Efficacy of Intravesical Nadofaragene Firadenovec for Patients With Bacillus Calmette-Guérin-Unresponsive Nonmuscle-Invasive Bladder Cancer: 5-Year Follow-Up From a Phase 3 Trial.

PURPOSE: Nadofaragene firadenovec-vncg is a nonreplicating adenoviral vector-based gene therapy for bacillus Calmette-Guérin (BCG)-unresponsive carcinoma in situ (CIS) with/without high-grade Ta/T1. We report outcomes following 5 years of planned follow-up. MATERIALS AND METHODS: This open-label phase 3 trial (NCT02773849) enrolled patients with BCG-unresponsive nonmuscle-invasive bladder cancer in 2 cohorts: CIS ± Ta/T1 (CIS; n = 107) and Ta/T1 without CIS (Ta/T1 cohort; n = 50). Patients received 75 mL (3 × 1011 vp/mL) nadofaragene firadenovec intravesically once every 3 months with cystoscopy and cytology assessments, with continued treatment offered to those remaining high grade recurrence-free (HGRF). RESULTS: One hundred fifty-seven patients were enrolled from 33 US sites (n = 151 included in efficacy analyses). Median follow-up was 50.8 months (interquartile range 39.1-60.0), with 27% receiving ≥ 5 instillations and 7.6% receiving treatment for ≥ 57 months. Of patients with CIS 5.8% (95% CI 2.2-12.2) were HGRF at month 57, and 15% (95% CI 6.1-27.8) of patients with high-grade Ta/T1 were HGRF at month 57. Kaplan-Meier-estimated HGRF survival at 57 months was 13% (95% CI 6.9-21.5) and 33% (95% CI 19.5-46.6) in the CIS and Ta/T1 cohorts, respectively. Cystectomy-free survival at month 60 was 49% (95% CI 40.0-57.1): 43% (95% CI 32.2-53.7) in the CIS cohort and 59% (95% CI 43.1-71.4) in the Ta/T1 cohort. Overall survival at 60 months was 80% (71.0, 86.0): 76% (64.6-84.5) and 86% (70.9-93.5) in the CIS and Ta/T1 cohorts, respectively. Only 5 patients (4 with CIS and 1 with Ta/T1) experienced clinical progression to muscle-invasive disease. CONCLUSIONS: At 60 months, nadofaragene firadenovec-vncg allowed bladder preservation in nearly half of the patients and proved to be a safe option for BCG-unresponsive nonmuscle-invasive bladder cancer.

NCCN Guidelines® Insights: Prostate Cancer, Version 3.2024.

The NCCN Guidelines for Prostate Cancer include recommendations for staging and risk assessment after a prostate cancer diagnosis and for the care of patients with localized, regional, recurrent, and metastatic disease. These NCCN Guidelines Insights summarize the panel's discussions for the 2024 update to the guidelines with regard to initial risk stratification, initial management of very-low-risk disease, and the treatment of nonmetastatic recurrence.

Technique and Outcomes of Concomitant Aortic and Caval Resection and Reconstruction for Retroperitoneal Tumors.

BACKGROUND: Major vascular involvement is often considered a contraindication to resection of malignant tumors, but in highly selected patients, it can be performed safely, with results that are highly dependent upon the tumor biology. Resection of both the aorta and inferior vena cava (IVC) is a rare undertaking, requiring both favorable tumor biology and a patient fit for a substantial surgical insult; nevertheless, it provides the possibility of a cure. METHODS: Patients requiring resection and reconstruction of both the aorta and IVC from 2009 through 2019 at 2 university medical centers were included. Patient characteristics, operative technique, and outcomes were retrospectively collected. RESULTS: We identified 9 patients, all with infrarenal reconstruction or repair of the aorta and IVC. All cases were performed with systemic heparinization and required simultaneous aortic and caval cross-clamping for tumor resection. No temporary venous or arterial bypass was used. Since arterial reperfusion with the IVC clamped was poorly tolerated in 1 patient, venous reconstruction was typically completed first. Primary repair was performed in 1 patient, while 8 required replacements. In 2 patients, aortic homograft was used for replacement of both the aortoiliac and iliocaval segments in contaminated surgical fields. In the remaining 6, Dacron was used for arterial replacement; either Dacron (n = 2) or polytetrafluoroethylene (n = 4) were used for venous replacement. Patients were discharged after a median stay of 8 days (range: 5-16). At median follow-up of 17 months (range 3-79 months), 2 patients with paraganglioma and 1 patient with Leydig cell carcinoma had cancer recurrences. Venous reconstructions occluded in 3 patients (38%), although symptoms were minimal. One patient presented acutely with a thrombosed iliac artery limb and bilateral common iliac artery anastomotic stenoses, treated successfully with thrombolysis and stenting. CONCLUSIONS: Patients with tumor involving both the aorta and IVC can be successfully treated with resection and reconstruction. En bloc tumor resection, restoration of venous return before arterial reconstruction, and most importantly, careful patient selection, all contribute to positive outcomes in this otherwise incurable population.

