{"title":"A New Standard of Care for Bladder Cancer","authors":"Edward M. Messing","doi":"10.3233/blc-239012","DOIUrl":"https://doi.org/10.3233/blc-239012","url":null,"abstract":"","PeriodicalId":54217,"journal":{"name":"Bladder Cancer","volume":null,"pages":null},"PeriodicalIF":1.1,"publicationDate":"2023-12-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138589611","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}
Elizabeth Y. Wang, Manuel Armas-Phan, Maxwell V. Meng, Stacy Loeb, Stacey A. Kenfield, Sima P. Porten
Abstract
BACKGROUND:
Few studies have specifically examined sleep health in patients with non-muscle invasive bladder cancer (NMIBC). Further study is warranted to inform future strategies in patients with NMIBC.
OBJECTIVE:
We aim to describe sleep health in a cohort of patients with NMIBC, and its relationship with quality of life (QOL).
METHODS:
We conducted an observational cross-sectional study in patients undergoing surveillance for NMIBC. The validated Pittsburgh Sleep Quality Index (PSQI) was used to assess sleep health (scores from 0-21) in the overall study population as well as stratified. We assessed QOL among participants with and without poor sleep quality using the SF-12 and QLQ-NMIBC-24.
RESULTS:
In a cohort of 94 NMIBC patients, median age was 67 years (IQR: 58, 72) and median time since initial diagnosis was 27 months (IQR: 9, 41). The mean PSQI score was 6.3 (SD: 3.8) and 64% percent of participants met or exceeded the PSQI cut-off score of 5, with a score of 5 or more indicating overall poor sleep quality. In those with poor sleep quality, there were statistically significant detriments in multiple QOL domains.
CONCLUSIONS:
In patients undergoing surveillance for NMIBC, there is a substantial burden of sleep disturbances and resulting decrements in QOL. These data support the need for future interventions to support sleep quality and highlight the importance of addressing sleep health as part of NMIBC survivorship care to improve QOL in patients with NMIBC.
{"title":"Wake-Up Call to Address Sleep Health in Non-Muscle Invasive Bladder Cancer: Underappreciated Contributor to Poor Quality of Life","authors":"Elizabeth Y. Wang, Manuel Armas-Phan, Maxwell V. Meng, Stacy Loeb, Stacey A. Kenfield, Sima P. Porten","doi":"10.3233/blc-230061","DOIUrl":"https://doi.org/10.3233/blc-230061","url":null,"abstract":"<h4><span>Abstract</span></h4><h3><span></span>BACKGROUND:</h3><p>Few studies have specifically examined sleep health in patients with non-muscle invasive bladder cancer (NMIBC). Further study is warranted to inform future strategies in patients with NMIBC.</p><h3><span></span>OBJECTIVE:</h3><p>We aim to describe sleep health in a cohort of patients with NMIBC, and its relationship with quality of life (QOL).</p><h3><span></span>METHODS:</h3><p>We conducted an observational cross-sectional study in patients undergoing surveillance for NMIBC. The validated Pittsburgh Sleep Quality Index (PSQI) was used to assess sleep health (scores from 0-21) in the overall study population as well as stratified. We assessed QOL among participants with and without poor sleep quality using the SF-12 and QLQ-NMIBC-24.</p><h3><span></span>RESULTS:</h3><p>In a cohort of 94 NMIBC patients, median age was 67 years (IQR: 58, 72) and median time since initial diagnosis was 27 months (IQR: 9, 41). The mean PSQI score was 6.3 (SD: 3.8) and 64% percent of participants met or exceeded the PSQI cut-off score of 5, with a score of 5 or more indicating overall poor sleep quality. In those with poor sleep quality, there were statistically significant detriments in multiple QOL domains.</p><h3><span></span>CONCLUSIONS:</h3><p>In patients undergoing surveillance for NMIBC, there is a substantial burden of sleep disturbances and resulting decrements in QOL. These data support the need for future interventions to support sleep quality and highlight the importance of addressing sleep health as part of NMIBC survivorship care to improve QOL in patients with NMIBC.</p>","PeriodicalId":54217,"journal":{"name":"Bladder Cancer","volume":null,"pages":null},"PeriodicalIF":1.1,"publicationDate":"2023-12-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138562520","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}
Isabella R. Pompa, David Qi, Anushka Ghosh, Saveli I. Goldberg, Fumiko Chino, Jason A. Efstathiou, Sophia C. Kamran
Abstract
BACKGROUND:
Bladder cancer is the tenth leading cause of cancer death in the United States (US). Advances in diagnosis, imaging, and treatments have led to improvements in bladder cancer management.
