being treated aggressively with use of radical prostatectomy. METHODS: We identified 9,346 patients diagnosed with nonmetastatic high grade (Gleason sum 8-10) adenocarcinoma of the prostate between 2004 and 2007. Multivariate Cox proportional hazards analysis was used to determine parameters that significantly predicted patients who underwent RP. RESULTS: 58% of all high grade patients were Gleason sum 8, and 37% and 5% were Gleason sum 9 and 10 respectively. Median follow-up was 19 months. 1,170 patients (12.5%) underwent initial treatment with RP, and 543 (5.5%) had RP as the only treatment during the study duration. In a multivariate model, PSA less than 20ng/ml (PSA ⬍10ng/ml OR 3.6, p⬍.0001; PSA 10-20ng/ml OR 1.8, p⬍.0001), age 66-70 years (vs. ⬎70 years OR 6.5, p⬍.0001), lower clinical tumor stage (T1 vs. T4 OR 3.4, p⫽.006; T2 vs. T4 OR 2.5, p⫽.04), and lower Charlson comorbidity score were significant predictors of patients more likely to undergo RP for treatment of prostate cancer. Patients of black race were less likely to have an RP (OR 0.6, p⬍.01). CONCLUSIONS: Radical prostatectomy is rare in men with high grade prostate cancer. Its use was significantly predicted by lower PSA, age, clinical tumor stage, Charlson score, and race. Source of Funding: None