Financial Toxicity Among Patients With Metastatic Prostate Cancer: A Mixed Methods Approach to Identify Effective Interventions.

INTRODUCTION: Financial toxicity associated with treatments for metastatic prostate cancer remains poorly defined. We sought to understand aspects of financial toxicity not captured in a commonly employed financial toxicity questionnaire and identify potential interventions to help alleviate financial toxicity through a convergent mixed methods approach. METHODS: Patients seen at our institution's advanced prostate cancer clinic were approached for completion of the Comprehensive Score for Financial Toxicity (COST-FACIT) questionnaire (quantitative analysis). A maximal variation purposive sample was chosen to participate in focus group discussions (qualitative analysis). Conventional content analysis was performed using an inductive approach. COST-FACIT scores were compared between patients experiencing high and low financial toxicity using Wilcoxon rank sum test. RESULTS: Three themes were identified through qualitative analysis: (1) workload, (2) coping strategies, and (3) communication. We found alignment with the existing theory of financial capacity across our findings. Two unique aspects of financial toxicity emerged that were not assessed quantitatively and deemed to be significant. Specifically, cost transparency (including health care teams knowledgeable about and willing to discuss costs) and inclusion of informal caregivers in financial toxicity screening and decision-making may guide future interventions aimed at limiting financial toxicity in this population. CONCLUSIONS: Prolonged treatment courses involving multiple lines of treatment with varying costs result in distinct financial toxicity components for patients with metastatic prostate cancer that are not assessed with COST-FACIT. Improving cost transparency, health care team knowledge and engagement, and providing resources to support informal caregivers may have a significant impact on the financial toxicity experienced by these patients.

A SEER-Medicare Based Quality Score for Patients With Metastatic Upper Tract Urothelial Carcinoma.

BACKGROUND: Population-based studies evaluating outcomes for metastatic upper tract urothelial carcinoma (mUTUC) are sparse and rarely capture both patients with de novo (synchronous) metastases and those who progress to metastatic disease (metachronous). Herein we evaluated the outcomes and costs associated with synchronous and metachronous mUTUC, utilizing a novel Methodology. Additionally, we created a guideline-based quality score to improve care in this space. PATIENTS AND METHODS: We identified all patients with mUTUC aged 66 years and older included in the SEER-Medicare linked database between 2004 and 2012. Achievement of 3 quality criteria was assessed: (1) cancer-specific survival (CSS)>12 months; (2) receipt of systemic therapy; (3) receipt of hospice/palliative care. Total healthcare and out-of-pocket costs were evaluated. Regression analyses were performed to assess characteristics associated with quality criteria and total healthcare costs. RESULTS: Of the 1223 patients identified, at least one quality criterion was met in just 40.2% and only 54 patients (4.4%) received palliative care. In multivariable analysis, patients with synchronous mUTUC (OR:0.55, 95%CI:0.41-0.72), and at least 3 comorbidities (OR:0.68, 95%CI:0.47-0.98) were less likely to achieve at least 1 quality criterion. Meeting at least 1 quality criterion was associated with increased costs ($94,677, 95%CI:87,702-101,652 versus $63,575, 95%CI:59,598-67,552). CONCLUSIONS: Less than half of patients with mUTUC met at least 1 quality criterion. Quality score achievement was associated with a modest increase in total healthcare spending. These findings not only provide guidance for future study of rare diseases using secondary data, but also highlight inadequacies in the current management of mUTUC.

Comparative cost-effectiveness of contemporary treatment strategies for stage IIA seminoma.

