Comparing the rate of immunotherapy treatment change due to toxicity by sex.

BACKGROUND: Immuno-oncology therapy (IO) is associated with a variety of treatment-related toxicities. However, the impact of toxicity on the treatment discontinuation rate between males and females is unknown. We hypothesized that immune-related adverse events would lead to more frequent treatment changes in females since autoimmune diseases occur more frequently in females. AIMS: Our aim was to determine if there was a difference in the rate of immunotherapy treatment change due to toxicity between males and females. METHODS AND RESULTS: The Oncology Research Information Exchange Network Avatar Database collected clinical data from 10 United States cancer centers. Of 1035 patients receiving IO, 447 were analyzed, excluding those who did not have documentation noting if a patient changed treatment (n = 573). Fifteen patients with unknown or gender-specific cancer were excluded. All cancer types and stages were included. The primary endpoint was documented treatment change due to toxicity. Four hundred and forty-seven patients (281 males and 166 females) received IO treatment. The most common cancers treated were kidney, skin, and lung for 99, 84, and 54 patients, respectively. Females had a shorter IO course than males (median 3.7 vs. 5.1 months, respectively, p = .02). Fifty-four patients changed treatment due to toxicity. There was no significant difference between females and males on chi-square test (11.4% vs. 12.5%, respectively, p = 0.75) and multivariable logistic regression (OR 0.924, 95% CI 0.453-1.885, p = .827). Significantly more patients with chronic obstructive pulmonary disease (COPD) changed therapy due to toxicity (OR 2.491, 95% CI 1.025-6.054, p = .044). CONCLUSION: Females received a shorter course of IO than males. However, there was no significant difference in the treatment discontinuation rate due to toxicity between males and females receiving IO. Toxicity-related treatment change was associated with COPD.

Extended versus standard pelvic lymph node dissection yields no difference in 3-year biochemical recurrence rates.

Background: extended pelvic lymph node dissection (ePLND) increases the detection rate of lymph node positive prostate cancer compared to a standard pelvic lymph node dissection (sPLND). However, improvement of patient outcomes remains questionable. Here we report and compare 3-year postoperative PSA recurrence rates between patients that underwent sPLND versus ePLND at the time of prostatectomy. Methods: 162 patients received a sPLND (which involvedremoval of periprostatic, external iliac, and obturator lymph nodes bilaterally), and 142 patients received an ePLND (which involved removal of periprostatic, external iliac, obturator, hypogastric, and common iliac nodes bilaterally). Decision to undergo ePLND versus sPLND at our institution was changed in 2016 based on the National Comprehensive Cancer Network guideline. The median follow-up time was 7 and 3 years for sPLND and ePLND patients, respectively. All node-positive patients were offered adjuvant radiotherapy. Kaplan-Meier analysis was carried out to assess the impact of a PLND on early postoperative PSA progression-free survival. Subgroup analyses were done for node-negative and node-positive patients, as well as Gleason score. Results: Gleason score and T stage were not significantly different between patients who received an ePLND and sPLND. The pN1 rate for ePLND and sPLND were 20% (28/142) and 6% (10/162), respectively. There was no difference in the use of adjuvant treatments in the pN0 patients. Significantly, more ePLND pN1 patients received adjuvant androgen deprivation therapy (25/28 vs. 5/10 P = 0.012) and radiation (27/28 vs. 4/10 P = 0.002). Yet, no difference in biochemical recurrence between ePLND and sPLND was observed (P = 0.44). This remained true in subgroup analyses of node-positive (P = 0.26), node-negative (P = 0.78), Gleason Score 6-7 (P = 0.51), and Gleason Score 8-10 (P = 0.77). Conclusions: PLND provided no additional therapeutic benefit, even though ePLND patients were significantly more likely to have node-positive disease and undergo adjuvant treatment, compared to a sPLND.

Annual trends of cystectomy complications: A contemporary analysis of the NSQIP database.