OBJECTIVE:
To evaluate longitudinal bladder cancer mortality trends from 1999–2020 in the US by gender, race, ethnicity, age, geographic region, and urbanization category.
METHODS:
Age-adjusted bladder cancer death and incidence rates of individuals in the US of all ages between 1999–2020 were obtained using the CDC WONDER and NAACCR databases. Trends and average annual percent changes (AAPC) in age-adjusted Bladder Cancer-Specific Mortality (BCSM) and incidence rates were estimated. Data were analyzed from May 2023 to October 2023.
RESULTS:
From 1999–2020, overall BCSM decreased by 0.4% annually, with a dramatic decrease in deaths between 2015–2020 (AAPC: –2.0% [95% CI: –2.6,–1.3]). However, BCSM rates and metastatic malignant bladder cancer incidence rates from 1999–2020 increased for individuals≥85 years old (AAPC for BCSM: 0.8% [95% CI:0.5,1.1]; AAPC for metastatic malignant incidence: 2.5% [95% CI: 2.0,2.9]). Increases in BCSM were found for certain years in the South, in rural areas, and for Non-Hispanic White and Asian or Pacific Islander individuals.
CONCLUSIONS:
Overall mortality from bladder cancer has been decreasing in the US over two decades. Upon disaggregation, increasing trends were found for BCSM and for metastatic malignant bladder cancer incidence for individuals≥85 years old from 1999–2020. Further evaluation of these trends is essential to understand how to target specific populations to improve patient outcomes.
{"title":"Longitudinal Analysis of Bladder Cancer-Specific Mortality Trends in the United States","authors":"Isabella R. Pompa, David Qi, Anushka Ghosh, Saveli I. Goldberg, Fumiko Chino, Jason A. Efstathiou, Sophia C. Kamran","doi":"10.3233/blc-230062","DOIUrl":"https://doi.org/10.3233/blc-230062","url":null,"abstract":"<h4><span>Abstract</span></h4><h3><span></span>BACKGROUND:</h3><p>Bladder cancer is the tenth leading cause of cancer death in the United States (US). Advances in diagnosis, imaging, and treatments have led to improvements in bladder cancer management.</p><h3><span></span>OBJECTIVE:</h3><p>To evaluate longitudinal bladder cancer mortality trends from 1999–2020 in the US by gender, race, ethnicity, age, geographic region, and urbanization category.</p><h3><span></span>METHODS:</h3><p>Age-adjusted bladder cancer death and incidence rates of individuals in the US of all ages between 1999–2020 were obtained using the CDC WONDER and NAACCR databases. Trends and average annual percent changes (AAPC) in age-adjusted Bladder Cancer-Specific Mortality (BCSM) and incidence rates were estimated. Data were analyzed from May 2023 to October 2023.</p><h3><span></span>RESULTS:</h3><p>From 1999–2020, overall BCSM decreased by 0.4% annually, with a dramatic decrease in deaths between 2015–2020 (AAPC: –2.0% [95% CI: –2.6,–1.3]). However, BCSM rates and metastatic malignant bladder cancer incidence rates from 1999–2020 increased for individuals≥85 years old (AAPC for BCSM: 0.8% [95% CI:0.5,1.1]; AAPC for metastatic malignant incidence: 2.5% [95% CI: 2.0,2.9]). Increases in BCSM were found for certain years in the South, in rural areas, and for Non-Hispanic White and Asian or Pacific Islander individuals.</p><h3><span></span>CONCLUSIONS:</h3><p>Overall mortality from bladder cancer has been decreasing in the US over two decades. Upon disaggregation, increasing trends were found for BCSM and for metastatic malignant bladder cancer incidence for individuals≥85 years old from 1999–2020. Further evaluation of these trends is essential to understand how to target specific populations to improve patient outcomes.</p>","PeriodicalId":54217,"journal":{"name":"Bladder Cancer","volume":null,"pages":null},"PeriodicalIF":1.1,"publicationDate":"2023-12-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138562739","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}
Priya Dave, Rutul D. Patel, Kush Desai, Jonathan Davila, Alex Sankin
Abstract
BACKGROUND:
A lack of standardization is pervasive in procedural application and reporting templates for TURBT with the use of a surgical checklist proposed as a means for quality improvement.