BACKGROUND: The Surgery in Early Metastatic Seminoma (SEMS) trial examined retroperitoneal lymph node dissection as first-line treatment for patients with isolated 1-3 cm retroperitoneal lymphadenopathy. To date, the standard of care for these patients has been either chemotherapy or radiotherapy. Herein, we evaluated the relative cost-effectiveness of these management strategies. METHODS: A microsimulation model assessed the cost-effectiveness of retroperitoneal lymph node dissection, chemotherapy, and radiotherapy for stage IIA seminoma. Sensitivity analyses were performed to evaluate model robustness. Retroperitoneal lymph node dissection recurrence probabilities were obtained from the SEMS trial. All other probability and utility values were obtained from published literature. Primary outcomes included costs from a commercial insurer's perspective, effectiveness (quality adjusted life-years [QALYs]), and incremental cost-effectiveness ratios using a willingness-to-pay threshold of $100 000/QALY. RESULTS: At a lifetime horizon, the mean costs per patient for retroperitoneal lymph node dissection, radiotherapy, and chemotherapy were $58 469, $98 783, and $104 096, and the mean QALYs were 40.61, 40.70, and 39.15, respectively. Retroperitoneal lymph node dissection was found to be the most cost-effective approach because of high costs and accrued disutility of chronic toxicities associated with radiotherapy (cost-effectiveness ratios = $433 845/QALY) and chemotherapy (dominated). On 1-way sensitivity analyses, retroperitoneal lymph node dissection was no longer cost-effective if the probabilities of infertility and cardiovascular toxicity after radiotherapy were less than 13% and 16%, respectively, or if the 2-year probability of progression after retroperitoneal lymph node dissection was more than 26%. CONCLUSIONS: Retroperitoneal lymph node dissection was the most cost-effective treatment approach for stage IIA seminoma. These findings support clinical guideline consideration of including retroperitoneal lymph node dissection as a treatment option for well-selected patients with stage IIA seminoma.

Coping Mechanisms for Financial Toxicity Among Patients With Metastatic Prostate Cancer: A Survey-based Assessment.

PURPOSE: Assessments of financial toxicity among patients with metastatic prostate cancer are lacking. Using patient surveys, we sought to identify coping mechanisms and assess characteristics associated with lower financial toxicity. MATERIALS AND METHODS: Surveys were administered to all patients seen at a single center's Advanced Prostate Cancer Clinic over a 3-month period. Surveys included the COST-FACIT (COmprehensive Score for Financial Toxicity) and coping mechanism questionnaires. Patients with metastatic disease (lymph nodes, bone, visceral) were included for analysis. Coping mechanisms were compared between patients experiencing low (COST-FACIT >24) vs high (COST-FACIT ≤24) financial toxicity using Fisher's exact test. Multivariable linear regression was used to evaluate characteristics associated with lower financial toxicity. RESULTS: Overall, 281 patients met inclusion criteria of which 79 reported high financial toxicity. In multivariable analysis, characteristics associated with lower financial toxicity included older age (estimate: 0.36, 95%CI: 0.21-0.52), applying for patient assistance programs (estimate: 4.42, 95%CI: 1.72-7.11), and an annual income of at least $100,000 (estimate: 7.81, 95%CI: 0.97, 14.66). Patients with high financial toxicity were more likely to decrease spending on basic goods (35% vs 2.5%, P < .001) and leisure activities (59% vs 15%, P > .001), as well as use savings (62% vs 17%, P < .001) to pay for their treatment. CONCLUSIONS: In this cross-sectional study, patients with metastatic prostate cancer and high financial toxicity were more likely to decrease spending on basic goods and leisure activities and use savings to pay for care. Understanding the impact of financial toxicity on patients' lives is crucial to inform shared decision-making and interventions designed to mitigate financial toxicity in this population.

The Impact of Medicare Low-income Subsidy on Access to Treatment, Treatment Choice, and Oncologic Outcomes in Patients With Metastatic Prostate Cancer.