INTRODUCTION: Despite significant morbidity, radical cystectomy (RC) is standard of care for muscle invasive bladder cancer, certain high-risk nonmuscle invasive tumors and after failure of intravesical or trimodal therapy. Modern efforts have hastened the recovery after this surgery without impact on overall complication rates. Our primary aim was to examine changes in complication rates of RC over time. METHODS: The National Surgical Quality Improvement Program database included 11,351 RC from 2006 to 2018 for nondisseminated bladder cancer. Baseline characteristics and complication rates were studied across time periods: 2006 to 2011, 2012 to 2014, and 2015 to 2018. Thirty-day complications, readmissions, and mortality were identified. RESULTS: Overall complication rates decreased over time (56.5%, 57.4%, 50.6%, P < 0.01). Infectious complications were stable, including UTIs (10.1%, 8.8%, 8.3% respectively, P = 0.11) and sepsis (10.4%, 8.8%, 8.7% respectively, P = 0.20). On multivariable analysis, ASA≥3 (OR 1.399, 95% CI 1.279-1.530) was associated with increased complications, while procedures in 2015 to 2018 (OR 0.825, 95% CI 0.722-0.942), laparoscopic/robotic approach (OR 0.555, 95%CI 0.494-0.622), and ileal conduit (OR 0.796, 95% CI 0.719-0.882) were associated with decreased complication rates. Other outcomes of interest included mean length of stay (LOS), which decreased over time (10.5, 9.8, 8.6 days, respectively, P < 0.01) and readmission (20.0%, 21.3%, 21.0%, respectively, P = 0.84) and mortality rates were stable (2.7%, 1.7%, 2.0%, respectively, P = 0.13). CONCLUSION: Decreased early complications and LOS after RC over time may reflect beneficial effects of recent advances in bladder cancer treatment such as enhanced recovery after surgery protocols and minimally invasive techniques. Further opportunities to improve long term outcomes, readmissions and infection rates are needed.

Wound Complication Rates after Inguinal Lymph Node Dissection: Contemporary Analysis of the NSQIP Database.

BACKGROUND: Inguinal lymph node dissection (ILND) is used for diagnosis and treatment in penile cancer (PC), vulvar cancer (VC), and melanomas draining to the inguinal lymph nodes. However, ILND is often characterized by its morbidity and high wound complication rate. Consequently, we aimed to characterize wound complication rates after ILND. STUDY DESIGN: The NSQIP database was queried for ILND performed from 2005 to 2018 for melanoma, PC, or VC. Thirty-day wound complications included wound disruption and superficial, deep, and organ-space surgical site infection. Multivariable logistic regression was performed with covariates, including cancer type, age, American Society of Anesthesiologists score ≥3, BMI ≥30, smoking history, diabetes, operative time, and concomitant pelvic lymph node dissection. RESULTS: A total of 1,099 patients had an ILND with 92, 115, and 892 ILNDs performed for PC, VC, and melanoma, respectively. Wound complications occurred in 161 (14.6%) patients, including 12 (13.0%), 17(14.8%), and 132 (14.8%) patients with PC, VC, and melanoma, respectively. Median length of stay was 1 day (interquartile range 0 to 3 days), and median operative time was 152 minutes (interquartile 83 to 192 minutes). Readmission rate was 12.7%. Wound complications were associated with longer operative time per 10 minutes (odds ratio 1.038, 95% CI 1.019 to 1.056, p < 0.001), BMI ≥30 (odds ratio 1.976, 95% CI 1.386 to 2.818, p < 0.001), and concomitant pelvic lymph node dissection (odds ratio 1.561, 95% CI 1.056 to 2.306, p = 0.025). CONCLUSIONS: Predictors of wound complications after ILND include BMI ≥30, longer operative time, and concomitant pelvic lymph node dissection. There have been efforts to decrease ILND complication rates, including minimally invasive techniques and modified templates, which are not captured by NSQIP, and such approaches may be considered especially for those with increased complication risks.

Chemotherapy Refractory Spindle-Cell Rhabdomyosarcoma of the Bladder Treated With Consolidative Ovarian-Sparing Radical Surgery.