OBJECTIVE:
To introduce a TURBT checklist to assess surgeon prediction accuracy and the impact of standardized documentation on quality of resection and oncologic outcomes
METHODS:
Nine critical elements of a high-quality TURBT identified by literature review were incorporated into a prospectively implemented checklist for operative reports. The checklist included both visualized and predicted tumor characteristics. A retrospective single-institution analysis compared quality of dictation pre- and post-checklist implementation. Surgeon predictions were compared to final pathology reports to determine rates of concordance. Kaplan-Meier curves examined the association of checklist use with recurrence free survival (RFS).
RESULTS:
333 operative reports were included in this analysis, of which 107 (32.1%) were completed pre-checklist implementation. The average number of critical elements reported was 8.69 with checklist use compared to 4.99 without (p < 0.001). There was no significant difference in RFS between the pre- and post-checklist cohorts (log-rank test p = 0.53). Surgeons were least and most accurate in predicting low grade tumor (43.5%) and absence of muscle invasion (96.6%), respectively.
CONCLUSIONS:
Incorporation of a TURBT surgical checklist improves operative dictation and quality of reporting but did not directly impact RFS. With quality of initial resection a proven correlate to recurrence rates, checklist implementation to improve surgical performance and long-term oncologic outcomes reveals an interesting area of exploration highlighting the need for more standardized methodology when performing these procedures.
{"title":"A Procedural Checklist for Transurethral Resection of Bladder Tumors (TURBT) Enhances Operative Dictation and Assesses Surgeon Accuracy of Tumor Characteristic Predictions","authors":"Priya Dave, Rutul D. Patel, Kush Desai, Jonathan Davila, Alex Sankin","doi":"10.3233/blc-230074","DOIUrl":"https://doi.org/10.3233/blc-230074","url":null,"abstract":"<h4><span>Abstract</span></h4><h3><span></span>BACKGROUND:</h3><p>A lack of standardization is pervasive in procedural application and reporting templates for TURBT with the use of a surgical checklist proposed as a means for quality improvement.</p><h3><span></span>OBJECTIVE:</h3><p>To introduce a TURBT checklist to assess surgeon prediction accuracy and the impact of standardized documentation on quality of resection and oncologic outcomes</p><h3><span></span>METHODS:</h3><p>Nine critical elements of a high-quality TURBT identified by literature review were incorporated into a prospectively implemented checklist for operative reports. The checklist included both visualized and predicted tumor characteristics. A retrospective single-institution analysis compared quality of dictation pre- and post-checklist implementation. Surgeon predictions were compared to final pathology reports to determine rates of concordance. Kaplan-Meier curves examined the association of checklist use with recurrence free survival (RFS).</p><h3><span></span>RESULTS:</h3><p>333 operative reports were included in this analysis, of which 107 (32.1%) were completed pre-checklist implementation. The average number of critical elements reported was 8.69 with checklist use compared to 4.99 without (<i>p</i> < 0.001). There was no significant difference in RFS between the pre- and post-checklist cohorts (log-rank test <i>p</i> = 0.53). Surgeons were least and most accurate in predicting low grade tumor (43.5%) and absence of muscle invasion (96.6%), respectively.</p><h3><span></span>CONCLUSIONS:</h3><p>Incorporation of a TURBT surgical checklist improves operative dictation and quality of reporting but did not directly impact RFS. With quality of initial resection a proven correlate to recurrence rates, checklist implementation to improve surgical performance and long-term oncologic outcomes reveals an interesting area of exploration highlighting the need for more standardized methodology when performing these procedures.</p>","PeriodicalId":54217,"journal":{"name":"Bladder Cancer","volume":null,"pages":null},"PeriodicalIF":1.1,"publicationDate":"2023-11-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138531804","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}
Valentina Grajales, Roberto Contieri, Wei Shen Tan, Marta Flores, Marcela Schultz, Rodrigo Pinochet, Alberto Bustamante, Ashish M. Kamat, Mario I. Fernández
Abstract
BACKGROUND:
Adjuvant bacillus Calmette-Guérin (BCG) is recommended for high-risk (HR) non-muscle invasive bladder cancer (NMIBC), but BCG shortages have led to exploration of reduced-dose regimens and shortened maintenance durations out of necessity, with limited data on treatment efficacy in Latin America.
