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General Quality of Life 2 Years Following Treatment for Prostate Cancer: What Influences Outcomes? Results From the Prostate Cancer Outcomes Study

David F. Penson, Ziding Feng, Alan Kuniyuki, Dale McClerran, Peter C. Albertsen, Dennis Deapen, Frank Gilliland, Richard Hoffman, Robert A. Stephenson, Arnold L. Potosky, Janet L. Stanford

From the Section of Urology, VA Puget Sound Health Care System and the Department of Urology, University of Washington, and the Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA; the Division of Urology, University of Connecticut School of Medicine, Farmington, CT; the Department of Preventive Medicine, University of Southern California, Los Angeles, CA; the Department of Internal Medicine, University of New Mexico School of Medicine, Albuquerque, NM; the Department of Urology, University of Utah School of Medicine, Salt Lake City, Utah; and the Applied Research Branch, Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, MD.

Address reprint requests to David F. Penson, MD, MPH, VAPSHCS Section of Urology, 112-UR, 1660 South Columbian Way, Seattle, WA 98108; email: penson{at}u.washington.edu.

	ABSTRACT

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Purpose: The goal of this study was to determine the relationship between primary treatment, urinary dysfunction, sexual dysfunction, and general health-related quality of life (HRQOL) in prostate cancer.

Methods: A sample of men with newly diagnosed prostate cancer between 1994 and 1995 was randomly selected from six population-based Surveillance, Epidemiology, and End Results registries. A baseline survey was completed by 2,306 men within 6 to 12 months of diagnosis, and these men also completed a follow-up HRQOL survey 2 years after diagnosis. Logistic regression models were used to determine whether primary treatment, urinary dysfunction, and sexual dysfunction were independently associated with general HRQOL outcomes approximately 2 years after diagnosis as measured by the Medical Outcomes Study 36-item Short Form Health Survey. The magnitude of this effect was estimated using least square means models.

Results: After adjustment for potential confounders, primary treatment was not associated with 2-year general HRQOL outcomes in men with prostate cancer. Urinary function and bother were independently associated with worse general HRQOL in all domains. Sexual function and bother were also independently associated with worse general HRQOL, although the relationship was not as strong as in the urinary domains.

Conclusion: Primary treatment is not associated with 2-year general HRQOL outcomes in prostate cancer. Although both sexual and urinary function and bother are associated with quality of life, men who are more bothered by their urination or impotence are more likely to report worse quality of life. This implies that future research should be directed toward finding ways to improve treatment-related outcomes or help patients better cope with their posttreatment urinary or sexual dysfunction.

	INTRODUCTION

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THERE ARE a number of treatment options available for localized prostate cancer, including radical prostatectomy, radiation therapy, hormonal ablation therapy, and expectant management. Randomized clinical trials are not yet available to determine whether one therapy is superior to another in prolonging life expectancy.¹ In this setting, quality-of-life issues are an important component of treatment decision-making. Each of the available treatments can result in short- and long-term side effects that may affect quality of life. In as much as each of these complications can have a considerable effect on a patient’s quality of life, it is important to understand the effect of treatment on quality of life in patients with localized prostate cancer.

To date, most studies assessing the relationship between localized prostate cancer treatment and health-related quality of life (HRQOL) have focused on the disease-specific quality of life domains. Although important, these domains represent only a limited portion of patients’ experience after treatment. Qualitative studies have demonstrated that treatment side effects, such as impotence and incontinence, may affect patients’ overall quality of life to a greater degree than previously recognized.^2–5 However, quantitative studies using validated instruments to compare the effect of treatment on general HRQOL have found conflicting results.^6–10 Contradictory findings from previous studies of general HRQOL in men with prostate cancer may result from the use of cross-sectional study designs used to address the research hypothesis. In cases for which a longitudinal approach was used, study populations were accrued from selected academic centers, which may not be representative of the general population of men with newly diagnosed prostate cancer.

The objective of this study was to assess the relationship between general HRQOL outcomes and primary treatment in the Prostate Cancer Outcomes Study (PCOS), a prospective, population-based cohort of men followed longitudinally after treatment. A secondary goal of this study was to assess the relationship between sexual and urinary function and bother and general HRQOL.

