Characterizing the real-world economic burden of metastatic castration-sensitive prostate cancer in the United States.

AIMS: To describe healthcare resource utilization (HRU) and costs of patients with metastatic castration-sensitive prostate cancer (mCSPC). METHODS: Linked data from Flatiron Metastatic PC Core Registry and Komodo's Healthcare Map were evaluated (01/2016-12/2021). Patients with chart-confirmed diagnoses for metastatic PC without confirmed castration resistance in Flatiron who initiated androgen deprivation therapy (ADT) monotherapy or advanced therapy for mCSPC in 2017 or later (index date) with a corresponding pharmacy or medical claim in Komodo Health were included. Advanced therapies considered were androgen-receptor signaling inhibitors, chemotherapies, estrogens, immunotherapies, poly ADP-ribose polymerase inhibitors, and radiopharmaceuticals. Patients with <12 months of continuous insurance eligibility before index were excluded. Per-patient-per-month (PPPM) all-cause and PC-related HRU and costs (medical and pharmacy; from a payer's perspective in 2022 $USD) were described in the 12-month baseline period and follow-up period (from the index date to castration resistance, end of continuous insurance eligibility, end of data availability, or death). RESULTS: Of 871 patients included (mean age: 70.6 years), 52% initiated ADT monotherapy as their index treatment without documented advanced therapy use. During baseline, 31% of patients had a PC-related inpatient admission and 94% had a PC-related outpatient visit; mean all-cause costs were $2551 PPPM and PC-related costs were $839 PPPM with $787 PPPM attributable to medical costs. Patients had a mean follow-up of 15 months, during which 38% had a PC-related inpatient admission and 98% had a PC-related outpatient visit; mean all-cause costs were $5950 PPPM with PC-related total costs of $4363 PPPM, including medical costs of $2012 PPPM. LIMITATIONS: All analyses were descriptive; statistical testing was not performed. Treatment effectiveness and clinical outcomes were not assessed. CONCLUSION: This real-world study demonstrated a significant economic burden in mCSPC patients, and a propensity to use ADT monotherapy in clinical practice despite the availability and guideline recommendations of advanced life-prolonging therapies.

Real-world economic burden of metastatic castration-resistant prostate cancer before and after first-line therapy initiation.

AIMS: To describe healthcare costs of patients with metastatic castration-resistant prostate cancer (mCRPC) initiating first-line (1 L) therapies from a US payer perspective. METHODS: Patients initiating a Flatiron oncologist-defined 1 L mCRPC therapy (index date) on or after mCRPC diagnosis were identified from linked electronic medical records/claims data from the Flatiron Metastatic Prostate Cancer (PC) Core Registry and Komodo's Healthcare Map. Patients were excluded if they initiated a clinical trial drug in 1 L, had <12 months of insurance eligibility prior to index, or no claims in Komodo's Healthcare Map for the Flatiron oncologist-defined index therapy. All-cause and PC-related total costs per-patient-per-month (PPPM), including costs for services and procedures from medical claims (i.e. medical costs) and costs from pharmacy claims (i.e. pharmacy costs), were described in the 12-month baseline period before 1 L therapy initiation (including the baseline pre- and post- mCRPC progression periods) and during 1 L therapy (follow-up). RESULTS: Among 459 patients with mCRPC (mean age 70 years, 57% White, 16% Black, 45% commercially-insured, 43% Medicare Advantage-insured, and 12% Medicaid-insured), average baseline all-cause total costs (PPPM) were $4,576 ($4,166 pre-mCRPC progression, $8,278 post-mCRPC progression). Average baseline PC-related total costs were $2,935 ($2,537 pre-mCRPC progression, $6,661 post-mCRPC progression). During an average 1 L duration of 8.5 months, mean total costs were $13,746 (all-cause) and $12,061 (PC-related) PPPM. The cost increase following 1 L therapy initiation was driven by higher PC-related outpatient and pharmacy costs. PC-related medical costs PPPM increased from $1,504 during baseline to $5,585 following 1 L mCRPC therapy initiation. LIMITATIONS: All analyses were descriptive; statistical testing was not performed. CONCLUSION: Incremental costs of progression to mCRPC are significant, with the majority of costs driven by higher PC-related costs. Using contemporary data, this study highlights the importance of utilizing effective therapies that slow progression and reduce healthcare resource demands despite the initial investment in treatment costs.

