Clinical genitourinary cancer最新文献

{"title":"Efficacy and Safety of Combination AKT and Androgen Receptor Signaling Inhibition in Metastatic Castration-Resistant Prostate Cancer: Systematic Review and Meta-Analysis","authors":"Tulika A.K. Nahar ,&nbsp;Maria Anna Bantounou ,&nbsp;Isabella Savin ,&nbsp;Nakul Chohan ,&nbsp;Niraj S. Kumar ,&nbsp;Aruni Ghose ,&nbsp;Ian J. McEwan","doi":"10.1016/j.clgc.2024.102244","DOIUrl":"10.1016/j.clgc.2024.102244","url":null,"abstract":"<div><h3>Background</h3><div>Metastatic castration-resistant prostate cancer (mCRPC) has a poor prognosis with current treatment options including chemotherapy and androgen receptor signaling inhibitor (ARSI) medications. Poly-ADP ribose polymerase (PARP) inhibitors alone and in combination with ARSI has recently been incorporated in management for mCRPC deficient in BRCA1/2 genes. However, downregulating androgen-receptor signaling using ARSIs can upregulate the PI3K/AKT/mTOR pathway, promoting tumor cell survival. This creates a rationale for co-targeting both these pathways. This systematic review aimed to investigate AKT inhibitors and ARSI combination therapy.</div></div><div><h3>Methods</h3><div>EMBASE, MEDLINE, and Scopus were searched from database inception to July 2023. Primary outcomes included objective response rate (ORR), prostate-specific antigen (PSA) response rate, adverse events (AEs), overall survival (OS), and radiographic progression-free survival (rPFS). Quality was assessed using the risk of bias tool (ROB2) and certainty of evidence with GRADE.</div></div><div><h3>Results</h3><div>Six clinical trials with 3 Phase I, 1 Phase II, 1 Phase III were included with 771 patients and a median age ranging from 67 years to 70 years. The pooled ORR was 30% (<em>n</em> = 5 studies, 95% CI, 3%-84%) and PSA response rate was 43% (<em>n</em> = 5 studies, 95% CI, 15%-77%). The median duration of rPFS ranged from 8.2 to 19.2 months in the intervention compared with 6.4 to 16.6 months in the placebo group. A 16% reduction in radiographic progression or death was reported in patients receiving dual therapy compared with those receiving placebo. This reduction was greater by PTEN-loss status, ranging from 23% to 61%. The median OS ranged from 15.6 to 18.9 months. No significant difference was reported in survival relative to placebo. 98.8% (767/776) of patients experienced AEs of any grade, with GRADE ≥3 AEs occurring in 65.9% (512/776) of patients. The most common AE and GRADE ≥3 AEs were diarrhoea (pooled prevalence = 70%, 95% CI, 57%-81%), and hyperglycaemia (pooled prevalence = 12%, 95% CI, 6%-20%), respectively.</div></div><div><h3>Conclusion</h3><div>Combined therapy reduced the risk of rPFS, with the response higher in PTEN-loss subgroup, with a modest but not significant increase in OS. Our AE estimates showed consistency with other studies. AEs of any grade were common with the majority experiencing at least 1 AE. (PROSPERO Registration Number: CRD420202352583)</div></div>","PeriodicalId":10380,"journal":{"name":"Clinical genitourinary cancer","volume":"22 6","pages":"Article 102244"},"PeriodicalIF":2.3,"publicationDate":"2024-10-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142645342","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":"Safety Analysis of Co-Administration of Radiation Therapy with Enfortumab Vedotin Based Regimens in Metastatic Urothelial Carcinoma","authors":"S.N. Seyedin ,&nbsp;G.K. Harada ,&nbsp;E. Garemanian ,&nbsp;D. Rafizadeh ,&nbsp;D. Kaakour ,&nbsp;S. Dwabe ,&nbsp;A. Rezazadeh ,&nbsp;M. Daneshvar ,&nbsp;N. Mar","doi":"10.1016/j.clgc.2024.102243","DOIUrl":"10.1016/j.clgc.2024.102243","url":null,"abstract":"<div><h3>Introduction/Background</h3><div>Enfortumab vedotin (EV) and pembrolizumab (P) is the standard of care for patients with locally advanced or metastatic urothelial carcinoma (la/mUC). Because radiation (RT) is frequently used for symptom palliation, we examined the safety of co-administering EV with RT.