OBJECTIVE:
Oncological outcomes of HR-NMIBC patients treated with reduced (RD,1/4th dose) vs full dose (FD) BCG instillations of Danish Strain 1331 BCG.
METHODS:
We performed a retrospective study of HR-NMIBC patients treated with BCG between 2003 and 2022 at our center in Santiago Chile. We stratified patients according to either RD (1/4th dose) or FD BCG. Univariate and multivariable Cox regression models were used to predict recurrence. Kaplan-Meier method was used to calculate survival estimates.
RESULTS:
Of a total of 200 patients, 116 (58%) had RD and 84 (42%) FD BCG. Median follow-up was 57 months (IQR: 29–100). Patients who received FD BCG had a lower risk of recurrence (HR: 0.41, 95% CI 0.22–0.74) and high-grade (HG)-recurrence (HR: 0.30, 95% CI 0.15–0.61; p = 0.001). More patients in the RD vs FD group progressed to MIBC (10/84 vs 2/116; p = 0.18). Additionally, patients were less likely to stop BCG treatment in the RD group compared to the FD group due to toxicity (5% vs 11%, p = 0.14).
CONCLUSIONS:
A 1/4th dose of Danish Strain 1331 BCG treatment was associated with worse recurrence free rate and HG-recurrence rate in our cohort. Patients with RD had lower discontinuation treatment rates due to a reduced toxicity profile. These findings would suggest that RD BCG would compromise oncological outcomes in HR-NMIBC patients.
背景:佐剂卡介苗(BCG)被推荐用于高风险(HR)非肌肉浸润性膀胱癌(NMIBC),但由于卡介苗的短缺,不得不探索减少剂量的方案和缩短维持时间,在拉丁美洲的治疗效果数据有限。目的:减少(RD,1/4剂量)与全剂量(FD)灌注丹麦株1331卡介苗治疗HR-NMIBC患者的肿瘤预后。方法:我们在智利圣地亚哥的中心对2003年至2022年间接受卡介苗治疗的HR-NMIBC患者进行了回顾性研究。我们根据RD(1/4剂量)或FD BCG对患者进行分层。单变量和多变量Cox回归模型用于预测复发率。采用Kaplan-Meier法计算生存估计。结果:在总共200例患者中,116例(58%)患有RD, 84例(42%)患有FD BCG。中位随访57个月(IQR: 29-100)。接受FD卡介苗的患者有较低的复发风险(HR: 0.41, 95% CI 0.22-0.74)和高级别(HG)复发风险(HR: 0.30, 95% CI 0.15-0.61;p = 0.001)。RD组与FD组中更多的患者进展为MIBC (10/84 vs 2/116;p = 0.18)。此外,与FD组相比,RD组患者由于毒性而停止BCG治疗的可能性更小(5% vs 11%, p = 0.14)。结论:在我们的队列中,1/4剂量的丹麦1331株卡介苗治疗与较差的无复发率和hg复发率相关。由于毒性降低,RD患者的停药率较低。这些发现表明RD卡介苗会损害HR-NMIBC患者的肿瘤预后。
{"title":"Comparative Analysis of Very Reduced vs Full Dose BCG Treatment for High-Risk Non-Muscle Invasive Bladder Cancer: A Contemporary Experience from Chile","authors":"Valentina Grajales, Roberto Contieri, Wei Shen Tan, Marta Flores, Marcela Schultz, Rodrigo Pinochet, Alberto Bustamante, Ashish M. Kamat, Mario I. Fernández","doi":"10.3233/blc-230047","DOIUrl":"https://doi.org/10.3233/blc-230047","url":null,"abstract":"<h4><span>Abstract</span></h4><h3><span></span>BACKGROUND:</h3><p>Adjuvant bacillus Calmette-Guérin (BCG) is recommended for high-risk (HR) non-muscle invasive bladder cancer (NMIBC), but BCG shortages have led to exploration of reduced-dose regimens and shortened maintenance durations out of necessity, with limited data on treatment efficacy in Latin America.</p><h3><span></span>OBJECTIVE:</h3><p>Oncological outcomes of HR-NMIBC patients treated with reduced (RD,1/4th dose) vs full dose (FD) BCG instillations of <i>Danish Strain</i> 1331 BCG.</p><h3><span></span>METHODS:</h3><p>We performed a retrospective study of HR-NMIBC patients treated with BCG between 2003 and 2022 at our center in Santiago Chile. We stratified patients according to either RD (1/4th dose) or FD BCG. Univariate and multivariable Cox regression models were used to predict recurrence. Kaplan-Meier method was used to calculate survival estimates.</p><h3><span></span>RESULTS:</h3><p>Of a total of 200 patients, 116 (58%) had RD and 84 (42%) FD BCG. Median follow-up was 57 months (IQR: 29–100). Patients who received FD BCG had a lower risk of recurrence (HR: 0.41, 95% CI 0.22–0.74) and high-grade (HG)-recurrence (HR: 0.30, 95% CI 0.15–0.61; <i>p</i> = 0.001). More patients in the RD vs FD group progressed to MIBC (10/84 vs 2/116; <i>p</i> = 0.18). Additionally, patients were less likely to stop BCG treatment in the RD group compared to the FD group due to toxicity (5% vs 11%, <i>p</i> = 0.14).</p><h3><span></span>CONCLUSIONS:</h3><p>A 1/4th dose of <i>Danish Strain</i> 1331 BCG treatment was associated with worse recurrence free rate and HG-recurrence rate in our cohort. Patients with RD had lower discontinuation treatment rates due to a reduced toxicity profile. These findings would suggest that RD BCG would compromise oncological outcomes in HR-NMIBC patients.</p>","PeriodicalId":54217,"journal":{"name":"Bladder Cancer","volume":null,"pages":null},"PeriodicalIF":1.1,"publicationDate":"2023-11-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138508171","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}
