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PD30-09 THE EFFECT OF ANDROGEN DEPRIVATION THERAPY FOR LOCALIZED PROSTATE CANCER ON CARDIOVASCULAR MORBIDITY ACCORDING TO LIFE EXPECTANCY
THE JOURNAL OF UROLOGYâ
Vol. 193, No. 4S, Supplement, Sunday, May 17, 2015
PD30-07 ADHERENCE TO EUROPEAN ASSOCIATION OF UROLOGY GUIDELINE RECOMMENDATION FOR PELVIC LYMPH NODE DISSECTION IN AN EUROPEAN HIGH-VOLUME CENTER Sami-Ramzi Leyh-Bannurah*, Jonas Schiffman, Alexander Haese, Georg Salomon, Thomas Steuber, Thorsten Schlomm, Burkhard Beyer, €us, Uwe Michl, Hans Heinzer, Hartwig Huland, Markus Graefen, Lars Buda Hamburg, Germany; Pierre Karakiewicz, Montreal, Canada INTRODUCTION AND OBJECTIVES: Contemporary adherence to European Association of Urology (EAU) guideline recommendation for pelvic lymph node dissection (PLND) at either open (ORP) or robot-assisted radical prostatectomy (RARP) in an European high-volume center is unknown. To assess guideline recommended and observed PLND rates at ORP or RARP in a high-volume center cohort. METHODS: We relied on a large European institutional database and focused on localized prostate cancer (PCa) patients, who were treated with either ORP or RARP, between 2010 and 2013. Categorical and multivariable logistic regression analyses targeted two endpoints: 1) probability of guideline recommended PLND and 2) probability of no PLND, when not recommended by EAU guidelines. RESULTS: Within 7,868 PCa patients, adherence to EAU PLND guideline recommendation was 97.1% at ORP and 96.8% at RARP. When PLND was not recommended, it was more frequently performed at RARP (71.6%) than at ORP (66.2%). At recommended PLND, 21.1% of ORP patients harbored lymph node invasion (LNI) (number needed to treat (NNT): 4.7) vs. 9.9% RARP (NNT: 10.1). At not recommended PLND, 2.9% of ORP patients harbored LNI (NNT: 34.5) vs. 1.4% in RARP (NNT: 71.4). CONCLUSIONS: Adherence to EAU guideline recommended PLND is high at this high-volume center. Neither ORP nor RARP represent a barrier for PLND, when recommended. However, a high number of patients underwent PLND despite absence of guideline recommendation. Possible staging advantages and PLND related complications needs to be individually considered, especially, when LNI risk is low. Source of Funding: none
PD30-08 CANCER-CONTROL OUTCOMES IN PATIENTS WITH CLINICALLY HIGH-RISK PROSTATE CANCER (PCA) TREATED WITH ROBOTICASSISTED LAPAROSCOPIC RADICAL PROSTATECTOMY (RALP): A MULTI-INSTITUTIONAL DATABASE ANALYSIS Firas Abdollah*, Akshay Sood, Jesse Sammon, Dane Klett, Daniel Pucheril, Detroit, MI; Burkhard Beyer, Hamburg, Germany; Nicola Fossati, Giorgio Gandaglia, Milan, Italy; Craig Rogers, Hans Stricker, Wooju Jeong, James Peabody, Detroit, MI; Alexander Haese, Hamburg, Germany; Francesco Montorsi, Milan, Italy; Markus Graefen, Hamburg, Germany; Alberto Briganti, Milan, Italy; Mani Menon, Detroit, MI INTRODUCTION AND OBJECTIVES: Given the relative novelty of RALP, many surgeons avoid using this procedure in patients presenting with clinically high-risk disease. This has contributed to the lack of literature addressing cancer control outcomes in these individuals after RALP. Therefore, we set to evaluate biochemical recurrence (BCR)-, and clinical recurrence (CR)-free survival rates in D’Amico clinically high-risk PCa patients treated with RALP and we set to further stratify these patients based on their risk of BCR after RALP. METHODS: We evaluated 1100 patients who underwent RALP adjuvant treatment, and pelvic node dissection, between 2002-2013 at 3 tertiary care centers. All patients had D’Amico clinically high-risk PCa. Regression tree analysis stratified patients into risk-groups based on tumor characteristics and corresponding BCR rate (defined as PSA value 0.2 ng/ml on two consecutive occasions). Area-underethe-curve was used to estimate the accuracy of the novel stratification model. KaplanMeier curves were used to estimate BCR-/CR-free survival rates in the entire cohort, and after stratification according to novel risk-groups. RESULTS: Mean age and PSA at surgery were 62.2 yrs (median: 63) and 11.3 ng/ml (median: 6.5), respectively. Biopsy GS was