Rural For-Profit Hospitals Are Associated With Higher Commercial Prices for 3 Common Urological Procedures.

INTRODUCTION: Rural patients lack access to urological services, and high local prices may dissuade underinsured patients from surgery. We sought to describe commercially insured prices for 3 urological procedures at rural vs metropolitan and for-profit vs nonprofit hospitals. METHODS: A cross-sectional analysis of commercially insured prices from the Turquoise Health Transparency data set was performed for ureteroscopy with laser lithotripsy, transurethral resection of bladder tumor, and transurethral resection of prostate. Hospital characteristics were linked using the Centers for Medicare and Medicaid Services Healthcare Cost Reporting Information System. Linear modeling analyzed median hospital price and its association with hospital characteristics. RESULTS: Overall, 1,532 hospitals reported urological prices in Turquoise. Median prices for each procedure were higher at rural for-profits (ureteroscopy $16,522, transurethral resection of bladder tumor $5,393, transurethral resection of prostate $9,999) vs rural nonprofits (ureteroscopy $4,512, transurethral resection of bladder tumor $2,788, transurethral resection of prostate $3,881) and metropolitan for-profits (ureteroscopy $5,411, transurethral resection of bladder tumor $3,420, transurethral resection of prostate $4,874). Rural for-profit status was independently associated with 160% higher price for ureteroscopy (relative cost ratio 2.60, P < .001), 50% higher for transurethral resection of bladder tumor (relative cost ratio 1.50, P = .002), and 113% higher for transurethral resection of prostate (relative cost ratio 2.13, P < .001). CONCLUSIONS: Prices are higher for 3 common urological surgeries at rural for-profit hospitals. Differential pricing may contribute to disparities for underinsured rural residents who lack access to nonprofit facilities. Interventions that facilitate transportation and price shopping may improve access to affordable urological care.

Association of Rural Hospital for-Profit Status With Higher Publicly Reported Prices for the Components of Inpatient Hematuria Evaluation Among Commercially Insured Patients.

INTRODUCTION: Rural patients have limited access to urological care and are vulnerable to high local prices. Little is known about price variation for urological conditions. We aimed to compare reported commercial prices for the components of inpatient hematuria evaluation between for-profit vs not-for-profit and rural vs metropolitan hospitals. METHODS: We abstracted commercial prices for the components of intermediate- and high-risk hematuria evaluation from a price transparency data set. We compared hospital characteristics between those that do and do not report prices for a hematuria evaluation using the Centers for Medicare and Medicaid Services Healthcare Cost Reporting Information System. Generalized linear modelling evaluated the association between hospital ownership and rural/metropolitan status with prices of intermediate- and high-risk evaluations. RESULTS: Of all hospitals, 17% of for-profits and 22% of not-for-profits report prices for hematuria evaluation. For intermediate-risk, median price at rural for-profit hospitals was $6,393 (interquartile range [IQR] $2,357-$9,295) compared to $1,482 (IQR $906-$2,348) at rural not-for-profits and $2,645 (IQR $1,491-$4,863) at metropolitan for-profits. For high-risk, rural for-profit hospitals' median price was $11,151 (IQR $5,826-$14,366) vs $3,431 (IQR $2,474-$5,156) at rural not-for-profits and $4,188 (IQR $1,973-$8,663) at metropolitan for-profits. Rural for-profit status was associated with an additional higher price for intermediate- (relative cost ratio 1.62, 95% CI 1.16-2.28, P = .005) and high-risk evaluations (relative cost ratio 1.50, 95% CI 1.15-1.97, P = .003). CONCLUSIONS: Rural for-profit hospitals report high prices for components of inpatient hematuria evaluation. Patients should be aware of prices at these facilities. These differences may dissuade patients from undergoing evaluation and lead to disparities.

