Casey Liveringhouse , Austin J. Sim , Jingsong Zhang , Rohit K. Jain , Shreyas U. Naidu , Lauren Linkowski , Logan W. Zemp , Alice Yu , Wade J. Sexton , Philippe E. Spiess , Scott M. Gilbert , Michael A. Poch , Julio Pow-Sang , Roger Li , Brandon J. Manley , Aram Vosoughi , Jasreman Dhillon , Hongzhi Xu , Javier F. Torres-Roca , Peter A.S. Johnstone , G. Daniel Grass
{"title":"A Single Institution Experience in the Management of Localized Neuroendocrine Carcinoma of the Bladder","authors":"Casey Liveringhouse , Austin J. Sim , Jingsong Zhang , Rohit K. Jain , Shreyas U. Naidu , Lauren Linkowski , Logan W. Zemp , Alice Yu , Wade J. Sexton , Philippe E. Spiess , Scott M. Gilbert , Michael A. Poch , Julio Pow-Sang , Roger Li , Brandon J. Manley , Aram Vosoughi , Jasreman Dhillon , Hongzhi Xu , Javier F. Torres-Roca , Peter A.S. Johnstone , G. Daniel Grass","doi":"10.1016/j.clgc.2024.102222","DOIUrl":"10.1016/j.clgc.2024.102222","url":null,"abstract":"<div><h3>Background</h3><div>Neuroendocrine carcinoma of the bladder (NEC-bladder) is a rare disease with poor outcomes and variable treatment approaches.</div></div><div><h3>Materials and Methods</h3><div>Patients with localized NEC-bladder treated with surgery or radiation between 2001-2021 were retrospectively identified. Rates of pathologic complete response (pCR) and downstaging were evaluated following NAC in surgically-treated patients. Progression-free survival (PFS) and overall survival (OS) were analyzed with univariable (log-rank) and multivariable (MVA; Cox regression) methods.</div></div><div><h3>Results</h3><div>Sixty-five patients were identified having a median age of 73. The tumor histology distribution was small cell (64.6%) or urothelial with NE differentiation (35.4%). Most patients (69.2%) received NAC. Patients received local therapy by surgery (78.5%) or chemoradiation (21.5%). The majority (62.7%) of surgical patients had ≥ pT2 with 37.3% having nodal involvement (pN+). The pCR and downstaging rates were 21.6% and 35.1%, respectively. At a median follow-up of 60 months (m), the median PFS and OS were 16.4m and 25.9m, respectively. NAC improved PFS (p=0.04) and downstaging improved PFS (p=0.012) and OS (p<0.001). Patients receiving NAC with ypN0 vs. ypN+ had median OS of 69.9m vs 15.3m, respectively (p<0.001). MVA identified receipt of NAC and pN as predictors of PFS; pN was predictive of OS. No differences in PFS or OS were seen between histology of primary tumor. The brain metastasis rate was 10.8% with all patients having small cell histology.</div></div><div><h3>Conclusions</h3><div>Optimized therapy in NEC-bladder includes NAC followed by local consolidation. Ascertainment of ypN0 is associated with long term survival, while pN+ remains associated with poor outcomes.</div></div>","PeriodicalId":10380,"journal":{"name":"Clinical genitourinary cancer","volume":"22 6","pages":"Article 102222"},"PeriodicalIF":2.3,"publicationDate":"2024-09-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142359548","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jason Zappia , Courtney Yong , James Slaven , Zhenije Wu , Linhui Wang , Hooman Djaladat , Erika Wood , Alireza Ghoreifi , Firas Abdollah , Matthew Davis , Alex Stephens , Giuseppe Simone , Gabriele Tuderti , Mark L. Gonzalgo , Dinno F. Mendiola , Ithaar H. Derweesh , Sohail Dhanji , Kevin Hakimi , Vitaly Margulis , Jacob Taylor , Chandru P. Sundaram