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8 in 57.7%, and clinical stage was T2c in 39.8%. Overall, 4.8% and 1.1% received adjuvant radiotherapy and adjuvant hormonal therapy, respectively. Mean (median) follow-up time was 53.3 (48.5) months. At 7-year the BCR-, and CR-free survival rates were respectively 56.2%, and 91.1%. Regression tree stratified patients into 5 novel risk-groups: 1) very low risk (Gleason score 6); 2) low risk (PSA 10 ng/ml, and GS¼7); 3) intermediate risk (PSA 10 ng/ml, and GS8); 4) high-risk (PSA >10 ng/ml, and GS¼7); 5) very high risk (PSA 10 ng/ml, and GS8). In these risk groups, 7-year BCR-free survival rate was respectively 85.5, 73.1, 49.0, 42.2, and 26.2% (p<0.001). Likewise, 7year CR-free survival rate was respectively 98.6, 96.0, 89.9, 88.1, and 83.2%. The accuracy of this model was 73% for BCR endpoint, and 70% for CR endpoint. CONCLUSIONS: Long-term, most patients with D’Amico clinically high-risk disease remain BCR/CR-free after RALP even without adjuvant treatment. However, men with D’Amico high-risk PCa do not share the same prognosis. Our novel tool allows accurate stratification of these patients based on routinely available pre-operative data, and it may be of great use in the pre-op counseling of patients. Source of Funding: None
PD30-09 THE EFFECT OF ANDROGEN DEPRIVATION THERAPY FOR LOCALIZED PROSTATE CANCER ON CARDIOVASCULAR MORBIDITY ACCORDING TO LIFE EXPECTANCY Marianne Schmid*, Hamburg, Germany; Jesse Sammon, Detroit, MI; Gally Reznor, Boston, MA; Victor Kapoor, Detroit, MI; Jaqueline Speed, Boston, MA; Firas Abdollah, Akshay Sood, Detroit, MI; Felix Chun, Hamburg, Germany; Adam Kibel, Boston, MA; Mani Menon, Detroit, MI; Margit Fisch, Hamburg, Germany; Maxine Sun, Montreal, Canada; Quoc-Dien Trinh, Boston, MA INTRODUCTION AND OBJECTIVES: Prior studies indicate increased risk of cardiac disease in patients with non-metastatic prostate cancer (PCa) undergoing androgen deprivation therapy (ADT). We investigate the dose-dependent effect of ADT on cardiac morbidity in PCa patients stratified according to life expectancy (LE). METHODS: 62,215 men diagnosed with localized PCa between 1991 and 2007 were identified within SEER registry areas and stratified according to LE (<5, 5-10, >10 years). We compared those who did not receive ADT to those who underwent ADT within 2 years of PCa diagnosis, calculated as monthly equivalent doses (1-7, 7-11, >11 doses), or orchiectomy. Adjusted Cox hazard models assessed the risk of coronary heart disease (CHD), acute myocardial infarction (AMI), sudden cardiac death (SCD), and related interventions. RESULTS: Patients undergoing ADT more frequently experienced any cardiovascular event compared to men who did not receive ADT (40.9 vs. 37.7%, p<0.001; Table 1). The hazard ratio (HR) for experiencing a cardiovascular event increased with the patients’ LE and/or the doses of ADT. Specifically, men with a LE >10 years receiving >11 doses of ADT were at greatest hazard for CHD (HR: 1.32, 95% CI: 1.25-1.39, p<0.001), AMI (HR: 1.24, 95% CI: 1.12-1.37, p<0.001), SCD (HR: 1.42, 95% CI: 1.23-1.63, p<0.001) and intervention HR: 1.13, 95% CI: 1.05-1.23, p<0.001). CONCLUSIONS: For PCa patients with localized disease and a decent LE, cumulative exposure to ADT with GnRH agonists is associated with increased risk of cardiac morbidity or mortality. Clinicians should carefully weigh the risks and benefits of ADT in patients with a prolonged LE.
