throbber
Previously Published Works
`UC San Francisco
`
`A University of California author or department has made this article openly available. Thanks to
`the Academic Senate’s Open Access Policy, a great many UC-authored scholarly publications
`will now be freely available on this site.
`Let us know how this access is important for you. We want to hear your story!
`http://escholarship.org/reader_feedback.html
`
`Peer Reviewed
`
`Title:
`Who is the average patient presenting with prostate cancer?
`Journal Issue:
`Urology, 66(5 SUPPL.)
`Author:
`Greene, KL
`Cowan, JE
`Cooperberg, MR
`Meng, MV
`DuChane, J
`Carroll, PR
`Publication Date:
`11-01-2005
`Series:
`UC San Francisco Previously Published Works
`Permalink:
`http://escholarship.org/uc/item/11k4j6r7
`DOI:
`https://doi.org/10.1016/j.urology.2005.06.082
`Local Identifier:
`375786
`Abstract:
`Prostate cancer screening, diagnosis, and treatment have changed dramatically in the last 20
`years. Patients with newly diagnosed prostate cancer have many treatment options available. We
`attempted to determine how patient demographics and quality of life (QOL) have changed, and we
`describe the average patient with newly diagnosed prostate cancer in the early 21st century. From
`the Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE) we identified 3003
`men with prostate cancer diagnosed between 1997 and 2003 for whom pretreatment demographic
`
`eScholarship provides open access, scholarly publishing
`services to the University of California and delivers a dynamic
`research platform to scholars worldwide.
`
`AVENTIS EXHIBIT 2210
`Mylan v. Aventis IPR2016-00712
`
`

`
`and QOL data were available. All patients completed both the University of California-Los Angeles
`Prostate Cancer Index (UCLA-PCI) and the Rand Medical Outcomes Study 36-Item Short-Form
`Health Survey (SF-36) as self-administered questionnaires at the time of diagnosis. We compared
`demographic variables (age at diagnosis, race/ethnicity, education, number of comorbidities,
`body mass index [BMI], and insurance type), treatment choice, and pretreatment QOL scores
`on the SF-36 and UCLA-PCI scales for the periods 1997 to 1999 or 2000 to 2003. Stratified
`analysis by risk category was performed for demographic and QOL data for the 2 periods.
`Race/ethnicity and insurance demographics were statistically different for the 2 periods. Low-
`risk patients also showed a statistically increased BMI in the 2000 to 2003 period. Risk category
`predicted performance on both inventories, with low-risk patients having better function than
`intermediate-risk patients and high-risk patients in the areas of urinary bother, bowel function and
`bother, and sexual function and bother, as well as in many general well-being and emotional health
`scales on the SF-36. We conclude that the "average" prostate cancer patient is white, 65 years of
`age, overweight, educated at a college level, and has 1 to 2 comorbidities. Patients report average
`or above-average pretreatment health-related QOL for all scales based on 2 validated instruments.
`In this cohort, more patients chose radical prostatectomy than any other form of treatment. © 2005
`Elsevier Inc. All rights reserved.
`Copyright Information:
`All rights reserved unless otherwise indicated. Contact the author or original publisher for any
`necessary permissions. eScholarship is not the copyright owner for deposited works. Learn more
`at http://www.escholarship.org/help_copyright.html#reuse
`
`eScholarship provides open access, scholarly publishing
`services to the University of California and delivers a dynamic
`research platform to scholars worldwide.
`
`

`
`WHO IS THE AVERAGE PATIENT PRESENTING WITH
`PROSTATE CANCER?
