- Email: [email protected]
PD34-11 TEMPORAL TRENDS IN THE UTILIZATION OF OBSERVATION FOR CLINICALLY LOCALIZED PROSTATE CANCER
THE JOURNAL OF UROLOGYâ
e900
lymph node metastases. At a mean/median postoperative follow up of 76/62 months, 44 (9.8%) patients developed BF, including 1 (0.2%) patient with distant metastasis and 22 (4.9%) patients after negative surgical margins. Blinded pathologist re-review of available prostatectomy specimens demonstrated upgrading to GG7 in the single metastatic case and 67% (12/18) of cases with BF after negative margins. Of the 6 confirmed GG3+3¼6 patients with BF after negative margins, 3 had preoperative androgen deprivation therapy and/or GG primary pattern 4 on preoperative biopsy, and none (0/6) had metastases at a median follow up of 147 months after surgery and a median 78 months after BF. CONCLUSIONS: Our study provides further support for the developing theory that GG pattern 3, as defined by current ISUP guidelines, lacks metastatic ability. These findings have implications for modification of surveillance recommendations in prostatectomy patients with pathologically confirmed GG3+3¼6. Additional follow up is warranted to determine whether rare BF after negative margins reflects microscopic systemic disease with delayed metastatic outgrowth or simply the ability for local “skip” invasion.
Vol. 191, No. 4S, Supplement, Tuesday, May 20, 2014
Source of Funding: Mr. Weiner is supported by funding from the Pritzker Summer Research Program and The National Institute of Diabetes and Digestive and Kidney Disease grant 2T35D062719-26.
Source of Funding: None
PD34-11 PD34-10 TRENDS IN MANAGEMENT OF LOW-RISK PROSTATE CANCER IN THE UNITED STATES: A POPULATION-BASED ANALYSIS Adam Weiner*, Chicago, IL; Ruth Etzioni, Seattle, WA; Scott Eggener, Chicago, IL INTRODUCTION AND OBJECTIVES: Non-curative initial management (NCIM) for low-risk prostate cancer has good long-term survival but is not commonly used. Our objectives were to measure temporal trends in the proportion of localized prostate cancer patients qualifying for and electing to use NCIM in the United States and analyze the association of factors affecting treatment choice. METHODS: Using 2004-2010 data generated by the Surveillance, Epidemiology, and End Results (SEER) Program, we identified all patients diagnosed with localized prostate cancer and measured trends in primary treatment. Low-risk prostate cancer was defined as Gleason 6, PSA < 10ng/ml, and cT1-cT2a. Logistic regression analyses were used to evaluate determinants of NCIM utilization as well as compare frequencies of Gleason 6, PSA < 10ng/ml, and cT1-cT2a disease by year. RESULTS: We identified 262,595 men diagnosed with localized prostate cancer between 2004 and 2009 with follow-up data through 2010. Of these men, 29% were low-risk. Among low-risk men, 22.8% elected NCIM. Radiation and surgery use declined 8% and 1% respectively while NCIM increased from 19% to 29% (OR 1.81, 95% CI 1.70-1.93, P < 0.001) (Figure). Increased age, decreased PSA, early clinical stage, and recent year of diagnosis were strong determinants of NCIM usage. However, use of NCIM among all localized prostate cancer increased <1%, from 21.4% to 21.9% (OR 1.14, 95% CI 1.10-1.19, P < 0.001). The frequencies of PSA <10 ng/ml and clinical stage T1-T2a disease increased from 73.6% to 78.4% (OR 1.31, 95% CI 1.27-1.55, P < 0.001) and 60.2% to 70.5% (OR 1.58, CI 1.53-1.62, P < 0.001), respectively. The frequency of Gleason 6 decreased from 54.2% to 43.6% (OR 0.65, 95% CI 0.64-0.67, P < 0.001). CONCLUSIONS: Among men with low-risk prostate cancer, increased age, lower PSA, and early clinical stage were associated with a higher likelihood of NCIM. NCIM use has increased among low-risk patients. However, due to an ongoing prostate cancer grade migration resulting in fewer men being classified as low-risk, NCIM use was stable among all localized prostate cancer patients.
