Oncology Long-term Satisfaction After Open Radical Prostatectomy Ted Lee, Michael Fenstermaker, Glen B. Taksler, and Herbert Lepor OBJECTIVE METHODS
RESULTS
CONCLUSION
To determine the association between baseline factors, post-treatment factors, and long-term satisfaction after radical prostatectomy (RP). Between January 2000 and March 2009, 1425 men who underwent RP by a single surgeon were enrolled in an institutional review boardeapproved, prospective, longitudinal outcomes study. Baseline characteristics and post-treatment functional and oncologic outcomes were captured through 2013. Patient survey responses from 875 (61.4%) of these men were used to evaluate satisfaction with treatment outcome and treatment decision. Overall, 88.2% and 91.0% men were satisfied to very satisfied with treatment outcome and treatment decision, respectively. Baseline sexual function was associated with satisfaction with both treatment outcome (adjusted odds ratio [aOR] ¼ 1.40; 95% confidence interval [CI], 1.01-1.93) and treatment decision (aOR ¼ 1.47; 95% CI, 1.08-2.01). Among post-treatment factors, higher University of California, Los Angeles Prostate Cancer Sexual Function (aOR ¼ 2.95; 95% CI, 2.06-4.22), University of California, Los Angeles Prostate Cancer Urinary Function (aOR ¼ 2.38; 95% CI, 1.663.40), and lower urinary tract symptom scores (aOR ¼ 1.91; 95% CI, 1.19-3.06) were predictors of satisfaction with outcome. Bother due to incontinence and sexual dysfunction, and perception of cure were independent predictors of both satisfaction with treatment outcome and treatment decision. Nearly 90% of men are satisfied with both their treatment outcome and treatment decision after open RP. Improving long-term satisfaction after RP requires efforts to provide realistic expectations and improve functional outcomes. UROLOGY 85: 1130e1136, 2015. 2015 Elsevier Inc.
A
pproximately 80% of prostate cancers in the United States are clinically localized to the prostate gland at the time of diagnosis.1 Radical prostatectomy (RP), radiation therapy, minimally invasive ablative therapy, active surveillance, and watchful waiting are treatment options for clinically localized prostate cancers.2 Of the >240,000 cases of prostate cancer diagnosed yearly in the United States, approximately half are managed initially with RP.3 The treatment decision for clinically localized prostate cancer must be individualized, balancing life expectancy, extent and aggressiveness of the disease, likelihood of achieving cure, complications of intervention, and impact of treatment on quality of life.4 Although patient satisfaction is recognized by the National Cancer Institute as a priority for outcomes assessment,5 few studies have examined satisfaction after any intervention for prostate cancer. Previous studies have demonstrated generally high rates of satisfaction after RP, ranging from 74% to 93%.6-8 Furthermore, both changes in sexual function, urinary Financial Disclosure: The authors declare that they have no relevant financial interests. From the Department of Urology, New York University School of Medicine, New York, NY; and the Medicine Institute, Cleveland Clinic, Cleveland, OH Address correspondence to: Herbert Lepor, M.D., Department of Urology, New York University School of Medicine, NYU Urology Associates, 150 East 32nd Street, 2nd Floor, New York, NY 10016. E-mail: [email protected] Submitted: December 22, 2014, accepted (with revisions): January 17, 2015
1130
ª 2015 Elsevier Inc. All Rights Reserved
function, and adjuvant therapies have been shown to be predictors of later satisfaction.8,9 However, none of the studies assessing satisfaction after intervention for prostate cancer have a follow-up time exceeding 2 years.6-9 For men with localized prostate cancer undergoing RP, median survival from the time of intervention is approximately 13 years.10 Thus, studies with an extended length of follow-up are required to identify whether satisfaction is durable over a clinically relevant period of time. A better understanding of patient’s long-term satisfaction after RP and the factors that influence satisfaction may help physicians adequately counsel patients regarding expectations for later quality of life. The purpose of this study was to investigate satisfaction with treatment outcome and treatment decision in a large cohort of men enrolled in the New York University longitudinal, prospective, RP outcomes study. We analyzed whether patient parameters, such as higher sexual function and urinary function, and post-treatment factors, such as adjuvant therapy, radiation therapy, and biochemical recurrence, predicted later satisfaction with long-term follow-up.
METHODS Sample Between October 2000 and March 2009, 1583 men underwent open RP by a single surgeon (H.L.). Before undergoing surgery, http://dx.doi.org/10.1016/j.urology.2015.01.020 0090-4295/15
What is your overall level of satisfaction with your outcome following radical prostatectomy? Very satisfied Satisfied Unsatisfied Very unsatisfied What is your overall level of satisfaction with decision to undergo radical prostatectomy? Very satisfied Satisfied Unsatisfied Very Unsatisfied Do you believe you are free of cancer? No Don’t know Yes If no, please explain why ___________________________________________ How bothered are you by the inability to control your urine (incontinence)? None Slight Moderate Severe How bothered are you by the inability to function sexually? None Slight Moderate Severe Figure 1. Satisfaction questionnaire material delivered to men among the longitudinal cohort. the men signed informed consent to participate in our Institutional Review Boardeapproved, prospective, longitudinal outcomes study capturing functional and oncologic outcomes.