	METHODS

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Study Subjects
PCOS participants were ascertained through the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) program, a national tumor registry that provides information on cancer incidence, treatment, and survival in residents of defined geographic regions of the United States. The methodology used in PCOS is described at length elsewhere.¹¹ In short, African-American, white, and Hispanic men diagnosed with prostate cancer from October 1, 1994, through October 31, 1995, who were residents of areas covered by one of six population-based state and regional tumor registries that participate in the SEER program were sampled. A rapid case ascertainment system was used to identify eligible patients within 6 months of diagnosis. The six tumor registries that participated in PCOS included the state registries of Connecticut, New Mexico, and Utah and the regional registries of Seattle-Puget Sound, Washington; Los Angeles County, California; and metropolitan Atlanta, Georgia. Men from 39 to 89 years of age were eligible for inclusion in the study, except for patients from the Seattle-Puget Sound registry, for which inclusion was limited to men ages 60 to 89 years. Eligible patients were sampled according to a prespecified sampling design to ensure a sample representative of the population of eligible prostate cancer patients. Sample weights were calculated as the inverse of the sampling proportions within each region, race-, and age-group stratum. This method permits estimates of combined data across age, race, and region strata that are appropriately weighted to the total number of eligible prostate cancer patients. The institutional review board of each participating institution approved the study.

Data Collection
Patients were contacted within 6 months of diagnosis and asked to complete a self-administered questionnaire. This survey obtained information on demographics, prostate cancer treatment, medical history, and both general and disease-specific HRQOL. General HRQOL was measured using selected domains from the Medical Outcomes Study 36-item Short-Form Health Survey (SF-36).¹² Disease-specific HRQOL was measured using selected items from the University of California, Los Angeles, Prostate Cancer Index¹³ and a number of other HRQOL instruments.^14,15 Patients were asked to report their urinary, sexual, and bowel function both at baseline (before diagnosis) and in the month before completing the 6-month questionnaire. Additional surveys were conducted at 12 and 24 months after diagnosis. To be included in this study, subjects had to have completed a survey at 24 months and either 6 or 12 months after diagnosis.

Baseline clinical information, such as stage, pathologic grade, serum prostate-specific antigen (PSA) levels, digital rectal examination (DRE) findings, and date and type of primary treatment, was ascertained using inpatient and outpatient medical record review for each subject. Abstraction was completed at least 1 year after diagnosis in physicians’ offices to ensure more complete collection of therapies given in the first year.

Data Elements
The primary outcomes of interest were 24-month HRQOL scores in the following six selected domains of the SF-36: mental health, role limitation caused by physical problems, role limitations caused by emotional problems, vitality, bodily pain, and health status. The individual scales of the SF-36 are scored from 0 to 100, with higher scores representing better quality of life. Primary treatment was categorized into one of four groups: radical prostatectomy, pelvic radiotherapy of any type, hormone ablation therapy (medical or surgical), or watchful waiting (consisting of patients who did not receive any of the previously mentioned therapies within 6 months of diagnosis). Men who received more than one treatment within 6 months of diagnosis were excluded from the analysis given the heterogeneous nature of this combined-treatment group and the relatively small sample sizes when the various combinations of therapy were examined individually. Men were considered potent (having adequate sexual function) at 24 months if they responded "yes" to the following question: "In the past month, have you had erections firm (hard) enough for sexual intercourse?" Men were considered to have significant sexual bother if their response to the question "Overall, how big a problem do you consider you sexual function to be?" was "moderate problem" or "big problem." Men were considered continent (having adequate urinary function) if they responded to the question "Over the past month, which of the following best describes you urinary control?" with either "total control" or "occasional leakage," as opposed to "frequent leakage" or "no control." Men were considered to have significant urinary bother if their response to the question "Overall, how big a problem have you had with leaking or dripping urine?" was either "moderate problem" or "big problem."

The investigators identified 27 observed covariates a priori that could influence prostate cancer treatment choice. These were controlled for in the statistical analysis using the modified propensity score technique described below. These independent variables included age at diagnosis; SEER registry; patient-reported race or ethnicity (African-American, white, Hispanic); highest level of education; annual household income; insurance status; presence or absence of a regular sexual partner; pathologic grade (Gleason sum 2 to 4, 5 to 6, 7, 8 to 10); clinical stage (categorized using a modified version of the tumor-node-metastasis stage system in which N+ or M+ patients are grouped with T4 patients into a single category); baseline PSA (0 to 4, 4.1 to 10, 10.1 to 20, and 20.1 or higher); presence or absence of an abnormal digital rectal exam; and patient or physician-reported weight loss, history of other malignancy within the past 5 years, arthritis, diabetes, inflammatory bowel disease, gastrointestinal ulcers, chronic obstructive pulmonary disease, cerebrovascular accident, hypertension, myocardial infarction, congestive heart failure, angina, or depression. In addition, baseline urinary leakage, sexual potency, and bowel dysfunction (defined as the presence of frequent or urgent bowel movements) were also included as covariates.