Use of a physical activity monitor to track perioperative activity of radical cystectomy patients. Our first glimpse at what our patients are doing before and after surgery.

PURPOSE: To optimize recovery after radical cystectomy (RC), providers stress the importance of ambulation and adequate rest. However, little is known about the activity and sleep habits of patients undergoing RC. Therefore, we utilized a wearable physical activity monitor (PAM) in the perioperative period to provide the first objective data on physical activity and sleep habits for RC patients. MATERIALS AND METHODS: We prospectively identified patients ≥60 years old with planned RC. Participants completed a 4-week prehabilitation exercise program prior to surgery. They wore a PAM for 7-day intervals: at baseline, after prehabilitation, at postoperative day (POD) 30 and POD90. We tracked physical activity via metabolic equivalents (METs). METs were categorized by intensity: light (MET 1.5-<3), moderate (MET 3-<6), and vigorous (MET ≥6). We calculated daily step totals. We tracked hours slept and number of sleep awakenings. We correlated activity and sleep with self-reported quality of life (QOL). RESULTS: Forty-two patients completed prehabilitation and RC. Moderate intensity exercise decreased at POD30 (61 minutes/d at baseline, 30 minutes/d at POD30, P = 0.005). Physical activity did not significantly differ for light or vigorous activity at any timepoint. RC did not significantly affect sleep. Sleep and physical activity were associated with mental and physical QOL, respectively. CONCLUSIONS: This is the first study utilizing patient-worn monitors in RC to track physical activity and sleep. This study gives patients and providers a better understanding of postcystectomy recovery expectations. With these results in mind, interventions may be implemented to optimize activity and sleep in the perioperative period.

Medication Payments by Insurers and Patients for the Treatment of Metastatic Castrate-Resistant Prostate Cancer.

PURPOSE: The implications of high prices for cancer drugs on health care costs and patients' financial burdens are a growing concern. Patients with metastatic castrate-resistant prostate cancer (mCRPC) are often candidates for multiple first-line systemic therapies with similar impacts on life expectancy. However, little is known about the gross and out-of-pocket (OOP) payments associated with each of these drugs for patients with employer-sponsored health insurance. We therefore aimed to determine the gross and OOP payments of first-line drugs for mCRPC and how the payments vary across drugs. METHODS: This retrospective cohort study included 4,298 patients with prostate cancer who initiated therapy with one of six drugs approved for first-line treatment of mCRPC between July 1, 2013, and June 30, 2019. We compared gross and OOP payments during the 6 months after initiation of treatment for mCRPC using private payer claims data across patients using different first-line drugs. RESULTS: Gross payments varied across drugs. Over the 6 months after the index prescription, mean unadjusted gross drug payments were highest for patients receiving sipuleucel-T ($115,525 USD) and lowest for patients using docetaxel ($12,804 USD). OOP payments were lower than gross drug payments; mean 6-month OOP payments were highest for cabazitaxel ($1,044 USD) and lowest for docetaxel ($296 USD). There was a wide distribution of OOP payments within drug types. CONCLUSION: Drugs for mCRPC are expensive with large differences in payments by drug type. OOP payments among patients with employer-sponsored health insurance are much lower than gross drug payments, and they vary both across and within first-line drug types, with some patients making very high OOP payments. Although lowering drug prices would reduce pharmaceutical spending for patients with mCRPC, decreasing patient financial burden requires understanding an individual patient's benefit design.

Should Transperineal Prostate Biopsy Be the Standard of Care?