PURPOSE: Patients eligible for Medicare Part D low-income subsidy have lower cost-sharing for both IV and oral cancer therapies. We evaluated associations between low-income subsidy and treatment choice, treatment initiation, and overall survival in patients with metastatic prostate cancer. MATERIALS AND METHODS: We identified men aged 66 years and older diagnosed with stage IV prostate cancer between 2010 and 2017 included in the Surveillance, Epidemiology, and End Results-Medicare linked data set. Using linear probability models, we evaluated the impact of low-income subsidy on type of first supplementary treatment (oral vs IV) among patients who received nonandrogen deprivation therapy supplementary systemic therapy, and initiation of any nonandrogen deprivation therapy supplementary systemic therapy. Overall survival was estimated with Kaplan-Meier curves. RESULTS: Of the 5,929 patients included, 1,766 (30%) had low-income subsidy. On multivariable analysis, those with low-income subsidy were more likely to receive oral as opposed to IV treatments compared to patients without low-income subsidy (probability difference: 17%, 95% CI 12, 22). However, patients with low-income subsidy were less likely to initiate any nonandrogen deprivation therapy supplementary systemic therapy (oral or IV) compared to those without low-income subsidy (probability difference: 7.9%, 95% CI 4.8-11). Additionally, patients with low-income subsidy experienced worse overall survival than those without low-income subsidy (P < .001). CONCLUSIONS: While low-income subsidy was associated with increased use of more expensive oral therapies in men with metastatic prostate cancer, barriers to accessing these treatments still exist. These findings stress the importance of continued efforts to improve health care access to low-income individuals.

The Impact of Metastasis Histopathology on Oncologic Outcomes for Patients With Surgically Resected Metastatic Renal Cell Carcinoma.

PURPOSE: Multiple prognostic models exist to assess survival among patients with metastatic clear cell renal cell carcinoma. However, the relative contribution of histopathological features of the metastasis has not been extensively studied. Herein, we compared models using clinical, primary tumor, and metastatic features to predict cancer-specific survival for patients with surgically resected metastatic clear cell renal cell carcinoma. MATERIALS AND METHODS: We studied 266 patients who had undergone nephrectomy between 1970 and 2019, and who had a single site of metastasis completely resected. Two versions of the metastatic clear cell renal cell carcinoma score published by Leibovich et al were calculated, using grade and necrosis from the primary tumor and using grade and necrosis from the metastasis. Predictive abilities of these 2 versions and a third model that included metastatic features only were compared using c-indexes from Cox proportional hazards models. RESULTS: A total of 197 patients died from renal cell carcinoma at a median of 2.3 years (IQR 1.1-4.5); median follow-up among survivors was 13.2 years (IQR 10.0-14.5). The Leibovich score using grade and necrosis from the metastasis (c=0.679) had similar predictive ability compared to the original Leibovich score using grade and necrosis from the primary tumor (c=0.675). A third model (c=0.707) demonstrated that metastasectomy within 2 years after nephrectomy, presence of bone metastasis, high grade, and sarcomatoid differentiation in the metastasis were significantly associated with cancer-specific survival. CONCLUSIONS: Scoring algorithms calculated using histopathological features of the metastasis can be used to predict cancer-specific survival for patients with surgically resected metastatic clear cell renal cell carcinoma. These findings are of particular importance for instances when primary tumor histopathology is not readily available.

Financial toxicity of oral therapies in advanced prostate cancer.

The treatment landscape of advanced prostate cancer (CaP) has evolved significantly over the past 20 years. As the number of oral anticancer treatment options continues to increase, so do the costs of these drugs. Furthermore, payment responsibility for these treatments is increasingly shifted from insurers to patients. In this narrative review, we sought to summarize existing assessments of financial toxicity (FT) associated with oral advanced CaP treatments, describe efforts targeted at limiting FT from these agents, and identify areas in need of further investigation. FT is understudied in advanced CaP. Oral treatment options are associated with significantly higher direct costs to patients compared to standard androgen deprivation therapy or chemotherapy. Financial assistance programs, Medicare low-income subsidies, and recent health policy changes help offset these costs for some patients. Physicians are reluctant to discuss treatment costs with patients and further work is needed to better understand best practices for inclusion of FT discussions in shared decision-making. Oral therapies for advanced CaP are associated with significantly higher patient out-of-pocket costs which may contribute to FT. Currently, little is known regarding the extent and severity of these costs on patients' lives. While recent policy changes have helped reduce these costs for some patients, more work is needed to better characterize FT in this population to inform interventions that improve access to care and lessen the harms associated with the cost of novel treatments.