</div></div><div><h3>Materials and Methods</h3><div>This single institution retrospective study selected patients with la/mUC, who received at least 1 dose of EV and initiated RT to any site within 30 days of each other. Patient characteristics, number of EV cycles received, the location of irradiated sites, RT dose/delivery approach, severity/type of radiation treatment-related adverse events (TRAEs), and symptom response after RT were recorded. The primary aim of this study was to examine radiation TRAEs, with severity graded using the CTCAE version 5.0 classification.</div></div><div><h3>Results</h3><div>Nine patients with 15 irradiated metastasis met eligibility criteria. The median radiation dose and cycles of EV were 30 Gy and 5 cycles respectively. Patients only experienced acute grade 1 or 2 TRAEs including fatigue, nausea, and dermatitis without desquamation. Chronic treatment-related toxicity was noted in 2 patients, which were grade 1 neck pain and 2 fatigue. All patients demonstrated some degree of symptom relief and four experienced complete resolution of their cancer-related symptoms at the irradiated site. One patient with limited disease burden completed stereotactic body radiation therapy and remains disease free 6 months after discontinuing all treatment.</div></div><div><h3>Conclusion</h3><div>This study demonstrates that co-administration of RT with EV-based regimens could be safe and effective for symptom palliation. Larger series examining this treatment combination are needed.</div></div>","PeriodicalId":10380,"journal":{"name":"Clinical genitourinary cancer","volume":"22 6","pages":"Article 102243"},"PeriodicalIF":2.3,"publicationDate":"2024-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142634595","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}

{"title":"Landscape of Genomic Profiling and Circulating Tumor DNA Among Rare Genitourinary Cancers","authors":"Austin G Kazarian,&nbsp;Raj R Bhanvadia,&nbsp;Zine-Eddine Khene,&nbsp;Thomas Gerald,&nbsp;Bailey Brooks,&nbsp;Yair Lotan,&nbsp;Isamu Tachibana,&nbsp;Kris Gaston,&nbsp;Sol Woldu,&nbsp;Vitaly Margulis","doi":"10.1016/j.clgc.2024.102245","DOIUrl":"10.1016/j.clgc.2024.102245","url":null,"abstract":"<div><div><ul><li><span>•</span><span><div>Current surveillance and treatment strategies of rare genitourinary cancers are heterogenous and often rely on classical imaging alone leaving opportunity for enhanced surveillance and treatment direction strategies.</div></span></li><li><span>•</span><span><div>Molecular residual disease assessment may offer many benefits to standard modalities including antecedent prediction of recurrence or progression compared to conventional surveillance, early and appropriate identification of patients appropriate for adjuvant treatment, potential for monitoring of treatment response, and adjudication of indeterminate imaging findings.</div></span></li><li><span>•</span><span><div>Comprehensive genomic profiling delineates tumor biology and actionable mutations for personalized medicine in this challenging to treat population including nonclassical targeted agents.