Financial Distress in Genitourinary Cancer: Insights From CDC National Health Interview Survey.

PURPOSE: This study leverages CDC National Health Interview Survey data to examine Financial Distress (FD) among genitourinary (GU) cancer survivors, specifically prostate cancer (PC), kidney cancer (KC), and bladder cancer (BC). It investigates the economic impacts faced by these patients, especially in relation to disparities in insurance coverage and its effects on material, psychological, and behavioral aspects of FD. METHODS: We retrospectively analyzed responses from GU cancer survivors, stratifying by cancer status and age (18-64 years, ≥65 years). Medical financial hardship was divided into three domains: material, psychological, and behavioral. Associations between cancer history, hardship, and clinical factors were assessed using generalized ordinal logistic regressions. RESULTS: Significant health care access disparities were found, particularly for mental health services, with 25% of younger BC survivors and 4.7% of younger KC survivors reporting affordability issues, in contrast to 2.7% of noncancer individuals. Dental care was also problematic, with higher avoidance rates among younger BC (27%) and KC (15%) survivors compared with the general population. Surprisingly, noncancer individuals reported more difficulty in affording prescriptions than BC survivors across both age groups. PC survivors, however, showed lower FD across all domains versus noncancer controls, indicating fewer concerns about medical bills and a lesser tendency to forgo care. CONCLUSION: The study underscores significant gaps in the financial support system for GU cancer survivors, with urgent needs in mental and dental health care access. Policy interventions, including comprehensive insurance reforms, are imperative to alleviate the financial burdens on these individuals.

Urine Biopsy as Dynamic Biomarker to Enhance Clinical Staging of Bladder Cancer in Radical Cystectomy Candidates.

PURPOSE: There is significant interest in identifying complete responders to neoadjuvant chemotherapy (NAC) before radical cystectomy (RC) to potentially avoid removal of a pathologically benign bladder. However, clinical restaging after NAC is highly inaccurate. The objective of this study was to develop a next-generation sequencing-based molecular assay using urine to enhance clinical staging of patients with bladder cancer. METHODS: Urine samples from 20 and 44 patients with bladder cancer undergoing RC were prospectively collected for retrospective analysis for molecular correlate analysis from two clinical trials, respectively. The first cohort was used to benchmark the assay, and the second was used to determine the performance characteristics of the test as it correlates to responder status as measured by pathologic examination. RESULTS: First, to benchmark the assay, known mutations identified in the tissue (MT) of patients from the Accelerated Methotrexate, Vinblastine, Doxorubicin, Cisplatin trial (ClinicalTrials.gov identifier: NCT01611662, n = 16) and a cohort from University of California-San Francisco (n = 4) were cross referenced against mutation profiles from urine (MU). We then determined the correlation between MU persistence and residual disease in pre-RC urine samples from a second prospective clinical trial (The pT0 trial; ClinicalTrials.gov identifier: NCT02968732). Residual MU status correlated strongly with residual disease status (pT0 trial; n = 44; P = .0092) when MU from urine supernatant and urine pellet were assessed separately and analyzed in tandem. The sensitivity, specificity, PPV, and NPV were 91%, 50%, 86%, and 63% respectively, with an overall accuracy of 82% for this second cohort. CONCLUSION: MU are representative of MT and thus can be used to enhance clinical staging of urothelial carcinoma. Urine biopsy may be used as a reliable tool that can be further developed to identify complete response to NAC in anticipation of safe RC avoidance.

Sequential intravesical gemcitabine-docetaxel vs. bacillus Calmette-Guerin (BCG) in the treatment of non-muscle invasive bladder cancer: A preliminary cost-effectiveness analysis.

