Download Full text

VOLUME
29
䡠
NUMBER
4
䡠
FEBRUARY
1
2011
JOURNAL OF CLINICAL ONCOLOGY
O R I G I N A L
R E P O R T
Comparison of Health-Related Quality of Life 5 Years After
SPIRIT: Surgical Prostatectomy Versus Interstitial Radiation
Intervention Trial
Juanita Mary Crook, Alfonso Gomez-Iturriaga, Kris Wallace, Clement Ma, Sharon Fung, Shabbir Alibhai,
Michael Jewett, and Neil Fleshner
From the University of Toronto, University Health Network, and Princess
Margaret Hospital, Toronto, Ontario,
Canada.
Submitted July 27, 2010; accepted
October 25, 2010; published online
ahead of print at www.jco.org on
December 13, 2010.
Presented at the American Society of
Clinical Oncology 2010 Genitourinary
Cancers Symposium, March 5-7,
2010, San Francisco, CA, and American Brachytherapy Society 2010
Annual Meeting, April 29-May 1,
2010, Atlanta, GA.
Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this
article.
Corresponding author: Juanita Mary
Crook, MD, FRCPC, British Columbia
Cancer Agency, Center for the Southern Interior, 399 Royal Ave, Kelowna,
BC, Canada, V1Y 5L3; e-mail: jcrook@
bccancer.bc.ca.
© 2010 by American Society of Clinical
Oncology
0732-183X/11/2904-362/$20.00
DOI: 10.1200/JCO.2010.31.7305
A
B
S
T
R
A
C
T
Purpose
The American College of Surgeons Oncology Group phase III Surgical Prostatectomy Versus
Interstitial Radiation Intervention Trial comparing radical prostatectomy (RP) and brachytherapy
(BT) closed after 2 years due to poor accrual. We report health-related quality of life (HRQOL) at
a mean of 5.3 years for 168 trial-eligible men who either chose or were randomly assigned to RP
or BT following a multidisciplinary educational session.
Patients and Methods
After initial lack of accrual, a multidisciplinary educational session was introduced for eligible
patients. In all, 263 men attended 47 sessions. Of those, 34 consented to random assignment, 62
chose RP, and 94 chose BT. Five years later, these 190 men underwent HRQOL evaluation by
using the cancer-specific 50-item Expanded Prostate Cancer Index Composite, the Short Form 12
Physical Component Score, and Short Form 12 Mental Component Score. Response rate was
88.4%. The Wilcoxon rank sum test was used to compare summary scores between the
two interventions.
Results
Of 168 survey responders, 60.7% had BT (9.5% randomly assigned) and 39.3% had RP (9.5%
randomly assigned). Median age was 61.4 years for BT and 59.4 for RP (P ⫽ .05). Median follow-up
was 5.2 years (range, 3.2 to 6.5 years). For BT versus RP, there was no difference in bowel or
hormonal domains, but men treated with BT scored better in urinary (91.8 v 88.1; P ⫽ .02) and
sexual (52.5 v 39.2; P ⫽ .001) domains, and in patient satisfaction (93.6 v 76.9; P ⬍ .001).
Conclusion
Although treatment allocation was random in only 19%, all patients received identical information
in a multidisciplinary setting before selecting RP, BT, or random assignment. HRQOL evaluated
3.2 to 6.5 years after treatment showed an advantage for BT in urinary and sexual domains and in
patient satisfaction.
J Clin Oncol 29:362-368. © 2010 by American Society of Clinical Oncology
INTRODUCTION
Radical prostatectomy (RP) and permanent seed
prostate brachytherapy (BT) are commonly offered
as definitive management for favorable-risk prostate
cancer (Gleason score ⱕ 6, prostate-specific antigen
[PSA] ⬍ 10, stage T1 to T2a)1 and are generally
considered to be equally effective.2-5 Since overall
survival following either intervention is ⬎ 90% at 10
years,6,7 the effect of treatment on health-related
quality of life (HRQOL) is important in decision
making. Given the lack of good clinical comparative
data, many patients make treatment decisions on
the basis of anecdotal experience or unsubstantiated opinion.
362
Because no randomized clinical trials had successfully addressed relative efficacy or quality of life
(QOL) following RP or BT,8-12 the American College of Surgeons Oncology Group (ACOSOG) undertook a phase III randomized trial to compare
overall survival, treatment efficacy, and QOL for
men with favorable-risk prostate cancer assigned to
one of these two options. The Surgical Prostatectomy Versus Interstitial Radiation Intervention
Trial (SPIRIT; ACOSOG Z0070) received Cancer
Therapy Evaluation Program (CTEP) approval in
2002 and subsequently opened in 31 centers across
North America. Unfortunately SPIRIT closed prematurely in April 2004, having accrued only 56 of
the intended 1,980 patients in 2 years.