</div></span></li></ul></div></div>","PeriodicalId":10380,"journal":{"name":"Clinical genitourinary cancer","volume":"22 6","pages":"Article 102245"},"PeriodicalIF":2.3,"publicationDate":"2024-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142678036","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":"Detection of Apical Cancer with Novel Imaging Modalities to Predict Apical Margin Positivity in Robotic Assisted Radical Prostatectomy","authors":"Vinayak G. Wagaskar,&nbsp;Ashutosh Maheshwari,&nbsp;Osama Zaytoun,&nbsp;Yashaswini Agarwal,&nbsp;Neeraja Tillu,&nbsp;Asher Mandel,&nbsp;Ash Tewari","doi":"10.1016/j.clgc.2024.102240","DOIUrl":"10.1016/j.clgc.2024.102240","url":null,"abstract":"<div><h3>Objectives</h3><div>To evaluate margin positivity at apex utilizing preoperative magnetic resonance imaging [MRI], micro-ultrasound [MUS], prostate specific membrane antigen positron emission tomography PSMA PET] scan, biopsy location and intraoperative timing of deep venous complex [DVC] ligation during robot assisted radical prostatectomy [RARP].</div></div><div><h3>Methods</h3><div>Institution review board approved retrospective study underwent RARP between November 2022 to March 2024. All patients underwent preoperative MRI, MUS and PSMA PET scan. Patients underwent RARP using either standard DVC [done prior apical dissection] ligation or delayed DVC [after prostate removal] technique. All patients underwent intra operative frozen section analysis by an experienced genitourinary pathologist. Descriptive statistics were performed. Data analyzed using R software version 4.3.3.</div></div><div><h3>Results</h3><div>Total 619 prostate cancer patients underwent RARP. Of these, 365 men underwent RARP using delayed DVC ligation technique and 254 men using standard DVC ligation technique. There was no statically significant difference in 2 groups on demographic parameters, MRI, MUS and PSMA-PET scan features. Sensitivity of MRI, MUS, PSMA-PET and prostate biopsy for detection of apical positive margin were 66%, 81%, 81% and 73% respectively. Specificity of MRI, MUS, PSMA-PET and prostate biopsy for detection of apical positive margin were 45%, 14%, 16% and 30% respectively. When all modalities are used accumulatively, apical cancer was missed only in 1% of cases.</div></div><div><h3>Conclusions</h3><div>With proper preoperative understanding of apical lesion location, timing of DVC ligation [standard vs delayed] doesn't impact apical positive surgical margins. Combination of MRI, MUS, PSMA-PET and prostate biopsy reduce apical positive surgical margin rates significantly.</div></div>","PeriodicalId":10380,"journal":{"name":"Clinical genitourinary cancer","volume":"22 6","pages":"Article 102240"},"PeriodicalIF":2.3,"publicationDate":"2024-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142634591","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":"Doxorubicin, Paclitaxel, and Cisplatin (ATP) for Relapsed/Refractory Germ Cell Tumors","authors":"Jenny J Xiang ,&nbsp;Matthew T Campbell ,&nbsp;Shi-Ming Tu ,&nbsp;John Araujo ,&nbsp;Yago Nieto ,&nbsp;John K Lin ,&nbsp;Lianchun Xiao ,&nbsp;Amishi Y Shah ,&nbsp;Jianbo Wang","doi":"10.1016/j.clgc.2024.102242","DOIUrl":"10.1016/j.clgc.2024.102242","url":null,"abstract":"<div><div>Patients with relapsed/refractory germ cell tumors (GCT) have limited treatment options and poor survival outcomes. We describe our institutional experience with doxorubicin, paclitaxel, and cisplatin (ATP) as an outpatient regimen for 35 patients with relapsed/refractory GCT between 2017 and 2022. Twenty-four patients received nonpalliative intent ATP, with a median of 2 lines of prior therapy, 23 (96%) having received at least 1 cisplatin-based regimen and 1 (4%) with a prior stem cell transplant. The objective response rate for the nonpalliative intent cohort was 37.5% (1 complete response and 8 partial responses). Post-ATP, 12 patients underwent stem cell transplant, 7 patients had surgical resections, and 4 patients received radiation. The median PFS was 4.3 months (95% CI: 3.8, 32.7) and median OS of 13.1 months (95% CI: 10.7, NA) for the nonpalliative intent cohort. Eleven patients received palliative intent ATP, with a median of 4 lines of prior therapy, all