{"title":"Survival Outcomes by Race Following Surgical Treatment for Upper Tract Urothelial Carcinoma","authors":"Jason Zappia , Courtney Yong , James Slaven , Zhenije Wu , Linhui Wang , Hooman Djaladat , Erika Wood , Alireza Ghoreifi , Firas Abdollah , Matthew Davis , Alex Stephens , Giuseppe Simone , Gabriele Tuderti , Mark L. Gonzalgo , Dinno F. Mendiola , Ithaar H. Derweesh , Sohail Dhanji , Kevin Hakimi , Vitaly Margulis , Jacob Taylor , Chandru P. Sundaram","doi":"10.1016/j.clgc.2024.102220","DOIUrl":"10.1016/j.clgc.2024.102220","url":null,"abstract":"<div><h3>Objective</h3><div>Discrepancies in survival outcomes of various genitourinary tract malignancies have been documented across different racial and ethnic groups. Here we sought to examine long-term survival outcomes of patients with upper tract urothelial carcinoma (UTUC) following radical nephroureterectomy (RNU) when stratified by race.</div></div><div><h3>Methods</h3><div>A multicenter retrospective analysis using the ROBUUST (ROBotic surgery for Upper tract Urothelial cancer Study) registry identified patients undergoing RNU for UTUC between 2015 and 2022 at 12 centers across the United States, Europe, and Asia. Patients were stratified by race (white, black, Hispanic, and Asian) and primary outcomes of interest-including recurrence-free survival (RFS), metastasis free survival (MFS) and overall survival (OS) - were assessed using univariate analysis, multivariate Cox regression modeling, and Kaplan-Meier analysis.</div></div><div><h3>Results</h3><div>1446 patients (white <em>n</em> = 652, black <em>n</em> = 70, Hispanic <em>n</em> = 87, and Asian <em>n</em> = 637) who underwent RNU for treatment of the UTUC were included in our analysis. Cox regression modeling demonstrated pathologic nodal staging to be a significant predictor of RFS (HR 2.25; <em>P</em> = .0010), MFS (HR 2.50; <em>P</em> = .0028), and OS (HR 5.11; <em>P</em> < .0001). When using whites as the reference group, there were no significant differences in RFS, MFS, or OS across racial groups.</div></div><div><h3>Conclusions</h3><div>Unlike other genitourinary tract malignancies, our study failed to demonstrate a survival disadvantage among minority racial groups with UTUC who underwent RNU. Furthermore, a significant difference in RFS, MFS, and OS was not identified across whites, blacks, Asians, or Hispanics with UTUC who underwent RNU.</div></div>","PeriodicalId":10380,"journal":{"name":"Clinical genitourinary cancer","volume":"22 6","pages":"Article 102220"},"PeriodicalIF":2.3,"publicationDate":"2024-09-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142322068","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Mona Nilsson , Kirsti Aas , Tor Å. Myklebust , Ylva Maria Gjelsvik , Tom Børge Johannesen , Sophie D. Fosså
{"title":"Adverse Health Outcomes 3 Years after Radical Prostatectomy Compared with Men in the General Population: A Study from the Cancer Registry of Norway","authors":"Mona Nilsson , Kirsti Aas , Tor Å. Myklebust , Ylva Maria Gjelsvik , Tom Børge Johannesen , Sophie D. Fosså","doi":"10.1016/j.clgc.2024.102219","DOIUrl":"10.1016/j.clgc.2024.102219","url":null,"abstract":"<div><h3>Introduction</h3><div>Studies about adverse health outcomes (AHOs) after radical prostatectomy (RP) in population-based contemporary prostate cancer (PCa) patients are limited, as well as knowledge about corresponding data from age-similar men from the general population (Norms). We compared selected AHOs (pad use, intercourse inability), related problems (bother) and quality of life (QoL) between PCa patients and Norms.</div></div><div><h3>Patients and methods</h3><div>The Cancer Registry of Norway (CRN) provided data on PCa patients diagnosed in 2017-2019 and treated with RP who completed the EPIC-26 and EORTC-QLQ-C30 questionnaires 24-48 months after surgery (n = 1501). The CRN also established a group of Norms (n = 1894). Dichotomized EPIC-26 outcomes: daily use of ≥1 pad (Item#3), quality of erections (Item#9) and related bother (Item#4a/#12). EORTC-QLQ-C30: quality of life (Item#30). Multivariable logistic regressions explored associations between selected covariates and outcomes.</div></div><div><h3>Results</h3><div>In total, 41% of the patients and 5% in Norms reported pad use, the comparable figures for intercourse inability being 84% (Patients) and 48% (Norms). Among pad users, 24% of the patients and 25% of the Norms described bother. 