Pub Date : 2025-03-01DOI: 10.1016/j.urolonc.2024.12.074
Juan Javier-DesLoges MD, Ana Flores Pimentel, Yu-Wei Chen MD, Yasoda Satpathy, James Michael Randall MD, Christopher Kane MD, Lisa Madlensky PhD, Matthew Savage PhD, Samuel Pena, Tyler Stewart MD, Aditya Bagrodia MD, Rana McKay MD
<div><h3>Introduction</h3><div>Germline testing is recommended for patients with high risk localized, locally advanced, and metastatic prostate cancer. Despite this recommendation, implementation of germline testing in prostate cancer has been suboptimal. There is a need for novel strategies to engage oncology clinicians and patients in germline testing and integrate germline testing into the clinic.</div></div><div><h3>Methods</h3><div>We designed a single-arm investigator-initiated study utilizing video education as a means of delivering pre-test counseling to patients who meet the National Cancer Comprehensive Network testing criteria for germline testing. Inclusion criteria includes men greater than or equal to 18 years of age, diagnosis of prostate cancer of any histology, and NCCN indication for germline testing. Patients who consented to the study underwent a one-on-one in-person education session with an educational video about germline testing. Patients completed pre and post-intervention questionnaires to assess their knowledge and satisfaction with the intervention. The primary endpoint was the proportion of patients who underwent germline testing among those enrolled to the study. Key secondary endpoints include the impact of education intervention on change in knowledge of germline testing and patient perceptions of germline testing.</div></div><div><h3>Results</h3><div>The study enrolled a total of 58 patients, 50 patients completed the study protocol. The majority of patients were White 78.0% (39/50), Non-Hispanic 92.0% (46/50), spoke English 98.0% (49/50), and were college educated 70% (35/50). The majority of patients had high risk localized disease 46.0% (23/50) or metastatic castrate sensitive prostate cancer 26.0% (13/5). Overall, 82.0% (41/50) of patients choose to participate in germline testing following the intervention. Of the tests ordered, 26.0% (13/50) were by urologists and 74.0% (37/50) were by medical oncologists. In this cohort 12.0% (6/50) of patients had a P/LP mutation, 14.0% (7/50) had a VUS. The most important factor influencing patients to pursue genetic testing would be if the results guide treatment selection. The most important factor influencing patients to not pursue genetic testing would be if the results had no clinical value. Most patients had a high level of understanding of genetics knowledge prior to the intervention with a mean score of 9.1 out of 11 in the genetics knowledge test. There was no significant increase or decrease genetics knowledge after the intervention (p = 0.88). A majority of patients were satisfied with the intervention and found it useful 94% (47/50).</div></div><div><h3>Conclusions</h3><div>The uptake of germline testing after the video intervention was high, most patients already had an understanding of genetics, but were more likely to pursue testing after the intervention and if it would influence their treatment. Furthermore, utilization of virtual educational aids should
{"title":"IMPROVING GERMLINE TESTING IN AT-RISK PATIENTS WITH PROSTATE CANCER","authors":"Juan Javier-DesLoges MD, Ana Flores Pimentel, Yu-Wei Chen MD, Yasoda Satpathy, James Michael Randall MD, Christopher Kane MD, Lisa Madlensky PhD, Matthew Savage PhD, Samuel Pena, Tyler Stewart MD, Aditya Bagrodia MD, Rana McKay MD","doi":"10.1016/j.urolonc.2024.12.074","DOIUrl":"10.1016/j.urolonc.2024.12.074","url":null,"abstract":"<div><h3>Introduction</h3><div>Germline testing is recommended for patients with high risk localized, locally advanced, and metastatic prostate cancer. Despite this recommendation, implementation of germline testing in prostate cancer has been suboptimal. There is a need for novel strategies to engage oncology clinicians and patients in germline testing and integrate germline testing into the clinic.