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Route of Administration for UGN-101 and Impact on Oncological and Safety Outcomes

Linehan, Jennifer; Gottlieb, Josh; Woldu, Solomon L; Labbate, Craig; Rose, Kyle; Sexton, Wade; Kaimakliotis, Hristos; Jacob, Joseph; Dickstein, Rian; Nieder, Alan; Bjurlin, Marc; Humphreys, Mitchell; Ghodoussipor, Saum; Quek, Marcus; O'Donnell, Michael; Eisner, Brian H; Feldman, Adam S; Matin, Surena F; Lotan, Yair; Murray, Katie S
BACKGROUND:UGN-101 can be used for chemoablation of low-grade upper tract urothelial carcinoma (UTUC). The gel can be administered via a retrograde route through a ureteral catheter or an antegrade route via a nephrostomy tube. OBJECTIVE:To report outcomes of UGN-101 by route of administration. DESIGN, SETTING, AND PARTICIPANTS/METHODS:We performed a retrospective review of 132 patients from 15 institutions who were treated with UGN-101 for low-grade UTUC via retrograde versus antegrade administration. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS/METHODS:Survival outcomes are reported per patient. Treatment, complications, and recurrence outcomes are reported per renal unit. Statistical analysis was performed for primary endpoints of oncological response and ureteral stricture occurrence. RESULTS AND LIMITATIONS/CONCLUSIONS:A total of 136 renal units were evaluated, comprising 78 retrograde and 58 antegrade instillations. Median follow-up was 7.4 mo. There were 120 cases (91%) of biopsy-proven low-grade UTUC. Tumors were in the renal pelvis alone in 89 cases (65%), in the ureter alone in 12 cases (9%), and in both in 35 cases (26%). Seventy-six patients (56%) had residual disease before UGN-101 treatment. Chemoablation with UGN-101 was used in 50/78 (64%) retrograde cases and 26/58 (45%) antegrade cases. A complete response according to inspection and cytology was achieved in 31 (48%) retrograde and 30 (60%) antegrade renal units (p = 0.1). Clavien grade 3 ureteral stricture occurred in 21 retrograde cases (32%) and only six (12%) antegrade cases (p < 0.01). Limitations include treatment bias, as patients in the antegrade group were more likely to undergo endoscopic mechanical ablation before UGN-101 instillation. CONCLUSIONS:These preliminary results show a significantly lower rate of stricture occurrence with antegrade administration of UGN-101, with no apparent impact on oncological efficacy. PATIENT SUMMARY/RESULTS:We compared results for two different delivery routes for the drug UGN-101 for treatment of cancer in the upper urinary tract. For the antegrade route, a tube is inserted through the skin into the kidney. For the retrograde route, a catheter is inserted past the bladder into the upper urinary tract. Our results show a lower rate of narrowing of the ureter (the tube draining urine from the kidney into the bladder) using the antegrade route, with no difference in cancer control.
PMID: 37263827
ISSN: 2405-4569
CID: 5543432

Urologists' perceptions and practices related to patient smoking and cessation: a national assessment from the 2021 American Urological Association Census