Rana M. Abdeltwab, Elaria Yacoub, Ahmed H. Rashad, Kyrillus S. Shohdy
Abstract
BACKGROUND:
Advanced urothelial carcinoma (UC) is an aggressive disease whose mutagenic processes are yet to be elucidated. Targeted therapies are urgently needed, but the road from bench to bedside is slowly progressing. In this review, we discuss urothelial carcinoma etiology, along with the most recent advances in UC candidate targeted therapies.
METHODOLOGY:
A comprehensive database search was performed. We aimed to review the most recent updates on UC genomics and targeted therapies. Pre-clinical as well as clinical studies were included.
RESULTS:
Our review highlights the advances in understanding the molecular basis of urothelial tumorigenesis, including smoking, chemical parasitic carcinogens, inheritance, and APOBEC3 editing enzymes. We discussed how these factors contributed to the current mutational landscape of UC. Therapeutic options for UC are still very limited. However, several promising therapeutic approaches are in development to leverage our knowledge of molecular targets, such as targeting fibroblast growth factor receptors (FGFR), DNA damage repair pathways, and HER2.
CONCLUSIONS:
Blindly testing targeted therapies based on other cancer data is not sufficient. UC-specific biomarkers are needed to precisely use the appropriate drug for the appropriate population. More efforts to understand UC biology and evolution are urgently needed.
{"title":"Molecular Basis of Tumorigenesis of Bladder Cancer and Emerging Concepts in Developing Therapeutic Targets","authors":"Rana M. Abdeltwab, Elaria Yacoub, Ahmed H. Rashad, Kyrillus S. Shohdy","doi":"10.3233/blc-230025","DOIUrl":"https://doi.org/10.3233/blc-230025","url":null,"abstract":"<h4><span>Abstract</span></h4><h3><span></span>BACKGROUND:</h3><p>Advanced urothelial carcinoma (UC) is an aggressive disease whose mutagenic processes are yet to be elucidated. Targeted therapies are urgently needed, but the road from bench to bedside is slowly progressing. In this review, we discuss urothelial carcinoma etiology, along with the most recent advances in UC candidate targeted therapies.</p><h3><span></span>METHODOLOGY:</h3><p>A comprehensive database search was performed. We aimed to review the most recent updates on UC genomics and targeted therapies. Pre-clinical as well as clinical studies were included.</p><h3><span></span>RESULTS:</h3><p>Our review highlights the advances in understanding the molecular basis of urothelial tumorigenesis, including smoking, chemical parasitic carcinogens, inheritance, and APOBEC3 editing enzymes. We discussed how these factors contributed to the current mutational landscape of UC. Therapeutic options for UC are still very limited. However, several promising therapeutic approaches are in development to leverage our knowledge of molecular targets, such as targeting fibroblast growth factor receptors (FGFR), DNA damage repair pathways, and HER2.</p><h3><span></span>CONCLUSIONS:</h3><p>Blindly testing targeted therapies based on other cancer data is not sufficient. UC-specific biomarkers are needed to precisely use the appropriate drug for the appropriate population. More efforts to understand UC biology and evolution are urgently needed.</p>","PeriodicalId":54217,"journal":{"name":"Bladder Cancer","volume":null,"pages":null},"PeriodicalIF":1.1,"publicationDate":"2023-11-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138531798","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}
François Radvanyi, Francisco X. Real, David McConkey
Abstract
In an accompanying paper, Mattias Hoglund discusses on what is a bladder cancer molecular subtype. He emphasizes the need to consider the aim of tumor classification, which is obviously critical to the approach. He also focuses on considering primarily the identity features of the neoplastic cells. Here, we provide a counterpoint. While largely agreeing with his views, we underline that other parameters that may vary in a spatial or temporal scale, and the tumor microenvironment, can also provide relevant information to render tumor classifications clinically useful. Furthermore, tumor heterogeneity and evolution during the disease course - natural or under therapeutic pressure - should be considered.
