Docetaxel chemotherapy in metastatic castration-resistant prostate cancer: cost of care in Medicare and commercial populations.

OBJECTIVE: To estimate the healthcare costs and characteristics of docetaxel chemotherapy episodes of care for men with metastatic castration-resistant prostate cancer (mCRPC). METHODS: This study used the Medicare 5% sample and MarketScan Commercial (2010-2013) claims data sets to identify men with mCRPC and initial episodes of docetaxel treatment. Docetaxel episodes included docetaxel claim costs from the first claim until 30 days after the last claim, with earlier termination for death, insurance disenrollment, or the end of a 24-month look-forward period from initial docetaxel index date. Docetaxel drug claim costs were adjusted for 2011 generic docetaxel introduction, while other costs were adjusted to 2015 values using the national average annual unit cost increase. RESULTS: This study identified 281 Medicare-insured and 155 commercially insured men, with 325 and 172 docetaxel episodes, respectively. The average number of cycles (unique docetaxel infusion days) per episode was 6.9 for Medicare and 6.3 for commercial cohorts. The average cost per episode was $28,792 for Medicare and $67,958 for commercial cohorts, with docetaxel drug costs contributing $2,588 and $13,169 per episode, respectively. The average cost per episode on docetaxel infusion days was $8,577 (30%) for Medicare and $28,412 (42%) for commercial. Non-docetaxel infusion day costs included $7,074 (25%) for infused or injected drugs for Medicare, $10,838 (16%) for commercial cohorts, and $6,875 (24%) and $9,324 (14%) for inpatient admissions, respectively. LIMITATIONS: The applicability is only to the metastatic castration-resistance clinical setting, rather than the metastatic hormone-sensitive setting, and the lack of data on the cost effectiveness of different sequencing strategies of a range of systemic therapies including enzalutamide, abiraterone, radium-223, and taxane chemotherapy. CONCLUSION: The majority of docetaxel episode costs in Medicare and commercial mCRPC populations were non-docetaxel drug costs. Future research should evaluate the total cost of care in mCPRC.

The Michigan Risk Score to predict peripherally inserted central catheter-associated thrombosis.

Essentials How best to quantify thrombosis risk with peripherally inserted central catheters (PICC) is unknown. Data from a registry were used to develop the Michigan Risk Score (MRS) for PICC thrombosis. Five risk factors were associated with PICC thrombosis and used to develop a risk score. MRS was predictive of the risk of PICC thrombosis and can be useful in clinical practice. SUMMARY: Background Peripherally inserted central catheters (PICCs) are associated with upper extremity deep vein thrombosis (DVT). We developed a score to predict risk of PICC-related thrombosis. Methods Using data from the Michigan Hospital Medicine Safety Consortium, image-confirmed upper-extremity DVT cases were identified. A logistic, mixed-effects model with hospital-specific random intercepts was used to identify factors associated with PICC-DVT. Points were assigned to each predictor, stratifying patients into four classes of risk. Internal validation was performed by bootstrapping with assessment of calibration and discrimination of the model. Results Of 23 010 patients who received PICCs, 475 (2.1%) developed symptomatic PICC-DVT. Risk factors associated with PICC-DVT included: history of DVT; multi-lumen PICC; active cancer; presence of another CVC when the PICC was placed; and white blood cell count greater than 12 000. Four risk classes were created based on thrombosis risk. Thrombosis rates were 0.9% for class I, 1.6% for class II, 2.7% for class III and 4.7% for class IV, with marginal predicted probabilities of 0.9% (0.7, 1.2), 1.5% (1.2, 1.9), 2.6% (2.2, 3.0) and 4.5% (3.7, 5.4) for classes I, II, III, and IV, respectively. The risk classification rule was strongly associated with PICC-DVT, with odds ratios of 1.68 (95% CI, 1.19, 2.37), 2.90 (95% CI, 2.09, 4.01) and 5.20 (95% CI, 3.65, 7.42) for risk classes II, III and IV vs. risk class I, respectively. Conclusion The Michigan PICC-DVT Risk Score offers a novel way to estimate risk of DVT associated with PICCs and can help inform appropriateness of PICC insertion.