`
`KIRSTEN L. GREENE, JANET E. COWAN, MATTHEW R. COOPERBERG, MAXWELL V. MENG,
`JANEEN DUCHANE, AND PETER R. CARROLL, FOR THE CANCER OF THE PROSTATE STRATEGIC
`UROLOGIC RESEARCH ENDEAVOR (CaPSURE) INVESTIGATORS
`
`ABSTRACT
`Prostate cancer screening, diagnosis, and treatment have changed dramatically in the last 20 years. Patients
`with newly diagnosed prostate cancer have many treatment options available. We attempted to determine
`how patient demographics and quality of life (QOL) have changed, and we describe the average patient with
`newly diagnosed prostate cancer in the early 21st century. From the Cancer of the Prostate Strategic
`Urologic Research Endeavor (CaPSURE) we identified 3003 men with prostate cancer diagnosed between
`1997 and 2003 for whom pretreatment demographic and QOL data were available. All patients completed
`both the University of California–Los Angeles Prostate Cancer Index (UCLA-PCI) and the Rand Medical
`Outcomes Study 36-Item Short-Form Health Survey (SF-36) as self-administered questionnaires at the time
`of diagnosis. We compared demographic variables (age at diagnosis, race/ethnicity, education, number of
`comorbidities, body mass index [BMI], and insurance type), treatment choice, and pretreatment QOL scores
`on the SF-36 and UCLA-PCI scales for the periods 1997 to 1999 or 2000 to 2003. Stratified analysis by risk
`category was performed for demographic and QOL data for the 2 periods. Race/ethnicity and insurance
`demographics were statistically different for the 2 periods. Low-risk patients also showed a statistically
`increased BMI in the 2000 to 2003 period. Risk category predicted performance on both inventories, with
`low-risk patients having better function than intermediate-risk patients and high-risk patients in the areas of
`urinary bother, bowel function and bother, and sexual function and bother, as well as in many general
`well-being and emotional health scales on the SF-36. We conclude that the “average” prostate cancer
`patient is white, 65 years of age, overweight, educated at a college level, and has 1 to 2 comorbidities.
`Patients report average or above-average pretreatment health-related QOL for all scales based on 2
`validated instruments. In this cohort, more patients chose radical prostatectomy than any other form of
`treatment. UROLOGY 66 (Suppl 5A): 76–82, 2005. © 2005 Elsevier Inc.
`
`CaPSURE is supported by TAP Pharmaceutical Products, Inc.
`(Lake Forest, IL). Partial funding to Dr. Carroll, Dr. Greene, J.
`Cowan, Dr. Meng, Dr. Cooperberg, Dr. DuChane, and the
`CaPSURE Investigators was also provided by TAP Pharmaceuti-
`cal Products, Inc. This research was additionally funded by Na-
`tional Institutes of Health/National Cancer Institute University of
`California-San Francisco SPORE (Specialized Program of Re-
`search Excellence) Grant No. P50 C89520.
`From the Department of Urology, Program in Urologic Oncol-
`ogy, Urologic Outcomes Research Group, UCSF/Mt. Zion Com-
`prehensive Cancer Center, University of California–San Fran-
`cisco, San Francisco, California, USA (KLG, JEC, MRC, MVM,
`PRC); and TAP Pharmaceutical Products, Inc., Lake Forest, Illi-
`nois, USA (JD).
`Reprint requests: Peter R. Carroll, MD, Department of Urol-
`ogy, University of California–San Francisco, 1600 Divisadero,
`Box 1695, San Francisco, California 94143-1695. E-mail:
`pcarroll@urol.ucsf.edu
`
`Prostate cancer is the most common noncutane-
`
`ous malignancy in men, with an anticipated
`232,090 new cases predicted for 2005 in the United
`States. With the advent of widespread prostate-
`specific antigen (PSA) screening, disease incidence
`has increased in the last 10 years.1 Despite this
`increase in incidence, however, rates of death due
`to prostate cancer have declined, and there has
`been a corresponding stage migration resulting in
`the diagnosis of men at lower risk and at an earlier
`clinical stage.2 Because early-stage prostate cancer
`may follow a prolonged and indolent clinical
`course for up to 15 years after diagnosis, newly
`diagnosed patients are living with prostate cancer,
`as well as the effects of treatment, for longer peri-
`ods with attendant implications for health-related
`quality of life (HRQOL).3,4 As a result, pretreat-
`
`© 2005 ELSEVIER INC.
`76 ALL RIGHTS RESERVED
`
`0090-4295/05/$30.00
`doi:10.1016/j.urology.2005.06.082
`
`

`
`ment quality of life (QOL) and ongoing HRQOL
`measurements for patients with prostate cancer are
`of increasing importance as patients are faced with
`treatment options that may affect physical, sexual,
`and emotional health and well-being.5,6 Although
`much of the literature has focused on treatment
`choices and outcomes for men with newly diag-
`nosed prostate cancer, we sought to describe the
`HRQOL, demographic, and socioeconomic status
`of men already diagnosed with prostate cancer and
`to determine how these factors have changed over
`time.
`
`METHODS
`
`The Cancer of the Prostate Strategic Urologic Research En-
`deavor (CaPSURE) is a longitudinal, observational disease
`registry of men with biopsy-proven adenocarcinoma of the
`prostate. The CaPSURE database contains demographic, clin-
`ical, treatment, and outcomes data for ⬎11,000 patients from
`40 urology practices across the United States (34 community
`based, 3 Veterans’ Administration, and 3 academic practices).