{"title":"What is a Bladder Cancer Molecular Subtype? – Counterpoint","authors":"François Radvanyi, Francisco X. Real, David McConkey","doi":"10.3233/blc-230059","DOIUrl":"https://doi.org/10.3233/blc-230059","url":null,"abstract":"<h4><span>Abstract</span></h4><p>In an accompanying paper, Mattias Hoglund discusses on what is a bladder cancer molecular subtype. He emphasizes the need to consider the aim of tumor classification, which is obviously critical to the approach. He also focuses on considering primarily the identity features of the neoplastic cells. Here, we provide a counterpoint. While largely agreeing with his views, we underline that other parameters that may vary in a spatial or temporal scale, and the tumor microenvironment, can also provide relevant information to render tumor classifications clinically useful. Furthermore, tumor heterogeneity and evolution during the disease course - natural or under therapeutic pressure - should be considered.</p>","PeriodicalId":54217,"journal":{"name":"Bladder Cancer","volume":null,"pages":null},"PeriodicalIF":1.1,"publicationDate":"2023-11-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138508186","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}
Yair Lotan, Daniel A. Barocas, Sam S. Chang, Siamak Daneshmand, Badrinath Konety, Joshua J. Meeks, Sima Porten, Jay D. Raman, Charles J. Rosser, Kristen R. Scarpato, Wade J. Sexton, John P. Sfakianos, Neal D. Shore, Robert S. Svatek
The role of biomarkers (aka, markers) in detecting and managing cancer is an evolving field. It is crucial to develop biomarkers robustly that mirror drug development in the pharmaceutical
{"title":"Commentary on Novitas LCD","authors":"Yair Lotan, Daniel A. Barocas, Sam S. Chang, Siamak Daneshmand, Badrinath Konety, Joshua J. Meeks, Sima Porten, Jay D. Raman, Charles J. Rosser, Kristen R. Scarpato, Wade J. Sexton, John P. Sfakianos, Neal D. Shore, Robert S. Svatek","doi":"10.3233/blc-230057","DOIUrl":"https://doi.org/10.3233/blc-230057","url":null,"abstract":"The role of biomarkers (aka, markers) in detecting and managing cancer is an evolving field. It is crucial to develop biomarkers robustly that mirror drug development in the pharmaceutical","PeriodicalId":54217,"journal":{"name":"Bladder Cancer","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-09-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135424913","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}
Elaine Chang, Noah M. Hahn, Seth P. Lerner, Jaleh Fallah, Sundeep Agrawal, Ashish M. Kamat, Vishal Bhatnagar, Robert S. Svatek, Adnan A. Jaigirdar, Peter Bross, Neal Shore, Max Kates, Karen Sachse, Jamie R. Brewer, Michael A. O’Donnell, Gary D. Steinberg, Charles J. Viviano, Erik Bloomquist, Maria J. Ribal, Matthew D. Galsky, Richard Oliver, Peter C. Black, Hikmat Al-Ahmadie, Kenneth Brothers, Kamal Pohar, Colin P. Dinney, Zhou Feng, Tracy M. Downs, Sima P. Porten, Angela B. Smith, Rick Bangs, Sarah P. Psutka, Neeraj Agarwal, Laleh Amiri-Kordestani, Daniel L. Suzman, Richard Pazdur, Paul G. Kluetz, Chana Weinstock
BACKGROUND: Despite recent drug development for non-muscle invasive bladder cancer (NMIBC), few therapies have been approved by the US Food and Drug Administration (FDA), and there remains an unmet clinical need. Bacillus Calmette-Guerin (BCG) supply issues underscore the importance of developing safe and effective drugs for NMIBC. OBJECTIVE: On November 18–19, 2021, the FDA held a public virtual workshop to discuss NMIBC research needs and potential trial designs for future development of effective therapies. METHODS: Representatives from various disciplines including urologists, oncologists, pathologists, statisticians, basic and translational scientists, and the patient advocacy community participated. The workshop format included invited lectures, panel discussions, and opportunity for audience discussion and comment. RESULTS: In a pre-workshop survey, 92% of urologists surveyed considered the development of