Fetal acidemia and electronic fetal heart rate patterns: is there evidence of an association?

OBJECTIVE: Despite the ubiquity of electronic fetal monitoring, the validity of the relationship between various fetal heart rate (FHR) patterns and fetal acidemia has not yet been established in a large unselected series of consecutive pregnancies. The aim of this study was to examine the published literature for evidence of such a relationship. METHODS: Four hypotheses based on assumptions in common clinical use were examined. The literature was searched for relationships between certain aspects of FHR patterns (e.g., degree of FHR variability, depth of decelerations), and fetal acidemia, or fetal vigor (5-minute Apgar score >or=7). We also attempted to relate duration of these patterns to the degree of acidemia. Using standardized FHR nomenclature we defined patterns based on baseline FHR variability, baseline rate, decelerations, and accelerations. RESULTS: The following relationships were observed: (1) Moderate FHR variability was strongly associated (98%) with an umbilical pH >7.15 or newborn vigor (5-minute Apgar score >or=7). (2) Undetectable or minimal FHR variability in the presence of late or variable decelerations was the most consistent predictor of newborn acidemia, though the association was only 23%. (3) There was a positive relationship between the degree of acidemia and the depth of decelerations or bradycardia. (4) Except for sudden profound bradycardia, newborn acidemia with decreasing FHR variability in combination with decelerations develops over a period of time approximating one hour. Most studies identified were observational and uncontrolled (grade III evidence of US Preventive Services Task Force); however, there was general agreement amongst the various studies, strengthening the validity of the observations. CONCLUSIONS: The validity of the relationship between certain FHR patterns and fetal acidemia and/or vigor, is supported by observations from the literature. In addition four assumptions commonly used in clinical management are supported. These conclusions need to be confirmed by a prospective examination of a large number of consecutive, unselected FHR patterns, and their relationship to newborn acidemia. Pending the completion of such studies, these observations can be used to justify certain aspects of current clinical management, and may assist in standardizing the diversity of opinions regarding FHR pattern management.

Patient experience in the treatment of metastatic castration-resistant prostate cancer: state of the science.

BACKGROUND: Contemporary therapies for metastatic castration-resistant prostate cancer (mCRPC) have shown survival improvements, which do not account for patient experience and health-related quality of life (HRQoL). METHODS: This literature review included a search of MEDLINE for randomized clinical trials enrolling ⩾50 patients with mCRPC and reporting on patient-reported outcomes (PROs) since 2010. RESULTS: Nineteen of 25 publications describing seven treatment regimens (10 clinical trials and nine associated secondary analyses) met the inclusion criteria and were critically appraised. The most commonly used measures were the Functional Assessment of Cancer Therapy-Prostate (n=5 trials) and Brief Pain Inventory Short Form (n=4 trials) questionnaires. The published data indicated that HRQoL and pain status augmented the clinical efficacy data by providing a better understanding of treatment impact in mCRPC. Abiraterone acetate and prednisone, enzalutamide, radium-223 dichloride and sipuleucel-T offered varying levels of HRQoL benefit and/or pain mitigation versus their respective comparators, whereas three treatments (mitoxantrone, estramustine phosphate and docetaxel, and cabazitaxel) had no meaningful impact on HRQoL or pain. The main limitation of the data were that the PROs utilized were not developed for use in mCRPC patients and hence may not have comprehensively captured symptoms important to this population. CONCLUSIONS: Recently published randomized clinical trials of new agents for mCRPC have captured elements of the patient experience while on treatment. Further research is required to standardize methods for measuring, quantifying and reporting on HRQoL and pain in patients with mCRPC in the clinical practice setting.

Astrocyte cytolysis by MHC class II-specific mouse T cell clones.