`Patients are enrolled in CaPSURE regardless of age, stage of
`disease, or intended treatment plan. They are treated accord-
`ing to the usual practices of their physicians, and are followed
`until they die or withdraw from the study. Additional details of
`the CaPSURE database methodology have been previously re-
`ported.7
`We identified 3003 men from the CaPSURE database who
`were diagnosed between 1997 and 2003 with prostate cancer
`and had available pretreatment demographic and QOL data.
`All patients with newly diagnosed prostate cancer were in-
`cluded regardless of stage or type of treatment.
`QOL data were compiled from self-administered question-
`naires including the University of California–Los Angeles
`Prostate Cancer Index (UCLA-PCI) and the Rand Medical
`Outcomes
`Study 36-Item Short-Form Health Survey
`(SF-36).8,9 The UCLA-PCI is a widely validated scale that mea-
`sures 6 domains of prostate cancer–related QOL including
`urinary function, urinary bother, bowel
`function, bowel
`bother, sexual function, and sexual bother. Each item is scored
`from 0 to 100, with higher scores representing better HRQOL.
`The SF-36 evaluates 8 domains of general QOL and well-be-
`ing, with summary scales for physical function, role limita-
`tions due to physical problems, bodily pain, general health,
`vitality, social functioning, role limitations due to emotional
`problems, mental health, physical health composite, and men-
`tal health composite. Again, each item is scored from 0 to 100,
`with higher scores indicating better outcomes. Reliability co-
`efficients for patients with prostate cancer range from 0.8 to
`0.95 for the UCLA-PCI and from 0.68 to 0.91 for the SF-
`36.10,11
`We compared demographic variables (age at diagnosis,
`race/ethnicity, level of education, number of comorbidities,
`body mass index [BMI], and insurance type) and pretreatment
`QOL scores on the SF-36 and UCLA-PCI scales for the periods
`1997 to 1999 and 2000 to 2003 and provided populations
`means for each scale as a reference.12,13 Patients were catego-
`rized as normal weight (BMI ⬍25), overweight (BMI 25 to
`29.9) or obese (BMI ⱖ30). Clinical information and treatment
`choice was gathered for all patients.
`Demographics and QOL scores were then analyzed by treat-
`ment choice and risk group (low, intermediate, or high) based
`on modified D’Amico risk categories.14 High-risk patients are
`those with PSA ⬎20 ng/mL or Gleason total grade 8 to 10 or
`Gleason primary grade 4 to 5 or clinical stage T3a. Intermedi-
`ate-risk patients are those with PSA 10.1 to 20 ng/mL or Glea-
`
`son total grade 7 or Gleason secondary grade 4 to 5 or clinical
`stage T2b to T2c. Low-risk patients are those with PSA ⱕ10
`ng/mL and Gleason total grade ⬍7 with no 4 to 5 pattern and
`clinical stage T1 to T2a.
`Patients’ pretreatment clinical and sociodemographic data
`were grouped by time category and compared using the ␹2
`test. The Student t test was used to compare mean pretreat-
`ment scores on the SF-36 and UCLA-PCI scales in the 2 time
`categories. This was done for the entire sample within risk
`groups.
`
`RESULTS
`
`DEMOGRAPHICS
`There were few demographic differences among
`patients diagnosed from 1997 to 1999 and those
`diagnosed from 2000 to 2003. Most patients in
`both periods were white, overweight, and aged 60
`to 70 years. Furthermore, the majority of patients
`in both periods had 1 to 2 comorbidities, had
`achieved a college-level education, and were cov-
`ered by private insurance. The percentage of pa-
`tients in other racial or ethnic groups decreased
`from 17% in 1997 to 1999 to 9% in 2000 to 2003,
`with a corresponding increase in white patients.
`This change in ethnic composition between the 2
`periods was statistically significant (P ⬍0.0001).
`The percentage of patients aged ⬍60 years in-
`creased from 23% in 1997 to 1999 to 28% in 2000
`to 2003, although this difference was not statisti-
`cally significant. Approximately 33% of all patients
`had ⱖ3 comorbidities in both periods, with only
`15% reporting no comorbidity. Only 25% of men
`diagnosed in 2000 to 2003 were of normal weight
`compared with 29% diagnosed in 1997 to 1999. Of
`patients with newly diagnosed prostate cancer,
`⬎60% report some level of college education, a
`mean that is higher than the national average of
`52% based on the 2000 US Census.15 In 2000 to
`2003, there were fewer patients with Medicare in-
`surance compared with the 1997 to 1999 period (P
`⬍0.03) (Table I).