Satisfaction Measures In March 2013, a comprehensive satisfaction survey was mailed to the 1425 men enrolled in our longitudinal outcomes study, who were not lost to follow-up and known to be alive. The survey was designed to capture the following satisfaction with treatment outcome (ie, cure, sexual function, and urinary function) and treatment decision (ie, selection of RP as compared with other treatment options), perception of being cancer free, and perception of bother due to sexual dysfunction and urinary incontinence. Satisfaction with outcome, satisfaction with decision, and measures of bother were captured using 4-item response scales (Fig. 1). Treatment outcome and UROLOGY 85 (5), 2015
treatment decision satisfaction were dichotomized as satisfied (satisfied or very satisfied) vs dissatisfied (unsatisfied or very unsatisfied). The survey was mailed in March 2013 to a total of 1425 men. Participants returned their responses via US postal service. Eight hundred seventy-five men (61.4%) mailed in responses to the questionnaire.
Baseline and Longitudinal Measures As part of the prospective longitudinal outcomes study, all participants completed a preoperative questionnaire including demographic data, along with assessments of urinary and sexual function and severity of lower urinary tract symptoms (LUTS). Baseline urinary function and sexual function were captured using the University of California, Los Angeles, Prostate Cancer Index urinary function score (UCLA-PCI-UFS) and sexual function score (UCLA-PCI-SFS).11 Severity of LUTS was 1131
Table 1. Pathologic and baseline characteristics of survey responders and nonresponders Nonresponders (N ¼ 672)* Age at operation, mean (SD), y Follow-up time, med (IQR), y Race, no. (%) Caucasian Other Marital status, no. (%) Married Other Preop UCLA-UFS, med (IQR) Preop UCLA-SFS, med (IQR) Preop AUASS, no. (%) Mild (7) Moderate/severe (8-35) D’Amico risk score, no. (%) Low Medium High Margins, no. (%) Positive Negative Pathologic stage, no. (%) pT2a pT2b pT2c pT3a pT3b/pT4 Surgical Gleason score, no. (%) 6 3þ4 4þ3 8 Biochemical recurrence, no. (%) Adjuvant hormonal therapy, no. (%) Radiation therapy, no. (%)
Responders (N ¼ 753)
58.9 (7.2) 9.2 (6.9-11.1)
58.9 (6.6) 9.3 (7.2-11.2)
592 (88.1) 80 (11.9)
708 (94.0) 45 (6.0)
574 98 100 70.8
662 91 100 79.2
(85.4) (14.6) (100-100) (50-87.5)
P Valuey .94 .212
RESULTS
CONCLUSION
To determine the association between baseline factors, post-treatment factors, and long-term satisfaction after radical prostatectomy (RP). Between January 2000 and March 2009, 1425 men who underwent RP by a single surgeon were enrolled in an institutional review boardeapproved, prospective, longitudinal outcomes study. Baseline characteristics and post-treatment functional and oncologic outcomes were captured through 2013. Patient survey responses from 875 (61.4%) of these men were used to evaluate satisfaction with treatment outcome and treatment decision. Overall, 88.2% and 91.0% men were satisfied to very satisfied with treatment outcome and treatment decision, respectively. Baseline sexual function was associated with satisfaction with both treatment outcome (adjusted odds ratio [aOR] ¼ 1.40; 95% confidence interval [CI], 1.01-1.93) and treatment decision (aOR ¼ 1.47; 95% CI, 1.08-2.01). Among post-treatment factors, higher University of California, Los Angeles Prostate Cancer Sexual Function (aOR ¼ 2.95; 95% CI, 2.06-4.22), University of California, Los Angeles Prostate Cancer Urinary Function (aOR ¼ 2.38; 95% CI, 1.663.40), and lower urinary tract symptom scores (aOR ¼ 1.91; 95% CI, 1.19-3.06) were predictors of satisfaction with outcome. Bother due to incontinence and sexual dysfunction, and perception of cure were independent predictors of both satisfaction with treatment outcome and treatment decision. Nearly 90% of men are satisfied with both their treatment outcome and treatment decision after open RP. Improving long-term satisfaction after RP requires efforts to provide realistic expectations and improve functional outcomes. UROLOGY 85: 1130e1136, 2015. 2015 Elsevier Inc.