INTRODUCTION: Treatment naïve patients with high-risk non-muscle invasive bladder cancer (NMIBC) are treated with bacillus Calmette-Guérin (BCG) therapy as the standard of care. Recently, intravesical sequential gemcitabine-docetaxel in the BCG-naïve setting was shown to be well-tolerated and effective, raising the possibility of a new first line intravesical therapy. Cost effectiveness of this intervention remains unknown; therefore, we designed a cost effectiveness study evaluating BCG vs. sequential gemcitabine-docetaxel in patients with high risk NMIBC. METHODS: Using TreeAgePro 2019 software, we developed a Markov model to evaluate BCG vs. gemcitabine-docetaxel from the U.S. Medicare perspective with a 2-year time horizon. Model probabilities and utilities were derived from published literature. Direct costs were obtained from Medicare cost databases. Our primary outcomes were effectiveness (measured in quality adjusted life years [QALYs]), cost and the incremental cost-effectiveness ratio with a willingness to pay threshold of $100,000. RESULTS: Our results indicate that while both treatments resulted in similar QALYs of 1.76, the mean costs per patient at 2 years were $12,363 and $7,090 for BCG and gemcitabine-docetaxel, respectively. Therefore, the BCG strategy was dominated by the gemcitabine-docetaxel strategy as it was equally effective and less costly. One way sensitivity analyses were completed and gemcitabine-docetaxel remained a cost-effective strategy. CONCLUSIONS: The findings of this preliminary cost-effectiveness analysis are novel in that they highlight a well tolerated, efficacious drug that is less expensive than the traditional gold standard therapy. In modern medicine, we are more often challenged by agents with marginally increased efficacy but at significantly higher costs; gemcitabine-docetaxel represents a rare entity which is a success for both patients and healthcare systems alike.

Feasibility and Outcomes of Renal Mass Biopsy for Anatomically Complex Renal Tumors.

OBJECTIVE: To compare the feasibility and outcomes of renal mass biopsies (RMB) of anatomically complex vs non-complex renal masses. METHODS: Our institutional renal tumor database was queried for patients who underwent RMB between 2005 and 2019 and with available nephrometry score. Complex masses were: (1) small (<2 cm), (2) entirely endophytic (nephrometry E=3), (3) hilar (h) or (4) partially endophytic (E=2) and anterior. Demographic and pathologic data were compared. Biopsies were deemed adequate if they resulted in a diagnosis. Concordance with surgical pathology was assessed. These were both presented using proportions. Factors associated with biopsy outcomes were identified using multivariable logistic regression. RMB sensitivity and specificity were calculated using contingency methods. RESULTS: A total of 306 RBMs were included, 179 complex and 127 non-complex. A total of 199 (65%) had an extirpative procedure. Complex lesions were less likely to have an adequate biopsy (89% vs 96%, P = .03), and to be concordant with final surgical pathology from an oncologic standpoint (89% vs 97%, P = .03). There was no significant difference in concordance of histology (76% vs 86%, P = .10) or grade (48 vs 51%, P = .66). On multivariable analyses, only male gender was associated with biopsy adequacy (OR 3.31, 95% CI 1.28-8.55, P = .01). Our overall sensitivity was 93%, specificity 93%, and accuracy 93%. There were no significant differences over time in biopsy outcomes during the study period. CONCLUSION: RMB of complex lesions is associated with excellent diagnostic yield, albeit lower than non-complex lesions. RMB should not be deferred in cases of anatomically complex lesions where additional data could improve clinical decision-making.

Association of Surgical Delay and Overall Survival in Patients With T2 Renal Masses: Implications for Critical Clinical Decision-making During the COVID-19 Pandemic.