Source of Funding: none
Vol. 193, No. 4S, Supplement, Sunday, May 17, 2015
PD30-07 ADHERENCE TO EUROPEAN ASSOCIATION OF UROLOGY GUIDELINE RECOMMENDATION FOR PELVIC LYMPH NODE DISSECTION IN AN EUROPEAN HIGH-VOLUME CENTER Sami-Ramzi Leyh-Bannurah*, Jonas Schiffman, Alexander Haese, Georg Salomon, Thomas Steuber, Thorsten Schlomm, Burkhard Beyer, €us, Uwe Michl, Hans Heinzer, Hartwig Huland, Markus Graefen, Lars Buda Hamburg, Germany; Pierre Karakiewicz, Montreal, Canada INTRODUCTION AND OBJECTIVES: Contemporary adherence to European Association of Urology (EAU) guideline recommendation for pelvic lymph node dissection (PLND) at either open (ORP) or robot-assisted radical prostatectomy (RARP) in an European high-volume center is unknown. To assess guideline recommended and observed PLND rates at ORP or RARP in a high-volume center cohort. METHODS: We relied on a large European institutional database and focused on localized prostate cancer (PCa) patients, who were treated with either ORP or RARP, between 2010 and 2013. Categorical and multivariable logistic regression analyses targeted two endpoints: 1) probability of guideline recommended PLND and 2) probability of no PLND, when not recommended by EAU guidelines. RESULTS: Within 7,868 PCa patients, adherence to EAU PLND guideline recommendation was 97.1% at ORP and 96.8% at RARP. When PLND was not recommended, it was more frequently performed at RARP (71.6%) than at ORP (66.2%). At recommended PLND, 21.1% of ORP patients harbored lymph node invasion (LNI) (number needed to treat (NNT): 4.7) vs. 9.9% RARP (NNT: 10.1). At not recommended PLND, 2.9% of ORP patients harbored LNI (NNT: 34.5) vs. 1.4% in RARP (NNT: 71.4). CONCLUSIONS: Adherence to EAU guideline recommended PLND is high at this high-volume center. Neither ORP nor RARP represent a barrier for PLND, when recommended. However, a high number of patients underwent PLND despite absence of guideline recommendation. Possible staging advantages and PLND related complications needs to be individually considered, especially, when LNI risk is low. Source of Funding: none
PD30-08 CANCER-CONTROL OUTCOMES IN PATIENTS WITH CLINICALLY HIGH-RISK PROSTATE CANCER (PCA) TREATED WITH ROBOTICASSISTED LAPAROSCOPIC RADICAL PROSTATECTOMY (RALP): A MULTI-INSTITUTIONAL DATABASE ANALYSIS Firas Abdollah*, Akshay Sood, Jesse Sammon, Dane Klett, Daniel Pucheril, Detroit, MI; Burkhard Beyer, Hamburg, Germany; Nicola Fossati, Giorgio Gandaglia, Milan, Italy; Craig Rogers, Hans Stricker, Wooju Jeong, James Peabody, Detroit, MI; Alexander Haese, Hamburg, Germany; Francesco Montorsi, Milan, Italy; Markus Graefen, Hamburg, Germany; Alberto Briganti, Milan, Italy; Mani Menon, Detroit, MI INTRODUCTION AND OBJECTIVES: Given the relative novelty of RALP, many surgeons avoid using this procedure in patients presenting with clinically high-risk disease. This has contributed to the lack of literature addressing cancer control outcomes in these individuals after RALP. Therefore, we set to evaluate biochemical recurrence (BCR)-, and clinical recurrence (CR)-free survival rates in D’Amico clinically high-risk PCa patients treated with RALP and we set to further stratify these patients based on their risk of BCR after RALP. METHODS: We evaluated 1100 patients who underwent RALP adjuvant treatment, and pelvic node dissection, between 2002-2013 at 3 tertiary care centers. All patients had D’Amico clinically high-risk PCa. Regression tree analysis stratified patients into risk-groups based on tumor characteristics and corresponding BCR rate (defined as PSA value 0.2 ng/ml on two consecutive occasions). Area-underethe-curve was used to estimate the accuracy of the novel stratification model. KaplanMeier curves were used to estimate BCR-/CR-free survival rates in the entire cohort, and after stratification according to novel risk-groups. RESULTS: Mean age and PSA at surgery were 62.2 yrs (median: 63) and 11.3 ng/ml (median: 6.5), respectively. Biopsy GS was