TEMPORAL TRENDS IN THE UTILIZATION OF OBSERVATION FOR CLINICALLY LOCALIZED PROSTATE CANCER Chad Ritch*, Amy Graves, Shenghua Ni, David Penson, Daniel Barocas, Nashville, TN INTRODUCTION AND OBJECTIVES: Over the past decade, the concept of Active Surveillance (AS) has been promoted as an alternative to definitive local treatment of low-risk prostate cancer (CaP). The extent to which this shift in ideology is reflected in practice patterns is unknown. As an initial step toward understanding how the use of observation has changed over time, we set out to describe the temporal trends in the utilization of observation for men over 65 years old with localized CaP, particularly among patients with low-risk disease. METHODS: Using the SEER-Medicare linked database, we identified men aged 66 years with localized CaP diagnosed on prostate biopsy between 2004-2009, with continuous Medicare Part A and B coverage for 1 year before and 2 years after diagnosis, without enrollment in Medicare HMO. Those diagnosed at autopsy or in a nursing home were also excluded. Observation was defined as not having received primary local therapy (PLT) or primary androgen deprivation therapy (PADT) within 1 year of diagnosis. Patients were risk stratified using the D’Amico criteria. We compared demographic and clinical variables by period of diagnosis (2004-2005, 2006-2007, 2008-2009) using the Kruskal Wallis test for continuous and Pearson chi-squared test for categorical variables. We used unadjusted logistic regression to evaluate the association between use of observation and time. RESULTS: A total of 75,651 men with localized CaP fulfilled inclusion criteria. Of these, 12,754(16.9%)underwent observation , 53,412 (70.6%) had PLT and 9,485 (12.5%) underwent PADT. From 2004-2009 there was a significant increase in the odds of undergoing observation versus treatment for all men (p<0.001). In addition, among the subset of low-risk men, there was a significant increase in use of observation versus treatment over the same period (p<0.001). (Figure 1) CONCLUSIONS: Utilization of observation for localized CaP in men over 65 has increased over time, in large part due to increased use among men with low-risk disease, suggesting that there is growing acceptance of AS. Further studies are needed to determine predictors of undergoing observation and whether these men are being observed actively, with frequent PSA testing and repeat biopsies.
THE JOURNAL OF UROLOGYâ
Vol. 191, No. 4S, Supplement, Tuesday, May 20, 2014
e901
Multivariate Analysis of Predictive Factors for Expectant Management Utilization
Source of Funding: None
Variable Year of Diagnosis, 2008 vs 2004 Year of Diagnosis, 2009 vs 2004 Year of Diagnosis, 2010 vs 2004 Year of Diagnosis, 2011 vs 2004 Age, 50-59 years vs < 50 years Age, 60-69 years vs < 50 years Age, 70-79 years vs < 50 years Age, >80 years vs < 50 years Charlson score, 2 vs 0 Race, African American vs white Race, Other non-white vs white Income, $46,000 vs < $30,000 Patient residence, rural vs metro Insurance, private/managed care vs federal/social Hospital type, comprehensive cancer center vs community Hospital type, teaching vs community Hospital location, midwest vs northeast
Odds Ratio 1.290 1.684 2.021 2.516 1.195 1.585 2.507 6.644 1.179 1.217 1.265 0.875 0.883 0.904
Confidence Interval 1.226-1.357 1.601-1.770 1.921-2.125 2.394-2.644 1.101-1.296 1.463-1.718 2.306-2.726 6.060-7.283 1.089-1.277 1.171-1.265 1.196-1.339 0.828-0.924 0.808-0.965 0.877-0.933
P-value < 0.001 < 0.0001 < 0.0001 < 0.0001 < 0.0001 < 0.0001 < 0.0001 < 0.0001 < 0.0001 < 0.001 < 0.0001 < 0.0001 < 0.05 < 0.0001
0.629
0.603-0.656
< 0.0001
1.169 0.876
1.120-1.221 0.845-0.907
< 0.0001 < 0.0001
PD34-12 HOSPITAL TYPE PREDICTS UNDERUSE OF EXPECTANT MANAGEMENT
Source of Funding: None
Matthew Maurice*, Robert Abouassaly, Hui Zhu, Cleveland, OH INTRODUCTION AND OBJECTIVES: Expectant management (EM), including active surveillance and watchful waiting, is a strategy to minimize prostate cancer overtreatment. We sought to evaluate contemporary trends in EM utilization and to identify factors associated with its uptake. METHODS: Using the National Cancer Database, a joint project of the Commission on Cancer of the American College of Surgeons and the American Cancer Society, we identified men with biopsy-proven low-risk (Gleason score 6, no Gleason pattern 4 or 5, cT1-cT2a) prostate cancer diagnosed between 2004-2011. We then classified men within this cohort as having undergone EM (no first-course surgery, radiation, hormone therapy, or