52% of patients and 35% Norms with intercourse inability. Only bilateral nerve-sparing surgery (NSS) significantly reduced the risk of pad use and intercourse inability. Compared to Norms, PCa patients were associated with pad use, intercourse inability, related bother, and good/ fair QoL.</div></div><div><h3>Conclusion</h3><div>In these population-based cohorts, 2 in 5 patients used pads 3 years after RP, compared to 1 in 20 Norms. Intercourse inability was reported by 4 of 5 patients compared to 1 of 2 Norms. PCa patients were associated with good/ fair QoL. Bilateral NSS significantly reduced the risk of AHOs, highlighting the importance of this approach. Function and bother are different dimensions of urinary and sexual AHOs and must be reported separately. The findings from this study should be considered when counselling patients before RP.</div></div>","PeriodicalId":10380,"journal":{"name":"Clinical genitourinary cancer","volume":"22 6","pages":"Article 102219"},"PeriodicalIF":2.3,"publicationDate":"2024-09-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142328249","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ming-Zhu Liu , Xiao-Ying Li , Xian-Shu Gao , Feng Lyu , Ming-Wei Ma , Jia-Yan Chen , Yan Gao , Xue-Ying Ren , Xue-Song Li
{"title":"Outcomes of Radical Radiotherapy for the Treatment of Localized Renal Pelvic and Ureteral Carcinoma Intolerant to Surgery: A Real-World Study","authors":"Ming-Zhu Liu , Xiao-Ying Li , Xian-Shu Gao , Feng Lyu , Ming-Wei Ma , Jia-Yan Chen , Yan Gao , Xue-Ying Ren , Xue-Song Li","doi":"10.1016/j.clgc.2024.102216","DOIUrl":"10.1016/j.clgc.2024.102216","url":null,"abstract":"<div><h3>Purpose</h3><div>To investigate the safety and efficacy of radical radiotherapy for localized inoperable renal pelvic and ureteral carcinoma.</div></div><div><h3>Methods</h3><div>23 patients who received radiotherapy were enrolled. The prescribed dose was 60 to 67.5 Gy in 25 fractions and for bulky tumors, SABR was used in the first 3 to 5 times with tumor center boosted synchronously with 6 to 8 Gy/f. The Kaplan–Meier method was used to calculate local control (LC), DMFS, CSS and OS. Univariate analysis was performed by the log-rank test. The change in the eGFR before and after radiotherapy was compared by paired t test. The side effects were graded by CTCAE, version 5.0.</div></div><div><h3>Results</h3><div>The median follow-up time was 17 months. The LC rates at 2 years after radiotherapy were 85.0%; the DMFS rates were 52.2%; the CSS rates were 83.0%; and the OS rates were 77.8%. The main failure mode after radiotherapy was distant metastasis. Univariate analysis revealed that T3-4 stage (<em>P</em> = .001), N+ status (<em>P</em> < .001) and a tumor volume ≥ 20 cc (<em>P</em> = .005) were poor prognostic factors for DMFS. There was no significant difference in the mean eGFR before and after radiotherapy (47.0 mL/min/1.73m<sup>2</sup> vs. 48.5 mL/min/1.73m<sup>2</sup>, <em>P</em> = .632). Only 1 patient developed acute grade 3 anemia. No patients developed grade 3 or higher late toxicities.</div></div><div><h3>Conclusion</h3><div>For localized inoperable renal pelvic and ureteral carcinoma, radiotherapy is well tolerable with high local control and expected to bring survival benefits. In such patients, radiotherapy may be an option when surgery is unsuitable.</div></div>","PeriodicalId":10380,"journal":{"name":"Clinical genitourinary cancer","volume":"22 6","pages":"Article 102216"},"PeriodicalIF":2.3,"publicationDate":"2024-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142318615","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Fady Baky , Nicole Liso , Brandon Williams , Andrea Knezevic , Samuel A. Funt , Darren R. Feldman , Brett Carver , Joel Sheinfeld , Richard S. Matulewicz