The brain is "immunologically privileged," in part because class I and II MHC antigens are not normally present on glia or neurons. However, under certain conditions such as transplantation, glial cells express MHC proteins at levels sufficient for glia to become targets of immune responses. Cultured astrocytes expressing very low levels of MHC class I protein are killed efficiently by MHC class I antigen-specific CTL. Mouse brain allografts, however, are rejected by CD4+ T cells that are likely to be class II MHC-specific. The level of expression of MHC class II antigen needed to trigger specific killing of astrocytes by CD4+ T cells, independent of exogenous antigen, has not been studied. We examined the role of glial class II MHC in the lysis of cultured neonatal mouse astrocytes by an alloreactive murine CD4+ CTL alone. IFN-gamma induced functionally relevant increases in MHC class II antigen on target cells. Astrocytes were lysed by the CD4+ clone only when class II MHC antigens reached levels readily detectable by flow cytometry. MHC class II expression and lysis increased when astrocytes were coincubated with IFN-gamma and TNF-alpha. Conversely, lysis decreased when class II expression was downregulated by IFN-alpha/beta or dbcAMP. Cytolysis by CD4+ clones was blocked by antibodies to CD4 and LFA-1 on T cells, and to ICAM-1 and class II molecules on astrocytes. The role of LFA-1 in CD4+ cell-mediated lysis was greater than that of LFA-1/ICAM-1 in CD8+ T cell-mediated lysis. CD4+ cells may lyse activated astrocytes when the immune privilege of the brain is compromised as in transplantation, tumors, and inflammatory diseases.

Mechanisms of melatonin-induced vasoconstriction in the rat tail artery: a paradigm of weak vasoconstriction.

1. Vasoconstrictor effects of melatonin were examined in isolated rat tail arteries mounted either in an isometric myograph or as cannulated pressurized segments. Melatonin failed by itself to mediate observable responses but preactivation of the arteries with vasopressin (AVP) reliably uncovered vasoconstriction responses to melatonin with maxima about 50% of maximum contraction. Further experiments were conducted with AVP preactivation to 5-10% of the maximum contraction. 2. Responses to melatonin consisted of steady contractions with superimposed oscillations which were large and irregular in isometric but small in isobaric preparations. Nifedipine (0.3 microM) reduced the responses and abolished the oscillations. Charybdotoxin (30 nM) increased the magnitude of the oscillations with no change in the maximum response. 3. Forskolin (0.6 microM) pretreatment increased the responses to melatonin compared to control and sodium nitroprusside (1 microM) treated tissues. The AVP concentration required for preactivation was 10 fold higher than control in both the forskolin and nitroprusside treated groups. 4. In isometrically-mounted arteries treated with nifedipine, melatonin receptor agonists had the potency order 2-iodomelatonin > melatonin > S20098 > GR196429, and the MT2-selective antagonist luzindole antagonized the effects of melatonin with a low pK(B) of 6.1+/-0.1. 5. It is concluded that melatonin elicits contraction of the rat tail artery via an mt1 or mt1-like receptor that couples via inhibition of adenylate cyclase and opening of L-type calcium channels. Calcium channels and charybdotoxin-sensitive K channels may be recruited into the responses via myogenic activation rather than being coupled directly to the melatonin receptors. 6. It is proposed that the requirement of preactivation for overt vasoconstrictor responses to melatonin results from the low effector reserve of the melatonin receptors together with the tail artery having threshold inertia. Potentiative interactions between melatonin and other vasoconstrictor stimuli probably also result from the threshold inertia. A simple model is presented and a general framework for consideration of interactions between weak vasoconstrictor agonists and other vasoconstrictor stimuli is discussed.

Effect of cold storage in University of Wisconsin solution on the responses of porcine hepatic arteries to 5-hydroxytryptamine and bradykinin in vitro.