Prostate Cancer, Version 4.2023, NCCN Clinical Practice Guidelines in Oncology.

The NCCN Guidelines for Prostate Cancer provide a framework on which to base decisions regarding the workup of patients with prostate cancer, risk stratification and management of localized disease, post-treatment monitoring, and treatment of recurrence and advanced disease. The Guidelines sections included in this article focus on the management of metastatic castration-sensitive disease, nonmetastatic castration-resistant prostate cancer (CRPC), and metastatic CRPC (mCRPC). Androgen deprivation therapy (ADT) with treatment intensification is strongly recommended for patients with metastatic castration-sensitive prostate cancer. For patients with nonmetastatic CRPC, ADT is continued with or without the addition of certain secondary hormone therapies depending on prostate-specific antigen doubling time. In the mCRPC setting, ADT is continued with the sequential addition of certain secondary hormone therapies, chemotherapies, immunotherapies, radiopharmaceuticals, and/or targeted therapies. The NCCN Prostate Cancer Panel emphasizes a shared decision-making approach in all disease settings based on patient preferences, prior treatment exposures, the presence or absence of visceral disease, symptoms, and potential side effects.

Association between hospital competition and quality of prostate cancer care.

BACKGROUND: Hospitals account for approximately 6% of United States' gross domestic product. We examined the association between hospital competition and outcomes in elderly with localized prostate cancer (PCa). We also assessed if race moderated this association. METHODS: Retrospective study using Surveillance, Epidemiology, and End Results (SEER) - Medicare database. Cohort included fee-for-service, African American and white men aged ≥ 66, diagnosed with localized PCa between 1998 and 2011 and their claims between 1997 and 2016. We used Hirschman-Herfindahl index (HHI) to measure of hospital competition. Outcomes were emergency room (ER) visits, hospitalizations, Medicare expenditure and mortality assessed in acute survivorship phase (two years post-PCa diagnosis), and long-term mortality. We used Generalized Linear Models for analyzing expenditure, Poisson models for ER visits and hospitalizations, and Cox models for mortality. We used propensity score to minimize bias. RESULTS: Among 253,176 patients, percent change in incident rate of ER visit was 17% higher for one unit increase in HHI (IRR: 1.17, 95% CI: 1.15-1.19). Incident rate of ER was 24% higher for whites and 48% higher for African Americans. For one unit increase in HHI, hazard of short-term all-cause mortality was 7% higher for whites and 11% lower for African Americans. The hazard of long-term all-cause mortality was 10% higher for whites and 13% higher for African Americans. CONCLUSIONS: Lower hospital competition was associated with impaired outcomes of localized PCa care. Magnitude of impairment was higher for African Americans, compared to whites. Future research will explore process through which competition affects outcomes and racial disparity.

NCCN Guidelines® Insights: Prostate Cancer, Version 1.2023.

The NCCN Guidelines for Prostate Cancer address staging and risk assessment after a prostate cancer diagnosis and include management options for localized, regional, recurrent, and metastatic disease. The NCCN Prostate Cancer Panel meets annually to reevaluate and update their recommendations based on new clinical data and input from within NCCN Member Institutions and from external entities. These NCCN Guidelines Insights summarizes much of the panel's discussions for the 4.2022 and 1.2023 updates to the guidelines regarding systemic therapy for metastatic prostate cancer.