chemotherapy) or active treatment. Patient and provider variables were analyzed using univariate and multivariate logistic regression models to determine predictors of EM selection. RESULTS: Of 287,562 men with low-risk prostate cancer, we identified 34,132 patients (11.9%) who received EM. Beginning in 2008, we observed a significant and steady rise in EM usage with time (range, 9.8% to 18.6%). Compared to 2004, patients diagnosed in 2011 had 2.5 times the odds of receiving EM (odds ratio [OR] 2.52, confidence interval [CI] 2.39-2.64, p<0.0001). Aside from year of diagnosis, age and Charlson score were strong predictors of EM usage (p<0.0001). Other strong predictors of EM included hospital type and insurance provider. Specifically, patients who were treated at comprehensive cancer centers or who had personal health insurance were significantly less likely to receive EM (OR 0.63, 0.60-0.66, p<0.0001 or OR 0.90, CI 0.88-0.93, p<0.0001, respectively). In addition, patient race, income, and area of residence as well as hospital location were significantly but weakly associated with EM (P<0.0001). CONCLUSIONS: In recent years, low-risk prostate cancer has been increasingly managed with EM, especially in older patients or patients with multiple comorbidities, who are least likely to benefit from active treatment. Unexpectedly, hospital type and insurance provider also predict EM usage, calling into question whether non-clinical factors are influencing EM selection.
Stone Disease: New Technology I Podium Tuesday, May 20, 2014
1:00 PM-3:00 PM
PD36-01 THE QUALITATIVE DIAGNOSIS FOR THE URINARY STONE COMPOSITION USING DUAL ENERGY COMPUTED TOMOGRAPHY Satoshi Yamaguchi*, Hiroki Inoue, Masayuki Tokumitsu, Noriaki Masui, Shigeo Kaneko, Hironori Ishida, Asahikawa, Japan INTRODUCTION AND OBJECTIVES: It is well known that uric acid stone is hardly visualized on plain film of the kidney, ureter and bladder (KUB) because of their radiolucency. In contrast, calcium containing stone is radiopaque and it is detected easily on KUB. Recently, Dual Energy (DE) computed tomography (CT) that applies X-ray at two different energies has developed and it can distinguish both stones more clearly. For example, uric acid can be readily identified by analyzing Hounsfield units (HU) acquired at both high energy (135kV) and low energy (80kV). Using DE-CT, we predicted stone composition and evaluated clinical usefulness of this imaging technique. METHODS: AquilionTM PRIME (Toshiba) was used for DE-CT. We reviewed 1169 renal/ureteral stones from 906 patients who underwent DE-CT in the process for diagnosis. The urinary stone compositions predicted by DE-CT were compared with the results of Fourier transform infrared spectroscopy (FTIR) of delivered stones after various interventions. The stone fragments were also subjected to ex vivo DE-CT when their volume was sufficient. The results of the ex vivo study were compared with those of the in vivo DE-CT. RESULTS: 232 stones were analyzed by DE-CT and FTIR. Main component of the stones were calcium oxalate (196), uric acid (22), carbonate apatite (11), and so on. The positive predictive value for the stone estimated definitely by DE-CT was 88.3% for calcium containing stone and 81.8% for uric acid stone. 156 stones were subjected to ex vivo DE-CT after FTIR, and the correlation of HU at
e900
lymph node metastases. At a mean/median postoperative follow up of 76/62 months, 44 (9.8%) patients developed BF, including 1 (0.2%) patient with distant metastasis and 22 (4.9%) patients after negative surgical margins. Blinded pathologist re-review of available prostatectomy specimens demonstrated upgrading to GG7 in the single metastatic case and 67% (12/18) of cases with BF after negative margins. Of the 6 confirmed GG3+3¼6 patients with BF after negative margins, 3 had preoperative androgen deprivation therapy and/or GG primary pattern 4 on preoperative biopsy, and none (0/6) had metastases at a median follow up of 147 months after surgery and a median 78 months after BF. CONCLUSIONS: Our study provides further support for the developing theory that GG pattern 3, as defined by current ISUP guidelines, lacks metastatic ability. These findings have implications for modification of surveillance recommendations in prostatectomy patients with pathologically confirmed GG3+3¼6. Additional follow up is warranted to determine whether rare BF after negative margins reflects microscopic systemic disease with delayed metastatic outgrowth or simply the ability for local “skip” invasion.