{"title":"Long-term Clinical Outcomes of Patients With Negative Pathology (pN0) at Primary Retroperitoneal Lymph Node Dissection","authors":"Fady Baky , Nicole Liso , Brandon Williams , Andrea Knezevic , Samuel A. Funt , Darren R. Feldman , Brett Carver , Joel Sheinfeld , Richard S. Matulewicz","doi":"10.1016/j.clgc.2024.102217","DOIUrl":"10.1016/j.clgc.2024.102217","url":null,"abstract":"<div><h3>Background</h3><div>Patients who undergo primary retroperitoneal lymph node dissection (pRPLND) for early-stage testicular cancer and have no cancer (pN0) found in the retroperitoneum are believed to have an excellent prognosis. However, some experience relapse, potentially due to limitations of current staging methods. We aim to describe long-term outcomes and relapse patterns among a contemporary cohort of patients found to be pN0 at pRPLND to identify opportunities for improved diagnostic approaches and optimal patient selection.</div></div><div><h3>Methods</h3><div>We reviewed our prospectively maintained database for patients who underwent pRPLND for nonseminomatous germ cell tumors at our tertiary cancer center during the period from January 1, 2000, through September 30, 2023 (n = 628). We excluded 282 patients with node-positive pathology for a final analytic cohort of 346 patients. Our primary outcome was recurrence-free survival (RFS). Secondary outcomes included timing and location of recurrence.</div></div><div><h3>Results</h3><div>Of 346 included patients with pN0 pathology, 23 experienced relapse with a 2-year RFS rate of 93% (95% confidence interval: 90, 96). Most recurrences (70%) occurred in the lungs and within 6 months of pRPLND. Serum tumor markers were positive in 43% of patients at the time of relapse. All patients who relapsed were treated with salvage chemotherapy; 6 patients required additional surgical procedures. There was no testis cancer–related deaths.</div></div><div><h3>Conclusions</h3><div>Two-year RFS for patients with pN0 pRPLND pathology is excellent. All recurrences were outside of the retroperitoneum, suggesting subclinical distant metastases at time of surgery and the benefits of a bilateral template dissection. Improved diagnostics may help better identify patients with disease within or outside of the retroperitoneum prior to pRPLND, helping guide treatment decisions.</div></div>","PeriodicalId":10380,"journal":{"name":"Clinical genitourinary cancer","volume":"22 6","pages":"Article 102217"},"PeriodicalIF":2.3,"publicationDate":"2024-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142303407","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Roles of Long Noncoding RNA in Prostate Cancer Pathogenesis","authors":"Tongyue Zhao , Feng Ma","doi":"10.1016/j.clgc.2024.102213","DOIUrl":"10.1016/j.clgc.2024.102213","url":null,"abstract":"<div><div>Prostate cancer stands as the most common cancer in men, and research into its genesis and spread is still vital. The idea that the human genome's transcriptional activity is more widespread than previously thought has received empirical validation through the application of deep sequencing-based transcriptome profiling techniques. An assortment of noncoding transcripts longer than 200 nucleotides is referred to as long noncoding RNAs (lncRNAs). Transposable elements comprise a substantial portion of the human genome, with projections indicating that their prospective proportion may reach 90%. Considering they can interact directly with proteins, alter the transcriptional activity of coding genes, and perhaps encode proteins, lncRNAs possess the capability to regulate a variety of biological processes. LncRNAs have been recognized to be key factors in the development of several types of human cancers, including lung, colorectal, and breast cancers, alongside other pathological processes that have a significant impact on the diagnosis and survival of cancer individuals. Furthermore, lncRNAs' discernible expression patterns throughout various cancer scenarios significantly raise their potential as biomarkers and therapeutic targets. We conducted an extensive analysis of the prevailing academic literature on the interaction between lncRNAs and prostate cancer in order to present a solid foundation for potential future studies on the prevention and intervention of prostate cancer. The discourse additionally expands on lncRNAs' prospective applications as targets and biomarkers for medical therapies.