Intravesical nadofaragene firadenovec gene therapy for BCG-unresponsive non-muscle-invasive bladder cancer: a single-arm, open-label, repeat-dose clinical trial.

BACKGROUND: BCG is the most effective therapy for high-risk non-muscle-invasive bladder cancer. Nadofaragene firadenovec (also known as rAd-IFNa/Syn3) is a replication-deficient recombinant adenovirus that delivers human interferon alfa-2b cDNA into the bladder epithelium, and a novel intravesical therapy for BCG-unresponsive non-muscle-invasive bladder cancer. We aimed to evaluate its efficacy in patients with BCG-unresponsive non-muscle-invasive bladder cancer. METHODS: In this phase 3, multicentre, open-label, repeat-dose study done in 33 centres (hospitals and clinics) in the USA, we recruited patients aged 18 years or older, with BCG-unresponsive non-muscle-invasive bladder cancer and an Eastern Cooperative Oncology Group status of 2 or less. Patients were excluded if they had upper urinary tract disease, urothelial carcinoma within the prostatic urethra, lymphovascular invasion, micropapillary disease, or hydronephrosis. Eligible patients received a single intravesical 75 mL dose of nadofaragene firadenovec (3 × 1011 viral particles per mL). Repeat dosing at months 3, 6, and 9 was done in the absence of high-grade recurrence. The primary endpoint was complete response at any time in patients with carcinoma in situ (with or without a high-grade Ta or T1 tumour). The null hypothesis specified a complete response rate of less than 27% in this cohort. Efficacy analyses were done on the per-protocol population, to include only patients strictly meeting the BCG-unresponsive definition. Safety analyses were done in all patients who received at least one dose of treatment. The study is ongoing, with a planned 4-year treatment and monitoring phase. This study is registered with ClinicalTrials.gov, NCT02773849. FINDINGS: Between Sept 19, 2016, and May 24, 2019, 198 patients were assessed for eligibility. 41 patients were excluded, and 157 were enrolled and received at least one dose of the study drug. Six patients did not meet the definition of BCG-unresponsive non-muscle-invasive bladder cancer and were therefore excluded from efficacy analyses; the remaining 151 patients were included in the per-protocol efficacy analyses. 55 (53·4%) of 103 patients with carcinoma in situ (with or without a high-grade Ta or T1 tumour) had a complete response within 3 months of the first dose and this response was maintained in 25 (45·5%) of 55 patients at 12 months. Micturition urgency was the most common grade 3-4 study drug-related adverse event (two [1%] of 157 patients, both grade 3), and there were no treatment-related deaths. INTERPRETATION: Intravesical nadofaragene firadenovec was efficacious, with a favourable benefit:risk ratio, in patients with BCG-unresponsive non-muscle-invasive bladder cancer. This represents a novel treatment option in a therapeutically challenging disease state. FUNDING: FKD Therapies Oy.

Mohs micrographic surgery for male genital tumors: Local recurrence rates and patient-reported outcomes.

BACKGROUND: Local recurrence rates (LRRs) after Mohs micrographic surgery (MMS) for male genital cancers have been reported in only a few small case series, and patient-reported outcomes (PROs) have not been studied. OBJECTIVE: To determine the LRR and PROs after MMS for male genital skin cancers. METHODS: Retrospective review of all male genital skin cancers removed with MMS between 2008 and 2019 at an academic center. LRR was determined by chart review and phone calls. PROs were assessed by survey. RESULTS: A total of 119 skin cancers in 108 patients were removed with MMS. Tumors were located on the penis (90/119) and scrotum (29/119). Diagnoses included squamous cell carcinoma in situ (n = 71), invasive squamous cell carcinoma (n = 32), extramammary Paget disease (n = 13), melanoma (n = 2), and basal cell carcinoma (n = 1). The LRR was 0.84% (1/119), with a mean follow-up time of 3.25 years (median, 2.36 years). The majority of survey respondents reported no changes in urinary (66%) or sexual functioning (57.5%) after surgery. LIMITATIONS: Retrospective single-center experience; short follow-up time; low survey response rate; no baseline functional data. CONCLUSION: MMS for male genital skin cancer has a low LRR and high patient-reported satisfaction with urinary and sexual function.