</div></div><div><h3>Methods</h3><div>We designed a single-arm investigator-initiated study utilizing video education as a means of delivering pre-test counseling to patients who meet the National Cancer Comprehensive Network testing criteria for germline testing. Inclusion criteria includes men greater than or equal to 18 years of age, diagnosis of prostate cancer of any histology, and NCCN indication for germline testing. Patients who consented to the study underwent a one-on-one in-person education session with an educational video about germline testing. Patients completed pre and post-intervention questionnaires to assess their knowledge and satisfaction with the intervention. The primary endpoint was the proportion of patients who underwent germline testing among those enrolled to the study. Key secondary endpoints include the impact of education intervention on change in knowledge of germline testing and patient perceptions of germline testing.</div></div><div><h3>Results</h3><div>The study enrolled a total of 58 patients, 50 patients completed the study protocol. The majority of patients were White 78.0% (39/50), Non-Hispanic 92.0% (46/50), spoke English 98.0% (49/50), and were college educated 70% (35/50). The majority of patients had high risk localized disease 46.0% (23/50) or metastatic castrate sensitive prostate cancer 26.0% (13/5). Overall, 82.0% (41/50) of patients choose to participate in germline testing following the intervention. Of the tests ordered, 26.0% (13/50) were by urologists and 74.0% (37/50) were by medical oncologists. In this cohort 12.0% (6/50) of patients had a P/LP mutation, 14.0% (7/50) had a VUS. The most important factor influencing patients to pursue genetic testing would be if the results guide treatment selection. The most important factor influencing patients to not pursue genetic testing would be if the results had no clinical value. Most patients had a high level of understanding of genetics knowledge prior to the intervention with a mean score of 9.1 out of 11 in the genetics knowledge test. There was no significant increase or decrease genetics knowledge after the intervention (p = 0.88). A majority of patients were satisfied with the intervention and found it useful 94% (47/50).</div></div><div><h3>Conclusions</h3><div>The uptake of germline testing after the video intervention was high, most patients already had an understanding of genetics, but were more likely to pursue testing after the intervention and if it would influence their treatment. Furthermore, utilization of virtual educational aids should ","PeriodicalId":23408,"journal":{"name":"Urologic Oncology-seminars and Original Investigations","volume":"43 3","pages":"Page 29"},"PeriodicalIF":2.4,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143509920","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}
Pub Date : 2025-03-01DOI: 10.1016/j.urolonc.2024.12.051
Cesare Saitta, Mimi V. Nguyen, Giacomo Musso, Kevin Hakimi, Dattatraya Patil, Hajime Tanaka, Luke Wang, Margaret F. Meagher, Dhruv Puri, Kit Yuen, Masaki Kobayashi, Shohei Fukuda, Giuseppe Garofano, Giovanni Lughezzani, Nicolò M. Buffi, Viraj Master, Ithaar H. Derweesh
Introduction
To compare outcomes in high-risk localized RCC (HRL-RCC) patients treated with adjuvant (AT) and neoadjuvant therapy (NT) utilizing a propensity score matched model (PSM)
Methods
We conducted a multicenter analysis for patients who underwent AT or NT. AT was defined as systemic therapy given postoperatively in absence of metastases; NT was presurgical therapy in setting of localized disease. AT and NT utilized included target molecular therapy (TMT) or immunotherapy (IO). PSM model was conducted using a nearest neighbor matching algorithm in a 1:2 ratio. Primary outcome was all-cause mortality (ACM); secondary outcomes were cancer-specific mortality (CSM) and recurrence. Cox regression multivariable analysis (MVA) was fitted to elucidate predictors of outcomes.
Results
After PSM 311 patients were analyzed [adjuvant n=221, 127 TMT vs. 94 IO; neoadjuvant n=90, 61 TMT vs. 29 IO]; median follow-up 44 (IQR 20-74) months. MVA revealed AT as associated with increased ACM (HR=1.97, p=0.007), CSM (HR=2.37, p=0.007) and recurrence (HR 1.64, p=0.02). Sub-analysis of AT cohort revealed IO to be associated with decreased ACM (HR 0.59, p=0.015). In the neoadjuvant cohort TMT and IO were associated with decreased ACM (HR 0.49; p=0.016; HR 0.32, p=0.016, respectively) and CSM risk (HR 0.47, p=0.036; HR 0.18, p=0.017).
Conclusions
Our findings suggest a potential advantage of NT for HRL-RCC. Adjuvant immunotherapy was associated with decreased risk of ACM, while in the neoadjuvant TMT and IO therapy had similar outcomes. Our findings call for consideration of a clinical trial to compare outcomes of AT vs. NT.