Cost-Effectiveness and Economic Impact of Bladder Cancer Management: An Updated Review of the Literature.

Bladder cancer remains one of the costliest malignancies to manage. We provide a narrative review of literature assessing the economic burden and cost-effectiveness of bladder cancer treatment and surveillance. This is an update to a previous review and focuses on data published within the past 10 years. We queried PubMed and MEDLINE for all bladder cancer cost-related literature between 2013 and 2023. After initial screening, 117 abstracts were identified, 50 of which were selected for inclusion in our review. Management of disease recurrence and treatment complications contributes significantly to the high cost of care. High-value interventions are therefore treatments that improve recurrence-free and overall survival at minimal additional toxicity. De-escalation of surveillance and diagnostic interventions may help to reduce costs in this space without compromising oncologic control. The persistently rising cost of novel cancer drugs undermines their value when only modest gains in efficacy are observed. Multiple cost-effectiveness analyses have been published and are useful for contextualizing the cost, efficacy, and impact on quality of life that interventions have in this population. Further cost-effectiveness work is needed to better characterize the impact that treatment costs have on patients' financial well-being and quality of life.

The Impact of Within-Consultation and Preconsultation Decision Aids for Localized Prostate Cancer on Patient Knowledge: Results of a Patient-Level Randomized Trial.

OBJECTIVE: To evaluate the role of timing (either before or during initial consultation) on the effectiveness of decision aids (DAs) to support shared-decision-making in a minority-enriched sample of patients with localized prostate cancer using a patient-level randomized controlled trial design. METHODS: We conducted a 3-arm, patient-level-randomized trial in urology and radiation oncology practices in Ohio, South Dakota, and Alaska, testing the effect of preconsultation and within-consultation DAs on patient knowledge elements deemed essential to make treatment decisions about localized prostate cancer, all measured immediately following the initial urology consultation using a 12-item Prostate Cancer Treatment Questionnaire (score range 0 [no questions correct] to 1 [all questions correct]), compared to usual care (no DAs). RESULTS: Between 2017 and 2018, 103 patients-including 16 Black/African American and 17 American Indian or Alaska Native men-were enrolled and randomly assigned to receive usual care (n = 33) or usual care and a DA before (n = 37) or during (n = 33) the consultation. After adjusting for baseline characteristics, there were no statistically significant proportional score differences in patient knowledge between the preconsultation DA arm (0.06 knowledge change, 95% CI -0.02 to 0.12, P = .1) or the within-consultation DA arm (0.04 knowledge change, 95% CI -0.03 to 0.11, P = .3) and usual care. CONCLUSION: In this trial oversampling minority men with localized prostate cancer, DAs presented at different times relative to the specialist consultation showed no improvement in patient knowledge above usual care.

Effect of Preoperative Multiparametric Magnetic Resonance Imaging on Oncologic and Functional Outcomes Following Radical Prostatectomy.