We present a case of chemotherapy refractory spindle cell rhabdomyosarcoma of the lower urinary tract in a 15-month-old female that ultimately required consolidative surgery with cystectomy, urethrectomy, ovarian-sparing hysterectomy, bilateral salpingectomy, anterior vaginal wall resection, and bilateral pelvic lymph node dissection. Genitourinary reconstruction was performed by ileal conduit creation and vaginoplasty. After completion of her maintenance postoperative chemotherapy regimen, the patient has remained disease-free for approximately 27 months.

Role of metastasectomy in the management of renal cell carcinoma.

Treatment of metastatic renal cell carcinoma (mRCC) has evolved with the development of a variety of systemic agents; however, these therapies alone rarely lead to a complete response. Complete consolidative surgery with surgical metastasectomy has been associated with improved survival outcomes in well-selected patients in previous reports. No randomized control trial exists to determine the effectiveness of metastasectomy. Therefore, reviewing observational studies is important to best determine which patients are most appropriate for metastasectomy for mRCC and if such treatment continues to be effective with the development of new systemic therapies such as immunotherapy. In this narrative review, we discuss the indications for metastasectomies, outcomes, factors associated with improved survival, and special considerations such as location of metastasis, number of metastases, synchronous metastases, and use of systemic therapy. Additionally, alternative treatment options and trials involving metastasectomy will be reviewed.

Inflammatory Hibernoma of the Renal Hilum Mimicking a Renal Pelvis Tumor.

We report on an enhancing, heterogenous renal pelvis mass growing over 2 years which was found to be a benign hibernoma with inflammatory and lipomatous features originating from the renal hilum. To our knowledge, this is the first case reported on a hibernoma compressing on the renal pelvis and second case of a hibernoma with the inflammatory variant.

Quantifying Publication Rates and Time to Publication for American Urological Association Podium Presentations.

PURPOSE: The American Urological Association (AUA) Annual Meeting serves as the premier platform for presenting unpublished research in urology. Among selected abstracts, podium presentations represent the most impactful submissions. While podium presentations receive a large audience through conference attendance and social media posts, it is unclear how often they manifest as publications in peer-reviewed journals. MATERIALS AND METHODS: Podium presentations from the 2017 AUA Annual Meeting were reviewed. Abstracts were assessed for publication between January 1, 2015 and May 31, 2020 allowing for a 3-year window of publication and accounting for publications prior to the submission deadline. Abstract authors were individually searched with key terms being added sequentially until <30 results were generated in PubMed®. Abstracts were deemed published if at least 1 author and 1 conclusion matched a manuscript. Publication rate, time to publication, and 2019 journal impact factor were collected. Statistical analysis was performed by linear and logistic regression. RESULTS: Of 872 podium presentations, 453 (51.9%) were published within 3 years. Median time from submission to publication was 12.5 months (IQR: 7.5-20.5). The number of articles published at 1, 2 and 3 years from submission was 203, 368 and 430, respectively. The median journal impact factor of publications was 3.2 (IQR: 2.0-5.8). Oncology studies (OR=1.21 [95% CI: 0.91-1.60], p=0.186) had similar rates of publication compared to non-oncology studies. CONCLUSIONS: While AUA podium presentations disseminate valuable data, approximately half were not published in peer-reviewed journals within 3 years. Therefore, care must be taken when promoting findings or adopting new practices based on these presentations alone.

The role of endoscopic management and adjuvant topical therapy for upper tract urothelial cancer.