alternatives to BCG as a high drug development priority for BCG-naïve high-risk patients. Key topics discussed included definitions of disease states; trial design for BCG-naïve NMIBC, BCG-unresponsive carcinoma in situ, and BCG-unresponsive papillary carcinoma; strengths and limitations of single-arm trial designs; assessing patient-reported outcomes; and considerations for assessing avoidance of cystectomy as an efficacy measure. CONCLUSIONS: The workshop discussed several important opportunities for trial design refinement in NMIBC. FDA encourages sponsors to meet with the appropriate review division to discuss trial design proposals for NMIBC early in drug development.
{"title":"Advancing Clinical Trial Design for Non-Muscle Invasive Bladder Cancer","authors":"Elaine Chang, Noah M. Hahn, Seth P. Lerner, Jaleh Fallah, Sundeep Agrawal, Ashish M. Kamat, Vishal Bhatnagar, Robert S. Svatek, Adnan A. Jaigirdar, Peter Bross, Neal Shore, Max Kates, Karen Sachse, Jamie R. Brewer, Michael A. O’Donnell, Gary D. Steinberg, Charles J. Viviano, Erik Bloomquist, Maria J. Ribal, Matthew D. Galsky, Richard Oliver, Peter C. Black, Hikmat Al-Ahmadie, Kenneth Brothers, Kamal Pohar, Colin P. Dinney, Zhou Feng, Tracy M. Downs, Sima P. Porten, Angela B. Smith, Rick Bangs, Sarah P. Psutka, Neeraj Agarwal, Laleh Amiri-Kordestani, Daniel L. Suzman, Richard Pazdur, Paul G. Kluetz, Chana Weinstock","doi":"10.3233/blc-230056","DOIUrl":"https://doi.org/10.3233/blc-230056","url":null,"abstract":"BACKGROUND: Despite recent drug development for non-muscle invasive bladder cancer (NMIBC), few therapies have been approved by the US Food and Drug Administration (FDA), and there remains an unmet clinical need. Bacillus Calmette-Guerin (BCG) supply issues underscore the importance of developing safe and effective drugs for NMIBC. OBJECTIVE: On November 18–19, 2021, the FDA held a public virtual workshop to discuss NMIBC research needs and potential trial designs for future development of effective therapies. METHODS: Representatives from various disciplines including urologists, oncologists, pathologists, statisticians, basic and translational scientists, and the patient advocacy community participated. The workshop format included invited lectures, panel discussions, and opportunity for audience discussion and comment. RESULTS: In a pre-workshop survey, 92% of urologists surveyed considered the development of alternatives to BCG as a high drug development priority for BCG-naïve high-risk patients. Key topics discussed included definitions of disease states; trial design for BCG-naïve NMIBC, BCG-unresponsive carcinoma in situ, and BCG-unresponsive papillary carcinoma; strengths and limitations of single-arm trial designs; assessing patient-reported outcomes; and considerations for assessing avoidance of cystectomy as an efficacy measure. CONCLUSIONS: The workshop discussed several important opportunities for trial design refinement in NMIBC. FDA encourages sponsors to meet with the appropriate review division to discuss trial design proposals for NMIBC early in drug development.","PeriodicalId":54217,"journal":{"name":"Bladder Cancer","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135769451","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}
Zhao Hongda, Liu Kang, Chi-Fai Ng, Jean de la Rosette, Pilar Laguna, Paolo Gontero, Joyce Baard, Ozcan Yildiz, Jeremy Yuen-Chun Teoh