© 2010 by American Society of Clinical Oncology
Downloaded from jco.ascopubs.org on June 15, 2013. For personal use only. No other uses without permission.
Copyright © 2011 American Society of Clinical Oncology. All rights reserved.
Quality of Life 5 Years After Prostatectomy or Brachytherapy
To promote informed and unbiased patient decisions, trialeligible patients at the University Health Network (UHN) were invited
to attend a multidisciplinary educational session before undergoing
individual urology or radiation oncology consultations. Among the
men attending these sessions, 190 underwent either BT or RP, either
by choice or according to random assignment. These men are the
subject of this QOL comparison in a single snapshot at a median of 5.2
years following treatment.
Table 1. Summary Statistics by Intervention
Domain
Urinary
Bowel
Sexual
Hormonal
PATIENTS AND METHODS
SPIRIT received approval of the Institutional Review Board at the UHN in
May 2002 and was enthusiastically endorsed by the urologists and genitourinary radiation oncologists. Initially, eligible patients met with a research assistant (K.W.) and viewed the ACOSOG-developed educational video, but
despite support of the consultants, no consents were obtained among the first
39 eligible patients. We then developed a small-group, multidisciplinary patient education session to provide the balanced information required for
informed decision making.13 Weekly sessions for eligible new patients and
their partners were held to compare RP and BT in a multidisciplinary setting,
to establish the rationale for randomized trials in general, and to introduce SPIRIT.
Following referral to the UHN, eligible patients were contacted by
phone and invited to attend the 1.5-hour early evening session before their
urology or radiation oncology consultations. In a small group setting,
accompanied by their spouse, friend, or family member, they met with a
research assistant, watched the ACOSOG informed consent video, and
listened to a prostate cancer patient who explained to the group why he had
chosen to participate in a clinical trial. Then a urologist and radiation
oncologist joined the group and together compared and contrasted RP and
BT, covering such topics as the requirement for anesthesia, length of
hospital stay, impact on activities during recovery, nature of the PSA
response, long-term urinary and sexual function, and options for salvage.
Subsequently, over the next 7 to 10 days, the men would attend their
individual specialty consultations. If either specialist felt that on the basis of
prostate size, voiding function, comorbidities, or patient preference, an
individual was more suited to one treatment or the other (or neither), the
patient was informed of the recommendation and was not offered participation in the trial. Of the 268 men attending the sessions, 34 chose random
assignment to SPIRIT, 94 chose BT, and 62 chose surgery, the remainder
being directed toward external beam radiation therapy or surveillance.
Treatment took place between September 2002 and July 2005.
Treatment-related adverse effects generally stabilize within 3 years.14
Host hospital and university institutional review board approval was obtained
to approach these 190 men for a QOL study at a median of 5.2 years (range, 3.2
to 6.5 years). An initial phone call verified their contact information, explained
the reason for evaluating their QOL at this time, and assessed possible participation. If interest was expressed, the questionnaires were subsequently mailed
out. Six men were lost to follow-up and 16 either declined or did not return the
questionnaires, leaving 168 participants (response rate, 88.5%).
The HRQOL instruments chosen for this evaluation were the prostate
cancer–specific 50-item Expanded Prostate Cancer Index Composite
(EPIC),15 Short Form 12 Physical Component Score (SF-12 PCS), Short Form 12
Mental Component Score (SF-12 MCS),16 and items regarding comorbidities and
use of medications or devices to supplement erections. Both the EPIC and SF-12
instruments have excellent reliability and validity. Function and bother subscales
elucidate how symptoms relate to impairment in each domain.
Analysis
The four primary end points of clinical interest designated for planned
comparisons between the two interventions were the summary scores from
the four prostate cancer–specific EPIC domains: urinary incontinence, urinary
irritation/obstruction, sexual function, and bowel function. For each domain,
higher total scores imply a better HRQOL, with the majority of questions using
www.jco.org
Patient satisfaction
SF-12 PCS
SF-12 MCS
Intervention
Mean
SD
P
BT
RP
BT
RP
BT
RP
BT
RP
BT
RP
BT
RP
BT
RP
91.82
88.15
93.0
94.37
52.54
39.22
93.52
89.98
93.63
76.89
55.88
55.42
44.72
43.19
8.53
11.47
11.62
8.91
24.06
25.35
8.27
12.79
12.03
27.49
9.69
8.85
5.28
5.81
.02
.34
.001
.1
⬍ .001
.38
.04
Abbreviations: SD, standard deviation; BT, brachytherapy; RP, radical prostatectomy; SF-12 PCS, Short Form 12 Physical Component Score; SF-12 MCS,
Short Form 12 Mental Component Score.