Upper tract urothelial carcinoma (UTUC) has traditionally been managed with radical nephroureterectomy, and while this approach remains the gold standard for high-risk disease, endoscopic, kidney-sparing management has increasingly been adopted for low-risk disease as it preserves kidney function without compromising oncologic outcomes. Ureteroscopy and percutaneous renal access not only provide diagnoses by tumor visualization and biopsy, but also enable treatment with electrocautery or laser ablation. Several modalities exist for laser ablative treatments including thulium:YAG, neodymium:YAG, holmium:YAG, and combinations of the preceding. Furthermore, due to high recurrence rates after endoscopic management, adjuvant intracavitary instillation of various agents such as mitomycin C and bacillus Calmette-Guerin have been used given benefits seen in non-muscle invasive urothelial bladder cancer. Other formulations also being studied include gemcitabine, anthracyclines, and immunotherapies. More recently, Jelmyto, a mitomycin reverse thermal gel, has been developed to allow for adequate drug delivery time and potency since urine flow could otherwise dilute and washout topical therapy. In this article, the authors review techniques, indications, best practices, and areas of current investigation in endoscopic management and adjuvant topical therapy for UTUC.

Treatment of Urethral Stricture Disease in Women: Nonsystematic Review of Surgical Techniques and Intraoperative Considerations.

Female urethral strictures are rare, but underdiagnosed pathologies that can cause voiding dysfunction. These strictures are best managed with open reconstruction, as endoscopic treatments have high rates of failure. A flap urethroplasty can be performed with vaginal, labial or bladder tissue. Meanwhile, graft urethroplasties can utilize vaginal, labial, buccal or lingual tissue. It is important to consider the etiology and type of stricture, local vascularity, and prior attempts at repair when selecting the type of repair. Multiple different techniques have been described with theoretical advantages to each one. While some studies have reviewed a few of the reconstructive techniques to treat female urethral strictures, no single study has accounted for each individual technique. In this review, we discuss techniques captured by a number of systematic reviews and other articles. We will herein focus on reviewing and describing each unique technique of reconstruction in the setting of female urethral stricture.

Yearly Trends of Overactive Bladder Medication Usage.

INTRODUCTION: Anticholinergics are associated with cognitive side effects and dementia. Agents such as trospium, fesoterodine and darifenacin have been shown to be less likely to cross the blood-brain barrier. Furthermore, in 2012, mirabegron was approved by the U.S. Food and Drug Administration as the first beta-3 adrenoreceptor agonist to treat overactive bladder (OAB). This study aims to examine prescribing patterns of OAB medications in the United States over time. METHODS: The 2013-2017 Medicare Part D Public Use File was used to identify prescribers of OAB medications including oxybutynin, tolterodine, trospium, darifenacin, solifenacin, fesoterodine and mirabegron. The number of claims and total annual expenditure for each medication for all prescribers, nonurologists and urologists were analyzed from 2013 to 2017. RESULTS: Oxybutynin was consistently the most prescribed OAB medication each year, comprising 53.9% of all OAB medication prescriptions in 2017. From 2013 to 2017, mirabegron claims increased from 140,401 to 1,617,439, making it the second most prescribed OAB medication. Solifenacin usage decreased each year. Trospium, darifenacin and fesoterodine were the least prescribed agents each year. These trends were similar for those ≥65 years old. Total annual expenditure for mirabegron increased yearly, and it had the highest total expenditure of OAB medications, with $658.6 million in 2017. CONCLUSIONS: Oxybutynin was consistently the most prescribed OAB medication every year. Mirabegron utilization steadily increased each year. Anticholinergic medications associated with fewer cognitive adverse effects, such as trospium, darifenacin and fesoterodine, were among the least prescribed.

Endoscopic Removal of an Intrauterine Device in the Left Distal Ureter.

Background: Intrauterine device (IUD) migration to the ureter is rare. Symptoms can vary, but often mimic renal colic. Radiographic imaging may aid the diagnosis of a foreign body in the ureter. Reports on endoscopic managements of a migrated IUD are not well described. Case Presentation: We present a 36-year-old woman with a history of IUD insertion. Her symptoms included hematuria, dysuria, and suprapubic/abdominal pressure. After the removal of her IUD by her gynecologist, her hematuria eventually stopped, but she presented again with persistent pain. CT revealed a radiopaque foreign body in the distal left ureter protruding into the bladder. A careful resection with a resectoscope uncovered a long cylindrical shaped foreign body, suspicious of a broken piece of the IUD. Conclusion: Although not always feasible and long-term results remain to be determined, endoscopic management is a safe and effective method of identifying and removing a retained IUD in the ureter. When evaluating a woman with abdominal pain who has an indwelling IUD, a spontaneous migration of the IUD should be considered in the differential diagnosis.