Matulewicz, Richard S; Meeks, William; Mbassa, Rachel; Fang, Raymond; Pittman, Ashley; Mossanen, Matthew; Furberg, Helena; Chichester, Lou-Anne; Lui, Michelle; Sherman, Scott E; Makarov, Danil V; Bjurlin, Marc A; Ostroff, Jamie S
OBJECTIVE:To assess urologists' perceptions and practices related to smoking and smoking cessation. MATERIALS AND METHODS/METHODS:Six survey questions were designed to assess beliefs, practices, and determinants related to tobacco use assessment and treatment (TUAT) in outpatient urology clinics. These questions were included in an annual census survey (2021) offered to all practicing urologists. Responses were weighted to represent the practicing US population of nonpediatric urologists (N=12,852). The primary outcome was affirmative responses to the question, "Do you agree it is important for urologists to screen for and provide smoking cessation treatment to patients in the outpatient clinic?" Practice patterns, perceptions, and opinions of optimal care delivery were assessed. RESULTS:In total, 98% of urologists agreed (27%) or strongly agreed (71%) that cigarette smoking is a significant contributor to urologic disease. However, only 58% agreed that TUAT is important in urology clinics. Most urologists (61%) advise patients who smoke to quit but do not provide additional cessation counseling or medications or arrange follow-up. The most frequently identified barriers to TUAT were lack of time (70%), perceptions that patients are unwilling to quit (44%), and lack of comfort prescribing cessation medications (42%). Additionally, 72% of respondents stated that urologists should provide a recommendation to quit and refer patients for cessation support. CONCLUSIONS:TUAT does not routinely occur in an evidence-based fashion in outpatient urology clinics. Addressing established barriers and facilitating these practices with multilevel implementation strategies can promote tobacco treatment and improve outcomes for patients with urologic disease.
PMID: 37422137
ISSN: 1527-9995
CID: 5539592

Treatment of Low-grade Intermediate-risk Nonmuscle-invasive Bladder Cancer With UGN-102 ± Transurethral Resection of Bladder Tumor Compared to Transurethral Resection of Bladder Tumor Monotherapy: A Randomized, Controlled, Phase 3 Trial (ATLAS)

Prasad, Sandip M; Huang, William C; Shore, Neal D; Hu, Brian; Bjurlin, Marc; Brown, Gordon; Genov, Pencho; Shishkov, Dimitar; Khuskivadze, Alexandre; Ganev, Tosho; Marchev, Dobri; Orlov, Igor; Kopyltsov, Evgeny; Zubarev, Vadim; Nosov, Alexander; Komlev, Dmitrii; Burger, Brent; Raju, Sunil; Meads, Andrew; Schoenberg, Mark
PURPOSE:Low-grade intermediate-risk nonmuscle-invasive bladder cancer is a chronic illness commonly treated by repetitive transurethral resection of bladder tumor. We compared the efficacy and safety of intravesical chemoablation with UGN-102 (a reverse thermal gel containing mitomycin), with or without subsequent transurethral resection of bladder tumor, to transurethral resection of bladder tumor alone in patients with low-grade intermediate-risk nonmuscle-invasive bladder cancer. MATERIALS AND METHODS:This prospective, randomized, phase 3 trial recruited patients with new or recurrent low-grade intermediate-risk nonmuscle-invasive bladder cancer to receive initial treatment with either UGN-102 once weekly for 6 weeks or transurethral resection of bladder tumor. Patients were followed quarterly by endoscopy, cytology, and for-cause biopsy. The primary end point was disease-free survival. All patients were followed for adverse events. RESULTS:Trial enrollment was halted by the sponsor to pursue an alternative development strategy after 282 of a planned 632 patients were randomized to UGN-102 ± subsequent transurethral resection of bladder tumor (n=142) or transurethral resection of bladder tumor monotherapy (n=140), rendering the trial underpowered to perform hypothesis testing. Patients were predominantly male and ≥65 years of age. Tumor-free complete response 3 months after initial treatment was achieved by 92 patients (65%) who received UGN-102 and 89 patients (64%) treated by transurethral resection of bladder tumor. The estimated probability of disease-free survival 15 months after randomization was 72% for UGN-102 ± transurethral resection of bladder tumor and 50% for transurethral resection of bladder tumor (hazard ratio 0.45). The most common adverse events (incidence ≥10%) in the UGN-102 group were dysuria, micturition urgency, nocturia, and pollakiuria. CONCLUSIONS:Primary, nonsurgical chemoablation with UGN-102 for the management of low-grade intermediate-risk nonmuscle-invasive bladder cancer offers a potential therapeutic alternative to immediate transurethral resection of bladder tumor monotherapy and warrants further investigation.
PMID: 37548555
ISSN: 1527-3792
CID: 5593912

Corrigendum to "Route of Administration for UGN-101 and Impact on Oncological and Safety Outcomes" [Eur. Urol. Focus (2023)]

Linehan, Jennifer; Gottlieb, Josh; Woldu, Solomon L; Labbate, Craig; Rose, Kyle; Sexton, Wade; Kaimakliotis, Hristos; Jacob, Joseph; Dickstein, Rian; Nieder, Alan; Bjurlin, Marc; Humphreys, Mitchell; Ghodoussipour, Saum; Quek, Marcus; O'Donnell, Michael; Eisner, Brian H; Feldman, Adam S; Matin, Surena F; Lotan, Yair; Murray, Katie S
PMID: 37640582
ISSN: 2405-4569
CID: 5618392

Smoking cessation pharmacotherapy use during index hospital admission following cystectomy for bladder cancer: A retrospective cohort study

Rapoport, Eli; Bjurlin, Marc A; Furberg, Helena; Donahue, Timothy F; Taneja, Samir S; Bochner, Bernard H; Ostroff, Jamie S; Matulewicz, Richard S
BACKGROUND:To identify gaps in urologic oncology quality and evidence-based smoking cessation care by assessing how often smoking cessation pharmacotherapy (SCP) is given in the inpatient setting following cystectomy. METHODS:The Premier Healthcare Database (PHD), a deidentified all-payer dataset, was used to generate nationally representative estimates of SCP receipt during hospitalization following cystectomy for patients with bladder cancer who smoke. Regressions were used to model associations between SCP receipt and patient- and hospital-level factors. RESULTS:Of the 21,624 patients who underwent cystectomy for bladder cancer, 3,676 patients (17.0%) were identified as current smokers, representing a weighted estimate of 16,063 admissions. Among these admissions, 27.9% of patients received SCP, the vast majority of which (91.5%) received exclusively nicotine replacement therapy. Rates of SCP receipt varied substantially across hospitals (median: 25.0%, IQR: 20.0-33.3, range: 0.0-60.0). Older age and black race (aOR = 0.59, 95% CI: 0.42-0.82) were associated with lower odds of SCP receipt. Increased patient comorbidity score was associated with higher odds of SCP receipt (aOR = 1.02, 95% CI: 1.01-1.03); specifically, chronic pulmonary disease, alcohol abuse, and depression were independently associated with SCP receipt. Hospital teaching status, bed capacity, and mean annual cystectomy volume were not associated with SCP receipt. SCP receipt was not associated with hospital length of stay nor 90-day readmission or mortality following cystectomy. CONCLUSIONS:SCP is infrequently given to patients who smoke during their hospitalization following cystectomy for bladder cancer, representing a gap in quality urologic oncology care and a missed opportunity to effectively intervene with evidence-based treatment.
PMID: 36529654
ISSN: 1873-2496
CID: 5394502

Untargeted Metabolomics to Characterize the Urinary Chemical Landscape of E-Cigarette Users

Hsiao, Yun-Chung; Matulewicz, Richard S; Sherman, Scott E; Jaspers, Ilona; Weitzman, Michael L; Gordon, Terry; Liu, Chih-Wei; Yang, Yifei; Lu, Kun; Bjurlin, Marc A
The health and safety of using e-cigarette products (vaping) have been challenging to assess and further regulate due to their complexity. Inhaled e-cigarette aerosols contain chemicals with under-recognized toxicological profiles, which could influence endogenous processes once inhaled. We urgently need more understanding on the metabolic effects of e-cigarette exposure and how they compare to combustible cigarettes. To date, the metabolic landscape of inhaled e-cigarette aerosols, including chemicals originated from vaping and perturbed endogenous metabolites in vapers, is poorly characterized. To better understand the metabolic landscape and potential health consequences of vaping, we applied liquid chromatography-mass spectrometry (LC-MS) based nontargeted metabolomics to analyze compounds in the urine of vapers, cigarette smokers, and nonusers. Urine from vapers (n = 34), smokers (n = 38), and nonusers (n = 45) was collected for verified LC-HRMS nontargeted chemical analysis. The altered features (839, 396, and 426 when compared smoker and control, vaper and control, and smoker and vaper, respectively) among exposure groups were deciphered for their structural identities, chemical similarities, and biochemical relationships. Chemicals originating from e-cigarettes and altered endogenous metabolites were characterized. There were similar levels of nicotine biomarkers of exposure among vapers and smokers. Vapers had higher urinary levels of diethyl phthalate and flavoring agents (e.g., delta-decalactone). The metabolic profiles featured clusters of acylcarnitines and fatty acid derivatives. More consistent trends of elevated acylcarnitines and acylglycines in vapers were observed, which may suggest higher lipid peroxidation. Our approach in monitoring shifts of the urinary chemical landscape captured distinctive alterations resulting from vaping. Our results suggest similar nicotine metabolites in vapers and cigarette smokers. Acylcarnitines are biomarkers of inflammatory status and fatty acid oxidation, which were dysregulated in vapers. With higher lipid peroxidation, radical-forming flavoring, and higher level of specific nitrosamine, we observed a trend of elevated cancer-related biomarkers in vapers as well. Together, these data present a comprehensive profiling of urinary biochemicals that were dysregulated due to vaping.
PMID: 36912507
ISSN: 1520-5010
CID: 5465842

Attitudes, Perceptions, and Use of Cancer-based Genetic Testing Among Healthy U.S. Adults and Those With Prostate or Breast/Ovarian Cancer

Thakker, Sameer; Loeb, Stacy; Giri, Veda N; Bjurlin, Marc A; Matulewicz, Richard S
INTRODUCTION/BACKGROUND:Differences in public awareness and uptake of genetic testing among patients with inheritable cancers are not well understood. The purpose of this study is to examine self-reported rates of undergoing cancer-specific genetic testing in patients with breast/ovarian cancer vs prostate cancer from a nationally representative sample of U.S. PATIENTS/METHODS:Secondary objectives include examining sources of genetic testing information and perceptions of genetic testing for both patient populations as well as the general public. METHODS:testing was used to compare differences among categorical variables. RESULTS:= .003). Health care professionals were the most common source of genetic testing information for patients with breast/ovarian cancer whereas the Internet was the most common source for patients with prostate cancer. CONCLUSIONS:Our results suggest a lack of awareness and limited utilization of genetic testing among patients with prostate cancer relative to breast/ovarian cancer. Patients with prostate cancer cite the Internet and social media as sources of information, which may be an avenue for more optimal dissemination of evidence-based information.
PMID: 37103438
ISSN: 2352-0787
CID: 5465322

IL-15 Superagonist NAI in BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer

Chamie, Karim; Chang, Sam S; Kramolowsky, Eugene; Gonzalgo, Mark L; Agarwal, Piyush Kumar; Bassett, Jeffrey C; Bjurlin, Marc; Cher, Michael L; Clark, William; Cowan, Barrett E; David, Richard; Goldfischer, Evan; Guru, Khurshid; Jalkut, Mark W; Kaffenberger, Samuel D; Kaminetsky, Jed; Katz, Aaron E; Koo, Alec S; Sexton, Wade J; Tikhonenkov, Sergei N; Trabulsi, Edouard J; Trainer, Andrew F; Spilman, Patricia; Huang, Megan; Bhar, Paul; Taha, Sharif A; Sender, Lennie; Reddy, Sandeep; Soon-Shiong, Patrick
IL-15 Superagonist NAI in BCG-Unresponsive NMIBCIn this trial, patients with BCG-unresponsive bladder CIS with or without Ta/T1 papillary disease or BCG-unresponsive high-grade Ta/T1 papillary NMIBC were treated with intravesical NAI, an IL-15 superagonist, plus BCG. Primary end points were CR at 3 or 6 months for patients with CIS disease and DFS rate at 12 months for those with high-grade Ta/T1 disease. CR rate was 71% (58 of 82 patients), and the DFS rate was 55.4%.
PMID: 38320011
ISSN: 2766-5526
CID: 5633282

Machine learning decision support model for radical cystectomy discharge planning

Zhao, Calvin C; Bjurlin, Marc A; Wysock, James S; Taneja, Samir S; Huang, William C; Fenyo, David; Matulewicz, Richard S
PURPOSE/OBJECTIVE:Timely and appropriate discharge placement for patients who have undergone radical cystectomy (RC) remains challenging. Our objective was to improve the discharge planning process by creating a machine learning model that helps to predict the need for non-home hospital discharge to a higher level of care. MATERIALS AND METHODS/METHODS:Patients undergoing elective radical cystectomy for bladder cancer from 2014-2019 were identified in the ACS-NSQIP database. A gradient boosted decision tree was trained on selected predischarge variables to predict discharge location, dichotomized into home and non-home. We used threshold-moving to calibrate model predictions and evaluated model performance on a testing set using receiver operating characteristic and precision recall curves. Model performance was further examined in subgroups of interest. RESULTS AND CONCLUSIONS/CONCLUSIONS:A total of 11,881 patients met inclusion criteria with a mean age of 68.6 years. 10.6% of patients undergoing RC had non-home discharges. Our model predicting non-home discharge achieved an area under the receiver operating characteristic curve of 0.80 and an average precision of 0.33. After threshold-moving, our model had a recall of 0.757 and a precision of 0.211. Top variables by importance were septic shock occurrence, ventilator-use greater than 48 hours, organ space surgical site infection and unplanned intubation. Our model shows strong performance in identifying patients who required non-home discharge to higher levels of care, outperforming commonly used clinical indices and prior work. Modern machine learning techniques may be applied to support more timely and appropriate clinical decision making.
PMID: 35750561
ISSN: 1873-2496
CID: 5282342

Systematic review of smoking relapse rates among cancer survivors who quit at the time of cancer diagnosis

Feuer, Zachary; Michael, Jamie; Morton, Elizabeth; Matulewicz, Richard S; Sheeran, Paschal; Shoenbill, Kimberly; Goldstein, Adam; Sherman, Scott; Bjurlin, Marc A
BACKGROUND:Tobacco cessation, at the time of cancer diagnosis, has been associated with better oncologic outcomes. Cancer diagnosis has been shown to serves as a "teachable moment," inspiring tobacco cessation. However, the sustainability of abstinence from smoking is understudied. Similarly, there is a paucity of data regarding the utility of behavioral/pharmacologic intervention to support continued smoking cessation. METHODS:A systematic literature review was conducted in August 2021 with no date limits. Relevant studies that reported tobacco smoking relapse rates for patients who quit at the time of cancer diagnosis were included. Our literature search identified 1620 articles and 29 met inclusion criteria. The primary endpoint of the study was smoking relapse rate. Secondary outcome was a descriptive assessment of behavioral and pharmacologic interventions to promote continued cessation. Exploratory outcomes included a regression analysis to examine associations between study factors and relapse rates. RESULTS:There were 3021 smokers who quit at the time of cancer diagnosis. Weighted overall relapse rate for the study population was 44 % (range 5-57 %). Interventions to support smoking cessation were employed in 17 of the 29 included studies and protocols were heterogenous, including behavioral, pharmacologic, or mixed intervention strategies. Exploratory analysis demonstrated no association between relapse rates and publication year, gender, or study type. Relapse rates were indirectly associated with age (p = .003), suggesting that younger patients were more likely to relapse. CONCLUSION/CONCLUSIONS:The sustainability of smoking cessation after a cancer diagnosis is understudied, and existing literature is difficult to interpret due to heterogeneity. Relapse rates remain significant and, although many studies have included the employment of an intervention to promote continued cessation, few studies have measured the effect of a protocolized intervention to support abstinence.
PMID: 35988307
ISSN: 1877-783x
CID: 5312382