OBJECTIVE: To test for an association between surgical delay and overall survival (OS) for patients with T2 renal masses. Many health care systems are balancing resources to manage the current COVID-19 pandemic, which may result in surgical delay for patients with large renal masses. METHODS: Using Cox proportional hazard models, we analyzed data from the National Cancer Database for patients undergoing extirpative surgery for clinical T2N0M0 renal masses between 2004 and 2015. Study outcomes were to assess for an association between surgical delay with OS and pathologic stage. RESULTS: We identified 11,848 patients who underwent extirpative surgery for clinical T2 renal masses. Compared with patients undergoing surgery within 2 months of diagnosis, we found worse OS for patients with a surgical delay of 3-4 months (hazard ratio [HR] 1.12, 95% confidence interval [CI] 1.00-1.25) or 5-6 months (HR 1.51, 95% CI 1.19-1.91). Considering only healthy patients with Charlson Comorbidity Index = 0, worse OS was associated with surgical delay of 5-6 months (HR 1.68, 95% CI 1.21-2.34, P= .002) but not 3-4 months (HR 1.08, 95% CI 0.93-1.26, P = 309). Pathologic stage (pT or pN) was not associated with surgical delay. CONCLUSION: Prolonged surgical delay (5-6 months) for patients with T2 renal tumors appears to have a negative impact on OS while shorter surgical delay (3-4 months) was not associated with worse OS in healthy patients. The data presented in this study may help patients and providers to weigh the risk of surgical delay versus the risk of iatrogenic SARS-CoV-2 exposure during resurgent waves of the COVID-19 pandemic.

Use of administrative data for comparative effectiveness research in the treatment of non-prostate genitourinary malignancies.

Comparative effectiveness research (CER) is imperative for objective and balanced assessment of treatment outcomes. CER that uses administrative databases (AD-CER) affords unique opportunities for large scale data analyses that potentially transcend limitations of small institutional datasets. Prostate cancer has received much attention from the AD-CER research community, whereas non-prostate genitourinary malignancies are less well-studied. The objective of this article is to review the currently available AD-CER that has been published in the non-prostate genitourinary malignancies space.

Understanding Treatment Disconnect and Mortality Trends in Renal Cell Carcinoma Using Tumor Registry Data.

BACKGROUND AND OBJECTIVES: The paradoxical rise in overall and cancer-specific mortality despite increased detection and treatment of renal cell carcinoma (RCC) is termed "treatment disconnect." We reassess this phenomenon by evaluating impact of missing data and rising incidence on mortality trends. RESEARCH DESIGN, SUBJECTS, AND MEASURES: Using Surveillance, Epidemiology, and End Results data, we identified patients with RCC diagnosis from 1973 to 2011. We estimated mortality rates by tumor size after accounting for lags from diagnosis to death using multiple imputations for missing data from 1983. Mortality rates were estimated irrespective of tumor size after adjustment for prior cumulative incidence using ridge regression. RESULTS: A total of 78,891 patients met inclusion criteria. Of 70,212 patients diagnosed since 1983, 10.4% had missing data. Significant attenuation in cancer-specific mortality was noted from 1983 to 2011 when comparing observed with imputed rates: Δobs0.05 versus Δimp0.10 (P=0.001, <2 cm tumors); Δobs0.29 versus Δimp0.18 (P=0.005, 2-4 cm tumors); Δobs0.46 versus Δimp-0.20 (P<0.001, 4-7 cm tumors); Δobs0.93 versus Δimp-0.15 (P<0.001, >7 cm tumors). Holding incidence of RCC constant to 2011 rates, temporal increase in overall mortality for all patients was attenuated (P<0.001) when comparing observed estimates (3.9-6.8) with 2011 adjusted estimates (5.9-7.1), suggesting that rapidly rising incidence may influence reported overall mortality trends. These findings were supported by assessment of mortality to incidence ratio trends. CONCLUSIONS: Missing data and rising incidence may contribute substantially to the "treatment disconnect" phenomenon when examining mortality rates in RCC using tumor registry data. Caution is advised when basing clinical and policy decisions on these data.