1. Responses to 5-hydroxytryptamine (5-HT), bradykinin and sodium nitroprusside (SNP) were examined in hepatic arteries of the pig 1 h after dissection (fresh) and following 24 h storage in either Ca(2+)-free Krebs solution or the cryopreservative University of Wisconsin (UW) solution. 2. In fresh arteries contracted to approximately 40% of the maximum response to potassium with U46619, a thromboxane A2-mimetic, concentration-response curves to 5-HT (10(-10)-10(-5) M) were biphasic, with relaxation at low concentrations (< 10(-8) M) and contraction at high concentrations. Bradykinin (10(-10)-10(-7) M) produced concentration-dependent relaxation of precontracted fresh arteries with no apparent constrictor response. 3. Following 24 h storage in Ca(2+)-free Krebs solution, relaxation responses to 5-HT and the sensitivity of the arteries to bradykinin were significantly reduced. Storage in UW solution did not affect relaxation responses to either 5-HT or bradykinin. Relaxation responses to SNP (10(-8)-10(-3) M) were unaffected by storage in either solution. 4. Treatment of fresh arteries with NG-nitro-L-arginine (L-NOARG, 10(-4) M) significantly attenuated the relaxation response to 5-HT and displaced the bradykinin concentration-response curve four fold to the right with no affect on its maximum relaxation. 5. From these results it is concluded that endothelial cell function is better preserved during cold storage in UW solution than in Ca(2+)-free Krebs solution.

The association between socioeconomic status, health insurance coverage, and quality of life in men with prostate cancer.

The objective of this study was to examine the effect of socioeconomic status and insurance status on health-related quality of life (HRQOL) outcomes in men with prostate cancer. The design was a retrospective cohort study using multiple sites, including both academic and private practice settings. A cohort of 860 men with newly diagnosed, biopsy-proven prostate cancer of any stage was identified within CaPSURE, a longitudinal disease registry of prostate cancer patients. HRQOL was assessed with validated instruments, including the RAND 36-item Health Survey (SF-36) and the UCLA Prostate Cancer Index. Covariates included insurance status, education level, annual income, age, stage, comorbidity, Gleason grade, baseline PSA, marital status, ethnicity and primary treatment. HRQOL measurements were taken at 3-6-month intervals. Analysis of covariance was used to determine the effect of SES and insurance status on the HRQOL domains at baseline and over time. Patients with lower annual income had significantly lower baseline HRQOL scores in the all of the domains of the SF-36 and four of eight disease-specific HRQOL domains. No relationship was seen between annual income and HRQOL outcomes over time. Conversely, health insurance status was associated with HRQOL over time, but not at baseline. Health insurance status appears to have a unique effect on general HRQOL outcomes in men after treatment for prostate cancer. This study confirms the commonly held belief that patients of lower SES tend to have worse quality of life at baseline and following treatment for their disease. These findings have important ramifications for clinicians, researchers and policy makers.

Changes in health-related quality of life in the first year after treatment for prostate cancer: results from CaPSURE.

OBJECTIVES: Treatment for prostate cancer has a significant impact on health-related quality of life (HRQOL). We examined HRQOL immediately after diagnosis and treatment and 1 and 2 years after treatment for a cohort of men with early and late-stage prostate cancer. METHODS: We studied 692 men enrolled in CaPSURE, a large national observational data base of patients with prostate cancer. General and disease-specific HRQOL were measured with validated instruments at study entry and quarterly thereafter. Individuals were grouped by initial treatment: radical prostatectomy, radiotherapy, hormonal therapy, and observation (ie, no treatment in first year). Trends in HRQOL scores were evaluated immediately after treatment through 2 years, adjusting for age and length of follow-up. RESULTS: Patients who underwent radical prostatectomy demonstrated statistically significant increases in functioning in general and in disease-specific components during the year after treatment when compared with scores immediately after treatment. Patients receiving radiotherapy and hormonal therapy had significant improvements in patient reports of health change during the year. CONCLUSIONS: Patients undergoing radical prostatectomy have low HRQOL scores just after treatment in almost all general and disease-specific areas, but at 1 year there is a sharp improvement. Patients undergoing observation, radiotherapy, or hormonal therapy remain stable over time. All treatment groups continue to have decrements in sexual function.

Approaches to missing data inference results from CaPSURE: an observational study of patients with prostate cancer.