PURPOSE OF REVIEW: We reviewed the advantages and disadvantages of transperineal prostate biopsy (TP-bx) to evaluate its potential role as the standard of care for prostate biopsy. RECENT FINDINGS: Studies have suggested no difference in prostate cancer (PCa) detection rate between TP-bx and transrectal biopsy (TR-bx) but have suggested potentially increased detection of anterior prostate tumors. Advances in anesthetic technique have obviated the need for sedation thus allowing TP-bx to become an office-based procedure, which in turn can decrease the overall cost of TP-bx. Furthermore, given the low rate of infectious complications after TP-bx, some have foregone peri-procedural antibiotics without a change in the rate of infectious complications. Recent procedural advances have made TP-bx a tolerable, office-based procedure. Given the similar diagnostic performance and the benefits for the patient and community, TP-bx should become the standard of care for prostate biopsy for most patients. Future efforts should address the barriers for more universal adoption.

End-of-Life Care for Patients With Metastatic Renal Cell Carcinoma in the Era of Oral Anticancer Therapy.

PURPOSE: New therapies including oral anticancer agents (OAAs) have improved outcomes for patients with metastatic renal cell carcinoma (mRCC). However, little is known about the quality of end-of-life (EOL) care and systemic therapy use at EOL in patients receiving OAAs or with mRCC. METHODS: We retrospectively analyzed EOL care for decedents with mRCC in two parallel cohorts: (1) patients (RCC diagnosed 2004-2015) from the University of North Carolina's Cancer Information and Population Health Resource (CIPHR) and (2) patients (diagnosed 2007-2015) from SEER-Medicare. We assessed hospice use in the last 30 days of life and existing measures of poor-quality EOL care: systemic therapy, hospital admission, intensive care unit admission, and > 1 ED visit in the last 30 days of life; hospice initiation in the last 3 days of life; and in-hospital death. Associations between OAA use, patient and provider characteristics, and EOL care were examined using multivariable logistic regression. RESULTS: We identified 410 decedents in the CIPHR cohort (53.4% received OAA) and 1,508 in SEER-Medicare (43.5% received OAA). Prior OAA use was associated with increased systemic therapy in the last 30 days of life in both cohorts (CIPHR: 26.5% v 11.0%; P < .001; SEER-Medicare: 23.4% v 11.7%; P < .001), increased in-hospital death in CIPHR, and increased hospice in the last 30 days in SEER-Medicare. Older patients were less likely to receive systemic therapy or be admitted in the last 30 days or die in hospital. CONCLUSION: Patients with mRCC who received OAAs and younger patients experienced more aggressive EOL care, suggesting opportunities to optimize high-quality EOL care in these groups.

Association between cognitive impairment and oral anticancer agent use in older patients with metastatic renal cell carcinoma.

BACKGROUND: Kidney cancer is the fastest-growing cancer diagnosis in the developed world. About 16% of new cases are stage IV, which has a low five-year survival rate. Many patients with metastatic renal cell carcinoma (mRCC) are older and may have mild cognitive impairment or dementia (MCI/D). Given prior reports of patients with dementia initiating less cancer therapy and the importance of oral anticancer agents (OAAs) in mRCC treatment, we investigated the prevalence of preexisting MCI/D in patients with mRCC and their OAA use. METHODS: SEER-Medicare patients were analyzed who were ≥65 years, diagnosed with mRCC between 2007 and 2015, and had Medicare part D coverage. Patterns and predictors of (a) OAA utilization within the 12 months following mRCC diagnosis and (b) adherence (percent of days covered [PDC] ≥ 80%) during the first 90 days following treatment initiation were assessed. RESULTS: Of the 2792 eligible patients, 268 had preexisting MCI/D, and 907 initiated OAA treatment within 12 months of mRCC diagnosis. Patients with preexisting MCI/D were less likely to begin an OAA than those without MCI/D (fully-adjusted HR 0.53, 95% CI 0.38-0.76). Among OAA initiators, a preexisting MCI/D diagnosis did not alter the likelihood that a person would be adherent (adjusted RR 0.84, 95% CI 0.55-1.28). CONCLUSIONS: Patients with preexisting MCI/D were half as likely to start an OAA during the year following mRCC diagnosis than patients without comorbid MCI/D. The 90-day adherence of OAA initiators was not significantly different between those with and without preexisting MCI/D. In light of this, clinicians should assess mRCC patients for cognitive impairment and take steps to optimize OAA utilization by those with MCI/D.