`
`CLINICAL CHARACTERISTICS AND TREATMENT
`When clinical characteristics and treatment
`choices were analyzed, PSA and clinical T stage
`were both significantly lower in patients diag-
`nosed in 2000 to 2003 compared with 1997 to
`1999 (P ⬍0.01). In contrast, Gleason total score
`ⱕ7 was increased in patients diagnosed in 2000
`to 2003 (P ⬍0.01). Most patients diagnosed
`from 2000 to 2003 were at low risk (48%), with
`PSA ⱕ10 ng/mL (83%), clinical stage T1 (58%),
`and Gleason total score 5 to 6 (66%). Signifi-
`cantly more patients in 2000 to 2003 chose rad-
`ical prostatectomy and fewer chose radiation
`therapy (P ⬍0.05) as initial treatment for pros-
`tate cancer. Rates of hormonal therapy, watchful
`waiting, and cryotherapy were unchanged be-
`tween the 2 periods (Table II).
`
`UROLOGY 66 (Supplement 5A), November 2005
`
`77
`
`

`
`TABLE I. Pretreatment demographics by period
`1997–1999,
`2000–2003,
`n (%)
`n (%)
`
`76 (23)
`149 (46)
`102 (31)
`
`0 (0)
`5 (2)
`11 (3)
`36 (11)
`271 (83)
`3 (1)
`
`47 (15)
`80 (25)
`61 (19)
`136 (42)
`
`54 (17)
`169 (52)
`102 (31)
`
`93 (29)
`167 (52)
`62 (19)
`
`94 (30)
`54 (17)
`162 (52)
`1 (⬍1)
`
`590 (28)
`893 (42)
`659 (31)
`
`7 (⬍1)
`16 (1)
`27 (1)
`117 (5)
`1957 (91)
`18 (1)
`
`279 (13)
`538 (26)
`413 (20)
`866 (41)
`
`308 (15)
`1163 (56)
`623 (30)
`
`518 (25)
`1062 (51)
`496 (24)
`
`657 (32)
`252 (12)
`1064 (52)
`68 (3)
`
`Demographics
`Age at diagnosis (yr)
`⬍60
`60–70
`⬎70
`Race/ethnicity
`Native American
`Asian American
`Latino
`African American
`White
`Other
`Education level
`High school or less
`High school graduate
`Some college
`College graduate
`Comorbidities
`0
`1–2
`ⱖ3
`BMI category
`Normal (⬍25)
`Overweight (25–29)
`Obese (ⱖ30)
`Insurance
`Medicare supplement
`Medicare
`Private
`Other
`BMI ⫽ body mass index.
`
`P Value
`0.2261
`
`⬍0.0001
`
`0.9096
`
`0.4552
`
`0.1169
`
`0.0031
`
`HRQOL
`A significant difference in mean pretreatment
`urinary bother score (P ⬍0.05) was identified in
`the group of patients diagnosed in the 1997 to
`1999 period compared with those diagnosed in
`the 2000 to 2003 period, with patients in the
`later period reporting less bother. Mean pretreat-
`ment SF-36 scores did not differ significantly be-
`tween the 2 periods. When pretreatment scores
`on the UCLA-PCI and SF-36 were compared
`with published means, all patients across both
`time intervals were within 1 standard deviation
`of the mean on all scales. Cohort means were
`lower than population means on only 2 scales,
`sexual
`function and urinary bother on the
`UCLA-PCI (Tables III and IV).
`
`RISK STRATIFICATION
`There was no significant difference in risk be-
`tween the 2 periods. In 1997 to 1999, 42% of pa-
`tients were low risk, 30% were intermediate risk,
`and 20% were high risk at diagnosis. In the group
`of patients diagnosed in 2000 to 2003, 48% were
`
`low risk, 33% were intermediate risk, and 18%
`were high risk (Table II).
`When pretreatment demographic and QOL data
`were stratified by risk category, the low-risk group
`had significant differences between the 2 periods
`for race/ethnicity and BMI. For low-risk patients,
`there were significantly more white patients and
`fewer African American patients in 2000 to 2003
`compared with 1997 to 1999 (P ⬍0.05). There
`were fewer normal-weight patients and more obese
`patients in 2000 to 2003, although the percentage
`of overweight patients was unchanged between the
`periods (P ⬍0.01). There were no significant dif-
`ferences in the SF-36 or UCLA-PCI scores among
`low-risk patients in the 2 periods.