OBJECTIVE: There are multiple reasons for missing data in observational studies; excluding patients with missing data can lead to significant bias. In this study, we evaluated several methods for assigning missing values to health service utilisation. DESIGN AND SETTING: Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE) is a US national database of men with prostate cancer. Physician visits and diagnostic tests for 342 patients newly diagnosed with prostate cancer were evaluated. PATIENTS AND PARTICIPANTS: Patients were followed for a full year (observed data, n = 228) and patients with incomplete data (predicted data, n = 114) were included. INTERVENTIONS: We used the following approaches for imputing missing data: assigning the group mean, a time-specific mean, a patient-specific mean, a stratified mean (by age, localised disease and insurance status) and carrying the last observation forward and/or backward. MAIN OUTCOME MEASURES AND RESULTS: All prediction strategies resulted in higher estimates (19.3 to 23.1) for annual physician visits than was observed (17.1 +/- 15.5), and differences were statistically significant for both the last observation carried forward (23.1 +/- 15.5) and the patient's individual mean (22.7 +/- 36.1) when predicting physician visits. The same strategies had higher predicted values for x-rays (1.8 +/- 5.1 and 1.8 +/- 4.4 vs 1.1 +/- 1.9 for the observed group), although the last observation carried forward was not statistically different from the observed value. CONCLUSIONS: We were unable to identify a single optimal strategy. However, imputation from individual means and the last observation carried forward methods did not perform as well as the other strategies. While the differences observed in this study were small, we anticipate that with increased length of follow-up and more dropouts, there would be greater differences among strategies.

Hospitalisation and resource utilisation in patients with schizophrenia following initiation of risperidone long-acting therapy in the Veterans Affairs Healthcare System.

OBJECTIVE: To examine hospitalisation rates and resource utilisation following initiation of risperidone long-acting therapy (RLAT) among US veterans with schizophrenia. METHODS: Encounter data were analysed from the Ohio Veterans Affairs (VA) Healthcare System. Adult patients (schizophrenia or schizoaffective disorder) with ≥1 medical or hospital visits with a diagnosis code of 295.xx, continuous enrolment from January 2003 through January 2006, and ≥4 injections of RLAT were selected. Analyses compared psychiatric-related resource utilisation pre- and post-exposure to RLAT; each patient served as his/her own control. The pre-exposure and post-exposure periods defined were equal in duration (e.g., a 6-month post-exposure period was matched with a 6-month pre-exposure period). Descriptive and comparative analyses (paired t tests, McNemar's test) were performed. RESULTS: Patients (n=106) were 51.9 years old (+/-10.2), male (93%), white (73%) and received on average 14 RLAT doses (+/-9.7; range, 4-47 injections) over 309 days (+/-196; range, 42-737 days). Most experienced a psychiatric-related hospitalisation prior to initiation; less than half experienced hospitalisation after initiation (75% vs. 42%; p<0.001). Relative to pre-initiation, fewer psychiatric-related hospitalisations (mean [SD] change, -0.8 [2.0]; p<0.001), shorter length of stay (-25 [63.6] days; p<0.001), fewer inpatient days/month (-3.1 [7.2] days) and one (2.8) additional outpatient visit/month (p<0.001) occurred post-initiation. LIMITATIONS: The absence of a control group in this pre-/post comparison may have resulted in exposure to a regression to the mean effect. Also, this study evaluated only one cohort of patients in a VA healthcare setting. CONCLUSIONS: VA patients with schizophrenia and schizoaffective disorder treated with RLAT experienced fewer hospitalisations and psychiatric-related inpatient days following RLAT initiation. Further studies utilising a control group and in non-VA populations are warranted.

Assessing homeostasis through circadian patterns.

An organism is thought to be in a dynamic state of homeostasis when each physiological and behavioral system reaches a delicate balance within the framework of other regulatory processes. Many biological systems target specific set-point variables and generate circadian patterns. In this article, we focus on specific measurements representative of two systems, namely deep-body temperature and activity counts. We examine data collected every 30 minutes in mice, assume there are underlying circadian patterns, and extend the approach presented in Brumback and Rice (1998, Journal of the American Statistical Association 93, 961-976) in order to obtain estimates in the presence of correlated data. We then assess homeostasis using these estimates and their statistical properties.

Urinary function and bother after radical prostatectomy or radiation for prostate cancer: a longitudinal, multivariate quality of life analysis from the Cancer of the Prostate Strategic Urologic Research Endeavor.