Vol. 191, No. 4S, Supplement, Tuesday, May 20, 2014
Source of Funding: Mr. Weiner is supported by funding from the Pritzker Summer Research Program and The National Institute of Diabetes and Digestive and Kidney Disease grant 2T35D062719-26.
Source of Funding: None
PD34-11 PD34-10 TRENDS IN MANAGEMENT OF LOW-RISK PROSTATE CANCER IN THE UNITED STATES: A POPULATION-BASED ANALYSIS Adam Weiner*, Chicago, IL; Ruth Etzioni, Seattle, WA; Scott Eggener, Chicago, IL INTRODUCTION AND OBJECTIVES: Non-curative initial management (NCIM) for low-risk prostate cancer has good long-term survival but is not commonly used. Our objectives were to measure temporal trends in the proportion of localized prostate cancer patients qualifying for and electing to use NCIM in the United States and analyze the association of factors affecting treatment choice. METHODS: Using 2004-2010 data generated by the Surveillance, Epidemiology, and End Results (SEER) Program, we identified all patients diagnosed with localized prostate cancer and measured trends in primary treatment. Low-risk prostate cancer was defined as Gleason 6, PSA < 10ng/ml, and cT1-cT2a. Logistic regression analyses were used to evaluate determinants of NCIM utilization as well as compare frequencies of Gleason 6, PSA < 10ng/ml, and cT1-cT2a disease by year. RESULTS: We identified 262,595 men diagnosed with localized prostate cancer between 2004 and 2009 with follow-up data through 2010. Of these men, 29% were low-risk. Among low-risk men, 22.8% elected NCIM. Radiation and surgery use declined 8% and 1% respectively while NCIM increased from 19% to 29% (OR 1.81, 95% CI 1.70-1.93, P < 0.001) (Figure). Increased age, decreased PSA, early clinical stage, and recent year of diagnosis were strong determinants of NCIM usage. However, use of NCIM among all localized prostate cancer increased <1%, from 21.4% to 21.9% (OR 1.14, 95% CI 1.10-1.19, P < 0.001). The frequencies of PSA <10 ng/ml and clinical stage T1-T2a disease increased from 73.6% to 78.4% (OR 1.31, 95% CI 1.27-1.55, P < 0.001) and 60.2% to 70.5% (OR 1.58, CI 1.53-1.62, P < 0.001), respectively. The frequency of Gleason 6 decreased from 54.2% to 43.6% (OR 0.65, 95% CI 0.64-0.67, P < 0.001). CONCLUSIONS: Among men with low-risk prostate cancer, increased age, lower PSA, and early clinical stage were associated with a higher likelihood of NCIM. NCIM use has increased among low-risk patients. However, due to an ongoing prostate cancer grade migration resulting in fewer men being classified as low-risk, NCIM use was stable among all localized prostate cancer patients.