Clinically localized type 1 and 2 papillary renal cell carcinomas have similar survival outcomes following surgery / Los carcinomas papilares de células renales tipo 1 y 2 localizados clínicamente tienen resultados de supervivencia similares después de la cirugía

Propósito Se intentó determinar la incidencia, hallazgos patológicos, factores pronósticos y resultados clínicos para pacientes con CCR papilar clínicamente localizado. Métodos Demográfico, Se recopilaron hallazgos clínicos y patológicos en todos los pacientes con CCRP sometidos a cirugía en cuatro centros médicos académicos. El punto final primario fue la supervivencia específica del cáncer (CSS). La supervivencia sin recaída (RFS) y la supervivencia general (OS) fueron puntos finales secundarios. Kaplan- Se obtuvieron estimaciones de Meier y se usaron modelos de regresión de riesgos proporcionales de Cox para evaluar predictores de mortalidad y recaída. Resultados Identificamos 626 CCPR, de los cuales 373 (60por ciento) fueron del tipo 1 y 253 (40 por ciento) fueron del tipo 2, con tres cuartas partes de todos los tumores siendo pT1. En comparación con los pacientes con tipo 1, aquellos con tipo 2 eran mayores (edad media: 63 frente a 61; (AU)

Purpose We aimed to determine incidence, pathologic fndings, prognostic factors and clinical outcomes for patients with clinically localized papillary RCC. Methods Demographic, clinical and pathologic fndings were collected on all patients with PRCC undergoing sur-gery at four academic medical centers. The primary end-point was cancer-specifc survival (CSS). Relapse-free survival (RFS) and overall survival (OS) were secondary endpoints. Kaplan­ Meier estimates were obtained, and Cox proportional hazard regression models were used to assess predictors of mortality and relapse. Results We identifed 626 PRCC, of which 373 (60 pertcent) were type 1 and 253 (40 pertcent) were type 2, with three-quar-ters of all tumors being pT1. Compared to patients with type 1, those with type 2 were older (mean age: 63 vs 61; (AU)

Contemporary Trends in the Utilization of Radiotherapy in Patients With Renal Cell Carcinoma.

OBJECTIVE: To examine the utilization of radiation therapy (RT) in patients with renal cell carcinoma (RCC) using a large national tumor registry. MATERIALS AND METHODS: Patients diagnosed with RCC were identified using the National Cancer Data Base. Our primary objective was to assess temporal trends in the utilization of RT. Our secondary objective was to identify patient and treatment factors associated with receipt of RT. The Cochran-Armitage test was used for trend analysis. Multivariable logistic regression was performed to identify factors associated with RT use. RESULTS: A total of 279,427 patients were diagnosed with RCC from 1998 to 2010. A total of 233,572 (83.6%) had localized or locally advanced disease, whereas the remaining 45,855 (16.4%) had metastatic disease. There was a decrease in radiotherapy across all patients during this period (1.5%-0.6%, P <.001); as salvage or adjuvant therapy with surgery (1.3%-0.3%, P <.001), and in patients with metastatic disease (33.3%-28.5%, P <.001). Factors associated with increased RT use in patients with nonmetastatic RCC included male gender, receipt of systemic therapy, higher stage, higher grade, nonacademic treatment facility, facility location, and sarcomatoid or other histology. CONCLUSION: In the National Cancer Data Base, we observed a decrease in the use of RT for patients with RCC from 1998 to 2010. Patients with more aggressive disease characteristics were more likely to receive RT. Well-designed clinical trials are needed to clarify the role of RT in the management of these patients.

Residual Parenchymal Volume, Not Warm Ischemia Time, Predicts Ultimate Renal Functional Outcomes in Patients Undergoing Partial Nephrectomy.