</div></div>","PeriodicalId":10380,"journal":{"name":"Clinical genitourinary cancer","volume":"22 6","pages":"Article 102213"},"PeriodicalIF":2.3,"publicationDate":"2024-08-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142252101","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Comparative Efficacy of Avelumab Maintenance Therapy Versus Continued Chemotherapy Followed by Pembrolizumab in Metastatic Urothelial Carcinoma With No Progression After 4 Cycles of Chemotherapy: A Retrospective Study Using Propensity Score Matching","authors":"Keita Kobayashi , Hiroaki Matsumoto , Shigeru Sakano , Mitsutaka Yamamoto , Masahiro Tsuchida , Yasuhide Tei , Kazuhiro Nagao , Kazuo Oba , Seiji Kitahara , Seiji Yano , Satoru Yoshihiro , Yoshiaki Yamamoto , Chietaka Ohmi , Hirotaka Komatsu , Taku Misumi , Jumpei Akao , Koji Shiraishi","doi":"10.1016/j.clgc.2024.102212","DOIUrl":"10.1016/j.clgc.2024.102212","url":null,"abstract":"<div><h3>Introduction</h3><p>In cases of metastatic and unresectable urothelial carcinoma with no disease progression after 4 cycles of chemotherapy, including platinum agents, treatment options include continuation of chemotherapy or switching to maintenance therapy with avelumab. This study compared the treatment outcomes of avelumab maintenance therapy with those of pembrolizumab in urothelial carcinoma using propensity score matching.</p></div><div><h3>Patients and Methods</h3><p>Between January 2017 and December 2022, 243 patients with metastatic and unresectable urothelial carcinoma were treated with either avelumab or pembrolizumab at the Yamaguchi University Hospital and its affiliated institutions. We retrospectively compared the oncological outcomes and adverse events by aligning patient characteristics and treatment backgrounds using propensity score matching.</p></div><div><h3>Results</h3><p>The analysis compared 36 cases receiving avelumab maintenance therapy after chemotherapy to 49 cases where patients, after receiving 4 courses of chemotherapy including platinum-based agents without disease progression, were subsequently administered pembrolizumab as a second-line treatment following disease progression. Using propensity score matching, 27 cases from each group were selected for comparison. From the initiation of prechemotherapy to disease progression on immune checkpoint inhibitors, the median progression-free survival was 20.7 and 23.3 months in the avelumab and pembrolizumab groups, respectively, with no statistically significant difference observed (<em>P</em> = .358). However, avelumab tended to have a lower rate of high-dose glucocorticoid treatment compared to pembrolizumab.</p></div><div><h3>Conclusion</h3><p>Progression-free survival was similar for avelumab maintenance therapy and the sequence of continued chemotherapy followed by pembrolizumab after no disease progression at four chemotherapy courses. Avelumab may require less high-dose glucocorticoid treatment, potentially enhancing safety.</p></div>","PeriodicalId":10380,"journal":{"name":"Clinical genitourinary cancer","volume":"22 6","pages":"Article 102212"},"PeriodicalIF":2.3,"publicationDate":"2024-08-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142172517","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Chengri Piao , Dongmei Liu , Zhen Liu , Liping Shan