Second opinion pathologic review in the management of prostate cancer.

INTRODUCTION Inter-institutional re-review of prostate needle biopsy (PNBx) material is required at many institutions before definitive treatment, but adds time and cost and may not significantly alter urologic management. We aim to determine the utility of universal PNBx re-review on influencing the decision to recommend definitive local therapy for patients with prostate cancer. MATERIALS AND METHODS: From 2017-2020, 590 prostate biopsy specimens from outside institutions were re-reviewed at our center for patients considering prostatectomy. Clinical and pathologic characteristics from initial and secondary review were analyzed. Potential for change in treatment candidacy (CTC) was determined by re-diagnosis to non-malignant tissue or change in candidacy for active surveillance (AS) versus definitive treatment (i.e. prostatectomy or radiation therapy). Thus, the following scenarios were considered CTC: downgrading to non-malignant tissue, downgrading ISUP Grade Group (GG) ≥ 2 to GG1, and upgrading GG1 to GG ≥ 2. Any changes between GG2 to GG5 were not considered CTC, as definitive treatment would be offered to all groups. RESULTS: Overall, 55 patients (9.3%) had potential for CTC based on secondary review, all of whom had initial pathologic GG (iGG) ≤ 2. Of the 152 patients with iGG1, 8 were downgraded to no malignancy and 41 were upgraded to GG2 or GG3. Of the 185 patients with iGG2, 6 were downgraded to GG1. No patients with iGG ≥ 3 qualified for a CTC. Features associated with CTC included iGG, number of positive cores, and highest core percentage. Upon multivariable analysis, only iGG1 diagnosis was predictive of CTC (OR 23.66, p < 0.001). CONCLUSION: Second review may be helpful in determining need for definitive treatment in patients with GG1 and GG2 prostate cancer, i.e. those considering AS. This process appears unnecessary in GG3+ patients, as management for patients considering surgery would not change. This may allow for judicious redirection of hospital resources.

Associations between Hospital Volume and Outcomes of Robot-Assisted Radical Prostatectomy.

PURPOSE: Robot-assisted radical prostatectomy has become the predominant surgical modality to manage localized prostate cancer in the U.S. However, there are few studies focusing on the associations between hospital volume and outcomes of robot-assisted radical prostatectomy. MATERIALS AND METHODS: We identified robot-assisted radical prostatectomies for clinically localized (cT1-2N0M0) prostate cancer diagnosed between 2010 and 2014 in the National Cancer Database. We categorized annual average hospital robot-assisted radical prostatectomy volume into very low, low, medium, high and very high by most closely sorting the final included patients into 5 equal-sized groups (quintiles). Outcomes included 30-day mortality, 90-day mortality, conversion (to open), prolonged length of stay (more than 2 days), 30-day (unplanned) readmission, positive surgical margin and lymph node dissection rates. RESULTS: A total of 114,957 patients were included in the study, and hospital volume was categorized into very low (3 to 45 cases per year), low (46 to 72), medium (73 to 113), high (114 to 218) and very high (219 or more). Overall 30-day mortality (0.12%), 90-day mortality (0.16%) and conversion rates (0.65%) were low. Multivariable logistic regressions showed that compared with the very low volume group, higher hospital volume was associated with lower odds of conversion to open surgery (OR 0.23, p <0.001 for very high), prolonged length of stay (OR 0.25, p <0.001 for very high), 30-day readmission (OR 0.53, p <0.001 for very high) and positive surgical margins (OR 0.61, p <0.001 for very high). Higher hospital volume was also associated with higher odds of lymph node dissection in the intermediate/high risk cohort (OR 3.23, p <0.001 for very high). CONCLUSIONS: Patients undergoing robot-assisted radical prostatectomy at higher volume hospitals are likely to have improved perioperative and superior oncologic outcomes compared to lower volume hospitals.

The Balance between Open and Robotic Training among Graduating Urology Residents-Does Surgical Technique Need Monitoring?