TEMPORAL TRENDS IN THE UTILIZATION OF OBSERVATION FOR CLINICALLY LOCALIZED PROSTATE CANCER Chad Ritch*, Amy Graves, Shenghua Ni, David Penson, Daniel Barocas, Nashville, TN INTRODUCTION AND OBJECTIVES: Over the past decade, the concept of Active Surveillance (AS) has been promoted as an alternative to definitive local treatment of low-risk prostate cancer (CaP). The extent to which this shift in ideology is reflected in practice patterns is unknown. As an initial step toward understanding how the use of observation has changed over time, we set out to describe the temporal trends in the utilization of observation for men over 65 years old with localized CaP, particularly among patients with low-risk disease. METHODS: Using the SEER-Medicare linked database, we identified men aged 66 years with localized CaP diagnosed on prostate biopsy between 2004-2009, with continuous Medicare Part A and B coverage for 1 year before and 2 years after diagnosis, without enrollment in Medicare HMO. Those diagnosed at autopsy or in a nursing home were also excluded. Observation was defined as not having received primary local therapy (PLT) or primary androgen deprivation therapy (PADT) within 1 year of diagnosis. Patients were risk stratified using the D’Amico criteria. We compared demographic and clinical variables by period of diagnosis (2004-2005, 2006-2007, 2008-2009) using the Kruskal Wallis test for continuous and Pearson chi-squared test for categorical variables. We used unadjusted logistic regression to evaluate the association between use of observation and time. RESULTS: A total of 75,651 men with localized CaP fulfilled inclusion criteria. Of these, 12,754(16.9%)underwent observation , 53,412 (70.6%) had PLT and 9,485 (12.5%) underwent PADT. From 2004-2009 there was a significant increase in the odds of undergoing observation versus treatment for all men (p<0.001). In addition, among the subset of low-risk men, there was a significant increase in use of observation versus treatment over the same period (p<0.001). (Figure 1) CONCLUSIONS: Utilization of observation for localized CaP in men over 65 has increased over time, in large part due to increased use among men with low-risk disease, suggesting that there is growing acceptance of AS. Further studies are needed to determine predictors of undergoing observation and whether these men are being observed actively, with frequent PSA testing and repeat biopsies.
THE JOURNAL OF UROLOGYâ
Vol. 191, No. 4S, Supplement, Tuesday, May 20, 2014
e901
Multivariate Analysis of Predictive Factors for Expectant Management Utilization
Source of Funding: None
Variable Year of Diagnosis, 2008 vs 2004 Year of Diagnosis, 2009 vs 2004 Year of Diagnosis, 2010 vs 2004 Year of Diagnosis, 2011 vs 2004 Age, 50-59 years vs < 50 years Age, 60-69 years vs < 50 years Age, 70-79 years vs < 50 years Age, >80 years vs < 50 years Charlson score, 2 vs 0 Race, African American vs white Race, Other non-white vs white Income, $46,000 vs < $30,000 Patient residence, rural vs metro Insurance, private/managed care vs federal/social Hospital type, comprehensive cancer center vs community Hospital type, teaching vs community Hospital location, midwest vs northeast
Odds Ratio 1.290 1.684 2.021 2.516 1.195 1.585 2.507 6.644 1.179 1.217 1.265 0.875 0.883 0.904
Confidence Interval 1.226-1.357 1.601-1.770 1.921-2.125 2.394-2.644 1.101-1.296 1.463-1.718 2.306-2.726 6.060-7.283 1.089-1.277 1.171-1.265 1.196-1.339 0.828-0.924 0.808-0.965 0.877-0.933
P-value < 0.001 < 0.0001 < 0.0001 < 0.0001 < 0.0001 < 0.0001 < 0.0001 < 0.0001 < 0.0001 < 0.001 < 0.0001 < 0.0001 < 0.05 < 0.0001
0.629
0.603-0.656
< 0.0001
1.169 0.876
1.120-1.221 0.845-0.907
< 0.0001 < 0.0001
PD34-12 HOSPITAL TYPE PREDICTS UNDERUSE OF EXPECTANT MANAGEMENT
Source of Funding: None