Patient- And Provider-Level Predictors of Survival Among Patients With Metastatic Renal Cell Carcinoma Initiating Oral Anticancer Agents.

PURPOSE: In an era of rapid expansion of FDA approvals for oral anticancer agents (OAAs), it is important to understand the factors associated with survival among real-world populations, which include groups not well-represented in pivotal clinical trials of OAAs, such as the elderly, racial minorities, and medically complex patients. Our objective was to evaluate patient- and provider-level characteristics' associations with mortality among a multi-payer cohort of metastatic renal cell carcinoma (mRCC) patients who initiated OAAs. METHODS: This retrospective cohort study was conducted using data from the North Carolina state cancer registry linked to multi-payer claims data for the years 2004 to 2015. Provider data were obtained from North Carolina Health Professions Data System and the National Plan & Provider Enumeration System. Included patients were individuals with mRCC who initiated an OAA and survived ≥90 days after beginning treatment. We estimated hazard ratios (HR) and corresponding 95% confidence limits (CL) using Cox hazard models for associations between patient demographics, patient clinical characteristics, provider-level factors, and 2-year all-cause mortality. RESULTS: The cohort included 207 patients with mRCC who received OAAs. In multivariable models, clinical variables such as frailty (HR: 1.36, 95% CL: 1.11-1.67) and de novo metastatic diagnosis (HR: 2.63, 95%CL: 1.67-4.16) were associated with higher all-cause mortality. Additionally, patients solely on Medicare had higher adjusted all-cause mortality compared with patients with any private insurance (HR: 2.35, 95% CL: 1.32-4.18). No provider-level covariates investigated were associated with all-cause mortality. CONCLUSIONS: Within a real-world population of mRCC patients taking OAAs, survival differed based on patient characteristics. In an era of rapid expansion of FDA approvals for OAAs, these real-world data underscore the continued importance of access to high-quality care, particularly for medically complex patients with limited resources.

Patient, provider, and hospital factors associated with oral anti-neoplastic agent initiation and adherence in older patients with metastatic renal cell carcinoma.

INTRODUCTION: Oral anti-neoplastic agents (OAAs) for metastatic renal cell carcinoma (mRCC) are associated with increased cancer-specific survival. However, racial disparities in survival persist and older adults have the lowest rates of cancer-specific survival. Research from other cancers demonstrates specialty access is associated with high-quality cancer care, but older adults receive cancer treatment less often than younger adults. We therefore examined whether patient, provider, and hospital characteristics were associated with OAA initiation, adherence, and cancer-specific survival after initiation and whether race, ethnicity, and/or age was associated with an increased likelihood of seeing a medical oncologist for diagnosis of mRCC. PATIENTS AND METHODS: We used Surveillance, Epidemiology, and End Results (SEER)Medicare data to identify patients ≥65 years of age who were diagnosed with mRCC from 2007 to 2015 and enrolled in Medicare Part D. Insurance claims were used to identify receipt of OAAs within twelve months of metastatic diagnosis, calculate proportion of days covered, and to identify the primary cancer provider and hospital. We examined provider and hospital characteristics associated with OAA initiation, adherence, and all-cause mortality after OAA initiation. RESULTS: We identified 2792 patients who met inclusion criteria. Increased OAA initiation was associated with access to a medical oncologist. Patients were less likely to begin OAA treatment if their primary oncologic provider was a urologist (hazard ratio [HR] 0.62; 95% confidence interval [CI] 0.49-0.77). Provider/hospital characteristics were not associated with differences in OAA adherence or mortality. Patients who started sorafenib (odds ratio [OR] 0.50; 95% CI 0.29-0.86), were older (aged >81 OR 0.56; 95% CI 0.34-0.92), and those living in high poverty ZIP codes (OR 0.48; 95% CI 0.29-0.80) were less likely to adhere to OAA treatment. Furthermore, provider characteristics did not account for differences in mortality once an OAA was initiated. Last, only age > 81 years was statistically and clinically associated with a decreased relative risk of seeing a medical oncologist (risk ratio [RR] 0.87; CI 0.82-0.92). CONCLUSION: Provider/hospital factors, specifically, being seen by a medical oncologist for mRCC diagnosis, are associated with OAA initiation. Older patients were less likely to see a medical oncologist; however, race and/or ethnicity was not associated with differences in seeing a medical oncologist. Patient factors are more critical to OAA adherence and mortality after OAA initiation than provider/hospital factors.