having received at least 1 cisplatin-based regimen, and 7 (64%) having received prior stem cell transplants. Within the palliative intent cohort, the objective response rate was 9% (1 partial response). Patients who received palliative intent ATP had a median PFS of 0.92 months (95% CI 0.46, NA) and median OS of 5.2 months (95% CI 3.3, NA). Treatment toxicities occurred in 5 (14%) patients who required dose reductions and 5 (14%) patients who were admitted for treatment related toxicities, most commonly for myelosuppression. Our results support the use of ATP in a primarily anthracycline naïve patient population and show the safety of continued cisplatin use in patients who have previously received cisplatin-based regimens. Therefore, ATP is a feasible and well tolerated chemotherapy regimen in the salvage setting and can serve as a bridge to other treatments for patients with relapsed/refractory GCT.</div></div>","PeriodicalId":10380,"journal":{"name":"Clinical genitourinary cancer","volume":"22 6","pages":"Article 102242"},"PeriodicalIF":2.3,"publicationDate":"2024-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142634592","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}

{"title":"Risk of Metachronous Upper Tract Urothelial Carcinoma After Ureteral Stenting in Patients With Bladder Cancer","authors":"Pietro Scilipoti ,&nbsp;Marco Moschini ,&nbsp;Mario de Angelis ,&nbsp;Mattia Longoni ,&nbsp;Luca Afferi ,&nbsp;Chiara Lonati ,&nbsp;Paolo Zaurito ,&nbsp;Renate Pichler ,&nbsp;Andrea Necchi ,&nbsp;Francesco Montorsi ,&nbsp;Alberto Briganti ,&nbsp;Andrea Mari ,&nbsp;Wojciech Krajewski ,&nbsp;Ekaterina Laukthina ,&nbsp;Benjamin Pradere ,&nbsp;Francesco Del Giudice ,&nbsp;Laura Mertens ,&nbsp;Andrea Gallioli ,&nbsp;Francesco Soria ,&nbsp;Paolo Gontero ,&nbsp;Roberto Carando","doi":"10.1016/j.clgc.2024.102241","DOIUrl":"10.1016/j.clgc.2024.102241","url":null,"abstract":"<div><h3>Objective</h3><div>Sparse data exist on the impact of upper urinary tract (UUT) decompression on the risk of UUT recurrence in patients with bladder cancer (BCa). This study aims to evaluate whether Double J stenting (DJS) can increase the risk of UUT recurrence compared to percutaneous nephrostomy (PCN) placement.</div></div><div><h3>Materials and methods</h3><div>We retrospectively analyzed data from 1550 patients with cTa-T3NanyM0 BCa who underwent radical cystectomy (RC) between at 12 tertiary care centers (1990-2020). Patients with complete follow-up, no prior history of UUT cancer, and who required UUT decompression for preoperative hydronephrosis were selected. Hydronephrosis grade was defined according to established scoring systems. UUT recurrence was diagnosed through imaging, urinary cytology, and confirmed by selective cytology and ureteroscopy when possible. Propensity scores were computed to determine overlap weights and balance groups. Kaplan–Meier analyses estimated UUT recurrence-free survival (RFS), cancer-specific (CSS), and overall survival (OS) before and after weighting. Cox regression analyses before and after weighting were fitted to predict UUT recurrence.</div></div><div><h3>Results</h3><div>Of 524 included patients, 132 (25%) and 392 (75%) patients were managed with DJS and PCN placement, respectively. Patients who received PCN had higher grade (≥ 3) of obstruction (34% vs. 14%) and pT3-4 tumors (70% vs. 36%) than patients with DJS. During a median follow-up of 19 months, 2-years UUT-RFS did not differ between groups (95% for PCN vs 92% for DJS, weighted HR 1.41, 95% CI, 0.55-3.59). There was no difference in 2-years weighted CSS (74% vs. 74%) and OS (67% vs 69%). Main limitations were the short follow-up and inclusion of patients uniquely undergoing RC.