{"title":"Markers in Identifying Pathological Complete Response Status in Muscle Invasive Bladder Cancer Patients Who Achieved Clinical Complete Response After Neoadjuvant Chemotherapy","authors":"Chengri Piao , Dongmei Liu , Zhen Liu , Liping Shan","doi":"10.1016/j.clgc.2024.102211","DOIUrl":"10.1016/j.clgc.2024.102211","url":null,"abstract":"<div><h3>Background</h3><p>Prior research has demonstrated a discrepancy between pathologic and clinical staging in individuals with muscle-invasive bladder cancer (MIBC) following neoadjuvant chemotherapy (NAC). These findings were the major reasons for the under-usage of the bladder preservation strategy. Hence, we aim to explore the reliable markers in identifying pathological complete response (ypCR) status in MIBC patients who achieved clinical complete response (cCR) after NAC.</p></div><div><h3>Methods</h3><p>Between January 2016 and April 2023, 161 consecutive MIBC patients treated with NAC and achieved cCR were enrolled in the study. Patient clinicopathologic information was documented. Multivariate binary logistic regression was used for determining adjusted odds ratios (OR) and 95% confidence intervals (CI). It considered statistically significant when a <em>P</em> < .05.</p></div><div><h3>Results</h3><p>Of the 161 MIBC patients with cCR after NAC, 64.0% (103/161) achieved ypCR after RC. The independent factors for ypCR status were the origin of MIBC (secondary vs. Primary) with odds ratios (OR) of 0.433 (<em>P</em> = .027), the pathological type (pure vs. mixed) with OR of 3.556 (<em>P</em> = .003), concurrent carcinoma in situ (yes vs. no) with OR of 0.360 (<em>P</em> = .016), and lymphovascular invasion (yes vs. no) with OR of 0.271 (<em>P</em> = .007).</p></div><div><h3>Conclusion</h3><p>This study demonstrated that primary MIBC, pure UC pathological type, absence of concurrent CIS, and LVI were significant predictors of ypCR in MIBC patients who achieved cCR after NAC and before surgery. These findings may contribute to the decision-making process of bladder preservation strategy in selected patients.</p></div>","PeriodicalId":10380,"journal":{"name":"Clinical genitourinary cancer","volume":"22 6","pages":"Article 102211"},"PeriodicalIF":2.3,"publicationDate":"2024-08-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142167620","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Bryan Wong , Jenny Peng , Di Maria Jiang , Karim Fizazi , Thomas Powles , Nick James , Srikala S. Sridhar
{"title":"Comparison of Industry-Sponsored Trials (IST) and Investigator-Initiated Trials (IIT) in Advanced Genitourinary Cancers in the United States, Canada, United Kingdom and France","authors":"Bryan Wong , Jenny Peng , Di Maria Jiang , Karim Fizazi , Thomas Powles , Nick James , Srikala S. Sridhar","doi":"10.1016/j.clgc.2024.102210","DOIUrl":"10.1016/j.clgc.2024.102210","url":null,"abstract":"<div><h3>Background</h3><p>Clinical trials are categorized as industry sponsored trials (ISTs) or investigator-initiated trials (IITs) based on the source of funding and sponsor of the trial. ISTs are usually run by pharmaceutical companies, and are primarily aimed at developing new drugs that ultimately gain regulatory approval. IITs are developed by academic investigators or cooperative groups, often sparked by a clinical need. Both are vital in advancing the field of oncology. To date, little has been published about current trends in ISTs or IITs in genitourinary (GU) oncology. The aim of this study was to assess growth trends of GU oncology ISTs and IITs in 4 countries with similar healthcare infrastructures.</p></div><div><h3>Methods</h3><p>We searched ClinicalTrials.gov for bladder, kidney, and prostate cancer trials conducted in the United States (US), Canada, France, and United Kingdom (UK) from January 2007 to December 2021. Trials were determined to be ISTs or IITs based on their funding source and sponsor. Trials were characterized based on type, purpose, phase, participants, masking, assignment, and allocation.</p></div><div><h3>Results</h3><p>Overall, 5,834 GU trials were identified, with a balanced distribution of ISTs (n = 3064, n = 52.5%) and IITs (n = 2770, 47.4%). By country, the US conducted the most GU trials (n = 3814) followed by Canada (n = 709), France (n = 677), and the UK (n = 634). Most ISTs were phase 3 trials with over 500 participants while most IITs were open-label phase 2 studies with only 20-49 participants. From 2017 onwards, there was a shift towards more ISTs, most noticeably in Canada and the UK. The COVID-19 pandemic did not have a major impact on the growth of ISTs and IITs.