Matthew Maurice*, Robert Abouassaly, Hui Zhu, Cleveland, OH INTRODUCTION AND OBJECTIVES: Expectant management (EM), including active surveillance and watchful waiting, is a strategy to minimize prostate cancer overtreatment. We sought to evaluate contemporary trends in EM utilization and to identify factors associated with its uptake. METHODS: Using the National Cancer Database, a joint project of the Commission on Cancer of the American College of Surgeons and the American Cancer Society, we identified men with biopsy-proven low-risk (Gleason score 6, no Gleason pattern 4 or 5, cT1-cT2a) prostate cancer diagnosed between 2004-2011. We then classified men within this cohort as having undergone EM (no first-course surgery, radiation, hormone therapy, or chemotherapy) or active treatment. Patient and provider variables were analyzed using univariate and multivariate logistic regression models to determine predictors of EM selection. RESULTS: Of 287,562 men with low-risk prostate cancer, we identified 34,132 patients (11.9%) who received EM. Beginning in 2008, we observed a significant and steady rise in EM usage with time (range, 9.8% to 18.6%). Compared to 2004, patients diagnosed in 2011 had 2.5 times the odds of receiving EM (odds ratio [OR] 2.52, confidence interval [CI] 2.39-2.64, p<0.0001). Aside from year of diagnosis, age and Charlson score were strong predictors of EM usage (p<0.0001). Other strong predictors of EM included hospital type and insurance provider. Specifically, patients who were treated at comprehensive cancer centers or who had personal health insurance were significantly less likely to receive EM (OR 0.63, 0.60-0.66, p<0.0001 or OR 0.90, CI 0.88-0.93, p<0.0001, respectively). In addition, patient race, income, and area of residence as well as hospital location were significantly but weakly associated with EM (P<0.0001). CONCLUSIONS: In recent years, low-risk prostate cancer has been increasingly managed with EM, especially in older patients or patients with multiple comorbidities, who are least likely to benefit from active treatment. Unexpectedly, hospital type and insurance provider also predict EM usage, calling into question whether non-clinical factors are influencing EM selection.
Stone Disease: New Technology I Podium Tuesday, May 20, 2014
1:00 PM-3:00 PM
PD36-01 THE QUALITATIVE DIAGNOSIS FOR THE URINARY STONE COMPOSITION USING DUAL ENERGY COMPUTED TOMOGRAPHY Satoshi Yamaguchi*, Hiroki Inoue, Masayuki Tokumitsu, Noriaki Masui, Shigeo Kaneko, Hironori Ishida, Asahikawa, Japan INTRODUCTION AND OBJECTIVES: It is well known that uric acid stone is hardly visualized on plain film of the kidney, ureter and bladder (KUB) because of their radiolucency. In contrast, calcium containing stone is radiopaque and it is detected easily on KUB. Recently, Dual Energy (DE) computed tomography (CT) that applies X-ray at two different energies has developed and it can distinguish both stones more clearly. For example, uric acid can be readily identified by analyzing Hounsfield units (HU) acquired at both high energy (135kV) and low energy (80kV). Using DE-CT, we predicted stone composition and evaluated clinical usefulness of this imaging technique. METHODS: AquilionTM PRIME (Toshiba) was used for DE-CT. We reviewed 1169 renal/ureteral stones from 906 patients who underwent DE-CT in the process for diagnosis. The urinary stone compositions predicted by DE-CT were compared with the results of Fourier transform infrared spectroscopy (FTIR) of delivered stones after various interventions. The stone fragments were also subjected to ex vivo DE-CT when their volume was sufficient. The results of the ex vivo study were compared with those of the in vivo DE-CT. RESULTS: 232 stones were analyzed by DE-CT and FTIR. Main component of the stones were calcium oxalate (196), uric acid (22), carbonate apatite (11), and so on. The positive predictive value for the stone estimated definitely by DE-CT was 88.3% for calcium containing stone and 81.8% for uric acid stone. 156 stones were subjected to ex vivo DE-CT after FTIR, and the correlation of HU at