{"title":"PROPENSITY SCORE-MATCHED ANALYSIS OF NEOADJUVANT VS. ADJUVANT THERAPY IN RENAL CELL CARCINOMA","authors":"Cesare Saitta, Mimi V. Nguyen, Giacomo Musso, Kevin Hakimi, Dattatraya Patil, Hajime Tanaka, Luke Wang, Margaret F. Meagher, Dhruv Puri, Kit Yuen, Masaki Kobayashi, Shohei Fukuda, Giuseppe Garofano, Giovanni Lughezzani, Nicolò M. Buffi, Viraj Master, Ithaar H. Derweesh","doi":"10.1016/j.urolonc.2024.12.051","DOIUrl":"10.1016/j.urolonc.2024.12.051","url":null,"abstract":"<div><h3>Introduction</h3><div>To compare outcomes in high-risk localized RCC (HRL-RCC) patients treated with adjuvant (AT) and neoadjuvant therapy (NT) utilizing a propensity score matched model (PSM)</div></div><div><h3>Methods</h3><div>We conducted a multicenter analysis for patients who underwent AT or NT. AT was defined as systemic therapy given postoperatively in absence of metastases; NT was presurgical therapy in setting of localized disease. AT and NT utilized included target molecular therapy (TMT) or immunotherapy (IO). PSM model was conducted using a nearest neighbor matching algorithm in a 1:2 ratio. Primary outcome was all-cause mortality (ACM); secondary outcomes were cancer-specific mortality (CSM) and recurrence. Cox regression multivariable analysis (MVA) was fitted to elucidate predictors of outcomes.</div></div><div><h3>Results</h3><div>After PSM 311 patients were analyzed [adjuvant n=221, 127 TMT vs. 94 IO; neoadjuvant n=90, 61 TMT vs. 29 IO]; median follow-up 44 (IQR 20-74) months. MVA revealed AT as associated with increased ACM (HR=1.97, p=0.007), CSM (HR=2.37, p=0.007) and recurrence (HR 1.64, p=0.02). Sub-analysis of AT cohort revealed IO to be associated with decreased ACM (HR 0.59, p=0.015). In the neoadjuvant cohort TMT and IO were associated with decreased ACM (HR 0.49; p=0.016; HR 0.32, p=0.016, respectively) and CSM risk (HR 0.47, p=0.036; HR 0.18, p=0.017).</div></div><div><h3>Conclusions</h3><div>Our findings suggest a potential advantage of NT for HRL-RCC. Adjuvant immunotherapy was associated with decreased risk of ACM, while in the neoadjuvant TMT and IO therapy had similar outcomes. Our findings call for consideration of a clinical trial to compare outcomes of AT vs. NT.</div></div>","PeriodicalId":23408,"journal":{"name":"Urologic Oncology-seminars and Original Investigations","volume":"43 3","pages":"Page 20"},"PeriodicalIF":2.4,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143510047","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}
Pub Date : 2025-03-01DOI: 10.1016/j.urolonc.2024.12.048
Leilei Xia, Anosh Dadabhoy, Luis Santos Molina, Erika Wood, Yeonsoo Lee, Gus Miranda, Jie Cai, Hooman Djaladat, Anne Schuckman, Siamak Daneshmand
Introduction
S1011 trial showed no benefits of extended lymphadenectomy (ELND) compared to standard LND (SLND) in patients with muscle-invasive bladder cancer (MIBC) undergoing radical cystectomy (RC). Debate still exists regarding the role of ELND in selected patients. We aim to investigate the impact of level of nodal metastasis (N+) on outcomes and rate of skip nodal metastases.
Methods
Using our IRB approved perspective institutional database, we identified patients with cT2-4aN0M0 urothelial cancer who underwent RC and super-extended LND +/- neoadjuvant chemotherapy (NAC) between 2002 and 2023. Level of LNs were divided into 3 levels (Figure 1): level 1 – external/internal iliac, and obturator LNs (SLND); level 2 - common iliac, pre-sciatic, and pre-sacral LNs (ELND); level 3 - paraaortic and paracaval LNs (ELND) The cohort was stratified into three groups based on the highest level of N+. Skip N+ was defined as having level 2 or 3 N+ without having lower-level positive nodes.
Results
A total of 738 patients were included and N+ was seen in 159 (21.5%) patients. Among patients with N+, 100 (62.9%) had highest/only N+ at level 1, 22 (13.8%) had highest N+ at level 2, and 37 (23.3%) had highest N+ at level 3 (Figure 2). Only 7 (4.4%) patients had skip N+ including 3 (1.9%) skip level 2 and 4 (2.5%) skip level 3. Two-year (2-y) recurrence free survival (RFS) for node negative, level 1, level 2, and level 3 N+ was 81%, 52%, 36%, and 23%, respectively and 2-y overall survival (OS) were 82%, 60%, 49%, and 27%, respectively. For patients with level 1 N+ who did not receive peri-operative chemotherapy (n=38), 2-y RFS was 45% and 2-y OS was 43%. However, for patients with higher level (2-3) N+ who did not receive peri-operative chemotherapy (n=16), 14 (88%) died within 2 years and 10 (63%) died within 1 year.