Statistical Analysis
All multivariable linear regression models were performed using the Survey Data Analysis statistical package (SUDAAN, Release 7.5, Research Triangle Institute, Research Triangle Park, NC). The Horvitz-Thompson weight, which is the inverse of the sampling proportion for each sampling stratum (defined by study center, age, and race), was used to obtain unbiased estimates of the regression parameters for all eligible prostate cancer patients in the PCOS areas. The reader is referred to a previous publication for greater detail concerning the sampling strategies used in PCOS.¹¹ A multinomial logistic regression model was used to predict the probability of a patient choosing one of four primary treatment choices given 27 covariates, which were chosen by a panel of experts. A propensity score was assigned to each patient using the predicted probability for the treatment he actually chose. The inverse of propensity was multiplied by the Horvitz-Thompson weight, and the new weights were used in the weighted multivariate linear regression models to estimate the independent effects of treatment and the disease-specific domains on general HRQOL. This inverse probability-of-treatment-weighted approach has been shown to be a preferred approach for causal inference models in observational studies¹⁶ because of its robustness against regression model specification and its natural tendency to mimic a clinical trial in which patients were randomly assigned to one of the four treatments with equal probability. Least square means were also calculated to better quantify the associations. All P values were two sided.

	RESULTS

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A total of 5,672 men were randomly sampled according to defined age and race or ethnicity strata from 11,137 men eligible for inclusion in PCOS. Of the 5,672 subjects, 4,736 (84%) were contacted and invited to participate in the study. Of these, 3,533 subjects (62%) completed a 6-month or a 12-month survey. Seventy-six percent of these men (2,693) also completed a 24-month follow-up survey. Of these 2,693 men, 387 received more than one form of active primary treatment within 6 months of diagnosis and were excluded from the study, making the final sample size 2,306 subjects. The frequency distribution of primary treatment in the cohort is presented in Table 1.

Controlling for potential confounders and primary treatment, we examined the independent association of 24-month urinary function and bother and general HRQOL outcomes using a multivariate logistic regression model. Significant differences were noted between men with total urinary control or occasional leakage when compared with men with frequent leakage or no control in five of the six general HRQOL domains examined (Fig 1). Overall HS did not vary among men with different urinary function. However, in the remaining five domains, general HRQOL was significantly reduced in men with poor urinary function, defined as frequent urinary leak or no urinary control whatsoever.

View larger version (35K): [in this window] [in a new window]   Fig 1. General health-related quality-of-life outcomes and urinary function.

View larger version (31K): [in this window] [in a new window]   Fig 2. General health-related quality-of-life outcomes and urinary bother.

View larger version (34K): [in this window] [in a new window]   Fig 3. General health-related quality-of-life outcomes and sexual function.

View larger version (33K): [in this window] [in a new window]   Fig 4. General health-related quality-of-life outcomes and sexual bother.

	DISCUSSION

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Whenever a study finds a negative result, as we have noted when assessing the relationship between long-term (2-year) general HRQOL outcomes and treatment, one must consider the possibility that a type II error may have occurred because of inadequate sample size. This is not likely to be the case in the current study. In fact, if we assume an 80% power for a two-sided test at alpha = 0.05 in post hoc calculations, the study had reasonable power to detect clinically meaningful differences¹⁷ in four of the six domains of general HRQOL (MH, RE, VT, and HS) when the two largest treatment groups, surgery and radiotherapy, are compared. In the RP domain, borderline power was noted, where the minimal detectable difference was 9.9. In the BP domain, the minimal detectable difference given the sample size was 17.7, which indicates that type II error must be considered. However, despite the issues with sample size in the one domain, this study is still in agreement with previous research on this topic.^6,7,18

Although a few studies have noted differences in general HRQOL outcomes after treatment for prostate cancer, each of these has certain limitations. For example, Davis et al¹⁹ reported general HRQOL outcomes in 511 men undergoing radical prostatectomy, interstitial brachytherapy, or external beam radiotherapy for localized prostate cancer. After age, comorbidity, and time since treatment was adjusted for, men undergoing external beam radiotherapy were found to have worse general HRQOL in the physical function, RP, and general health domains of the SF-36. Although these results are compelling, the cross-sectional and observational nature of the study may introduce bias and limit the validity of the conclusions. Akakura et al²⁰ completed a randomized clinical trial comparing surgery with external beam radiotherapy in men with T2b and T3 prostate cancer who also received a common hormone ablation regimen following treatment. They found that men undergoing radical prostatectomy reported worse HRQOL scores in the social activity domain. Although the use of a randomized clinical trial design may minimize selection bias, the restriction of the cohort to men with stage T2b and T3 who received hormone ablation therapy may limit the generalizability of the study. By using a population-based approach and controlling numerous covariates, this study has overcome many of the limitations of prior studies.