PURPOSE: A minimum number of index procedures is required for graduation. Without thresholds for surgical technique, it is unclear if robotic and open learning is balanced. We assessed the distribution of robotic and open surgeries performed by residents upon graduation. MATERIALS AND METHODS: Voluntary Accreditation Council for Graduate Medical Education resident case logs from 11 institutions were de-identified and trends in robotic and open major surgeries were compared using Wilcoxon rank sum and 2-sample t-tests. RESULTS: A total of 89,199 major cases were recorded by 209 graduates from 2011 to 2017. The median proportion of robotic cases increased from 2011 to 2017 in reconstruction (4.7% to 15.2%), oncology (27.5% to 54.2%) and pediatrics (0% to 10.9%) (all values p <0.001). Robotic and open cases remained most divergent in reconstruction, with a median of 12 robotic (IQR 9-19) to 70 open cases (IQR 55-106) being performed by residents in 2017. Similar observations occurred in pediatrics. In oncology the number of robotic procedures superseded that of open in 2016 and rose to a median of 148 robotic (IQR 108-214) to 121 open cases (IQR 90-169) in 2017, with the driver being robotic prostatectomy. Substantial differences in surgical technique were observed between institutions and among graduates from the same institution. CONCLUSIONS: Although robotic volume is increasing, the balance of surgical technique and the pace of change differ in reconstruction, oncology and pediatrics, as well as among individual institutions and graduates themselves. This raises questions about whether more specific guidelines are needed to ensure equity and standardization in training.

Prolonged Length of Stay After Robotic Prostatectomy: Causes and Risk Factors.

BACKGROUND: Robot-assisted radical prostatectomy (RARP) can generally be performed with 1-2 nights of postoperative monitoring before discharge from the hospital. Little is known about what causes individual patients to remain in hospital beyond the second postoperative day. METHODS: Data for RARPs performed between 2013 and 2015 were extracted from the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database. The fraction of cases with prolonged length of stay (PLOS) that can be reasonably attributed to complications was examined. Logistic regression was performed to identify risk factors for PLOS in the overall population and separately in the population of patients with PLOS without any perioperative complications. RESULTS: Of 11,440 patients, 10,342 (90.4%) were discharged on postoperative days 0-2; 80.6% (887/1101) of patients with PLOS did not experience any perioperative complications. The most common complication was bleeding requiring transfusion, but this was present in only 5.6% (62/1101) of patients with PLOS. Logistic regression identified predictors of PLOS as age, race, wound class, American Society of Anesthesiologists class, smoking, diabetes, dyspnea, dependent functional health status, congestive heart failure, operative time, and pelvic lymph node dissection. Results of this regression were insensitive to the exclusion of patients who experienced no perioperative complications. CONCLUSIONS: This study utilizes logistic regression on NSQIP data to identify risk factors for PLOS after RARP and, in particular, to evaluate the role of postoperative complications in PLOS. The analysis shows that postoperative complications account for a small minority of cases of PLOS after RARP.

Bladder Cancer, Version 3.2020, NCCN Clinical Practice Guidelines in Oncology.

This selection from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Bladder Cancer focuses on the clinical presentation and workup of suspected bladder cancer, treatment of non-muscle-invasive urothelial bladder cancer, and treatment of metastatic urothelial bladder cancer because important updates have recently been made to these sections. Some important updates include recommendations for optimal treatment of non-muscle-invasive bladder cancer in the event of a bacillus Calmette-Guérin (BCG) shortage and details about biomarker testing for advanced or metastatic disease. The systemic therapy recommendations for second-line or subsequent therapies have also been revised. Treatment and management of muscle-invasive, nonmetastatic disease is covered in the complete version of the NCCN Guidelines for Bladder Cancer available at NCCN.org. Additional topics covered in the complete version include treatment of nonurothelial histologies and recommendations for nonbladder urinary tract cancers such as upper tract urothelial carcinoma, urothelial carcinoma of the prostate, and primary carcinoma of the urethra.

The LACE + index as a predictor of 90-day urologic surgery outcomes.