`For patients in the intermediate-risk group, pre-
`treatment demographics show significant differ-
`ences between the 2 periods for race/ethnicity and
`insurance status. Again, there were more white pa-
`tients and fewer African American patients in 2000
`to 2003 (P ⬍0.01). Additionally, fewer patients in
`2000 to 2003 had Medicare insurance (P ⬍0.05).
`The QOL scales showed significant differences
`for intermediate-risk patients in the 2 periods. For
`
`78
`
`UROLOGY 66 (Supplement 5A), November 2005
`
`

`
`TABLE II. Pretreatment clinical data and treatment choice by time interval
`Clinical
`1997–1999, n (%)
`2000–2003, n (%)
`First treatment
`Radical prostatectomy
`Cryosurgery
`Brachytherapy
`External beam radiation
`Orchiectomy
`LHRH agonist
`LHRH antagonist
`Antiandrogen
`5␣-reductase inhibitor
`Watchful waiting
`PSA category (ng/mL)
`ⱕ4
`4.1–10
`10.1–20
`⬎20
`Gleason total score
`2–4
`5–6
`7
`8–10
`T stage
`1
`2
`3
`Risk category
`132 (42)
`Low
`122 (39)
`Intermediate
`62 (20)
`High
`LHRH ⫽ luteinizing hormone–reducing hormone; PSA ⫽ prostate-specific antigen; T stage ⫽ tumor stage.
`
`1249 (58)
`73 (3)
`444 (21)
`214 (10)
`1 (⬍1)
`92 (4)
`2 (⬍1)
`14 (1)
`1 (⬍1)
`50 (2)
`
`328 (16)
`1401 (67)
`264 (13)
`90 (4)
`
`22 (1)
`1410 (66)
`556 (26)
`144 (7)
`
`1236 (58)
`885 (41)
`20 (1)
`
`1020 (48)
`705 (33)
`381 (18)
`
`171 (52)
`7 (2)
`88 (27)
`43 (13)
`0 (0)
`9 (3)
`2 (1)
`2 (1)
`1 (⬍1)
`4 (1)
`
`46 (15)
`187 (60)
`55 (18)
`22 (7)
`
`11 (3)
`213 (66)
`77 (24)
`20 (6)
`
`141 (43)
`178 (54)
`8 (2)
`
`P Value
`0.0110
`
`0.0083
`
`0.0059
`
`⬍0.0001
`
`0.0807
`
`TABLE III. University of California–Los Angeles Prostate Cancer Index pretreatment scales by
`period compared with age-appropriate reference means*
`1997–1999
`2000–2003
`Patients (n)
`Mean Score
`Patients (n)
`Mean Score
`322
`90
`2118
`89
`322
`88
`2127
`88
`307
`60
`2046
`60
`316
`50
`2083
`51
`321
`82
`2099
`85
`320
`93
`2099
`92
`
`Reference
`Mean Score
`89
`88
`53
`54
`86
`92
`
`P Value
`0.68
`0.46
`0.82
`0.44
`0.03
`0.49
`
`Variable
`Bowel bother
`Bowel function
`Sexual bother
`Sexual function
`Urinary bother
`Urinary function
`
`Adapted from J Urol.12
`* The mean age of Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE) patients in this analysis is 65.1 years (median 65.0 years).
`
`the SF-36 inventory, scores for 2000 to 2003 were
`higher in the mental composite score, mental
`health, role emotional, and social function scales
`compared with 1997 to 1999 (P ⬍0.05). On the
`UCLA-PCI, the urinary bother scale had a higher
`mean score in 2000 to 2003 period compared with
`1997 to 1999 (P ⬍0.05). In the high-risk group,
`there were no significant difference is patient de-
`mographics or QOL scores between the 2 periods
`(Table V).