Evaluation of mild cognitive impairment and dementia in patients with metastatic renal cell carcinoma.

BACKGROUND: Dementia and cancer are both more common in adults as they age. As new cancer treatments become more popular, it is important to consider how these treatments might affect older patients. This study evaluates metastatic renal cell carcinoma (mRCC) as a risk factor for older adults developing mild cognitive impairment or dementia (MCI/D) and the impact of mRCC-directed therapies on the development of MCI/D. METHODS: We identified patients diagnosed with mRCC in a Surveillance, Epidemiology, and End Results (SEER)-Medicare dataset from 2007 to 2015 and matched them to non-cancer controls. Exclusion criteria included age < 65 years at mRCC diagnosis and diagnosis of MCI/D within the year preceding mRCC diagnosis. The main outcome was time to incident MCI/D within one year of mRCC diagnosis for cases or cohort entry for non-cancer controls. Cox proportional hazards models were used to measure associations between mRCC and incident MCI/D as well as associations of oral anticancer agent (OAA) use with MCI/D development within the mRCC group. RESULTS: Patients with mRCC (n = 2533) were matched to non-cancer controls (n = 7027). mRCC (hazard ratio [HR] 8.52, p < .001), being older (HR 1.05 per 1-year age increase, p < .001), and identifying as Black (HR 1.92, p = .047) were predictive of developing MCI/D. In addition, neither those initiating treatment with OAAs nor those who underwent nephrectomy were more likely to develop MCI/D. CONCLUSIONS: Patients with mRCC were more likely to develop MCI/D than those without mRCC. The medical and surgical therapies evaluated were not associated with increased incidence of MCI/D. The increased incidence of MCI/D in older adults with mRCC may be the result of the pathology itself or risk factors common to the two disease processes.

The Impact of Health Delivery Integration on Cancer Outcomes.

Although integrated health care has largely been associated with increases in prices and static or decreased quality across many disease states, it has shown some successes in improving cancer care. However, its impact is largely equivocal, making consensus statements difficult. Critically, integration does not necessarily translate to clinical coordination, which might be the true driver behind the success of integrated health care delivery. Moving forward, it is important to establish payment models that support clinical care coordination. Shifting from a fragmented health system to a coordinated one may improve evidence-based cancer care, outcomes, and value for patients.

Provider- and patient-level predictors of oral anticancer agent initiation and adherence in patients with metastatic renal cell carcinoma.