OBJECTIVE: To examine relative contributions of functional parenchymal preservation and renal ischemia following nephron-sparing surgery (NSS). While residual functional parenchymal volume (FPV) is proposed as the key factor in predicting functional outcomes following NSS, efforts to curtail ischemia time continue to add technical complexity to partial nephrectomy. METHODS: Our kidney cancer database was queried for patients who underwent NSS with warm ischemia time (WIT). Patients with cross-sectional imaging for FPV calculation were included. Cylindrical volume approximation methodology was used to calculate FPV, accounting for the volume of tumor's endophytic component. Percent estimated glomerular filtration rate (eGFR) preservation, perioperatively and at 6 months, was the outcome metric. Spearman correlation and linear regression analyses were used to evaluate associations of WIT and %FPV preservation with renal function preservation. RESULTS: Of the 179 patients included, median preoperative eGFR was 88.4 (9.5% chronic kidney disease III or IV), tumor size was 2.7 cm (interquartile range [IQR] 2.0-3.6 cm), and R.E.N.A.L. nephrometry was low in 34%, intermediate in 57%, and high in 9%. Median WIT was 30 minutes (IQR 24-36), resulting in 97.4% FPV preservation. Median postoperative eGFR at 6.4 months was 80.5 (19.1% chronic kidney disease III or IV), a median of 93.1% eGFR preservation (IQR 85.1-101.7). At discharge, WIT (P <.001), not %FPV (P = .112), was associated with %eGFR preservation. However, 6 months following surgery, on multivariable analysis, both preoperative eGFR (linear regression coefficient = -0.208, P = .006) and %FPV preservation (linear regression coefficient = 0.491, P = .001), but not WIT (P = .946), demonstrated statistically significant association with %eGFR preservation. CONCLUSION: Residual FPV, and not WIT, appears to be the main predictor of ultimate renal function following NSS.

Comparison of testicular dose delivered by intensity-modulated radiation therapy (IMRT) and volumetric-modulated arc therapy (VMAT) in patients with prostate cancer.

A small decrease in testosterone level has been documented after prostate irradiation, possibly owing to the incidental dose to the testes. Testicular doses from prostate external beam radiation plans with either intensity-modulated radiation therapy (IMRT) or volumetric-modulated arc therapy (VMAT) were calculated to investigate any difference. Testicles were contoured for 16 patients being treated for localized prostate cancer. For each patient, 2 plans were created: 1 with IMRT and 1 with VMAT. No specific attempt was made to reduce testicular dose. Minimum, maximum, and mean doses to the testicles were recorded for each plan. Of the 16 patients, 4 received a total dose of 7800 cGy to the prostate alone, 7 received 8000 cGy to the prostate alone, and 5 received 8000 cGy to the prostate and pelvic lymph nodes. The mean (range) of testicular dose with an IMRT plan was 54.7 cGy (21.1 to 91.9) and 59.0 cGy (25.1 to 93.4) with a VMAT plan. In 12 cases, the mean VMAT dose was higher than the mean IMRT dose, with a mean difference of 4.3 cGy (p = 0.019). There was a small but statistically significant increase in mean testicular dose delivered by VMAT compared with IMRT. Despite this, it unlikely that there is a clinically meaningful difference in testicular doses from either modality.

Splenogonadal fusion: a rare etiology of solid testicular mass.

A 35-year-old man presented with a painless left scrotal mass. Pathologic examination after orchiectomy revealed splenogonadal fusion. Splenogonadal fusion is an exceptionally rare, typically benign, congenital anomaly. Splenogonadal fusion should be included in the differential diagnosis of a left-sided testicular mass.

Piperlongumine inhibits NF-κB activity and attenuates aggressive growth characteristics of prostate cancer cells.

BACKGROUND: Elevated NF-κB activity has been previously demonstrated in prostate cancer cell lines as hormone-independent or metastatic characteristics develop. We look at the effects of piperlongumine (PL), a biologically active alkaloid/amide present in piper longum plant, on the NF-κB pathway in androgen-independent prostate cancer cells. METHODS: NF-κB activity was evaluated using Luciferase reporter assays and Western blot analysis of p50 and p65 nuclear translocation. IL-6, IL-8, and MMP-9 levels were assessed using ELISA. Cellular adhesion and invasiveness properties of prostate cancer cells treated with PL were also assessed. RESULTS: NF-κB DNA-binding activity was directly down-regulated with increasing concentrations of PL, along with decreased nuclear translocation of p50 and p65 subunits. Expression of IL-6, IL-8, MMP-9, and ICAM-1 was attenuated, and a decrease of cell-to-matrix adhesion and invasiveness properties of prostate cancer cells were observed. CONCLUSIONS: PL-mediated inhibition of NF-κB activity decreases aggressive growth characteristics of prostate cancer cells in vitro.