`
`When all years were combined and demograph-
`ics were stratified by risk group, age at diagnosis,
`race/ethnicity, education, and insurance were sig-
`nificantly different. Low-risk patients tended to be
`white, younger, with some college education, and
`private insurance. In contrast, the high-risk cate-
`gory contained a higher percentage of men who
`were older, who had high school education or less,
`and who had Medicare or Medicare supplement
`insurance. Additionally, a higher percentage of in-
`
`UROLOGY 66 (Supplement 5A), November 2005
`
`79
`
`

`
`TABLE IV. Pretreatment Rand Medical Outcomes Study 36-Item Short Form scales by period
`compared with age-appropriate reference means*
`1997–1999
`2000–2003
`Patients
`Mean Score
`Patients
`Mean Score
`324
`84
`2109
`84
`324
`70
`2087
`72
`313
`51
`2004
`52
`319
`77
`2125
`78
`313
`51
`2004
`51
`321
`85
`2105
`85
`320
`80
`2107
`83
`320
`79
`2114
`80
`325
`86
`2111
`88
`319
`66
`2126
`67
`
`Reference
`Mean Score
`68
`58
`50
`77
`50
`65
`76
`59
`79
`57
`
`P Value
`0.79
`0.09
`0.09
`0.07
`0.93
`0.99
`0.15
`0.66
`0.12
`0.40
`
`Variable
`Bodily pain
`General health
`Mental composite score
`Mental health
`Physical composite score
`Physical function
`Role emotional
`Role physical
`Social function
`Vitality
`
`Adapted from SF-36 Health Survey: Manual & Interpretation Guide.13
`* The mean age of Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE) patients in this analysis is 65.1 years (median 65.0 years).
`
`TABLE V. Comparison of pretreatment demographics by period and risk category
`Intermediate
`Risk
`1997–
`2000–
`1999
`2003
`(%)
`(%)
`
`Low Risk
`1997–
`2000–
`1999
`2003
`(%)
`(%)
`
`P Value
`0.11
`
`P Value
`0.43
`
`High Risk
`1997–
`2000–
`1999
`2003
`(%)
`(%)
`
`Demographic
`Age at diagnosis (yr)
`⬍60
`60–70
`⬎70
`Race/ethnicity
`Native American
`Asian American
`Latino
`African American
`White
`Other
`Education level
`High school or less
`High school graduate
`Some college
`College graduate
`Comorbidities
`0
`1–2
`ⱖ3
`BMI
`Normal (⬍25)
`Overweight (25–29)
`Obese (ⱖ30)
`Insurance
`Medicare supplement
`Medicare
`Private
`Other
`BMI ⫽ body mass index.
`
`27
`54
`19
`
`0
`2
`2
`11
`85
`1
`
`12
`27
`20
`41
`
`18
`53
`29
`
`32
`55
`13
`
`26
`12
`60
`1
`
`32
`44
`24
`
`0
`1
`1
`4
`93
`1
`
`10
`25
`21
`45
`
`16
`56
`28
`
`24
`52
`24
`
`30
`10
`57
`3
`
`0.03
`
`0.74
`
`0.76
`
`0.01
`
`0.44
`
`21
`46
`33
`
`0
`0
`6
`11
`83
`1
`
`18
`22
`16
`44
`
`14
`53
`33
`
`23
`51
`26
`
`33
`20
`47
`0
`
`26
`40
`34
`
`0
`1
`1
`5
`92
`1
`
`17
`26
`18
`38
`
`15
`54
`31
`
`26
`52
`22
`
`34
`13
`50
`4
`
`0.06
`
`0.60
`
`0.91
`
`0.65
`
`0.04
`
`16
`31
`53
`
`0
`5
`0
`11
`82
`2
`
`13
`27
`21
`39
`
`15
`52
`34
`
`31
`48
`21
`
`34
`24
`41
`0
`
`19
`38
`43
`
`0
`1
`2
`9
`88
`1
`
`15
`28
`19
`37
`
`12
`58
`30
`
`25
`48
`26
`
`36
`16
`44
`4
`
`80
`
`UROLOGY 66 (Supplement 5A), November 2005
`
`P Value
`0.31
`
`0.08
`
`0.95
`
`0.62
`
`0.56
`
`0.18
`
`

`
`TABLE VI. Comparison of demographics by risk group: 1997–2003
`Demographics
`Low Risk, n (%)
`Intermediate Risk, n (%)
`High Risk, n (%)
`Age at diagnosis (yr)
`⬍60
`60–70
`⬎70
`Race/ethnicity
`Native American
`Asian American
`Latino
`African American
`White
`Other
`Education level
`High school or less
`High school graduate
`Some college
`College graduate
`Comorbidities
`0
`1–2
`ⱖ3
`BMI
`Normal (⬍25.0)
`Overweight (25.0–29.0)
`Obese (ⱖ30.0)
`Insurance
`Medicare supplement
`Medicare
`Private
`Other
`BMI ⫽ body mass index.