PURPOSE: This study assessed the ability of the LACE + [Length of stay, Acuity of admission, Charlson Comorbidity Index (CCI) score, and Emergency department visits in the past 6 months] index to predict adverse outcomes after urologic surgery. METHODS: LACE + scores were retrospectively calculated for all consecutive patients (n = 9824) who received urologic surgery at one multi-center health system over 2 years (2016-2018). Coarsened exact matching was employed to sort patient data before analysis; matching criteria included duration of surgery, BMI, and race among others. Outcomes including unplanned hospital readmission, emergency room visits, and reoperation were compared for patients with different LACE + quartiles. RESULTS: 722 patients were matched between Q1 and Q4; 1120 patients were matched between Q2 and Q4; 2550 patients were matched between Q3 and Q4. Higher LACE + score significantly predicted readmission within 90 days (90D) of discharge for Q1 vs Q4 and Q2 vs Q4. Increased LACE + score also significantly predicted 90D emergency room visits for Q1 vs Q4, Q2 vs Q4, and Q3 vs Q4. LACE + score was also significantly predictive of 90D reoperation for Q1 vs Q4. LACE + score did not predict 90D reoperation for Q2 vs Q4 or Q3 vs Q4 or 90D readmission for Q3 vs. Q4. CONCLUSION: These results suggest that LACE + may be a suitable prediction model for important patient outcomes after urologic surgery.

Suprapubic Versus Urethral Catheter for Urinary Drainage After Robot-Assisted Radical Prostatectomy.

PURPOSE OF REVIEW: To review the evidence regarding the usage of suprapubic tube (SPT) versus indwelling urethral catheter (IUC) after robot-assisted radical prostatectomy (RARP). RECENT FINDINGS: Available data on the use of SPT for urinary drainage after RARP is somewhat limited mostly because of the variations of study designs and non-standardized outcomes. Although it may provide some mild benefit in terms of catheter-related pain and discomfort, the benefit seems not to be clinically significant. The evidence in the literature so far does not support routine usage of SPT as the primary urinary drainage method after RARP. Further higher-quality studies that can show clinically significant advantages over IUC are still needed to justify its usage.

Implementing a patient safety culture survey to identify and target process improvements in academic ambulatory urology practices: a multi-institutional collaborative.

INTRODUCTION: A shared professional culture focused on patient safety is critical to delivering high-quality care. There is a need for objective metrics to help identify target areas for improvement in patient safety culture. The Medical Office Survey on Patient Safety Culture (SOPS) was developed and validated by the United States Agency for Healthcare Research and Quality to measure patient safety culture in the ambulatory setting. In this study we report on safety culture and practices in six academic urology clinics utilizing this validated questionnaire. MATERIALS AND METHODS: The SOPS was administered to all staff in ambulatory urology practices affiliated with participating centers. Percent positive responses were calculated for each of 10 validated composite domains and were compared between sites and respondent roles. Nonparametric statistical analyses were performed to identify differences between groups. RESULTS: The survey was administered to 185 staff members, with an overall response rate of 66%. Within each domain there was substantial variability between sites, with significant differences observed in staff training (p = 0.034), office processes/standardization (p = 0.008), patient care tracking (p = 0.047), communication about errors (p = 0.001), and organizational learning (p = 0.015). Similar variation was seen between respondent roles with significant differences for patient care tracking (p = 0.002) and communication about errors (p = 0.014). CONCLUSIONS: The SOPS is a clinically useful tool to identify issues impacting a practice's safety culture. Substantial variability was observed within each composite domain at the levels of practice site and respondent role. Comparing composite domain results between clinics will allow leadership to identify gaps and evaluate policies and resources of higher performing peer sites.

Microbiome signatures in prostate cancer.

We have established a microbiome signature for prostate cancer using an array-based metagenomic and capture-sequencing approach. A diverse microbiome signature (viral, bacterial, fungal and parasitic) was observed in the prostate cancer samples compared with benign prostate hyperplasia controls. Hierarchical clustering analysis identified three distinct prostate cancer-specific microbiome signatures. The three signatures correlated with different grades, stages and scores of the cancer. Thus, microbiome signature analysis potentially provides clinical diagnosis and outcome predictions. The array data were validated by PCR and targeted next-generation sequencing (NGS). Specific NGS data suggested that certain viral genomic sequences were inserted into the host somatic chromosomes of the prostate cancer samples. A randomly selected group of these was validated by direct PCR and sequencing. In addition, PCR validation of Helicobacter showed that Helicobacter cagA sequences integrated within specific chromosomes of prostate tumor cells. The viral and Helicobacter integrations are predicted to affect the expression of several cellular genes associated with oncogenic processes.