</div></div><div><h3>Conclusions</h3><div>These results suggest that ureteral DJS does not increase the risk of developing UUT recurrence in BCa patients with hydronephrosis requiring UUT decompression. However, UUT recurrence was rare, and associations were weak, with findings susceptible to bias. Randomized trials are needed to validate these results.</div></div>","PeriodicalId":10380,"journal":{"name":"Clinical genitourinary cancer","volume":"22 6","pages":"Article 102241"},"PeriodicalIF":2.3,"publicationDate":"2024-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142593692","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":"The Impact of Concomitant Medications on the Overall Survival of Patients Treated with Systemic Therapy for Advanced or Metastatic Renal Cell Carcinoma: A Systematic Review and Meta-analysis","authors":"Ichiro Tsuboi ,&nbsp;Akihiro Matsukawa ,&nbsp;Mehdi Kardoust Parizi ,&nbsp;Marcin Miszczyk ,&nbsp;Tamás Fazekas ,&nbsp;Robert J. Schulz ,&nbsp;Stefano Mancon ,&nbsp;Giulio Litterio ,&nbsp;Ekaterina Laukhtina ,&nbsp;Tatsushi Kawada ,&nbsp;Satoshi Katayama ,&nbsp;Takehiro Iwata ,&nbsp;Kensuke Bekku ,&nbsp;Pawel Rajwa ,&nbsp;Koichiro Wada ,&nbsp;Pierre I. Karakiewicz ,&nbsp;Motoo Araki ,&nbsp;Shahrokh F. Shariat","doi":"10.1016/j.clgc.2024.102237","DOIUrl":"10.1016/j.clgc.2024.102237","url":null,"abstract":"<div><div>Although immune checkpoint inhibitors (ICI) and/or tyrosine kinase inhibitors (TKI) are the standard treatment of advanced unresectable or metastatic renal cell carcinoma (RCC), the impact of concomitant medications remains unclear. We aimed to evaluate the impact of concomitant medications on survival outcomes in patients treated with systemic therapy for advanced unresectable or metastatic RCC. In August 2024, PubMed, Scopus, and Web of Science were queried for studies evaluating concomitant medications in patients with advanced unresectable or metastatic RCC (PROSPERO: CRD42024573252). The primary outcome was overall survival (OS). A fixed- or random-effects model was used for meta-analysis according to heterogeneity. We identified 22 eligible studies (5 prospective and 17 retrospective) comprising 16,072 patients. Concomitant medications included proton pump inhibitors (PPI) (n = 3959), antibiotics (n = 571), statins (n = 5466), renin-angiotensin system inhibitors (RASi) (n = 6615), and beta-blockers (n = 1964). Both concomitant PPI and antibiotics were significantly associated with worse OS in patients treated with ICI (PPI: HR: 1.22, <em>P</em> = .01, and antibiotics: HR: 2.09, <em>P</em> &lt; .001). Concomitant statins, RASi, or beta-blocker were significantly associated with improved OS in patients treated with TKI (statins: HR: 0.81, <em>P</em> = .03, RASi: HR: 0.63, <em>P</em> &lt; .001, beta-blocker: HR: 0.69, <em>P</em> &lt; .001, respectively). In patients treated with ICI, RASi was significantly associated with improved OS (HR: 0.64, <em>P</em> = .02). Concomitant use of antibiotics or PPI with ICI can reduce its oncologic efficacy. Conversely, concomitant statins, RASi, or beta-blockers can enhance the oncologic efficacy of TKI. When initiating systemic therapy for metastatic RCC, it may be important for clinicians to assess baseline co-medications and recognize their possible positive or negative effects.</div></div>","PeriodicalId":10380,"journal":{"name":"Clinical genitourinary cancer","volume":"22 6","pages":"Article 102237"},"PeriodicalIF":2.3,"publicationDate":"2024-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142640490","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}