Alpha Blocker and 5-Alpha Reductase Inhibitor Prescribing Habits among Urologists and Primary Care Physicians.

INTRODUCTION: While primary care physicians often prescribe medical therapy for voiding symptoms attributed to benign prostate enlargement, it is not clear to what extent they use novel or varied agents. We describe alpha blocker and 5-alpha reductase inhibitor prescribing habits of primary care physicians and compare them with those of urologists. METHODS: Within Medicare Part D we identified providers who prescribed alpha blockers and 5-alpha reductase inhibitors in 2015. We determined the proportions that prescribed 1 versus multiple agents, different types of agents and both types of medications, and compared them between providers. RESULTS: Overall 94% (9,327) of urologists, 50% (54,253) of internal medicine physicians and 61% (60,063) of family medicine physicians prescribed an alpha blocker in 2015. Urologists were more likely to prescribe multiple alpha blockers. However, they were also more likely to predominantly use a single agent. A higher percentage of urologists prescribed newer agents (alfuzosin, silodosin) while a higher percentage of primary care physicians prescribed older agents (terazosin, doxazosin). For 5-alpha reductase inhibitors 87.5% (8,692) of urologists, 32.0% (34,598) of internal medicine physicians and 34.4% (33,720) of family medicine physicians issued prescriptions. Urologists were more likely to prescribe a single 5-alpha reductase inhibitor predominantly and prescribe multiple 5-alpha reductase inhibitors. More primary care physicians prescribed alpha blockers without also prescribing 5-alpha reductase inhibitors. CONCLUSIONS: Most primary care physicians prescribed alpha blockers to Medicare beneficiaries. Urologists were more likely to use diverse as well as newer agents, signaling greater awareness of medical options, although also more complex cases. Urologists were more likely to habitually prescribe single medications. As primary care physicians are involved in the initial treatment of these patients, further education regarding medical options and appropriate indications should be considered.

Receiving Industry Payments is Associated with Prescribing Habits of Tadalafil.

INTRODUCTION: We evaluated whether industry payments for tadalafil are associated with prescribing habits among urologists and primary care physicians. METHODS: The Medicare Part D Public Use File and Open Payments Program database were linked to identify urologists and primary care physicians who prescribed and received a payment for tadalafil in 2015. We determined whether the presence and extent of payment were associated with tadalafil prescription habits. Statistical tests included the chi-squared test, Mann-Whitney U test, logistic regression and Pearson correlation coefficient. RESULTS: Within 2015 Medicare Part D 2,602 urologists and 3,095 primary care physicians prescribed tadalafil. In the 2015 Open Payments/General Payments database 2,304 urologists and 12,465 primary care physicians received a payment from Eli Lilly and Company pertaining to tadalafil. The range of individual payments was $10.21 to $15,478.88 (median $25.16) for urologists and $1.39 to $21,681 (median $20.11) for primary care physicians. The presence of payment was associated with prescription of tadalafil for primary care physicians (OR 4.48, 95% CI 3.67-5.50, p <0.001) but not for urologists (p=0.922). Urologist prescription was not associated with increasing payment amount or greater number of payments. For primary care physicians there was an association of prescribing tadalafil with increasing payment amount (OR 1.01, 95% CI 1.00-1.02, p=0.02) and increasing number of payments (OR 1.15, 95% CI 1.03-1.28, p=0.01). There were weak but statistically significant correlations between claim count and payment amount for urologists and primary care physicians (r=0.063 and r=0.1, respectively, p <0.05). CONCLUSIONS: There is a significant relationship between payments and tadalafil prescribing habits. Scrutiny of these relationships has value in improving transparency and reflects the importance of the Open Payments system.