Background: Advancements in imaging technology have been associated with changes to operative planning in treatment of localized prostate cancer. The impact of these changes on postoperative outcomes is understudied. Objective: To compare oncologic and functional outcomes between men who had computed tomography (CT) and those who had multiparametric magnetic resonance imaging (mpMRI) prior to undergoing radical prostatectomy. Design setting and participants: In this retrospective cohort study, we identified all men who underwent radical prostatectomy (n = 1259) for localized prostate cancer at our institution between 2009 and 2016. Of these, 917 underwent preoperative CT and 342 mpMRI. Outcome measurements and statistical analysis: Biochemical recurrence-free survival, positive margin status, postoperative complications, and 1-yr postprostatectomy functional scores (using the 26-item Expanded Prostate Cancer Index Composite [EPIC-26] questionnaire) were compared between those who underwent preoperative CT and those who underwent mpMRI using propensity score weighted Cox proportional hazard regression, logistic regression, and linear regression models. Results and limitations: Baseline and 1-yr follow-up EPIC-26 data were available for 449 (36%) and 685 (54%) patients, respectively. After propensity score weighting, no differences in EPIC-26 functional domains were observed between the imaging groups at 1-yr follow-up. Positive surgical margin rates (odds ratio 1.03, 95% confidence interval [CI] 0.77-1.38, p = 0.8) and biochemical recurrence-free survival (hazard ratio 1.21, 95% CI 0.84-1.74, p = 0.3) were not significantly different between groups. Early and late postoperative complications occurred in 219 and 113 cases, respectively, and were not different between imaging groups. Our study is limited by a potential selection bias from the lack of functional scores for some patients. Conclusions: In this single-center study of men with localized prostate cancer undergoing radical prostatectomy, preoperative mpMRI had minimal impact on functional outcomes and oncologic control compared with conventional imaging. These findings challenge the assumptions that preoperative mpMRI improves operative planning and perioperative outcomes. Patient summary: In this study, we assessed whether the type of prostate imaging performed prior to surgery for localized prostate cancer impacted outcomes. We found that urinary and sexual function, cancer control, and postoperative complications were similar regardless of whether magnetic resonance imaging or computed tomography was utilized prior to surgery.

Perioperative and Oncologic Outcomes Associated with Simultaneous Radical Cystectomy and Nephroureterectomy.

OBJECTIVE: To compare the perioperative and oncologic outcomes associated with RCNU to a matched cohort undergoing RC alone. Simultaneous radical cystectomy and nephroureterectomy (RCNU) for synchronous upper tract and bladder urothelial carcinoma is an uncommon procedure. Sparse literature exists comparing outcomes in patients treated with radical cystectomy (RC) alone versus RCNU. METHODS: Adults treated with RCNU for urothelial carcinoma of the bladder (UCB) and upper tract urothelial carcinoma (UTUC) between 1980 and 2020 were identified. Patients were matched 2:1 to patients undergoing RC alone for UCB based on age (+/- 5 years), gender, BMI (+/- 5), Charlson Comorbidity Index, pathologic staging (stage ≤pT2 vs >pT2), and receipt of neoadjuvant chemotherapy. Outcomes included overall survival (OS), recurrence free survival (RFS), cancer specific survival (CSS), 30-day complications, length of stay (LOS), operative time, and estimated blood loss (EBL). RESULTS: A total of 39 patients undergoing RCNU were identified and matched to 74 patients undergoing RC. There were no significant differences in LOS, EBL, or 30-day complication rates. Operative time was significantly longer in the RC cohort. OS (HR 0.58, CI 0.35-0.97, P = .036) was significantly better for patients undergoing RC alone, while no significant difference was noted in RFS (HR 0.65, 0.34-1.24) and CSS (HR 0.58, CI 0.31-1.08, P = .08). CONCLUSIONS: Patients undergoing RCNU had significantly lower OS compared to a matched group of patients undergoing RC alone. Perioperative outcomes between the groups did not differ significantly. This data can inform patient counseling for treatment of this rare disease state.

Cost-effectiveness of Adjuvant Pembrolizumab After Nephrectomy for High-risk Renal Cell Carcinoma: Insights for Patient Selection From a Markov Model.