PURPOSE: We measure the effect of time on urinary function and bother during the first 2 years following treatment for early stage prostate cancer. MATERIALS AND METHODS: We studied urinary function and bother in 564 men recently diagnosed with early stage prostate cancer and treated with radiotherapy or radical prostatectomy with or without nerve sparing. Outcomes were assessed with the UCLA Prostate Cancer Index, which is a validated, health related quality of life instrument that includes these 2 domains. To minimize the influence of other factors we adjusted for age, co-morbidity, general health, pad use, anticholinergics or procedures for urethral stricture. All subjects were drawn from the Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE), which is a national longitudinal database. RESULTS: Urinary function improved with time during the first year after surgery but remained fairly constant during year 2. Urinary function remained stable throughout the 2 years after radiation. Urinary bother was worse after radiation throughout the 2 years, although it improved markedly by the end of year 1. Age, ethnicity and co-morbidity did not impact urinary function or bother but being married did have an advantage. CONCLUSIONS: Patients undergoing surgery or radiation showed different longitudinal profiles of urinary function and bother during the first 2 years after treatment.

Participation by radiologists and other specialists in percutaneous vascular and nonvascular interventions: findings from a seven-state database.

PURPOSE: To determine the relative degree of participation by radiologists and other specialists in percutaneous interventional procedures. MATERIALS AND METHODS: By using 1992 Medicare Part B claims data that covered seven states, the specialty of the physician provider was determined for all services performed within various percutaneous vascular and nonvascular interventional procedure codes. RESULTS: Radiologists' performance of interventional procedures in descending percentage of participation was as follows: renal cyst aspiration (92.7%), biliary decompression (90.5%), abdominal or retroperitoneal mass biopsy (87.7%), lung or mediastinal biopsy (84.2%), noncardiac angioplasty (76.8%), pancreatic biopsy (75.2%), upper urinary tract decompression (73.7%), liver biopsy (43.7%), renal biopsy (38.4%), certain types of abscess drainages (38.2%), and thoracentesis with tube insertion (29.4%). They had only small roles in thoracentesis for aspiration (4.7%) and tube thoracostomy (1.7%). CONCLUSION: Despite controversy between radiologists and other specialists over who should perform percutaneous interventions, radiologists have maintained strong predominance in many types of these procedures. In others, they have a shared, but still major, role.

Use of imaging tests for staging newly diagnosed prostate cancer: trends from the CaPSURE database.

PURPOSE: We describe secular trends in the use of imaging tests to stage prostate cancer, evaluate the impact of selected clinical factors on test use and compare physician actual use with recommendations in recently published literature. MATERIALS AND METHODS: This retrospective nonrandomized analysis of a longitudinal disease registry enrolled 3,557 men diagnosed with prostate cancer between 1989 and 1997 at 29 urology practices throughout the United States. Using logistic regression the odds of performing pelvic computerized tomography (CT), pelvic magnetic resonance imaging (MRI), bone scan and excretory urogram were determined annually from 1989 to 1997. The frequency of test use was compared with recommendations from a recent urology literature synopsis. RESULTS: Use of MRI, CT, bone scan and excretory urogram was unchanged from 1989 to 1997. Compared to recent findings in the clinical literature bone scan, CT and MRI were used too frequently in patients at low risk for metastatic disease. CONCLUSIONS: Urologists may be overusing bone scan, CT and MRI to stage tumors in patients with a low risk of advanced prostate cancer. Further studies are needed to assess the relationship between individual staging strategies and clinical outcomes.

Transitions in health-related quality of life during the first nine months after diagnosis with prostate cancer.