Conclusions
The therapeutic benefit of ELND is very small for patients with higher level of N+ due to the poor prognosis without chemotherapy. The incidence of skip N+ is low and diagnostic benefit of ELND may also be limited. The role of ELND in the post-S1011 era may be very limited and further prospective studies are needed to identify if any MIBC patients benefit from ELND.
{"title":"LEVEL OF NODAL METASTASIS IN PATIENTS UNDERGOING RADICAL CYSTECTOMY AND LYMPHADENECTOMY: IS THERE A ROLE OF EXTENDED LYMPHADENECTOMY IN THE POST-S1011 ERA?","authors":"Leilei Xia, Anosh Dadabhoy, Luis Santos Molina, Erika Wood, Yeonsoo Lee, Gus Miranda, Jie Cai, Hooman Djaladat, Anne Schuckman, Siamak Daneshmand","doi":"10.1016/j.urolonc.2024.12.048","DOIUrl":"10.1016/j.urolonc.2024.12.048","url":null,"abstract":"<div><h3>Introduction</h3><div>S1011 trial showed no benefits of extended lymphadenectomy (ELND) compared to standard LND (SLND) in patients with muscle-invasive bladder cancer (MIBC) undergoing radical cystectomy (RC). Debate still exists regarding the role of ELND in selected patients. We aim to investigate the impact of level of nodal metastasis (N+) on outcomes and rate of skip nodal metastases.</div></div><div><h3>Methods</h3><div>Using our IRB approved perspective institutional database, we identified patients with cT2-4aN0M0 urothelial cancer who underwent RC and super-extended LND +/- neoadjuvant chemotherapy (NAC) between 2002 and 2023. Level of LNs were divided into 3 levels (Figure 1): level 1 – external/internal iliac, and obturator LNs (SLND); level 2 - common iliac, pre-sciatic, and pre-sacral LNs (ELND); level 3 - paraaortic and paracaval LNs (ELND) The cohort was stratified into three groups based on the highest level of N+. Skip N+ was defined as having level 2 or 3 N+ without having lower-level positive nodes.</div></div><div><h3>Results</h3><div>A total of 738 patients were included and N+ was seen in 159 (21.5%) patients. Among patients with N+, 100 (62.9%) had highest/only N+ at level 1, 22 (13.8%) had highest N+ at level 2, and 37 (23.3%) had highest N+ at level 3 (Figure 2). Only 7 (4.4%) patients had skip N+ including 3 (1.9%) skip level 2 and 4 (2.5%) skip level 3. Two-year (2-y) recurrence free survival (RFS) for node negative, level 1, level 2, and level 3 N+ was 81%, 52%, 36%, and 23%, respectively and 2-y overall survival (OS) were 82%, 60%, 49%, and 27%, respectively. For patients with level 1 N+ who did not receive peri-operative chemotherapy (n=38), 2-y RFS was 45% and 2-y OS was 43%. However, for patients with higher level (2-3) N+ who did not receive peri-operative chemotherapy (n=16), 14 (88%) died within 2 years and 10 (63%) died within 1 year.</div></div><div><h3>Conclusions</h3><div>The therapeutic benefit of ELND is very small for patients with higher level of N+ due to the poor prognosis without chemotherapy. The incidence of skip N+ is low and diagnostic benefit of ELND may also be limited. The role of ELND in the post-S1011 era may be very limited and further prospective studies are needed to identify if any MIBC patients benefit from ELND.</div></div>","PeriodicalId":23408,"journal":{"name":"Urologic Oncology-seminars and Original Investigations","volume":"43 3","pages":"Page 19"},"PeriodicalIF":2.4,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143510151","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}
Pub Date : 2025-03-01DOI: 10.1016/j.urolonc.2024.10.021
Paolo Traverso M.D., Ph.D. , Alessandro Carfì Ph.D. , Alessandra Bulanti M.Sc. , Martina Fabbi M.D. , Veronica Giasotto M.D. , Matilde Mattiauda M.D. , Lorenzo Lo Monaco M.D. , Stefano Tappero M.D. , Giovanni Guano M.D. , Federica Balzarini M.D. , Marco Borghesi M.D., Ph.D. , Fulvio Mastrogiovanni Ph.D. , Carlo Terrone M.D., Ph.D.