Efficacy of Split Schedule Versus Conventional Schedule Neoadjuvant Cisplatin-Based Chemotherapy for Muscle-Invasive Bladder Cancer.

Neoadjuvant cisplatin-based chemotherapy (NAC; 70 mg/m2) is standard of care for muscle-invasive bladder carcinoma (MIBC). Many patients (pts) cannot receive cisplatin because of renal impairment, and administration of cisplatin 35 mg/m2 on day 1 + 8 or 1 + 2 (i.e., split schedule) is a commonly used alternative. In this retrospective analysis, we compared complete (pT0) and partial (

National Variation in Opioid Prescription Fills and Long-Term Use in Opioid Naïve Patients after Urological Surgery.

PURPOSE: Prescription opioid use is increasing, leading to increased addiction and mortality. Postoperative care is often the first exposure to opioids of a patient but little data exist on national prescription patterns in urology. We examined post-discharge opioid fills after urological procedures and the association with long-term use. MATERIALS AND METHODS: We identified patients in a private national insurance database who underwent 1 of 15 urological procedures between October 1, 2010 and September 30, 2014. Patients with an opioid fill in the preceding 6 months were excluded from study. Claims for opioids from 30 days before the operation until 7 days after discharge characterized an initial prescription. Factors associated with persistent opioid use (an opioid claim 91 to 180 days after the operation) and chronic opioid use (10 or more refills of a 120-day or greater supply in the year after the operation) were analyzed using multivariable logistic regression. RESULTS: Overall 96,580 patients were included in study, of whom 49,391 (51%) filled an initial opioid prescription. Variation in the initial prescribed amount existed within procedures. Persistent use occurred in 6.2% of patients while chronic use occurred in 0.8%. Increased prescription in patients treated with transurethral prostate resection, vasectomy, female sling surgery, cystoscopy and stent insertion were associated with an increased risk of persistent as well as chronic use. CONCLUSIONS: National variation in opioid prescribing practice exists after urological operations. Patients who fill larger amounts of opioids after certain major and minor urological procedures are at increased risk for long-term opioid use. This provides evidence for procedure specific prescribing guidelines to minimize risk and promote standardization.

Active Surveillance as Initial Management of Newly Diagnosed Prostate Cancer: Data from the PURC.

PURPOSE: We describe contemporary active surveillance utilization and variation in a regional prostate cancer collaborative. We identified demographic and disease specific factors associated with active surveillance in men with newly diagnosed prostate cancer. MATERIALS AND METHODS: We analyzed data from the PURC (Pennsylvania Urologic Regional Collaborative), a cooperative effort of urology practices in southeastern Pennsylvania and New Jersey. We determined the rates of active surveillance among men with newly diagnosed NCCN® (National Comprehensive Cancer Network®) very low, low or intermediate prostate cancer and compared the rates among participating practices and providers. Univariate and multivariable analyses were used to identify factors associated with active surveillance utilization. RESULTS: A total of 1,880 men met inclusion criteria. Of the men with NCCN very low or low risk prostate cancer 57.4% underwent active surveillance as the initial management strategy. Increasing age was significantly associated with active surveillance (p <0.001) while adverse clinicopathological variables were associated with decreased active surveillance use. Substantial variation in active surveillance utilization was observed among practices and providers. CONCLUSIONS: More than 50% of men with low risk disease in the PURC collaborative were treated with active surveillance. However, substantial variation in active surveillance rates were observed among practices and providers in academic and community settings. Advanced age and favorable clinicopathological factors were strongly associated with active surveillance. Analysis of regional collaboratives such as the PURC may allow for the development of strategies to better standardize treatment in men with prostate cancer and offer active surveillance in a more uniform and systematic fashion.