BACKGROUND: The evidence regarding perioperative adjuvant chemotherapy and personalized surveillance strategies for upper tract urothelial carcinoma is limited. OBJECTIVE: To evaluate whether adjuvant gemcitabine containing chemotherapy affects the oncological outcomes of advanced upper tract urothelial carcinoma (UTUC). METHODS: The CROES-UTUC registry is an observational, international, multi-center study on patients diagnosed with UTUC. Patient and disease characteristics from 2380 patients with UTUC were collected, and finally 738 patients were included in this analysis. The primary outcome of this study was recurrence-free survival. Propensity score matching was performed. Kaplan-Meier and multivariate Cox regression analyses were performed by stratifying patients according to the treatment of adjuvant chemotherapy. RESULTS: A total of 738 patients were included in this analysis, and 59 patients received adjuvant chemotherapy (AC), including 50 patients who received gemcitabine. A propensity score matching was performed, including 50 patients who received gemcitabine containing treatment and 50 patients without adjuvant chemotherapy. Disease recurrence occurred in 34.0% of patients. The recurrence rate in the AC group was 22.0%, which was significantly lower than the non-AC group (46.0%). Kaplan-Meier analyses also showed that AC was associated with a lower likelihood of tumor recurrence (p = 0.047). However, AC was not significantly associated with a higher overall survival (OS) (p = 0.908) and cancer-specific survival (CSS) (p = 0.979). Upon multivariate Cox regression analysis, AC was associated with a lower risk of tumor recurrence (HR = 0.297, p = 0.028). CONCLUSION: The present study confirms that adjuvant gemcitabine containing chemotherapy could decrease the risk of tumor recurrence in patients with locally advanced UTUC following nephroureterectomy. However, more studies are need to draw a clearer image of the value of this treatment method.
{"title":"Impact of Adjuvant Gemcitabine Containing Chemotherapy Following Radical Nephroureterectomy for Patients with Upper Tract Urothelial Carcinoma: Results from a Propensity-Score Matched Cohort Study","authors":"Zhao Hongda, Liu Kang, Chi-Fai Ng, Jean de la Rosette, Pilar Laguna, Paolo Gontero, Joyce Baard, Ozcan Yildiz, Jeremy Yuen-Chun Teoh","doi":"10.3233/blc-230041","DOIUrl":"https://doi.org/10.3233/blc-230041","url":null,"abstract":"BACKGROUND: The evidence regarding perioperative adjuvant chemotherapy and personalized surveillance strategies for upper tract urothelial carcinoma is limited. OBJECTIVE: To evaluate whether adjuvant gemcitabine containing chemotherapy affects the oncological outcomes of advanced upper tract urothelial carcinoma (UTUC). METHODS: The CROES-UTUC registry is an observational, international, multi-center study on patients diagnosed with UTUC. Patient and disease characteristics from 2380 patients with UTUC were collected, and finally 738 patients were included in this analysis. The primary outcome of this study was recurrence-free survival. Propensity score matching was performed. Kaplan-Meier and multivariate Cox regression analyses were performed by stratifying patients according to the treatment of adjuvant chemotherapy. RESULTS: A total of 738 patients were included in this analysis, and 59 patients received adjuvant chemotherapy (AC), including 50 patients who received gemcitabine. A propensity score matching was performed, including 50 patients who received gemcitabine containing treatment and 50 patients without adjuvant chemotherapy. Disease recurrence occurred in 34.0% of patients. The recurrence rate in the AC group was 22.0%, which was significantly lower than the non-AC group (46.0%). Kaplan-Meier analyses also showed that AC was associated with a lower likelihood of tumor recurrence (p = 0.047). However, AC was not significantly associated with a higher overall survival (OS) (p = 0.908) and cancer-specific survival (CSS) (p = 0.979). Upon multivariate Cox regression analysis, AC was associated with a lower risk of tumor recurrence (HR = 0.297, p = 0.028). CONCLUSION: The present study confirms that adjuvant gemcitabine containing chemotherapy could decrease the risk of tumor recurrence in patients with locally advanced UTUC following nephroureterectomy. However, more studies are need to draw a clearer image of the value of this treatment method.","PeriodicalId":54217,"journal":{"name":"Bladder Cancer","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135769129","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}