Although the finding that there are no significant differences in long-term general HRQOL outcomes among treatments for prostate cancer is important, the observation that urinary bother seems to have a stronger association with general HRQOL than does urinary function is perhaps the most meaningful result in this study. Prior studies demonstrate that urinary function and bother are two distinct entities that, although related, do not correlate as well as one might expect.^8,21 Therefore, understanding the unique relationship between each of these domains and general HRQOL is crucial for understanding patients’ experience after prostate cancer and its treatment. The results of this study indicate that, although both urinary dysfunction and bother are associated with reduced HRQOL, the association between urinary bother and reduced HRQOL may be the greater of the two. Although therapeutic interventions that improve urinary function, such as placement of an artificial urinary sphincter, can improve HRQOL,²² perhaps providers should also focus on finding ways to help patients cope with the bother caused by urinary dysfunction, such as educational programs and support groups. Future research in prostate cancer should examine whether interventions designed to reduce urinary bother can improve overall HRQOL.

This study also demonstrates the surprisingly broad relationship between sexual dysfunction and general HRQOL. The observation that both sexual function and bother are associated with reduced general HRQOL agrees with prior qualitative studies on the quality-of-life effect of erectile dysfunction. Bokhour et al² studied 48 men who had received treatment for prostate cancer and were experiencing sexual dysfunction. They noted four domains of HRQOL affected by men’s sexuality, including sexual intimacy, everyday interactions with women, sexual imaging and fantasy life, and men’s perception of their masculinity. Importantly, the effect of prostate cancer treatment–related sexual dysfunction was especially severe in the patient’s everyday interactions with women and their own perception of their masculinity (which is a critical component of their self-image). This study quantifies the relationship between sexual dysfunction and patients’ overall quality of life and demonstrates that this association is considerably broader than one might expect.

Despite our attempt to control for variables that might affect HRQOL outcomes, the study is still limited by its observational design. It is possible that we were unable to control for all potential confounders that could introduce bias into the analysis. The inclusion of a diverse list of covariates, including baseline function, multiple sociodemographic factors (such as marital status, education, race, income, and so on), and clinical characteristics (including treatment, stage, grade, PSA, age, comorbidities, and so on), and the use of propensity weighting on the basis of these covariates, should minimize this potential problem. Furthermore, some recall bias may have been introduced into the analysis because the baseline interview required that subjects recall their pretreatment functional status. However, prior studies in the PCOS data set demonstrated reasonably high agreement between baseline recall of function and actual pretreatment functional status, indicating minimal, if any, recall bias in the study.²³

In conclusion, results from the PCOS indicate that there are no significant long-term general health-related quality-of-life differences amomg primary treatments for prostate cancer. When patients are stratified by urinary function or bother, men with worse urinary function or bother seem to have poorer general HRQOL. The relationship between urinary bother and HRQOL seems to be stronger than the relationship between urinary function and HRQOL. When prostate cancer patients are stratified by sexual function or sexual bother, men with worse sexual function or bother can expect to have poorer general HRQOL. The magnitude of the association with HRQOL seems to be similar between sexual function and bother. Therapeutic interventions should be targeted to both improve function and alleviate bother.

	ACKNOWLEDGMENTS

 
We thank the men who, by their participation in PCOS, have contributed to a better understanding of the effects of prostate cancer on men’s lives. We also thank the physicians in the six SEER areas who assisted us in the collection of data from their patients and from medical records. We thank all of the study managers and chart abstractors for their outstanding efforts in data collection. Finally, we thank all of the staff in the six cancer registries for their help with the study.

	NOTES

 
Supported by the following contracts from the National Cancer Institute, National Institutes of Health, Department of Health and Human Services, Bethesda, MD, to each of the participating institutions: N01-PC-67007, N01-PC-67009, N01-PC-67010, N01-PC-67006, N01-PC-67005, and N01-PC-67000. While this work was completed, Dr. Penson was supported by a Level I Career Development Award from the Health Services Research and Development Service, Department of Veterans Affairs.

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Submitted July 23, 2002; accepted November 25, 2002.

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This Article Abstract Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Save to my personal folders Download to citation manager Rights & Permissions Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Penson, D. F. Articles by Stanford, J. L. Search for Related Content PubMed PubMed Citation Articles by Penson, D. F. Articles by Stanford, J. L.