PURPOSE: The KEYNOTE-564 trial demonstrated that adjuvant pembrolizumab after nephrectomy for clear cell renal cell carcinoma decreased the risk of disease progression and potentially overall mortality as well. Herein, we used a Markov model to weigh the costs, toxicities, and efficacy of pembrolizumab to further investigate its utility. MATERIALS AND METHODS: Decision-analytic Markov modeling was used to conduct a cost-utility analysis of adjuvant pembrolizumab versus observation after nephrectomy for high-risk clear cell renal cell carcinoma, using data from KEYNOTE-564 to inform model probabilities. Primary outcomes were quality-adjusted life years, Medicare costs, and incremental cost-effectiveness ratios. The willingness-to-pay threshold utilized was $100,000/quality-adjusted life year. RESULTS: At 5 years, adjuvant treatment with pembrolizumab resulted in 0.3 additional quality-adjusted life years at an additional cost of $99,484 relative to observation. Pembrolizumab was found not to be cost-effective at a 5-year time horizon (incremental cost-effectiveness ratio=$326,534). On sensitivity analysis, pembrolizumab became cost-effective if its per cycle cost was <$5,064 (base=$10,278) or its 5-year progression benefit was >18.8% (base 9%). Upon simulation, pembrolizumab was cost-effective for 29% of patients at 5 years. Specifically, we found that pembrolizumab would be cost-effective at 5 years for patients with at least a 59% 5 year risk of progression, which corresponds to a Mayo Progression-free Survival Score ≥10. CONCLUSIONS: At current prices, adjuvant pembrolizumab was found to be cost-effective only for the highest risk subset of clear cell renal cell carcinoma patients 5 years after treatment, including patients with complete metastasectomy, regional lymph node involvement, or ≥7cm pT3 tumors with sarcomatoid features. Longer-term trial data, including overall survival results, are necessary to confirm these extrapolations.

Comparative cost-effectiveness of neoadjuvant chemotherapy regimens for muscle-invasive bladder cancer: Results according to VESPER data.

BACKGROUND: The VESPER trial demonstrated improved progression-free (PFS) and (preliminarily) overall survival (OS) with six cycles of neoadjuvant dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin (ddMVACx6) versus four cycles of gemcitabine and cisplatin (GCx4) before radical cystectomy (RC) for muscle-invasive bladder cancer (MIBC), but with increased toxicity. This study compares the cost-effectiveness of these regimens. METHODS: A cost-effectiveness analysis of neoadjuvant ddMVACx6 and GCx4 was performed using a decision-analytic Markov model with 5-year, 10-year, and lifetime horizons. Probabilities were derived from reported VESPER data. Utility values were obtained from the literature. Primary outcomes were effectiveness measured in quality-adjusted life years (QALY) and incremental cost-effectiveness ratio (ICER) with a willingness to pay threshold of $100,000 per QALY. One-way and probabilistic sensitivity analyses were performed to evaluate the robustness of the model. RESULTS: At 5 years, ddMVACx6 improved QALYs by 0.30 at an additional cost of $16,100, rendering it cost-effective relative to GCx4 (ICER: $53,284/QALY). Additionally, probabilistic sensitivity analysis found ddMVACx6 to be cost-effective in 79% and 81% of microsimulations at10-year and lifetime horizons, respectively. One-way sensitivity analysis demonstrated a minimum difference in 5-year progression of 0.9% and progression mortality of 0.7% between ddMVACx6 and GCx4 was necessary for ddMVACx6 to remain cost-effective. CONCLUSIONS: Neoadjuvant ddMVACx6 was more cost-effective than GCx4 for MIBC. These data, together with the improved PFS and (albeit preliminary) OS noted in VESPER, support use of this regimen in appropriate candidates for neoadjuvant chemotherapy before RC. LAY SUMMARY: We performed a benefit-to-cost analysis using evidence from a randomized controlled trial that compared two different chemotherapy treatments before bladder removal for bladder cancer that had invaded into the bladder muscle. Despite being more expensive and having a greater likelihood of toxicity, six cycles of dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin was more cost-effective (or had higher value) than four cycles of gemcitabine and cisplatin.

The Association Between Financial Toxicity and Treatment Regret in Men With Localized Prostate Cancer.