Likert-type or similar ordinal response scales (eg, no, very small, small, moderate, big problem). Four primary comparisons were performed between the
intervention arms, with one comparison for each of the four primary EPIC
HRQOL domain measures by using a Wilcoxon rank sum test with consideration of the Bonferroni correction for multiple testing.17 The nonparametric
Mann-Whitney test was used to compare the summary scores of the two
interventions. The estimated difference between the two intervention arms
with the standard deviations (SDs) is presented for each of the four EPIC
domains (Table 1). The response distribution for representative EPIC items
(including domain-specific University of California, Los Angeles-Prostate
Cancer Index bother items) are tabulated and summarized via stacked bar
charts (Figs 1 and 2).
When comparing baseline characteristics and comorbidities, continuous
variables were compared by using analysis of variance (ANOVA) and categoric
variables using Fisher’s exact test. SAS version 9.1 (SAS Institute, Cary, NC)
and R version 2.7 (www.r-project.org) statistical software was used for
the analysis.
RESULTS
Sixty-six men were treated by RP (16 randomly assigned; 50 choice)
and 102 received BT (16 randomly assigned; 86 choice). The median
time from treatment to the QOL assessment was 5.2 years (range, 3.2
to 6.5 years). Median age of the entire cohort was 60 years (range, 45 to
73 years) with patients in the BT cohort being an average of 2 years
older than patients in the RP cohort (median age for BT, 61.4 years; for
RP, 59.4 years; P ⫽ .05). None of the comorbidities assessed, including
diabetes, heart disease, and hypertension, showed a difference between the two intervention cohorts (Table 2). Only 7.1% were current
smokers while 52.4% were former smokers, and 39.5% were lifetime
nonsmokers. A college education or higher was reported in 81.6%.
Mean baseline PSA was similar (5.5 ng/mL for BT and 5.3 ng/mL for
RP; P ⫽ .38), although mean baseline International Prostate Symptom Score (IPSS) was lower in the BT cohort (5.8 v 8.6; P ⫽ .02).
The results of comparison of the four cancer-specific EPIC
domains are provided in Table 1. There was no difference between
the two groups in the bowel or hormonal domains or in the SF-12
PCS. There was a borderline difference in the SF-12 MCS (P ⫽ .04),
a statistically significant difference in the urinary domain (P ⫽ .02),
© 2010 by American Society of Clinical Oncology
Downloaded from jco.ascopubs.org on June 15, 2013. For personal use only. No other uses without permission.
Copyright © 2011 American Society of Clinical Oncology. All rights reserved.
363
Crook et al
More than once a day
About once a day
More than once a week
About once a week
Rarely or never
P < .0001
90
70
60
50
40
Percentage
50
40
20
10
10
100
0
RP
More than once a day
About once a day
More than once a week
About once a week
Rarely or never
P = .18
80
70
60
50
40
B
60
50
40
20
10
0
RP
No problem
Very small problem
Small problem
Moderate problem
Big problem
P = .83
80
70
60
50
40
C
Very poor
Poor
Fair
Good
Very good
P = .003
80
70
60
50
40
30
20
10
10
RP
RP
90
20
BT
BT
100
30
0
Not firm enough for
any sexual activity
Firm enough for
masturbation and
foreplay only
Enough for intercourse
70
10
90
None at all
P = .002
80
30
100
RP
90
20
BT
BT
100
30
0
Percentage
60
30
90
C
70
20
BT
Very poor to none
Poor
Fair
Good
Very good
P = .007
80
30
0
B
100
90
Percentage
Percentage
80
A
Percentage
100
Percentage
A
0
BT
RP
Fig 1. Stacked bar charts on three selected questions from the Expanded
Prostate Cancer Index Composite urinary domain illustrating patient responses
for the two interventions concerning (A) urinary leakage, (B) pain and burning with
urination, and (C) weak stream or incomplete emptying. BT, brachytherapy; RP,
radical prostatectomy.
Fig 2. Stacked bar charts on three selected questions from the Expanded
Prostate Cancer Index Composite sexual domain illustrating patient responses
for the two interventions concerning (A) the ability to have an erection, (B) the
quality of erections, and (C) the ability to function sexually. BT, brachytherapy; RP,
radical prostatectomy.
and highly significant differences in the sexual domain (P ⫽ .001)
and patient satisfaction score (P ⬍ .001), all favoring BT.
Individual questions were examined within the urinary domain (Fig 1) to ascertain which symptoms predominated at 5 years.