Health-Related Quality of Life (HRQOL) is an important outcome measure in the study of prostate cancer. There are few data regarding the effect of sociodemographic variables, such as insurance status, educational level, marital status or income, on HRQOL. We examined whether these or other sociodemographic and clinical variables are predictive of HRQOL outcomes using an observational database of prostate cancer patients accrued from a wide array of clinical practice settings. We studied 131 patients with newly-diagnosed prostate cancer who had been followed for at least nine months. Patients were enrolled in CaPSURE(TM), a large, observational database of patients with prostate cancer. General and disease-specific HRQOL were measured with established, validated instruments at diagnosis and nine months later. Sociodemographic data and co-morbidity counts were recorded at baseline. Multivariate regression analysis was used to determine whether sociodemographic or clinical variables were predictive of baseline HRQOL or HRQOL changes during the study period. Several sociodemographic and clinical variables demonstrated significant associations with HRQOL. We found improvements in general and disease-specific domains of HRQOL during the nine months after diagnosis. For married patients, Emotional Well-Being and Family Functioning scores were better at baseline (+11.8, P<0.02), but Family Functioning declined over the nine month study period (-18.5, P=0.0006). Older patients had slightly better baseline performance in several domains of HRQOL, but experienced greater HRQOL decrements over time than did younger patients. Increasing comorbidity was associated with worse baseline general HRQOL. Early tumor stage was predictive of better scores in general HRQOL domains at baseline. Limited palpable disease stage (T2A/T2B) was predictive of worse Sexual Function and Sexual Bother at nine months (-8.6, P=0.04; -24, P=0.008). After initial decreases, patients appear to experience an improvement in general and disease-specific HRQOL within nine months of initial diagnosis with prostate cancer. Marital status is associated with better HRQOL, while advancing age is associated with more significant HRQOL declines over time. Patients with lower stage disease were noted to have better general HRQOL at baseline, although decreases in the physical domains were noted at nine months. These data shed new light on patients' experience with prostate cancer and suggest that HRQOL outcomes over time may occur in a predictable manner.

Sexual function and bother after radical prostatectomy or radiation for prostate cancer: multivariate quality-of-life analysis from CaPSURE. Cancer of the Prostate Strategic Urologic Research Endeavor.

OBJECTIVES: To measure the effect of treatment choice (pelvic irradiation [XRT] versus radical prostatectomy [RP] with or without nerve sparing) on sexual function and sexual bother during the first 2 years after treatment. METHODS: We studied sexual function and sexual bother in 438 men recently diagnosed with early-stage prostate cancer and treated with XRT or RP with or without nerve sparing. Outcomes were assessed with the University of California, Los Angeles Prostate Cancer Index, a validated health-related quality-of-life instrument that includes these two domains. To minimize the influence of other factors, we adjusted for age, comorbidity, general health, and previous treatment for erectile dysfunction. All subjects were drawn from CaPSURE, a national, longitudinal data base. RESULTS: Sexual function improved over time during the first year in all treatment groups; however, during the second year, sexual function began to decline in the XRT group. Older patients who received XRT showed substantial declines in sexual function throughout the 2 years, and older patients who underwent RP experienced a return of very low baseline sexual function. Sexual function was improved by the use of nerve-sparing procedures or erectile aids. Alterations in sexual bother were ameliorated by many factors, including age, general health perceptions, and sexual function. CONCLUSIONS: Patients undergoing XRT or RP with or without nerve sparing all showed comparable rates of improvement in sexual function during the first year after treatment for early-stage prostate cancer. However, in the second year after treatment, patients treated with XRT began to show declining sexual function; patients treated with RP did not.

Quality of life before death for men with prostate cancer: results from the CaPSURE database.

PURPOSE: We examined changes in health related quality of life during the 12 months before death in men with prostate cancer. MATERIALS AND METHODS: We studied patients from CapSure, which is a longitudinal observational cohort of men with biopsy proved prostate cancer treated in community and academic urology practices across the United States. Of all men in the cohort who died while being followed for prostate cancer 131 who had submitted health related quality of life surveys during the 6 months before death were included in this analysis. Health related quality of life was measured with the RAND 36-Item Health Survey, an established validated instrument that comprises 4 physical and 4 mental domains. RESULTS: On univariate analysis all 8 domains of the 36-Item Health Survey substantially decreased in the final year of life. On multivariate analysis only physical function decreased more rapidly in men dying of prostate cancer compared to those dying of other cancer or benign causes. CONCLUSIONS: Quality of life begins a steady and inexorable decline in the final 12 months of life in men with prostate cancer. Increased attention to quality of life changes may provide new clinical opportunities to enhance quality of care in the final year of life in these men.