BACKGROUND: Financial toxicity is emerging as an important patient-centered outcome and is understudied in prostate cancer patients. We sought to understand the association between financial burden and treatment regret in men with localized prostate cancer to better evaluate the role of financial discussions in patient counseling. METHODS: Utilizing the Comparative Effectiveness Analysis of Surgery and Radiation dataset, we identified all men accrued between 2011 and 2012 who underwent surgery, radiation, or active surveillance for localized prostate cancer. Financial burden and treatment regret were assessed at 3- and 5-year follow-up. The association between financial burden and regret was assessed using multivariable longitudinal logistic regression controlling for demographic and disease characteristics, treatment, functional outcomes, and patient expectations. RESULTS: Of the 2924 eligible patients, regret and financial burden assessments for 3- and/or 5-year follow-up were available for 81% (n = 2359). After adjustment for relevant covariates, financial burden from "finances in general" was associated with treatment regret at 3 years (odds ratio [OR] = 2.47, 95% confidence interval [CI] = 1.33 to 4.57; P = .004); however, this association was no longer statistically significant at 5-year follow-up (OR = 1.19, 95% CI = 0.56 to 2.54; P = .7). CONCLUSIONS: In this population-based sample of men with localized prostate cancer, we observed associations between financial burden and treatment regret. Our findings suggest indirect treatment costs, especially during the first 3 years after diagnosis, may impact patients more profoundly than direct costs and are important for inclusion in shared decision making.

Out-of-Pocket Cost Burden Associated With Contemporary Management of Advanced Prostate Cancer Among Commercially Insured Patients.

PURPOSE: Out-of-pocket costs represent an important component of financial toxicity and may impact patients' receipt of care. Herein, we evaluated patient-level factors associated with out-of-pocket costs for contemporary advanced prostate cancer treatment options. MATERIALS AND METHODS: We identified all commercially insured men receiving treatment for advanced prostate cancer between 2007 and 2019 within the OptumLabs Data Warehouse®. Patients were categorized into 3 treatment groups: androgen deprivation monotherapy, novel hormonal therapy, and nonandrogen systemic therapy. The primary outcome was out-of-pocket costs in the first year of treatment. The associations of treatment and patient variables with out-of-pocket costs were assessed using multivariable regression models. All costs were adjusted to reflect 2019 U.S. dollars using the Consumer Price Index. RESULTS: In a cohort of 13,409 men 81% (n = 10,926) received androgen deprivation monotherapy, 6% (n = 832) novel hormonal therapy, and 12% (n = 1,651) nonandrogen systemic therapy. Mean treatment-related out-of-pocket costs in the first year were $165, $4,236, and $994 for androgen deprivation monotherapy, novel hormonal therapy, and nonandrogen systemic therapy, respectively. The adjusted difference in annual treatment-related out-of-pocket costs for novel hormonal therapy and nonandrogen systemic therapy were $2,581 (95% CI: $1,923-$3,240) and $752 (95% CI: $600-$903) higher than androgen deprivation monotherapy, respectively. Patient characteristics associated (P < .05) with higher treatment-related out-of-pocket costs included older age (65-74 years), Black race, lower comorbidity scores, and lower household income. CONCLUSIONS: Patients receiving novel hormonal therapy for advanced prostate cancer had substantially higher treatment-related out-of-pocket costs. In addition to raising awareness among prescribers, these data support the inclusion of treatment associated financial toxicity in shared decision making for advanced prostate cancer and call attention to subgroups of patients particularly vulnerable to financial toxicity.

Unplanned Conversion From Partial to Radical Nephrectomy: An Analysis of Incidence, Etiology, and Risk Factors.

PURPOSE: Conversions from partial to radical nephrectomy are uncommon and reports on this topic are rare. In this study we present a detailed analysis of conversions from partial to radical nephrectomy in a single-institutional contemporary experience and provide an analysis of preoperative risk factors. MATERIALS AND METHODS: Patients who underwent converted (cases) and completed (controls) partial nephrectomy from 2000 to 2015 were matched 1:1 for analysis. Perioperative imaging was reviewed and RENAL (for radius, exophytic/endophytic properties, anterior/posterior descriptor, and location relative to the polar line) nephrometry scores were calculated. Reasons for conversions were abstracted from operative reports. Multivariable conditional logistic regression analyses were used to assess preoperative risk factors for conversion. RESULTS: A total of 168 cases (6.1% of all partial nephrectomies) were identified and matched on tumor size, year of surgery, and surgical approach to 168 controls. Conversion rates decreased from 13% in 2000-2003 to 4% in 2012-2015. Oncologic considerations, such as concern for upstaging and positive margins, were the most cited (56%) reasons for conversion. On multivariable analyses, male sex (odds ratio 2.34; P = .03), Charlson score (odds ratio per 1-unit increase: 1.28; P = .03), posterior and middle (on anteroposterior axis) location (reference: anterior, odds ratio 2.83, P = .02 and odds ratio 6.38, P < .001, respectively) and hilar location (reference: peripheral/central, odds ratio 5.61; P < .001) were associated with increased odds of conversion. CONCLUSIONS: Rates of conversion from partial to radical nephrectomy in our experience were low and decreased over time. Preoperative characteristics such as hilar, posterior, and middle locations were significantly associated with conversions after controlling for tumor size, and offer guidance for operative planning and patient counseling.