Questions regarding how often urine leakage occurred, urinary
control, and the degree of problem with dripping or leaking urine
all showed a P value ⬍ .001 in favor of BT, whereas none of the
questions on irritative and obstructive symptoms, which might
persist in a BT population, showed a difference. In the sexual
domain, many of the questions showed a highly significant difference in favor of BT, including questions on the ability to have
an erection (P ⬍ .001), the quality of erections (P ⬍ .001), the
frequency of erections (P ⫽ .003), awakening with an erection
(P ⫽ .002), and the ability to function sexually (P ⫽ .003; Fig 2).
The associated degree of the problem with these changes, as evaluated by the “bother” scores of EPIC, also reached significance but
at levels of P ⫽ .02 to P ⫽ .049.
The median current PSA for the RP cohort is ⬍ 0.05 ng/mL
(mean, 0.03 ng/mL; SD, 0.19) and for the BT cohort, it is 0.05
ng/mL (mean, 0.15 ng/mL; SD, 0.36) Readings reported as ⬍ 0.05
ng/mL were treated as zero.
364
© 2010 by American Society of Clinical Oncology
JOURNAL OF CLINICAL ONCOLOGY
Downloaded from jco.ascopubs.org on June 15, 2013. For personal use only. No other uses without permission.
Copyright © 2011 American Society of Clinical Oncology. All rights reserved.
Quality of Life 5 Years After Prostatectomy or Brachytherapy
valid summary scores. Whether evaluated as small, singleinstitution studies19,25 or as population-based assessments, it is
expected that HRQOL will have stabilized 2 to 3 years after RP.14,21
Physician-reported data suggest that men undergoing prostate
BT are also prone to urinary, bowel, and sexual adverse effects. Urinary symptoms are largely irritative and obstructive (ie, frequency,
nocturia, and dysuria) and are at their worst in the first 2 to 6 months,
improving by 12 months.26-28 However, as is the case after RP,
physician-reported morbidity may underestimate adverse HRQOL
effects when compared with patient-reported data.
Table 2. Baseline Characteristics
Characteristic
Age, years
Median
SD
IPSS
Median
SD
PSA, ng/mL
Median
SD
Potency
Medications for DM,
HT, or CVD
Brachytherapy
Prostatectomy
No.
No.
%
%
P
.05
61.4
6.2
59.4
5.9
5.8
4.7
8.6
7.0
5.5
2.1
5.3
2.8
.02
.38
87.1
94.8
.17
50
40.9
.27
Abbreviations: SD, standard deviation; IPSS: International Prostate Symptom
Score; PSA, prostate-specific antigen; DM, diabetes mellitus; HT, hypertension; CVD, cardiovascular disease.
All BT procedures were performed by one experienced individual (J.M.C.). However, patients referred from a community urologist
who declined the trial and chose surgery returned to their referring
urologist. Thus, 30% of the prostatectomies were performed in the
community rather than at the UHN. Table 3 provides the summary
results for each domain compared between randomly assigned patients in SPIRIT and those who followed their preference (choice), and
Table 4 for UHN surgeons compared with community surgeons.
DISCUSSION
Urinary incontinence and erectile dysfunction are recognized as
common sequelae of RP12,18,19 and have been evaluated in many
single-institution studies by using physician-reported data. However, adverse urinary and sexual HRQOL effects are more prevalent
when using patient-reported data.20-24 Prospective assessment of
postprostatectomy HRQOL using validated HRQOL instruments
allows the outcomes to be expressed in psychometrically robust,
Instruments for Evaluating HRQOL after RP or BT
Prostate intervention–related symptoms can be measured by
various instruments that include subscales to measure urinary, bowel,
and sexual function. One such instrument, the 20-item University of
California, Los Angeles-Prostate Cancer Index, was revised following
input from patients and physicians15 to create the 50-item EPIC. EPIC
was validated in a cohort comprising controls and patients with prostate cancer who had undergone RP, BT, or external beam radiation.11
The advantages of EPIC include the presence of multi-item bother
scales for each HRQOL domain, the addition of irritative urinary
symptoms and bother assessment, and improved bowel domain characteristics to evaluate hematochezia, the most common bowel toxicity
after irradiation. Treatment-related changes can thus be separated
into five discrete domains: urinary incontinence, urinary irritation/
obstruction, and sexual, bowel, and hormonal functions. Changes in
these intrinsic visceral functions may dramatically alter QOL, indirectly affecting psychosocial function and emotional distress, as measured by the SF-12 PCS or SF-12 MCS scores. The combination of
EPIC and the two SF-12 forms provides a valid measure of HRQOL
related to prostate cancer therapy.