{"title":"Avelumab First-Line Maintenance for Locally Advanced or Metastatic Urothelial Carcinoma: Results From the Real-World US PATRIOT-II Study","authors":"Petros Grivas ,&nbsp;Pedro Barata ,&nbsp;Helen Moon ,&nbsp;Shilpa Gupta ,&nbsp;Thomas Hutson ,&nbsp;Cora N. Sternberg ,&nbsp;Jason R. Brown ,&nbsp;Vaidehi Dave ,&nbsp;Chad Downey ,&nbsp;Alicia C. Shillington ,&nbsp;Howard M. Katzenstein ,&nbsp;Melissa Kirker ,&nbsp;Sarah Hanson ,&nbsp;Frank X. Liu ,&nbsp;Valerie Morris ,&nbsp;Abhijeet Bhanegaonkar ,&nbsp;Guru P. Sonpavde","doi":"10.1016/j.clgc.2024.102238","DOIUrl":"10.1016/j.clgc.2024.102238","url":null,"abstract":"<div><h3>Introduction</h3><div>In JAVELIN Bladder 100, avelumab first-line maintenance (1LM) improved overall survival (OS) and progression-free survival (PFS) in patients with locally advanced/metastatic urothelial carcinoma (la/mUC) without progression following 1L platinum-based chemotherapy (PBC) versus best supportive care. PATRIOT-II describes real-world outcomes with avelumab 1LM.</div></div><div><h3>Patients and Methods</h3><div>This observational, retrospective study of avelumab 1LM in US community/academic centers used medical record data collected from avelumab initiation for ≥12 months to assess survival, safety, and healthcare resource utilization; analyses are descriptive.</div></div><div><h3>Results</h3><div>The study included 160 patients from 37 centers (median age, 70 years; 77% male). Avelumab 1LM was initiated at a median of 4 weeks (IQR 3-6) after PBC completion. Median follow-up from avelumab 1LM was 16 months (IQR 11-21). At study end, 19.4% of patients continued avelumab; 73.7% had discontinued due to progression, adverse events (AEs), or performance status deterioration. Median PFS and OS from avelumab initiation were 5.4 months (95% CI, 3.8-6.9) and 24.4 months (95% CI, 20.4-28.4), respectively. Grade ≥3 treatment-related AEs (TRAEs) occurred in 15 patients (9.4%); 35 (21.9%) had any-grade immune-related AEs, and 23 (14.3%) received high-dose systemic corticosteroids for AEs. Forty-four patients (27.5%) were hospitalized during the avelumab treatment period, of whom 13 (8.1%) were hospitalized due to TRAEs. Limitations of this study include a small sample size, potential selection bias, and missing/unknown data.</div></div><div><h3>Conclusion</h3><div>These results align with the JAVELIN Bladder 100 clinical trial and other real-world studies, supporting avelumab 1LM use in patients with la/mUC without progression following 1L PBC.</div></div>","PeriodicalId":10380,"journal":{"name":"Clinical genitourinary cancer","volume":"22 6","pages":"Article 102238"},"PeriodicalIF":2.3,"publicationDate":"2024-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142634590","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}

{"title":"NODESAFE Nomogram: A Novel Score System to Predict Lymph Node Involvement at the Time of Nephrectomy or Nodal Recurrence in Nonmetastatic Renal Cell Carcinoma","authors":"Cesare Saitta ,&nbsp;Giuseppe Garofano ,&nbsp;Jonathan A. Afari ,&nbsp;Hajime Tanaka ,&nbsp;Dattatraya Patil ,&nbsp;Kit L. Yuen ,&nbsp;Luke Wang ,&nbsp;Julian Cortes ,&nbsp;Margaret F. Meagher ,&nbsp;Dhruv Puri ,&nbsp;Clara Cerrato ,&nbsp;Mimi V. Nguyen ,&nbsp;Kevin Hakimi ,&nbsp;Masaki Kobayashi ,&nbsp;Shohei Fukuda ,&nbsp;Marco Paciotti ,&nbsp;Massimo Lazzeri ,&nbsp;Giovanni Lughezzani ,&nbsp;Nicolò M. Buffi ,&nbsp;Yasuhisa Fujii ,&nbsp;Ithaar H. Derweesh","doi":"10.1016/j.clgc.2024.102232","DOIUrl":"10.1016/j.clgc.2024.102232","url":null,"abstract":"<div><h3>Objective</h3><div>We sought to develop a preoperative nomogram called NODESAFE (NODE SAFEty) to predict nodal involvement (NI) at time of surgery or subsequent follow up in localized renal cell carcinoma (RCC), as the role of lymphadenectomy in localized RCC remains controversial.