</p></div><div><h3>Conclusion</h3><p>The gap between ISTs and IITs continues to widen, likely driven by resource and funding challenges faced by investigators. Barriers to completing IITs need to be better understood to promote IIT development and maintain their academically driven intentions.</p></div>","PeriodicalId":10380,"journal":{"name":"Clinical genitourinary cancer","volume":"22 6","pages":"Article 102210"},"PeriodicalIF":2.3,"publicationDate":"2024-08-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142201808","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Dimitra Rafailia Bakaloudi , Elizabeth L. Koehne , Leonidas N. Diamantopoulos , Sarah K. Holt , Rishi R. Sekar , Fady Ghali , Funda Vakar-Lopez , Yaw A. Nyame , Sarah P. Psutka , John L. Gore , Claire M. de la Calle , Daniel W. Lin , George R. Schade , Jay J. Liao , Andrew C. Hsieh , Todd Yezefski , Jessica E. Hawley , Evan Y. Yu , R. Bruce Montgomery , Petros Grivas , Jonathan L. Wright
{"title":"Small Cell Bladder Cancer: Treatment Patterns for Local Disease and Associated Outcomes. A Retrospective Cohort Study","authors":"Dimitra Rafailia Bakaloudi , Elizabeth L. Koehne , Leonidas N. Diamantopoulos , Sarah K. Holt , Rishi R. Sekar , Fady Ghali , Funda Vakar-Lopez , Yaw A. Nyame , Sarah P. Psutka , John L. Gore , Claire M. de la Calle , Daniel W. Lin , George R. Schade , Jay J. Liao , Andrew C. Hsieh , Todd Yezefski , Jessica E. Hawley , Evan Y. Yu , R. Bruce Montgomery , Petros Grivas , Jonathan L. Wright","doi":"10.1016/j.clgc.2024.102208","DOIUrl":"10.1016/j.clgc.2024.102208","url":null,"abstract":"<div><h3>Background</h3><p>Small cell bladder cancer (SCBC) is a rare histologic subtype with relative paucity of data regarding treatment response and outcomes. We reviewed 2 databases to compare outcomes in patients with localized SCBC treated with cystectomy versus concurrent chemoradiotherapy (CCRT). We hypothesized that survival would be similar with these therapy approaches.</p></div><div><h3>Methods</h3><p>We retrospectively reviewed our institutional and SEER-Medicare databases to identify patients with SCBC. Overall survival (OS) was determined from the date of diagnosis to last follow-up/death. For those with nonmetastatic disease, a multivariate Cox analysis was used to compare locoregional therapy with neoadjuvant chemotherapy (NAC) + cystectomy versus CCRT.</p></div><div><h3>Results</h3><p>We identified 53 patients in our institutional database and 1166 patients in SEER-Medicare with localized SCBC. Median OS (mOS) with NAC + cystectomy was 46 months (95% CI, 21-72) and 45 months (95% CI, 0-104) in the institutional and SEER-Medicare databases, respectively, whereas mOS with CCRT was 26 months (95% CI, 5-47) and 23 months (95% CI, 18-28) in the 2 series, respectively. In multivariate analysis, NAC followed by cystectomy was associated with an approximately 30% reduction in mortality compared to CCRT in both institutional and national databases but did not reach statistical significance (Institution HR 0.71, 95% CI, 0.22-2.4, <em>P</em> = .58; SEER HR 0.73, 95% CI, 0.49-1.08; <em>P</em> = .11).</p></div><div><h3>Conclusions</h3><p>SCBC is very aggressive with limited survival observed in our institutional and SEER-Medicare datasets regardless of locoregional therapy used. There is an unmet need to define the optimal locoregional therapy for nonmetastatic stage and identify novel therapeutic targets.</p></div>","PeriodicalId":10380,"journal":{"name":"Clinical genitourinary cancer","volume":"22 6","pages":"Article 102208"},"PeriodicalIF":2.3,"publicationDate":"2024-08-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142167735","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}