Urinary and bowel domains do not show marked differences
related to interval of follow-up from 2 years to 4 years after intervention, regardless of whether a patient undergoes RP or BT. Assessment
during this steady-state allows the long-term, stable effects of RP and
BT on HRQOL function to be described before possible HRQOL
effects from cancer recurrence or progression might occur that could
complicate data analysis. Such an analysis was planned in the QOL
companion study to SPIRIT—ACOSOG Z0071.
Table 3. Summary Statistics by Intervention to Compare Patients Randomly Assigned to SPIRIT With Patients Who Had a Choice Within Each Intervention
Domain
Urinary
Sexual
Patient satisfaction
Intervention
No. of
Patients
Mean
SD
P
BT SPIRIT
BT choice
RP SPIRIT
RP choice
BT SPIRIT
BT choice
RP SPIRIT
RP choice
BT SPIRIT
BT choice
RP SPIRIT
RP choice
15
86
15
52
15
84
15
52
15
86
15
52
93.37
91.54
82.87
89.83
61.1
50.91
38.54
39.43
98.44
92.73
79.69
76.0
3.36
9.16
12.05
10.86
25.72
23.55
28.86
24.44
6.25
12.64
29.18
27.18
.82
.02ⴱ
.09
.86
.08
.43
Abbreviations: SPIRIT, Surgical Prostatectomy Versus Interstitial Radiation Intervention Trial; SD, standard deviation; BT, brachytherapy; RP, radical prostatectomy.
ⴱ
Not significant after Bonferroni correction.
www.jco.org
© 2010 by American Society of Clinical Oncology
Downloaded from jco.ascopubs.org on June 15, 2013. For personal use only. No other uses without permission.
Copyright © 2011 American Society of Clinical Oncology. All rights reserved.
365
Crook et al
Table 4. Summary Statistics to Compare UHN Surgery With Community Surgery Within Each Domain
Domain
Urinary
Sexual
Patient satisfaction
Surgery Site
No. of Patients
Mean
SD
P
UHN
Community
UHN
Community
UHN
Community
47
20
47
20
47
20
87.98
88.52
39.32
38.97
79.89
70.0
10.38
13.95
26.74
22.47
27.7
26.41
.45
1.0
.06
Abbreviations: UHN, University Health Network; SD, standard deviation.
The experience with SPIRIT illustrates the difficulty in undertaking a comparison of established competing treatments in a randomized trial. Even when the involved specialists can achieve and maintain
a neutral stance, the North American patient-consumer can be quite
partisan. In contrast, Giberti et al29 recently published a randomized
comparison of RP and BT in which 200 men were randomly assigned
in a single Italian center over a 3.5-year period. The article does not
discuss methods of recruitment or difficulties encountered in obtaining informed consent. SPIRIT has demonstrated that such an achievement is not possible in North America. Our multidisciplinary patient
education session was strikingly successful compared with experience
in other centers, resulting in 34 of the 52 consents to SPIRIT obtained
across North America in a 2-year period. Even so, our recruitment rate
was only 1 in 6.
Given the experience with SPIRIT and the expense involved in
undertaking a large-scale, multicenter randomized trial, it is unlikely
that this question will be readdressed in a randomized study in North
America. This does not, however, preclude prospective collection of
HRQOL data in a nonrandomized setting such as a registration trial
conducted in a manner similar to this study. If all men are equally well
informed about both treatment options and considered equally appropriate for either, then the HRQOL comparison should be valid. In
the present report, 19% of the participants were randomly assigned
and although the numbers are small, their results were consistent with
the overall results (Table 3).
Patients are willing to accept self-limited acute adverse effects
associated with recovery. These have been well documented for both
modalities and are quite different. Late effects have been less well
documented and, at the time of this study, never compared in a
randomized trial. Since PSA screening has reduced the age at diagnosis
of prostate cancer by a decade, long-term QOL considerations are
even more important in treatment choice. The need for reliable data is
paramount. It has been well established that physician-reported QOL
and adverse effects frequently underestimate their frequency, severity,
and importance. This study has the advantage of not only being
patient-reported but also of patient anonymity; the questionnaires
were not administered or discussed with the patients by any of the
treating physicians.
Some limitations of this study need to be acknowledged. All
the BT procedures were performed by one experienced operator
who has published extensively on prostate BT, quality assurance,
and predictors of morbidity.28,30-32 The degree of satisfaction with
BT expressed by the study cohort may not translate directly to the
wider practice of BT. In contrast to the BT cohort, 30% of men
undergoing RP returned to their community urologist for surgery.