BACKGROUND: Improving oral anticancer agent (OAA) initiation and adherence is the important quality-of-care issues, particularly since one fourth of anticancer agents being developed will be administered orally. Our objective was to identify provider- and patient-level characteristics associated with OAA initiation and adherence among individuals with metastatic renal cell carcinoma (mRCC). METHODS: We used state cancer registry data linked to multi-payer claims data to identify patients with mRCC diagnosed in 2004-2015. Provider data were obtained from North Carolina Health Professions Data System and the National Plan & Provider Enumeration System. We estimated risk ratios (RRs) and corresponding 95% confidence limits (CLs) using modified Poisson regression to evaluate factors associated with OAA initiation and adherence. RESULTS: Among the 207 (out of 687) patients who initiated an OAA following mRCC diagnosis and survived 90 days, median proportion of days covered was 0.91. Patients with a modal provider specializing in hematology/medical oncology were much more likely to initiate OAAs than those seen by other specialties. Additionally, patients with a female provider were more likely to initiate OAAs than those with a male provider. Compared to patients treated by providers practicing in both urban and rural areas, patients with providers practicing solely in urban areas were more likely to initiate OAAs, after controlling for patient-level factors (RR = 1.37; 95% CL: 1.09-1.73). Medicare patients were less likely to be adherent than those with private insurance (RR = 0.61; 95% CL: 0.42-0.87). CONCLUSIONS: Our results suggest that provider- and patient-level factors influence OAA initiation in patients with mRCC but only insurance type was associated with adherence.

Initial Findings from a High Genetic Risk Prostate Cancer Clinic.

OBJECTIVE: To improve prostate cancer screening for high-risk men, we developed an early detection clinic for patients at high genetic risk of developing prostate cancer. Despite the rapidly growing understanding of germline variants in driving aggressive prostate cancer and the increased availability of genetic testing, there is little evidence surrounding how best to screen these men. METHODS: We are reporting on the first 45 patients enrolled, men between the ages of 35-75, primarily with known pathogenic germline variants in prostate cancer susceptibility genes. Screening consists of an intake lifestyle survey, PSA, DRE, and SelectMDx urine assay. A biopsy was recommended for any of the following indications: 1) abnormal DRE, 2) PSA above threshold, or 3) SelectMDx above threshold. The primary outcomes were number needed to screen, and number needed to biopsy to diagnose a patient with prostate cancer. RESULTS: Patients enrolled in the clinic included those with BRCA1 (n=7), BRCA2 (n=16), Lynch Syndrome (n=6), and CHEK2 (n = 4) known pathogenic germline variants. The median age and PSA were 58 (range 35-71) and 1.4 ng/ml (range 0.1-11.4 ng/ml), respectively. 12 patients underwent a prostate needle biopsy and there were 4positive biopsies for prostate cancer. CONCLUSION: These early data support the feasibility of opening a dedicated clinic for men at high genetic risk of prostate cancer. This early report on the initial enrollment of our long-term study will help optimize early detection protocols and provide evidence for personalized prostate cancer screening in men with key pathogenic germline variants.

Patterns and Predictors of Oral Anticancer Agent Use in Diverse Patients With Metastatic Renal Cell Carcinoma.

PURPOSE: Availability of targeted oral anticancer agents (OAAs) has transformed care for patients with metastatic renal cell carcinoma (mRCC). Our objective was to identify patterns and predictors of OAA use within 12 months after mRCC was detected to understand real-world adoption of OAAs. METHODS: We used a novel, North Carolina cancer registry-linked multipayer claims data resource to examine patterns of use of five oral therapies among patients with mRCC diagnosed in 2006-2015, with claims through 2016. Patients were required to have 12 months of continuous enrollment before metastatic index date. Log-Poisson models estimated unadjusted and adjusted risk ratios (RRs) for associations between patient characteristics and OAA use. In sensitivity analyses, we used a competing risk framework to estimate adjusted risk differences in OAA use. RESULTS: Our population-based study of 713 patients demonstrated low (37%) OAA use during the first year after metastatic index date among both publicly and privately insured patients, with shifting patterns of use consistent with regulatory approvals over time. Compared with patients age 18-49 years, patients age 70-74 years were half likely to use OAAs (95% confidence limit [CL], 0.34 to 0.78) and patients age 80+ years were 71% less likely to use OAAs (95% CL, 0.17 to 0.50). Patients with two comorbidities (RR, 0.73; 95% CL, 0.55 to 0.98) and those with 3+ comorbidities (RR, 0.68; 95% CL, 0.50 to 0.91) were less likely to receive OAA than those without comorbidities. Patients with higher frailty also had lower OAA utilization (RR, 0.67; 95% CL, 0.52 to 0.85). CONCLUSION: These findings suggest a need to better understand the system-level and provider-level drivers of OAA underuse, as well as OAA adherence and associated survival.