Sexual function outcomes of radiation and androgen deprivation therapy for localized prostate cancer in men with good baseline function.

BACKGROUND: Sexual dysfunction, including erectile dysfunction and loss of libido, are common among men undergoing treatment for localized prostate cancer. Both local treatments and systemic androgen deprivation therapy may contribute to these outcomes and are differentially indicated based on disease characteristics. We sought to compare sexual function through 5 years after radiation treatment with and without androgen deprivation therapy in men with good baseline sexual function to better understand long-term effects in this understudied subset of patients. METHODS: We retrospectively reviewed a prospectively assembled population-based cohort of men who underwent radiation with and without androgen deprivation therapy for intermediate or high-risk localized prostate cancer. Sexual function was assessed longitudinally over 5 years. Men with erections sufficient for intercourse at baseline were selected for inclusion. RESULTS: Out of 167 patients included, 73 underwent radiation alone and 94 received androgen deprivation therapy plus radiation (51 with intermediate and 43 with high-risk disease). Androgen deprivation therapy use was associated with worse sexual function through 1 year regardless of disease risk. This difference was no longer statistically significant at 3 years in the intermediate-risk group. Compared to radiation alone, androgen deprivation therapy in high-risk disease was associated with worse sexual function at 3 years (effect: -20.3 points, CI [-31.8, -8.8], p < 0.001) but not at 5 years (effect: -3.4, CI [-17.2, 10.5], p = 0.63). CONCLUSIONS: Androgen deprivation therapy plus radiation is associated with worse sexual function through 3-years follow-up in men with high-risk prostate cancer compared to radiation alone. The addition of androgen deprivation therapy in the treatment of intermediate-risk disease does not appear to result in worse sexual function at 3 or 5-year follow-up compared to radiation alone.

Decision aids for localized prostate cancer in diverse minority men: Primary outcome results from a multicenter cancer care delivery trial (Alliance A191402CD).

BACKGROUND: Decision aids (DAs) can improve knowledge for prostate cancer treatment. However, the relative effects of DAs delivered within the clinical encounter and in more diverse patient populations are unknown. A multicenter cluster randomized controlled trial with a 2×2 factorial design was performed to test the effectiveness of within-visit and previsit DAs for localized prostate cancer, and minority men were oversampled. METHODS: The interventions were delivered in urology practices affiliated with the NCI Community Oncology Research Program Alliance Research Base. The primary outcome was prostate cancer knowledge (percent correct on a 12-item measure) assessed immediately after a urology consultation. RESULTS: Four sites administered the previsit DA (39 patients), 4 sites administered the within-visit DA (44 patients), 3 sites administered both previsit and within-visit DAs (25 patients), and 4 sites provided usual care (50 patients). The median percent correct in prostate cancer knowledge, based on the postvisit knowledge assessment after the intervention delivery, was as follows: 75% for the pre+within-visit DA study arm, 67% for the previsit DA only arm, 58% for the within-visit DA only arm, and 58% for the usual-care arm. Neither the previsit DA nor the within-visit DA had a significant impact on patient knowledge of prostate cancer treatments at the prespecified 2.5% significance level (P = .132 and P = .977, respectively). CONCLUSIONS: DAs for localized prostate cancer treatment provided at 2 different points in the care continuum in a trial that oversampled minority men did not confer measurable gains in prostate cancer knowledge.