366
© 2010 by American Society of Clinical Oncology
In addition, there were slightly more nonresponders from the RP
cohort (16%) compared with the BT cohort (8.5%). Finally, since
the same HRQOL instruments were not used at baseline, a change
from baseline could not be evaluated for the individual patient.
Although there was no difference in the reported distribution of
medical comorbidities, age may affect the sexual and urinary effects of prostate cancer treatment.33 Nonetheless, the BT cohort
still fared better in the urinary and sexual domain despite being 2
years older than the RP cohort. Baseline urinary and sexual function may have influenced patients’ choices of treatment modality;
the RP cohort did have a higher IPSS at baseline, but prior potency
was reported at a similar frequency in both cohorts.
A recently published randomized trial by Giberti et al29 involved
a similar patient cohort with favorable-risk prostate cancer and similar
exclusion criteria, although men in the Giberti trial were an average of
5 years older. All surgical patients had bilateral nerve-sparing surgery
performed by the same surgeon. At the 5-year follow-up (available for
87%), Giberti et al reported no significant differences in urinary or
sexual function between BT and RP. Mild postoperative incontinence
was seen in 13% of the patients who recovered spontaneously, while
those with severe incontinence had corrective surgery. Good erectile
function at 5 years was reported in 65% of RP and 68% of BT patients
(78% at 1 year).
In contrast, in this study, a statistically significant difference in
favor of BT was found in the both the urinary and sexual domains.
Although specific questions relating to incontinence showed a highly
significant difference (P ⬍ .001), overall the mean scores in the urinary
domain were separated by only a 3.7-point difference (P ⫽ .02), which
is equivalent to a small effect size34 and may have questionable clinical
significance (Appendix, online only). Although bilateral nerve sparing
was the surgical standard for RP at the UHN, men operated on in the
community fared equally well in the sexual domain (Table 4). Overall,
erections firm enough for sexual activity were reported by 79% of men
treated with BT compared with 48% of those treated by RP (P ⬍ .001),
and 66% of men after BT had erections at least half the time when they
wanted as compared with 40% after surgery (P ⫽ .003). In terms of
erectile aids, no patients had penile prostheses, 63% were using phosphodiesterase 5 (PDE-5) with the addition of penile injections in 5%,
2% were using Muse, and 2% a vacuum device. There was no difference in the use of PDE-5 between the two interventions, but more men
in the RP group used injections, Muse, or a vacuum device (7 v 1).
Giberti et al29 do not mention PDE-5 use, the encouragement of which
in our BT population may have prevented a late decline in erectile function.
JOURNAL OF CLINICAL ONCOLOGY
Downloaded from jco.ascopubs.org on June 15, 2013. For personal use only. No other uses without permission.
Copyright © 2011 American Society of Clinical Oncology. All rights reserved.
Quality of Life 5 Years After Prostatectomy or Brachytherapy
Clearly there is a need for long-term comparative outcomes for
QOL after definitive treatment for early-stage favorable-risk prostate
cancer. Although an active surveillance approach is becoming more
widespread,35 especially for older men, many younger men and their
physicians are more comfortable with definitive treatment, especially
given the lack of ability to monitor progression of disease with certainty. To make an informed choice on treatment versus surveillance,
and specifically which type of treatment, an accurate representation of
the tradeoffs is necessary.
It should be recalled that this report is essentially a single-center
study, with all BT performed by a single operator and the majority of
the surgery done by two experienced university urologists. It was not
our intent, when these men in the study cohorts first presented, to
enter into this type of HRQOL comparison. A prospective multicenter
registration study with a larger number of patients for comparing
these modalities, such as that recently published by Sanda et al36
assessing the evolution of early toxicity, will undoubtedly yield worthwhile data with longer follow-up.