`
`P Value
`⬍0.0001
`
`0.0208
`
`⬍0.0001
`
`0.1643
`
`0.8491
`
`⬍0.0001
`
`89 (18)
`187 (38)
`217 (44)
`
`1 (⬍1)
`6 (1)
`7 (1)
`49 (10)
`423 (86)
`6 (1)
`
`76 (16)
`132 (28)
`95 (20)
`177 (37)
`
`60 (12)
`277 (57)
`146 (30)
`
`128 (27)
`232 (49)
`115 (24)
`
`172 (37)
`73 (16)
`199 (43)
`16 (3)
`
`363 (31)
`529 (45)
`281 (24)
`
`4 (⬍1)
`10 (1)
`14 (1)
`61 (5)
`1074 (92)
`10 (1)
`
`121 (10)
`288 (25)
`237 (21)
`509 (44)
`
`191 (17)
`638 (55)
`324 (28)
`
`292 (26)
`593 (52)
`260 (23)
`
`334 (30)
`121 (11)
`648 (57)
`26 (2)
`
`217 (24)
`366 (41)
`303 (34)
`
`2 (⬍1)
`5 (1)
`20 (2)
`54 (6)
`800 (90)
`5 (1)
`
`154 (18)
`220 (25)
`151 (17)
`341 (39)
`
`125 (14)
`470 (54)
`271 (31)
`
`219 (26)
`442 (52)
`192 (23)
`
`294 (35)
`112 (13)
`410 (49)
`25 (3)
`
`termediate- or high-risk patients were Latino or
`African American (Table VI).
`
`DISCUSSION
`Based on this above analysis, the average prostate
`cancer patient diagnosed currently is aged 65
`years, white, overweight, and educated at a level
`above the national average,15 with 1 to 2 comor-
`bidities and private insurance. Most patients
`present at an early clinical stage, with a PSA ⬍10
`ng/mL, and may be classified as low risk. Further-
`more, newly diagnosed patients will report average
`to above-average HRQOL at the time of diagnosis
`based on widely validated scales. Men in this study
`generally scored at or above national means for
`sexual, urinary, and bladder function and bother
`on the UCLA-PCI inventory.12 Similarly, patients
`in the CaPSURE cohort scored at or above pub-
`lished means for age-matched populations on the
`SF-36.13 The improvement in urinary and sexual
`function domains noted in more contemporary pa-
`tients may reflect the increasing use of screening in
`asymptomatic patients instead of limiting screen-
`ing to those presenting to urologists with symp-
`toms such as urinary changes and sexual function.
`
`Not surprisingly, increasing risk category corre-
`lated with older patient age at diagnosis and eth-
`nicity. African American and Latino men are
`known to be at increased risk of prostate cancer
`diagnosis and death, and generally present at a
`later stage.1 Level of education has been correlated
`with increased prostate cancer screening, which
`may explain why higher level of educational attain-
`ment correlates with lower risk.16 The explanation
`for the significant association between insurance
`status and increased risk may reflect increased pa-
`tient age, as older patients are more likely to have
`Medicare insurance, although this area merits fur-
`ther investigation.
`Despite the well-documented stage migration in
`prostate cancer, more patients in this study chose
`radical prostatectomy as initial treatment. In con-
`trast, the percentage of patients who chose watch-
`ful waiting was low (1% to 2%) and unchanged
`across the periods examined. These findings may
`be a reflection of the CaPSURE cohort, in which
`patients are recruited by urologists at the time of
`prostate cancer diagnosis. Several reports have
`shown that patient treatment choice tends to re-
`flect physician specialty.17,18 Of interest is the fact
`
`UROLOGY 66 (Supplement 5A), November 2005
`
`81
`
`

`
`that many men are overweight or obese and have
`significant associated comorbidities. Such patients
`are more likely to have competing causes of death
`and present with worse QOL not only at baseline
`but also over time.19,20
`With the combination of generally average to
`above-average HRQOL and low-risk disease, men
`with newly diagnosed prostate cancer face the pos-
`sibility of significant decline in QOL with all forms
`of treatment with the possible exception of active
`surveillance. In contrast, men with early-stage dis-
`ease have excellent chances for cure with many
`different choices of therapy. Physicians should
`consider baseline QOL and patient age and health
`status when counseling them about treatment
`choices.