Impact of Early Confirmatory Tests on Upgrading and Conversion to Treatment in Prostate Cancer Patients on Active Surveillance.

OBJECTIVES: To assess the impact of confirmatory tests on active surveillance (AS) biopsy disease reclassification and progression to treatment in men with favorable risk prostate cancer (FRPC). METHODS: We searched the MUSIC registry for men with FRPC managed with AS without or with a confirmatory test. Confirmatory tests included (1) repeat prostate biopsy, (2) genomic tests, (3) prostate magnetic resonance imaging (MRI), or (4) MRI followed by a post-MRI biopsy. Confirmatory test results were deemed reassuring (RA) or nonreassuring (nonRA) according to predefined criteria. Kaplan-Meier curves and multivariable Cox regression models were used to compare surveillance biopsy disease reclassification-free survival and treatment-free survival. RESULTS: Of the 2,514 men with FRPC who were managed on AS, 1211 (48%) men obtained a confirmatory test. We noted differences in the 12-month unadjusted surveillance biopsy disease reclassification-free probability (68%, 83%, and 90%, P < .0001) and 24-month unadjusted treatment-free probability (55%, 81%, and 79%, P < .0001), for men with nonRA confirmatory tests, no confirmatory test, and RA confirmatory tests, respectively. Excluding patients with genomic confirmatory tests, men with RA confirmatory tests were associated with a lower hazard (hazard ratio [HR] 0.57, 95% confidence interval [CI] 0.38-0.84, P = .005) and men with nonRA confirmatory tests had an increased hazard (HR 1.97, 95% CI 1.22-3.19, P = .006) of surveillance disease reclassification compared with men without confirmatory tests in the multivariable model. CONCLUSION: These data suggest men with RA confirmatory tests have less surveillance biopsy reclassification and remain on AS longer than men with nonRA test results. Confirmatory tests may help risk stratify men considering active surveillance.

The Feasibility and Impact of a Presurgical Exercise Intervention Program (Prehabilitation) for Patients Undergoing Cystectomy for Bladder Cancer.

OBJECTIVE: To assess the feasibility of a prehabilitation program for cystectomy patients and to determine the effectiveness of the program in improving strength and functional capacity in the peri-operative period. MATERIALS AND METHODS: This phase I/II study accrued patients ≥60 years old from January 2013 to October 2017 with biopsy-proven bladder cancer, Karnofsky performance score ≥70 and a sedentary baseline lifestyle to participate in a 4-week supervised preoperative exercise training program. Primary outcomes were feasibility and safety; secondary outcomes included changes in fitness, patient-reported QOL, peri-operative complications and readmissions. Student's ttests and Wilcoxon signed-rank test were performed. RESULTS: Fifty-four patients enrolled in the program. Successful completion, defined as patients who began the program and adhered to >70% of the sessions, was attained by 41 of 51 patients (80.4%, 90% CI [71%-90%]). There were no adverse events. Fitness and patient-reported QOL improved postintervention, with sustained improvements in general and mental health 90-days postsurgery. The primary limitation is no control group. CONCLUSION: Prehabilitation prior to cystectomy is feasible, safe, and results in improvements in patient strength, endurance and sustained improvements in patient-reported QOL from baseline. Efforts to further evaluate the impact of prehabilitation in this population in an expanded and randomized fashion are warranted.