Objective
The Contact Surface Area (CSA) is a predictor for peri-operative parameters and represents the contact area between the tumor and the organ. A precise method for calculating CSA is yet to be found. We tested a new CSA calculation method as a predictor of intra-operative parameters in robot assisted partial nephrectomy (RAPN).
Materials & Methods
The study population consisted of all consecutive patients treated with RAPN at a single high-volume European institution (between 2020 to 2023; 82 patients). We proposed a new method to measure the real value of CSA using an algorithm that leverages the geometry of kidneys and tumors obtained from 3D reconstruction. These reconstructions were obtained using the certified software Materialized Mimics InPrint. The peri-operative parameters of patients were recorded in an anonymous database. We explored the correlation between real CSA (RCSA), CSA of Hsieh (HCSA), PADUA and R.E.N.A.L. scores with peri-operative parameters using Spearman's correlation. Furthermore, we examined which of RCSA, PADUA and R.E.N.A.L. score better describes the intra-operative parameters, Warm Ischemia Time (WIT), Operating Time (OT), and Estimated Blood Loss (EBL) using Receiver Operating Characteristic (ROC) curve analysis. Multivariable linear regression analyses were performed.
Results
Seventy-eight patients were prospectively enrolled. We observed a significant correlation between RCSA and WIT (P < 0.001), OT (P < 0.001) and EBL (P < 0.001). Moreover, RCSA outperformed both the PADUA and R.E.N.A.L. score as demonstrated in the ROC curve analysis. In ROC analysis was chosen a threshold for each of the parameters: for WIT 20 minutes, for OT 180 minutes and for EBL 200 mL. At multivariable regression analysis, RCSA emerged as the only independent predictor for WIT (P = 0.002), OT (P = 0.01) and EBL (P < 0.001).
Conclusions
Our original 3D RCSA calculation method was associated to intra-operative surgical outcomes. As compared to PADUA and RENAL score, our calculated RCSA represented a more reliable predictor of intra-operative parameters.
{"title":"Innovative 3D method predicts surgery outcomes by calculating real contact surface of renal tumor","authors":"Paolo Traverso M.D., Ph.D. , Alessandro Carfì Ph.D. , Alessandra Bulanti M.Sc. , Martina Fabbi M.D. , Veronica Giasotto M.D. , Matilde Mattiauda M.D. , Lorenzo Lo Monaco M.D. , Stefano Tappero M.D. , Giovanni Guano M.D. , Federica Balzarini M.D. , Marco Borghesi M.D., Ph.D. , Fulvio Mastrogiovanni Ph.D. , Carlo Terrone M.D., Ph.D.","doi":"10.1016/j.urolonc.2024.10.021","DOIUrl":"10.1016/j.urolonc.2024.10.021","url":null,"abstract":"<div><h3>Objective</h3><div>The Contact Surface Area (CSA) is a predictor for peri-operative parameters and represents the contact area between the tumor and the organ. A precise method for calculating CSA is yet to be found. We tested a new CSA calculation method as a predictor of intra-operative parameters in robot assisted partial nephrectomy (RAPN).</div></div><div><h3>Materials & Methods</h3><div>The study population consisted of all consecutive patients treated with RAPN at a single high-volume European institution (between 2020 to 2023; 82 patients). We proposed a new method to measure the real value of CSA using an algorithm that leverages the geometry of kidneys and tumors obtained from 3D reconstruction. These reconstructions were obtained using the certified software Materialized Mimics InPrint. The peri-operative parameters of patients were recorded in an anonymous database. We explored the correlation between real CSA (RCSA), CSA of Hsieh (HCSA), PADUA and R.E.N.A.L. scores with peri-operative parameters using Spearman's correlation. Furthermore, we examined which of RCSA, PADUA and R.E.N.A.L. score better describes the intra-operative parameters, Warm Ischemia Time (WIT), Operating Time (OT), and Estimated Blood Loss (EBL) using Receiver Operating Characteristic (ROC) curve analysis. Multivariable linear regression analyses were performed.