e657
8 in 57.7%, and clinical stage was T2c in 39.8%. Overall, 4.8% and 1.1% received adjuvant radiotherapy and adjuvant hormonal therapy, respectively. Mean (median) follow-up time was 53.3 (48.5) months. At 7-year the BCR-, and CR-free survival rates were respectively 56.2%, and 91.1%. Regression tree stratified patients into 5 novel risk-groups: 1) very low risk (Gleason score 6); 2) low risk (PSA 10 ng/ml, and GS¼7); 3) intermediate risk (PSA 10 ng/ml, and GS8); 4) high-risk (PSA >10 ng/ml, and GS¼7); 5) very high risk (PSA 10 ng/ml, and GS8). In these risk groups, 7-year BCR-free survival rate was respectively 85.5, 73.1, 49.0, 42.2, and 26.2% (p<0.001). Likewise, 7year CR-free survival rate was respectively 98.6, 96.0, 89.9, 88.1, and 83.2%. The accuracy of this model was 73% for BCR endpoint, and 70% for CR endpoint. CONCLUSIONS: Long-term, most patients with D’Amico clinically high-risk disease remain BCR/CR-free after RALP even without adjuvant treatment. However, men with D’Amico high-risk PCa do not share the same prognosis. Our novel tool allows accurate stratification of these patients based on routinely available pre-operative data, and it may be of great use in the pre-op counseling of patients. Source of Funding: None
PD30-09 THE EFFECT OF ANDROGEN DEPRIVATION THERAPY FOR LOCALIZED PROSTATE CANCER ON CARDIOVASCULAR MORBIDITY ACCORDING TO LIFE EXPECTANCY Marianne Schmid*, Hamburg, Germany; Jesse Sammon, Detroit, MI; Gally Reznor, Boston, MA; Victor Kapoor, Detroit, MI; Jaqueline Speed, Boston, MA; Firas Abdollah, Akshay Sood, Detroit, MI; Felix Chun, Hamburg, Germany; Adam Kibel, Boston, MA; Mani Menon, Detroit, MI; Margit Fisch, Hamburg, Germany; Maxine Sun, Montreal, Canada; Quoc-Dien Trinh, Boston, MA INTRODUCTION AND OBJECTIVES: Prior studies indicate increased risk of cardiac disease in patients with non-metastatic prostate cancer (PCa) undergoing androgen deprivation therapy (ADT). We investigate the dose-dependent effect of ADT on cardiac morbidity in PCa patients stratified according to life expectancy (LE). METHODS: 62,215 men diagnosed with localized PCa between 1991 and 2007 were identified within SEER registry areas and stratified according to LE (<5, 5-10, >10 years). We compared those who did not receive ADT to those who underwent ADT within 2 years of PCa diagnosis, calculated as monthly equivalent doses (1-7, 7-11, >11 doses), or orchiectomy. Adjusted Cox hazard models assessed the risk of coronary heart disease (CHD), acute myocardial infarction (AMI), sudden cardiac death (SCD), and related interventions. RESULTS: Patients undergoing ADT more frequently experienced any cardiovascular event compared to men who did not receive ADT (40.9 vs. 37.7%, p<0.001; Table 1). The hazard ratio (HR) for experiencing a cardiovascular event increased with the patients’ LE and/or the doses of ADT. Specifically, men with a LE >10 years receiving >11 doses of ADT were at greatest hazard for CHD (HR: 1.32, 95% CI: 1.25-1.39, p<0.001), AMI (HR: 1.24, 95% CI: 1.12-1.37, p<0.001), SCD (HR: 1.42, 95% CI: 1.23-1.63, p<0.001) and intervention HR: 1.13, 95% CI: 1.05-1.23, p<0.001). CONCLUSIONS: For PCa patients with localized disease and a decent LE, cumulative exposure to ADT with GnRH agonists is associated with increased risk of cardiac morbidity or mortality. Clinicians should carefully weigh the risks and benefits of ADT in patients with a prolonged LE.
Source of Funding: none