In conclusion, the 168 men in this QOL cohort were fully informed about their treatment options and were felt to be equally
appropriate for either RP or BT. Five years after treatment with one of
these two options, either by choice or by random assignment, a QOL
REFERENCES
1. D’Amico AV, Vogelzang NJ: Prostate brachytherapy: Increasing demand for the procedure despite the lack of standardized quality assurance and
long term outcome data. Cancer 86:1632-1634,
1999
2. Potters L, Morgenstern C, Calugaru E, et al:
12-year outcomes following permanent prostate
brachytherapy in patients with clinically localized
prostate cancer. J Urol 173:1562-1566, 2005
3. D’Amico AV, Whittington R, Malkowicz SB, et
al: Biochemical outcome after radical prostatectomy, external beam radiation therapy, or interstitial
radiation therapy for clinically localized prostate cancer. JAMA 280:969-974, 1998
4. Polascik TJ, Pound CR, DeWeese TL, et al:
Comparison of radical prostatectomy and iodine 125
interstitial radiotherapy for the treatment of clinically
localized prostate cancer: A 7-year biochemical (PSA)
progression analysis. Urology 51:884-889, 1998; discussion 889-890
5. Stokes SH: Comparison of biochemical
disease-free survival of patients with localized carcinoma of the prostate undergoing radical prostatectomy, transperineal ultrasound-guided radioactive
seed implantation, or definitive external beam irradiation. Int J Radiat Oncol Biol Phys 47:129-136,
2000
6. Pound CR, Partin AW, Eisenberger MA, et al:
Natural history of progression after PSA elevation
following radical prostatectomy. JAMA 281:15911597, 1999
7. Ragde H, Blasko JC, Grimm PD, et al: Brachytherapy for clinically localized prostate cancer: Results at 7- and 8-year follow-up. Semin Surg Oncol
13:438-443, 1997
8. Davis JW, Kuban DA, Lynch DF, et al: Quality
of life after treatment for localized prostate cancer:
Differences based on treatment modality. J Urol
166:947-952, 2001
www.jco.org
assessment shows an advantage for BT over RP in the urinary and
sexual domains and also in patient satisfaction.
AUTHORS’ DISCLOSURES OF POTENTIAL CONFLICTS
OF INTEREST
The author(s) indicated no potential conflicts of interest.
AUTHOR CONTRIBUTIONS
Conception and design: Juanita Mary Crook, Shabbir Alibhai,
Neil Fleshner
Administrative support: Kris Wallace
Provision of study materials or patients: Juanita Mary Crook, Kris
Wallace, Michael Jewett, Neil Fleshner
Collection and assembly of data: Alfonso Gomez-Iturriaga, Kris Wallace
Data analysis and interpretation: Juanita Mary Crook, Clement Ma,
Sharon Fung, Shabbir Alibhai
Manuscript writing: Juanita Mary Crook, Alfonso Gomez-Iturriaga, Kris
Wallace, Clement Ma, Sharon Fung, Shabbir Alibhai, Michael Jewett,
Neil Fleshner
Final approval of manuscript: Juanita Mary Crook, Alfonso
Gomez-Iturriaga, Kris Wallace, Clement Ma, Sharon Fung, Shabbir
Alibhai, Michael Jewett, Neil Fleshner
9. Stone NN, Stock RG: Practical considerations
in permanent brachytherapy for localized adenocarcinoma of the prostate. Urol Clin North Am 30:351362, 2003
10. Lee WR, Hall MC, McQuellon RP, et al: A
prospective quality-of-life study in men with clinically localized prostate carcinoma treated with radical prostatectomy, external beam radiotherapy, or
interstitial brachytherapy. Int J Radiat Oncol Biol
Phys 51:614-623, 2001
11. 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
12. Bacon CG, Giovannucci E, Testa M, et al: The
impact of cancer treatment on quality of life outcomes for patients with localized prostate cancer.
J Urol 166:1804-1810, 2001
13. Wallace K, Fleshner N, Jewett M, et al: Impact of a multi-disciplinary patient education session
on accrual to a difficult clinical trial: The Toronto
experience with the surgical prostatectomy versus
interstitial radiation intervention trial. J Clin Oncol
24:4158-4162, 2006
14. Miller DC, Sanda MG, Dunn RL, et al: Longterm outcomes among localized prostate cancer
survivors: Health-related quality-of-life changes after radical prostatectomy, external radiation, and
brachytherapy. J Clin Oncol 23:2772-2780, 2005
15. Wei JT, Dunn RL, Litwin MS, et al: Development and validation of the expanded prostate cancer
index composite (EPIC) for comprehensive assessment of health-related quality of life in men with
prostate cancer. Urology 56:899-905, 2000
16. Resnick B, Nahm ES: Reliability and validity
testing of the revised 12-item Short-Form Health
Survey in older adults. J Nurs Meas 9:151-161, 2001
17. Perneger TV: What’s wrong with Bonferroni
adjustments. BMJ 316:1236-1238, 1998
18. Dillioglugil O, Leibman BD, Leibman NS, et al:
Risk factors for complications and morbidity after