`
`CONCLUSION
`The results of our investigation indicate that the
`average prostate cancer patient is low-risk, edu-
`cated at a level above the national mean, with av-
`erage to above-average scores on all domains of
`widely validated QOL scales. The dual goals of
`treatment for newly diagnosed prostate cancer in
`the 21st century will be to cure the patient’s disease
`while maximizing and maintaining HRQOL.
`
`REFERENCES
`1. Jemal A, Murray T, Ward E, et al: Cancer statistics,
`2005. CA Cancer J Clin 55: 10 –30, 2005.
`2. Cooperberg MR, Lubeck DP, Mehta SS, et al: Time
`trends in clinical risk stratification for prostate cancer: impli-
`cations for outcomes (data from CaPSURE). J Urol 170
`(suppl): S21–S27, 2003.
`3. Wei JT, Dunn RL, Sandler HM, et al: Comprehensive
`comparison of health-related quality of life after contemporary
`therapies for localized prostate cancer. J Clin Oncol 20: 557–
`566, 2002.
`4. Johansson JE, Andren O, Andersson SO, et al: Natural
`history of early, localized prostate cancer. JAMA 291: 2713–
`2719, 2004.
`5. Lubeck DP, Litwin MS, Henning JM, et al: Measure-
`ment of health-related quality of life in men with prostate
`
`cancer: the CaPSURE database. Qual Life Res 6: 385–392,
`1997.
`6. Talcott JA, and Clark JA: Quality of life in prostate
`cancer. Eur J Cancer 41: 922–931, 2005.
`7. Lubeck DP, Litwin MS, Henning JM, et al, for the CaP-
`SURE [Cancer of the Prostate Strategic Urologic Research En-
`deavor] Research Panel: The CaPSURE database: a methodol-
`ogy for clinical practice and research in prostate cancer.
`Urology 48: 773–777, 1996.
`8. Litwin MS, Hays RD, Fink A, et al: The UCLA Prostate
`Cancer Index: development, reliability, and validity of a
`health-related quality of life measure. Med Care 36: 1002–
`1012, 1998.
`9. Ware JE Jr, and Sherbourne CD: The MOS 36-item
`short-form health survey (SF-36). I. Conceptual framework
`and item selection. Med Care 30: 473– 483, 1992.
`10. Ware JE Jr, and Gandek B: Overview of the SF-36
`Health Survey and the International Quality of Life Assess-
`ment (IQOLA) Project. J Clin Epidemiol 51: 903–912, 1998.
`11. Lev EL, Eller LS, Gejerman G, et al: Quality of life of
`men treated with brachytherapies for prostate cancer. Health
`Qual Life Outcomes 2: 28, 2004.
`12. Litwin MS: Health related quality of life in older men
`without prostate cancer. J Urol 161: 1180 –1184, 1999.
`13. Ware JE Jr, Kosinski M, and Gandek B: SF-36 Health
`Survey: Manual & Interpretation Guide. Lincoln, Rhode Island,
`QualityMetric Incorporated, 1993, p 10.
`14. D’Amico AV, Whittington R, Malkowicz SB, et al: Bio-
`chemical outcome after radical prostatectomy, external beam
`radiation therapy, or interstitial radiation therapy for clinically
`localized prostate cancer. JAMA 280: 969 –974, 1998.
`15. United States Census 2000, 2000. Available at: http://
`www.census.gov. Accessed April 24, 2005.
`16. Steenland K, Rodriguez C, Mondul A, et al: Prostate
`cancer incidence and survival in relation to education (United
`States). Cancer Causes Control 15: 939 –945, 2004.
`17. Fowler JE, Flanagan M, Gleason DM, et al: Evaluation
`of an implant that delivers leuprolide for 1 year for the pallia-
`tive treatment of prostate cancer. Urology 55: 639 – 642, 2000.
`18. Donovan JL, Frankel SJ, Faulkner A, et al: Dilemmas in
`treating early prostate cancer: the evidence and a question-
`naire survey of consultant urologists in the United Kingdom.
`BMJ 318: 299 –300, 1999.
`19. Freedland SJ, Isaacs WB, Mangold LA, et al: Stronger
`association between obesity and biochemical progression after
`radical prostatectomy among men treated in the last 10 years.
`Clin Cancer Res 11: 2883–2888, 2005.
`20. Anast JW, Sadetsky N, Pasta DJ, et al: The impact of
`obesity on health related quality of life before and after radical
`prostatectomy (data from CaPSURE). J Urol 173: 1132–1138,
`2005.
`
`82
`
`UROLOGY 66 (Supplement 5A), November 2005

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket