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The Evolution of Nadofaragene Firadenovec: A Review and the Path Forward Nadofaragene Firadenovec 的演变:回顾与展望
IF 1.1 4区 医学
Bladder Cancer Pub Date : 2024-05-09 DOI: 10.3233/blc-230083
Alexis R. Steinmetz, Sharada Mokkapati, David McConkey, Colin P. Dinney
{"title":"The Evolution of Nadofaragene Firadenovec: A Review and the Path Forward","authors":"Alexis R. Steinmetz, Sharada Mokkapati, David McConkey, Colin P. Dinney","doi":"10.3233/blc-230083","DOIUrl":"https://doi.org/10.3233/blc-230083","url":null,"abstract":"<h4><span>Abstract</span></h4><h3><span></span>BACKGROUND:</h3><p>The intravesical gene therapy nadofaragene firadenovec (rAd-IFNα/Syn3) was FDA approved in 2022 for non-muscle invasive bladder cancer (NMIBC) unresponsive to frontline treatment with BCG, and the first gene therapy developed for bladder cancer. This non-replicating recombinant adenovirus vector delivers a copy of the human interferon alpha-2b gene into urothelial and tumor cells, causing them to express this pleotropic cytokine with potent antitumor effects.</p><h3><span></span>OBJECTIVE:</h3><p>To provide a historical overview describing how several decades of preclinical and clinical studies investigating the role of interferon in the treatment of bladder cancer ultimately led to the development of gene therapy with nadofaragene for NMIBC.</p><h3><span></span>METHODS:</h3><p>We conducted a review of the literature using PubMed, Google Scholar, and ClinicalTrials.gov to summarize our knowledge of the evolution of interferon-based therapy in NMIBC.</p><h3><span></span>RESULTS:</h3><p>The FDA approval of this therapy represents an important landmark in urologic oncology and several decades of research dedicated to the study of interferon’s direct and indirect antitumor properties in NMIBC. The data gathered from the phase 1, 2, and 3 clinical trials continue to provide additional insights into the precise mechanisms underlying both the efficacy of and resistance to nadofaragene.</p><h3><span></span>CONCLUSIONS:</h3><p>Nadofaragene leverages the cytotoxic, anti-angiogenic, and immune-modulatory roles of interferon to effectively treat NMIBC that is resistant to BCG. Ongoing studies of resistance mechanisms and prognostic biomarkers have been promising; these will ultimately improve patient selection and allow for the modulation of factors in the tumor or immune microenvironment to further increase therapeutic response.</p>","PeriodicalId":54217,"journal":{"name":"Bladder Cancer","volume":"23 1","pages":""},"PeriodicalIF":1.1,"publicationDate":"2024-05-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140939028","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Multi-Center Assessment of Lymph-Node Density and Nodal-Stage to Predict Disease-Specific Survival in Patients with Bladder Cancer Treated by Radical Cystectomy 多中心评估淋巴结密度和结节分期,预测膀胱癌根治术患者的疾病特异性生存率
IF 1.1 4区 医学
Bladder Cancer Pub Date : 2024-05-08 DOI: 10.3233/blc-230086
Erik J. van Gennep, Francesco Claps, Peter J. Bostrom, Shahrokh F. Shariat, Yann Neuzillet, Alexandre R. Zlotta, Carlo Trombetta, Markus Eckstein, Laura S. Mertens, Rossana Bussani, Maximilian Burger, Joost L. Boormans, Bernd Wullich, Arndt Hartmann, Roman Mayr, Nicola Pavan, Riccardo Bartoletti, M. Carmen Mir, Damien Pouessel, John van der Hoeven, Theo H. van der Kwast, Yves Allory, Tahlita C.M. Zuiverloon, Yair Lotan, Bas W.G. van Rhijn
{"title":"Multi-Center Assessment of Lymph-Node Density and Nodal-Stage to Predict Disease-Specific Survival in Patients with Bladder Cancer Treated by Radical Cystectomy","authors":"Erik J. van Gennep, Francesco Claps, Peter J. Bostrom, Shahrokh F. Shariat, Yann Neuzillet, Alexandre R. Zlotta, Carlo Trombetta, Markus Eckstein, Laura S. Mertens, Rossana Bussani, Maximilian Burger, Joost L. Boormans, Bernd Wullich, Arndt Hartmann, Roman Mayr, Nicola Pavan, Riccardo Bartoletti, M. Carmen Mir, Damien Pouessel, John van der Hoeven, Theo H. van der Kwast, Yves Allory, Tahlita C.M. Zuiverloon, Yair Lotan, Bas W.G. van Rhijn","doi":"10.3233/blc-230086","DOIUrl":"https://doi.org/10.3233/blc-230086","url":null,"abstract":"<h4><span>Abstract</span></h4><h3><span></span>BACKGROUND:</h3><p>Prognostic tools in pathological-node (pN) patients after radical cystectomy (RC) are needed.</p><h3><span></span>OBJECTIVES:</h3><p>To evaluate the prognostic impact of lymph node (LN)-density on disease-specific survival (DSS) in patients with bladder cancer (BC) undergoing RC with pelvic lymph node dissection.</p><h3><span></span>METHODS:</h3><p>We analyzed a multi-institutional cohort of 1169 patients treated with upfront RC for cT1-4aN0M0 urothelial BCat nine centers. LN-densitywas calculated as the ratio of the number of positive LNs×100% to the number of LNs removed. The optimal LN-density cut-off value was defined by creating a time-dependent receiver operating characteristic (ROC) curve in pN patients. Univariable and multivariable Cox’ regression analyses were used to assess the effect of conventional Tumor Nodes Metastasis (TNM) nodal staging system, LN-density and other LN-related variables on DSS in the pN-positive cohort.</p><h3><span></span>RESULTS:</h3><p>Of the 1169 patients, 463 (39.6%) patients had LN-involvement. The area under the ROC curve was 0.60 and the cut-off for LN-density was set at 20%, 223 of the pN-positive patients (48.2%) had a LN-density.20%. In multivariable models, the number of LN-metastases (HR 1.03, p = 0.005) and LN-density, either as continuous (HR 1.01, p = 0.013) or as categorical variable (HR 1.37, p = 0.014), were independently associated with worse DSS, whereas pN-stage was not.</p><h3><span></span>CONCLUSIONS:</h3><p>LN-density.20% was an independent predictor of worse DSS in BC patients with LN-involvement at RC. The integration of LN-density and other LN-parameters rather than only conventional pN-stage may contribute to a more refined risk-stratification in BC patients with nodal involvement.</p>","PeriodicalId":54217,"journal":{"name":"Bladder Cancer","volume":"47 1","pages":""},"PeriodicalIF":1.1,"publicationDate":"2024-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140942360","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Ensuring Successful Biomarker Studies in Bladder Preservation Clinical Trials for Non-muscle Invasive Bladder Cancer. 确保非肌浸润性膀胱癌保留膀胱临床试验中的生物标志物研究取得成功。
IF 1 4区 医学
Bladder Cancer Pub Date : 2024-03-12 eCollection Date: 2024-01-01 DOI: 10.3233/BLC-230082
David J McConkey, Brian C Baumann, Stephanie Cooper Greenberg, David J DeGraff, Scott E Delacroix, Jason A Efstathiou, Jared Foster, Susan Groshen, Edward E Kadel, Francesca Khani, William Y Kim, Seth P Lerner, Trevor Levin, Joseph C Liao, Matthew I Milowsky, Joshua J Meeks, David T Miyamoto, Kent W Mouw, Eugene J Pietzak, David B Solit, Debasish Sundi, Abdul Tawab-Amiri, Pamela J West, Sara E Wobker, Alexander W Wyatt, Andrea B Apolo, Peter C Black
{"title":"Ensuring Successful Biomarker Studies in Bladder Preservation Clinical Trials for Non-muscle Invasive Bladder Cancer.","authors":"David J McConkey, Brian C Baumann, Stephanie Cooper Greenberg, David J DeGraff, Scott E Delacroix, Jason A Efstathiou, Jared Foster, Susan Groshen, Edward E Kadel, Francesca Khani, William Y Kim, Seth P Lerner, Trevor Levin, Joseph C Liao, Matthew I Milowsky, Joshua J Meeks, David T Miyamoto, Kent W Mouw, Eugene J Pietzak, David B Solit, Debasish Sundi, Abdul Tawab-Amiri, Pamela J West, Sara E Wobker, Alexander W Wyatt, Andrea B Apolo, Peter C Black","doi":"10.3233/BLC-230082","DOIUrl":"10.3233/BLC-230082","url":null,"abstract":"","PeriodicalId":54217,"journal":{"name":"Bladder Cancer","volume":"10 1","pages":"1-8"},"PeriodicalIF":1.0,"publicationDate":"2024-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11181871/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141592067","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Evaluation of the Effects of Opium on the Expression of SOX2 and OCT4 in Wistar Rat Bladder 评估鸦片对 Wistar 大鼠膀胱中 SOX2 和 OCT4 表达的影响
IF 1.1 4区 医学
Bladder Cancer Pub Date : 2024-02-28 DOI: 10.3233/blc-230076
Iman Menbari Oskouie, Leila Zareian Baghdadabad, Rahil Mashhadi, Parisa Zahmatkesh, Akram Mirzaei, Alireza Khajavi, Maryam Noori, Gholamreza Mesbah, Seyed Mohammad Kazem Aghamir
{"title":"Evaluation of the Effects of Opium on the Expression of SOX2 and OCT4 in Wistar Rat Bladder","authors":"Iman Menbari Oskouie, Leila Zareian Baghdadabad, Rahil Mashhadi, Parisa Zahmatkesh, Akram Mirzaei, Alireza Khajavi, Maryam Noori, Gholamreza Mesbah, Seyed Mohammad Kazem Aghamir","doi":"10.3233/blc-230076","DOIUrl":"https://doi.org/10.3233/blc-230076","url":null,"abstract":"<h4><span>Abstract</span></h4><h3><span></span>BACKGROUND:</h3><p>\u0000Bladder cancer is a malignancy greatly affected by behavioral habits. The aim of this study was to examine the effect of opium on changes in the expression of <i>OCT4</i> and <i>SOX2</i> in the bladder tissue of rats.</p><h3><span></span>METHOD:</h3><p>\u0000Thirty six rats were divided into six groups: 24 rats in the addicted group received morphine and opium for 4 months with 12 rats in the control group. Blood testing was done for the evaluation of CBC, MDA, and TAC. The bladder tissue was removed and checked by histopathological examination. All total RNA was extracted, then cDNAs were synthesized and the OCT<i>4</i> and <i>SOX2</i> gene expressions were evaluated by Real-time PCR.</p><h3><span></span>RESULTS:</h3><p>\u0000The <i>OCT4</i> mRNA expression level in the opium group of rats was significantly increased compared to the control group (13.5 and 6.8 fold in males and females respectively). Also, in the morphine group, similar augmentation was detected (3.8 and 6.7 fold in males and females respectively). The <i>SOX2</i> mRNA over-expression level was seen in the morphine group of both genders as compared to the control group (3.7 and 4.2 fold in male and female respectively) but in the opium group, enhancement of mRNA level was seen only in males (6.6 fold). Opium increases both <i>OCT4</i> and <i>SOX2</i> expression more than morphine in male rats, but in female rats, <i>SOX2</i> is increased more by morphine.</p><h3><span></span>CONCLUSION:</h3><p>\u0000Over expression of <i>OCT4</i> and <i>SOX2</i> was observed in rats treated with opium and morphine. Increased <i>OCT4</i> and <i>SOX2</i> expression was seen in opium-treated male rats, but in female rats, <i>SOX2</i> was increased more by morphine.</p>","PeriodicalId":54217,"journal":{"name":"Bladder Cancer","volume":"17 1","pages":""},"PeriodicalIF":1.1,"publicationDate":"2024-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140019912","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Patterns of Smoking Cessation Strategies and Perception of E-cigarette Harm Among Bladder Cancer Survivors 1 膀胱癌幸存者的戒烟策略模式和对电子烟危害的认知 1
IF 1.1 4区 医学
Bladder Cancer Pub Date : 2024-02-19 DOI: 10.3233/blc-230093
Jobin Chandi, Srinath Soundararajan, William Bukowski, Wes Britt, Kristin Weiss, Richard S. Matulewicz, Hannah Kay, Adam O. Goldstein, Kimberly A. Shoenbill, Marc A. Bjurlin
{"title":"Patterns of Smoking Cessation Strategies and Perception of E-cigarette Harm Among Bladder Cancer Survivors 1","authors":"Jobin Chandi, Srinath Soundararajan, William Bukowski, Wes Britt, Kristin Weiss, Richard S. Matulewicz, Hannah Kay, Adam O. Goldstein, Kimberly A. Shoenbill, Marc A. Bjurlin","doi":"10.3233/blc-230093","DOIUrl":"https://doi.org/10.3233/blc-230093","url":null,"abstract":"<h4><span>Abstract</span></h4><h3><span></span>BACKGROUND:</h3><p>\u0000Cigarette smoking is the leading preventable cause of bladder cancer (BC). Some proponents of e-cigarettes describe their use as a risk mitigation strategy despite potential carcinogen exposure and uncertain long-term risks.</p><h3><span></span>OBJECTIVE:</h3><p>\u0000We assessed smoking cessation strategies, including e-cigarette use, and harm perception among patients with BC.</p><h3><span></span>METHODS:</h3><p>\u0000We performed a cross-sectional study on a convenience sample of patients with BC at a single institution from August 2021 –October 2022. The survey instrument was sourced from the Cancer Patient Tobacco Use Questionnaire (C-TUQ) from the American Association for Cancer Research with standardized questions on tobacco use, cessation questions, and e-cigarette harm perceptions.</p><h3><span></span>RESULTS:</h3><p>Of the 104 surveyed BC patients (mean age: 72 years; 27% female; 55% with muscle-invasive disease), 20% were current smokers (median pack years: 40) and 51% were former smokers (median pack years: 20). A minority (9%) had quit smoking at the time of diagnosis. Pharmacotherapy for smoking cessation included nicotine patches (25%), gum (21%), lozenges (8%), e-cigarettes (8%), and Varenicline/Bupropion (4%). Notably, 43% of patients who continued to smoke expressed willingness to switch to e-cigarettes as a cessation aid. E-cigarette users (11%) more commonly perceived e-cigarettes as non-harmful compared to former (4%) and non-smokers (4%) (<i>P</i> = .048), though all groups regarded e-cigarettes as equally addictive as traditional cigarettes.</p><h3><span></span>CONCLUSIONS:</h3><p>\u0000Despite the prevalence of BC survivors who continue to smoke, a significant proportion perceive e-cigarettes as a viable and less harmful cessation aid. The infrequent use of FDA-approved pharmacotherapies underscores potential implementation gaps. These findings highlight the need for further research and targeted interventions in addressing smoking cessation among BC survivors.</p>","PeriodicalId":54217,"journal":{"name":"Bladder Cancer","volume":"262 1","pages":""},"PeriodicalIF":1.1,"publicationDate":"2024-02-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139921200","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Noninvasive Tests for Bladder Cancer Detection and Surveillance: A Systematic Review of Commercially Available Assays 用于膀胱癌检测和监控的无创检验:市售检测方法系统回顾
IF 1.1 4区 医学
Bladder Cancer Pub Date : 2024-02-14 DOI: 10.3233/blc-230096
John R. Heard, Anirban P. Mitra
{"title":"Noninvasive Tests for Bladder Cancer Detection and Surveillance: A Systematic Review of Commercially Available Assays","authors":"John R. Heard, Anirban P. Mitra","doi":"10.3233/blc-230096","DOIUrl":"https://doi.org/10.3233/blc-230096","url":null,"abstract":"<h4><span>Abstract</span></h4><h3><span></span>BACKGROUND:</h3><p>\u0000An important reason for the high health care costs associated with bladder cancer is the need for frequent cystoscopy for detection and surveillance of this disease. Cytologic analysis of voided urine specimens can assist, but is too inaccurate to replace cystoscopy. In an effort to create reliable, objective, noninvasive mechanisms for detecting bladder cancer, a number of urine-based molecular tests have been developed with the ultimate goal of reducing the frequency of cystoscopy.</p><h3><span></span>OBJECTIVE:</h3><p>\u0000To summarize the performance of urine-based biomarker tests, currently commercially available in the US, as part of the initial workup for hematuria and for bladder cancer surveillance.</p><h3><span></span>METHODS:</h3><p>\u0000In accordance with PRISMA guidelines we performed a systematic review of the literature on the performance of NMP22, BTA, UroVysion, ImmunoCyt/uCyt, CxBladder, and Bladder EpiCheck. Median sensitivity, specificity, negative (NPV) and positive predictive values (PPV) were calculated for each test based on the included studies.</p><h3><span></span>RESULTS:</h3><p>\u0000Twenty-eight studies met inclusion criteria for the performance of five urine-based biomarker tests in the setting hematuria workup. Median sensitivity ranged from 65.7% –100% and specificity ranged from 62.5% –93.8% . Median NPV ranged from 94.2% –98.3% and PPV ranged from 29% –58.7% . Fourteen studies met inclusion criteria for the performance of six tests in the setting of bladder cancer surveillance. Median sensitivity ranged from 22.6% –92.0% and specificity from 20.5% –97.9% . Median NPV ranged from 52.9% –96.5% and PPV ranged from 48.1% –75.7% .</p><h3><span></span>CONCLUSIONS:</h3><p>\u0000Our analysis finds that while these tests may provide some clinical utility, none of the assays have thus far demonstrated objective evidence to supplant the gold diagnostic standard.</p>","PeriodicalId":54217,"journal":{"name":"Bladder Cancer","volume":"18 1","pages":""},"PeriodicalIF":1.1,"publicationDate":"2024-02-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139769534","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Effect of Bacille Calmette-Guérin for Non–Muscle-Invasive Bladder Cancer After Prostate Radiotherapy 卡介苗治疗前列腺放疗后非肌层浸润性膀胱癌的效果
IF 1.1 4区 医学
Bladder Cancer Pub Date : 2024-01-22 DOI: 10.3233/blc-230073
Adri M. Durant, Yeonsoo S. Lee, Lanyu Mi, Kassem Faraj, Timothy D. Lyon, Parminder Singh, Mark D. Tyson II
{"title":"Effect of Bacille Calmette-Guérin for Non–Muscle-Invasive Bladder Cancer After Prostate Radiotherapy","authors":"Adri M. Durant, Yeonsoo S. Lee, Lanyu Mi, Kassem Faraj, Timothy D. Lyon, Parminder Singh, Mark D. Tyson II","doi":"10.3233/blc-230073","DOIUrl":"https://doi.org/10.3233/blc-230073","url":null,"abstract":"<h4><span>Abstract</span></h4><h3><span></span>BACKGROUND:</h3><p>Little is known about the impact of prior prostate radiation therapy (RT) on the Bacille Calmette-Guerin (BCG) immunotherapy response in patients with non-muscle invasive bladder cancer (NMIBC).</p><h3><span></span>OBJECTIVE:</h3><p>We hypothesized that the damaging radiation effects on the bladder could negatively influence BCG efficacy.</p><h3><span></span>METHODS:</h3><p>Men with a history of high-risk NMIBC were identified within the Surveillance, Epidemiology, and End Results–Medicare database. All patients completed adequate BCG defined as at least 5 plus 2 treatments completed within 12 months. Patients were stratified into 2 groups: with prior RT for prostate cancer and without prior RT before the diagnosis of NMIBC. The primary endpoint was a 5-year composite for progression defined as disease progression requiring systemic chemotherapy, checkpoint inhibitors, radical or partial cystectomy, or cancer-specific death.</p><h3><span></span>RESULTS:</h3><p>We identified 3,466 patients with NMIBC, including 145 with prior RT for prostate cancer. Five-year progression occurred in 471 patients (13.6%). Patients with prior RT were older than patients without prior RT (77.0 vs 75.0 years; <i>P</i> &lt; .001). The distribution of T stage was significantly different at diagnosis between the RT and non-RT groups (RT: Ta, 44.8% ; Tis, 18.6% ; T1, 36.6% ; without RT: Ta, 40.9% ; Tis, 10.8% ; T1, 48.3% ; <i>P</i> = .002). No difference in the risk of total progression was observed between patients with and without prior RT (<i>P</i> = .67). Similarly, no difference was observed after multivariable adjustment (hazard ratio, 0.99; 95% CI, 0.61-1.58; <i>P</i> = .95).</p><h3><span></span>CONCLUSION:</h3><p>For patients with NMIBC who undergo adequate BCG treatment, prior RT for prostate cancer was not associated with worse 5-year progression-free survival.</p>","PeriodicalId":54217,"journal":{"name":"Bladder Cancer","volume":"1 1","pages":""},"PeriodicalIF":1.1,"publicationDate":"2024-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139560846","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Potential of an mRNA-Based Urine Assay (Xpert ® Bladder Cancer Detection 1) in Hematuria Patients - Results from a Cohort Study 基于 mRNA 的尿液检测(Xpert ® 膀胱癌检测 1)在血尿患者中的应用潜力--一项队列研究的结果
IF 1.1 4区 医学
Bladder Cancer Pub Date : 2024-01-08 DOI: 10.3233/blc-230089
Claudia Schmitz-Dräger, Peter J. Goebell, Ellen Paxinos, Ekkehardt Bismarck, Jack Chen, Priya Balakrishnan, Michael Bates, Thomas Ebert, Bernd J. Schmitz-Dräger, Natalya Benderska-Söder
{"title":"Potential of an mRNA-Based Urine Assay (Xpert ® Bladder Cancer Detection 1) in Hematuria Patients - Results from a Cohort Study","authors":"Claudia Schmitz-Dräger, Peter J. Goebell, Ellen Paxinos, Ekkehardt Bismarck, Jack Chen, Priya Balakrishnan, Michael Bates, Thomas Ebert, Bernd J. Schmitz-Dräger, Natalya Benderska-Söder","doi":"10.3233/blc-230089","DOIUrl":"https://doi.org/10.3233/blc-230089","url":null,"abstract":"<h4><span>Abstract</span></h4><h3><span></span>BACKGROUND AND OBJECTIVE:</h3><p>Assessment of patients with hematuria (aH) remains a challenge in urological practice, balancing the benefits of diagnosing a potentially underlying bladder cancer (UCa) against the risks of possibly unnecessary diagnostic interventions. This study analyzes the potential of an mRNA-based urine assay, the Xpert<sup>®</sup> Bladder Cancer Detection- CE-IVD (Xpert BC-D), in patients with hematuria.</p><h3><span></span>MATERIALS AND METHODS:</h3><p>Overall, 368 patients with newly observed painless hematuria and no history of UCa were included in this observational study. Patients received urological workup, including urethrocystoscopy (WLC), upper tract imaging, urine cytology and Xpert BC-D. Patients with positive WLC were recommended to undergo tumor resection (TUR-B).</p><h3><span></span>RESULTS:</h3><p>After excluding non-assessable cases, 324 patients were considered for analysis (188 males, 136 females; median age: 61 years). Eight of twenty-eight patients with a positive TUR-B had Ta low grade (LG) tumors; the others were diagnosed with high grade (HG) lesions (Ta: 4, CIS: 2, T1:11, &gt; T1:3). The Xpert BC-D was more sensitive than urine cytology (96% vs. 61%) (<i>p</i> = 0.002). Increased risk ratios (RR) were observed for gross hematuria, gender, urine cytology, and positive Xpert BC-D (all <i>p</i> &lt; 0.05). Age and positive Xpert BC-D remained independent predictors of UCa in multivariate analysis. Simulating a triage with WLC restricted to patients with positive Xpert BC-D could have saved 240 (74.1%) assessments at the cost of missing one pTa LG tumor.</p><h3><span></span>CONCLUSIONS:</h3><p>The results suggest a potential role for Xpert BC-D in preselecting patients with hematuria for either further invasive diagnosis or an alternate diagnostic procedure.</p>","PeriodicalId":54217,"journal":{"name":"Bladder Cancer","volume":"17 1","pages":""},"PeriodicalIF":1.1,"publicationDate":"2024-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139408145","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Efficacy of Antibody Drug Conjugates Alone and in Combination with other Agents in Metastatic Urothelial Carcinoma: A Scoping Review 抗体药物共轭物单独或与其他药物联合治疗转移性尿路上皮癌的疗效:范围界定综述
IF 1.1 4区 医学
Bladder Cancer Pub Date : 2024-01-04 DOI: 10.3233/blc-230070
Michael J. Grant, Paul Stockhammer, Matthew R. Austin, Zsuzsanna Nemeth, Daniel P. Petrylak
{"title":"Efficacy of Antibody Drug Conjugates Alone and in Combination with other Agents in Metastatic Urothelial Carcinoma: A Scoping Review","authors":"Michael J. Grant, Paul Stockhammer, Matthew R. Austin, Zsuzsanna Nemeth, Daniel P. Petrylak","doi":"10.3233/blc-230070","DOIUrl":"https://doi.org/10.3233/blc-230070","url":null,"abstract":"<h4><span>Abstract</span></h4><h3><span></span>INTRODUCTION:</h3><p>\u0000Antibody drug conjugates represent a promising class of antineoplastic agents comprised of a monoclonal antibody linked to a potent cytotoxic payload for targeted delivery of chemotherapy to tumors. Various antibody drug conjugates have demonstrated impressive efficacy in patients with metastatic urothelial carcinoma in clinical trials, leading to two FDA approved therapies and several other agents and combinations in clinical development.</p><h3><span></span>MATERIALS AND METHODS:</h3><p>\u0000A comprehensive systematic review was undertaken utilizing the principles of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. Queried databases included Ovid MEDLINE, Ovid Embase, Web of Science Core Collection and Cochrane CENTRAL Trials. The search sought to identify prospective therapeutic clinical trials in humans with metastatic urothelial carcinoma with a single-arm or randomized controlled trial design investigating antibody drug conjugate-containing regimens.</p><h3><span></span>RESULTS:</h3><p>\u0000The literature search yielded 4,929 non-duplicated articles, of which 30 manuscripts and conference abstracts were included, which derived from 15 clinical trials including 19 separate cohorts with efficacy outcome results. Eleven trials investigated ADC monotherapy, while two investigated combination regimens, and the remaining two studies were mixed. Five unique ADC targets were represented including Nectin-4, Trop-2, HER2, Tissue Factor, and SLITRK6. Twelve clinical trial cohorts required prior treatment (63%). Objective response rate was reported for all studies and ranged from 27–52% for ADC monotherapies and 34–75% for ADC plus anti-PD-1 agents. Time to event outcome reporting was highly variable.</p><h3><span></span>CONCLUSION:</h3><p>\u0000In addition to enfortumab vedotin and sacituzumab govitecan, various HER2-targeted antibody drug conjugates and ADC-anti-PD-1 combination regimens have demonstrated efficacy in clinical trials and are poised for clinical advancement.</p>","PeriodicalId":54217,"journal":{"name":"Bladder Cancer","volume":"144 1","pages":""},"PeriodicalIF":1.1,"publicationDate":"2024-01-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139408138","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Patterns of Smoking Cessation Strategies and Perception of E-cigarette Harm Among Bladder Cancer Survivors. 膀胱癌幸存者的戒烟策略模式和对电子烟危害的认知。
IF 1 4区 医学
Bladder Cancer Pub Date : 2024-01-01 Epub Date: 2024-03-12 DOI: 10.3233/BLC-230093
Jobin Chandi, Srinath Soundararajan, William Bukowski, Wes Britt, Kristin Weiss, Richard S Matulewicz, Hannah Kay, Adam O Goldstein, Kimberly A Shoenbill, Marc A Bjurlin
{"title":"Patterns of Smoking Cessation Strategies and Perception of E-cigarette Harm Among Bladder Cancer Survivors.","authors":"Jobin Chandi, Srinath Soundararajan, William Bukowski, Wes Britt, Kristin Weiss, Richard S Matulewicz, Hannah Kay, Adam O Goldstein, Kimberly A Shoenbill, Marc A Bjurlin","doi":"10.3233/BLC-230093","DOIUrl":"10.3233/BLC-230093","url":null,"abstract":"<p><strong>Background: </strong>Cigarette smoking is the leading preventable cause of bladder cancer (BC). Some proponents of e-cigarettes describe their use as a risk mitigation strategy despite potential carcinogen exposure and uncertain long-term risks.</p><p><strong>Objective: </strong>We assessed smoking cessation strategies, including e-cigarette use, and harm perception among patients with BC.</p><p><strong>Methods: </strong>We performed a cross-sectional study on a convenience sample of patients with BC at a single institution from August 2021 - October 2022. The survey instrument was sourced from the Cancer Patient Tobacco Use Questionnaire (C-TUQ) from the American Association for Cancer Research with standardized questions on tobacco use, cessation questions, and e-cigarette harm perceptions.</p><p><strong>Results: </strong>Of the 104 surveyed BC patients (mean age: 72 years; 27% female; 55% with muscle-invasive disease), 20% were current smokers (median pack years: 40) and 51% were former smokers (median pack years: 20). A minority (9%) had quit smoking at the time of diagnosis. Pharmacotherapy for smoking cessation included nicotine patches (25%), gum (21%), lozenges (8%), e-cigarettes (8%), and Varenicline/Bupropion (4%). Notably, 43% of patients who continued to smoke expressed willingness to switch to e-cigarettes as a cessation aid. E-cigarette users (11%) more commonly perceived e-cigarettes as non-harmful compared to former (4%) and non-smokers (4%) (<i>P</i> = .048), though all groups regarded e-cigarettes as equally addictive as traditional cigarettes.</p><p><strong>Conclusions: </strong>Despite the prevalence of BC survivors who continue to smoke, a significant proportion perceive e-cigarettes as a viable and less harmful cessation aid. The infrequent use of FDA-approved pharmacotherapies underscores potential implementation gaps. These findings highlight the need for further research and targeted interventions in addressing smoking cessation among BC survivors.</p>","PeriodicalId":54217,"journal":{"name":"Bladder Cancer","volume":"10 1","pages":"61-69"},"PeriodicalIF":1.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11192552/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141443757","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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