A
pproximately 80% of prostate cancers in the United States are clinically localized to the prostate gland at the time of diagnosis.1 Radical prostatectomy (RP), radiation therapy, minimally invasive ablative therapy, active surveillance, and watchful waiting are treatment options for clinically localized prostate cancers.2 Of the >240,000 cases of prostate cancer diagnosed yearly in the United States, approximately half are managed initially with RP.3 The treatment decision for clinically localized prostate cancer must be individualized, balancing life expectancy, extent and aggressiveness of the disease, likelihood of achieving cure, complications of intervention, and impact of treatment on quality of life.4 Although patient satisfaction is recognized by the National Cancer Institute as a priority for outcomes assessment,5 few studies have examined satisfaction after any intervention for prostate cancer. Previous studies have demonstrated generally high rates of satisfaction after RP, ranging from 74% to 93%.6-8 Furthermore, both changes in sexual function, urinary Financial Disclosure: The authors declare that they have no relevant financial interests. From the Department of Urology, New York University School of Medicine, New York, NY; and the Medicine Institute, Cleveland Clinic, Cleveland, OH Address correspondence to: Herbert Lepor, M.D., Department of Urology, New York University School of Medicine, NYU Urology Associates, 150 East 32nd Street, 2nd Floor, New York, NY 10016. E-mail: [email protected] Submitted: December 22, 2014, accepted (with revisions): January 17, 2015
1130
ª 2015 Elsevier Inc. All Rights Reserved
function, and adjuvant therapies have been shown to be predictors of later satisfaction.8,9 However, none of the studies assessing satisfaction after intervention for prostate cancer have a follow-up time exceeding 2 years.6-9 For men with localized prostate cancer undergoing RP, median survival from the time of intervention is approximately 13 years.10 Thus, studies with an extended length of follow-up are required to identify whether satisfaction is durable over a clinically relevant period of time. A better understanding of patient’s long-term satisfaction after RP and the factors that influence satisfaction may help physicians adequately counsel patients regarding expectations for later quality of life. The purpose of this study was to investigate satisfaction with treatment outcome and treatment decision in a large cohort of men enrolled in the New York University longitudinal, prospective, RP outcomes study. We analyzed whether patient parameters, such as higher sexual function and urinary function, and post-treatment factors, such as adjuvant therapy, radiation therapy, and biochemical recurrence, predicted later satisfaction with long-term follow-up.
METHODS Sample Between October 2000 and March 2009, 1583 men underwent open RP by a single surgeon (H.L.). Before undergoing surgery, http://dx.doi.org/10.1016/j.urology.2015.01.020 0090-4295/15
What is your overall level of satisfaction with your outcome following radical prostatectomy? Very satisfied Satisfied Unsatisfied Very unsatisfied What is your overall level of satisfaction with decision to undergo radical prostatectomy? Very satisfied Satisfied Unsatisfied Very Unsatisfied Do you believe you are free of cancer? No Don’t know Yes If no, please explain why ___________________________________________ How bothered are you by the inability to control your urine (incontinence)? None Slight Moderate Severe How bothered are you by the inability to function sexually? None Slight Moderate Severe Figure 1. Satisfaction questionnaire material delivered to men among the longitudinal cohort. the men signed informed consent to participate in our Institutional Review Boardeapproved, prospective, longitudinal outcomes study capturing functional and oncologic outcomes.
Satisfaction Measures In March 2013, a comprehensive satisfaction survey was mailed to the 1425 men enrolled in our longitudinal outcomes study, who were not lost to follow-up and known to be alive. The survey was designed to capture the following satisfaction with treatment outcome (ie, cure, sexual function, and urinary function) and treatment decision (ie, selection of RP as compared with other treatment options), perception of being cancer free, and perception of bother due to sexual dysfunction and urinary incontinence. Satisfaction with outcome, satisfaction with decision, and measures of bother were captured using 4-item response scales (Fig. 1). Treatment outcome and UROLOGY 85 (5), 2015
treatment decision satisfaction were dichotomized as satisfied (satisfied or very satisfied) vs dissatisfied (unsatisfied or very unsatisfied). The survey was mailed in March 2013 to a total of 1425 men. Participants returned their responses via US postal service. Eight hundred seventy-five men (61.4%) mailed in responses to the questionnaire.
Baseline and Longitudinal Measures As part of the prospective longitudinal outcomes study, all participants completed a preoperative questionnaire including demographic data, along with assessments of urinary and sexual function and severity of lower urinary tract symptoms (LUTS). Baseline urinary function and sexual function were captured using the University of California, Los Angeles, Prostate Cancer Index urinary function score (UCLA-PCI-UFS) and sexual function score (UCLA-PCI-SFS).11 Severity of LUTS was 1131
Table 1. Pathologic and baseline characteristics of survey responders and nonresponders Nonresponders (N ¼ 672)* Age at operation, mean (SD), y Follow-up time, med (IQR), y Race, no. (%) Caucasian Other Marital status, no. (%) Married Other Preop UCLA-UFS, med (IQR) Preop UCLA-SFS, med (IQR) Preop AUASS, no. (%) Mild (7) Moderate/severe (8-35) D’Amico risk score, no. (%) Low Medium High Margins, no. (%) Positive Negative Pathologic stage, no. (%) pT2a pT2b pT2c pT3a pT3b/pT4 Surgical Gleason score, no. (%) 6 3þ4 4þ3 8 Biochemical recurrence, no. (%) Adjuvant hormonal therapy, no. (%) Radiation therapy, no. (%)
Responders (N ¼ 753)
58.9 (7.2) 9.2 (6.9-11.1)
58.9 (6.6) 9.3 (7.2-11.2)
592 (88.1) 80 (11.9)
708 (94.0) 45 (6.0)
574 98 100 70.8
662 91 100 79.2
(85.4) (14.6) (100-100) (50-87.5)
P Valuey .94 .212