</div></div><div><h3>Methods</h3><div>We conducted a multicenter retrospective analysis of RCC patients who underwent primary surgical resection. Patients with clinical metastasis at presentation were excluded. NI was defined as presence of histological RCC with lymphadenectomy at time of surgery, or subsequent development histologically proven NI. The dataset was divided into training (70%) and testing subsets to facilitate model evaluation which was constructed through a stepwise multivariable logistic regression (MLR) model. Accuracy was tested with receiver operator characteristic estimated area under the curve (AUC).</div></div><div><h3>Results</h3><div>Total 3308 patients (2221 [67.1%] male) met inclusion criteria. During follow-up 25 patients (0.76 %) experienced nodal recurrence, and 22/25 were preoperatively classified as cN0. In our cohort, 112 (3.4%) patients had clinical lymphadenopathy preoperatively (cN1), and 34/112 were pN1. The following covariates were found to be statically significant on a MLR model: hypertension (Odds ratio [OR] 3.35, &lt; .001), Charlson Comorbidity Index ≥ 5 (OR 1.93 <em>P</em> = .025), tumor size ≥ 6 cm (OR 2.63, <em>P</em> = .001), tumor necrosis at CT scan (OR 1.83, <em>P</em> = .036), cN1 (OR 5.59, <em>P</em> &lt; .001) and CRP ≥ 8.5 mg/L (1.96, <em>P</em> = .018). Testing the prediction performance of the model in the validation set AUC of the model was 0.89. NODESAFE demonstrated a sensitivity of 83.9%, specificity of 86.1% and 99.1% negative predictive values using a 4% threshold probability.</div></div><div><h3>Conclusion</h3><div>Combining clinical features, serum biomarkers and radiographic findings, we developed a model capable of predicting NI with high degree of accuracy. NODESAFE may refine clinical decision making with respect to the performance of lymphadenectomy at the time of surgery, postsurgical surveillance, and spur consideration for adjuvant therapy.</div></div>","PeriodicalId":10380,"journal":{"name":"Clinical genitourinary cancer","volume":"22 6","pages":"Article 102232"},"PeriodicalIF":2.3,"publicationDate":"2024-10-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142552863","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":"High Sensitivity Circulating Tumor-DNA Assays in Renal Cell Carcinoma–Are we there yet?","authors":"Fady Sidhom ,&nbsp;Shefali Patel ,&nbsp;Arpita Desai ,&nbsp;Arnab Basu","doi":"10.1016/j.clgc.2024.102235","DOIUrl":"10.1016/j.clgc.2024.102235","url":null,"abstract":"<div><div>As therapeutics in renal cell carcinoma (RCC) continues to advance with approval of novel treatments and recently, adjuvant therapy, the need for highly sensitive tests that go beyond traditional methods to measure disease is becoming more crucial. Tumor informed high sensitivity circulating tumor DNA (ctDNA) assays originally developed for detection of minimal residual disease (MRD) theoretically could be utilized for initial detection of occult disease but also potentially for risk and response assessment in the management of advanced RCC. There are concerns related to the sensitivity of ctDNA based assays in RCC. This article aims to summarize the available evidence for high sensitivity MRD assays in RCC. We included studies with both localized and metastatic stages of RCC. The studies show a varying sensitivity depending on disease settings but a high specificity (∼100%) regardless. Detectable ctDNA appeared to be a significant negative prognostic risk factor for subsequent progressive disease. ctDNA may provide significant lead time allowing physicians to adapt therapy. Several high sensitivity assays with novel analytic approaches are in development for solid tumors including RCC.</div></div>","PeriodicalId":10380,"journal":{"name":"Clinical genitourinary cancer","volume":"22 6","pages":"Article 102235"},"PeriodicalIF":2.3,"publicationDate":"2024-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142634594","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}