radical retropubic prostatectomy. J Urol 157:17601767, 1997
19. Dalkin BL, Christopher BA, Shawler D: Health
related quality of life outcomes after radical prostatectomy: Attention to study design and the patientbased importance of single-surgeon studies. Urol
Oncol 24:28-32, 2006
20. Talcott JA, Rieker P, Clark JA, et al: Patientreported symptoms after primary therapy for early
prostate cancer: Results of a prospective cohort
study. J Clin Oncol 16:275-283, 1998
21. Talcott JA, Manola J, Clark JA, et al: Time course
and predictors of symptoms after primary prostate cancer therapy. J Clin Oncol 21:3979-3986, 2003
22. Potosky AL, Legler J, Albertsen PC, et al:
Health outcomes after prostatectomy or radiotherapy for prostate cancer: Results from the Prostate
Cancer Outcomes Study. J Natl Cancer Inst 92:
1582-1592, 2000
23. Madalinska JB, Essink-Bot ML, de Koning HJ,
et al: Health-related quality-of-life effects of radical
prostatectomy and primary radiotherapy for screendetected or clinically diagnosed localized prostate
cancer. J Clin Oncol 19:1619-1628, 2001
24. Schapira MM, Lawrence WF, Katz DA, et al:
Effect of treatment on quality of life among men
with clinically localized prostate cancer. Med Care
39:243-253, 2001
25. Brandeis JM, Litwin MS, Burnison CM, et al:
Quality of life outcomes after brachytherapy for early
stage prostate cancer. J Urol 163:851-857, 2000
26. Keyes M, Miller S, Moravan V, et al: Predictive
factors for acute and late urinary toxicity after permanent prostate brachytherapy: Long-term outcome in 712 consecutive patients. Int J Radiat Oncol
Biol Phys 73:1023-1032, 2009
27. Merrick GS, Butler WM, Wallner KE, et al:
Long-term urinary quality of life after permanent
prostate brachytherapy. Int J Radiat Oncol Biol Phys
56:454-461, 2003
28. Crook J, Fleshner N, Roberts C, et al: Longterm urinary sequelae following 125iodine prostate
brachytherapy. J Urol 179:141-145, 2008
29. Giberti C, Chiono L, Gallo F, et al: Radical
retropubic prostatectomy versus brachytherapy for
© 2010 by American Society of Clinical Oncology
Downloaded from jco.ascopubs.org on June 15, 2013. For personal use only. No other uses without permission.
Copyright © 2011 American Society of Clinical Oncology. All rights reserved.
367
Crook et al
low-risk prostatic cancer: A prospective study.
World J Urol 27:607-612, 2009
30. Crook J, Patil N, Ma C, et al: Magnetic resonance imaging-defined treatment margins in iodine125 prostate brachytherapy. Int J Radiat Oncol Biol
Phys 77:1079-1084, 2010
31. Neill M, Studer G, Le L, et al: The nature and
extent of urinary morbidity in relation to prostate
brachytherapy urethral dosimetry. Brachytherapy
6:173-179, 2007
32. Martens C, Pond G, Webster D, et al: Relationship of the International Prostate Symptom
score with urinary flow studies, and catheterization
rates following 125I prostate brachytherapy. Brachytherapy 5:9-13, 2006
33. Stanford JL, Feng Z, Hamilton AS, et al:
Urinary and sexual function after radical prostatectomy for clinically localized prostate cancer: The
Prostate Cancer Outcomes Study. JAMA 283:354360, 2000
34. Cohen J: Statistical Power Analysis for the Behavioral Sciences (ed 2). Hillsdale, New Jersey, 1988
35. Klotz L, Zhang L, Lam A, et al: Clinical results
of long-term follow-up of a large, active surveillance
cohort with localized prostate cancer. J Clin Oncol
28:126-131, 2010
36. Sanda MG, Dunn RL, Michalski J, et al:
Quality of life and satisfaction with outcome
among prostate-cancer survivors. N Engl J Med
358:1250-1261, 2008
■ ■ ■
Journal of Clinical Oncology: The Ideal Place to Publish Your Research
• Impact Factor of 17.793: JCO’s published arcles were cited 104,253 mes and accounted for fully 9.7% of all
oncology journal citaons in 2009.
• Rapid Turnaround: JCO averages just 9 weeks from final manuscript acceptance to online publicaon.
• Maximum Exposure: More than 25,000 of the world’s leading oncology professionals receive JCO and more than
300,000 unique visitors per month visit jco.org.
• No Exclusivity Clause: Authors may reproduce or reuse their own material published in JCO for educaonal
purposes at no charge.
• Outstanding Reputaon: With an acceptance rate of less than 15%, JCO publishes only the highest quality
manuscripts across all oncology disciplines.
• Internaonal Coverage: JCO is available globally in 28 countries and in 15 internaonal edions.
To submit a manuscript, visit submit.jco.org.
368
© 2010 by American Society of Clinical Oncology
JOURNAL OF CLINICAL ONCOLOGY
Downloaded from jco.ascopubs.org on June 15, 2013. For personal use only. No other uses without permission.
Copyright © 2011 American Society of Clinical Oncology. All rights reserved.