</div></div><div><h3>Results</h3><div>Seventy-eight patients were prospectively enrolled. We observed a significant correlation between RCSA and WIT (<em>P <</em> 0.001), OT (<em>P <</em> 0.001) and EBL (<em>P <</em> 0.001). Moreover, RCSA outperformed both the PADUA and R.E.N.A.L. score as demonstrated in the ROC curve analysis. In ROC analysis was chosen a threshold for each of the parameters: for WIT 20 minutes, for OT 180 minutes and for EBL 200 mL. At multivariable regression analysis, RCSA emerged as the only independent predictor for WIT (<em>P =</em> 0.002), OT (<em>P =</em> 0.01) and EBL (<em>P <</em> 0.001).</div></div><div><h3>Conclusions</h3><div>Our original 3D RCSA calculation method was associated to intra-operative surgical outcomes. As compared to PADUA and RENAL score, our calculated RCSA represented a more reliable predictor of intra-operative parameters.</div></div>","PeriodicalId":23408,"journal":{"name":"Urologic Oncology-seminars and Original Investigations","volume":"43 3","pages":"Pages 192.e11-192.e19"},"PeriodicalIF":2.4,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142628963","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}
Pub Date : 2025-03-01DOI: 10.1016/j.urolonc.2024.12.267
Giuseppe Fallara M.D. , Federico Belladelli M.D. , Daniele Robesti M.D. , Bernard Malavaud M.D., Ph.D. , Côme Tholomier M.D. , Sharada Mokkapati Ph.D. , Francesco Montorsi M.D. , Colin P. Dinney M.D. , Pavlos Msaouel M.D., Ph.D. , Alberto Martini M.D.
Objectives
Survival outcomes of patients with metastatic urothelial carcinoma (mUC) are still suboptimal and strategies to enhance response to immune-oncology (IO) compounds are under scrutiny. In preclinical studies, it has been demonstrated that antihistamines may reverse macrophage immunosuppression, reactivate T cell cytotoxicity, and enhance the immunotherapy response. We aimed to evaluate the role of concomitant antihistamines administration on oncological outcomes among patients with mUC.
Materials and Methods
We relied on individual patient data from IMvigor210 (phase II single-arm trial on second line atezolizumab for mUC) and IMvigor211 trials (phase III randomized trial on second line atezolizumab vs chemotherapy for mUC). Among individuals treated with IO we identified patients who did and did not receive antihistamines. Multivariable Cox or competing-risks regression models were used to predict progression-free survival (PFS), overall survival (OS), and cancer-specific survival (CSS). The impact of antihistamines on the outcomes was assessed after adjusting for potential confounders.
Results
Among 896 patients with locally advanced or metastatic urothelial cancer who had progressed after first-line chemotherapy, 155 (17 %) received antihistamines during the delivery of IO. Patients receiving antihistamines had longer OS (Hazard Ratio [HR]:0.59; 95 % Confidence interval [CI]: 0.47-0.74; P < 0.001), PFS (HR:0.70; 95 %CI: 0.57-0.87; P = 0.001) and CSS [sHR:0.58; 95 %CI:0.45-0.75; P < 0.001)] relative to those who had not used antihistamine drugs. A sensitivity analysis, after the exclusion of patients who experienced adverse events and received antihistamines, yielded similar findings of prolonged CSS (sHR 0.78; 95 %CI: 0.59-0.98, P = 0.031) and OS (HR 0.71; 95 %CI: 0.52-0.94, P = 0.021).
Conclusions
Concomitant antihistamines administration was associated with improved OS, CSS, and PFS in patients receiving atezolizumab as second line treatment for mUC. Further mechanistic and clinical investigation is warranted to elucidate the role of antihistamines in IO.
{"title":"Concomitant antihistamine administration is associated with improved survival outcomes in patients with locally advanced or metastatic urothelial carcinoma treated with atezolizumab. Analysis of individual participant data from IMvigor210 and IMvigor211","authors":"Giuseppe Fallara M.D. , Federico Belladelli M.D. , Daniele Robesti M.D. , Bernard Malavaud M.D., Ph.D. , Côme Tholomier M.D. , Sharada Mokkapati Ph.D. , Francesco Montorsi M.D. , Colin P. Dinney M.D. , Pavlos Msaouel M.D., Ph.D. , Alberto Martini M.D.","doi":"10.1016/j.urolonc.2024.12.267","DOIUrl":"10.1016/j.urolonc.2024.12.267","url":null,"abstract":"<div><h3>Objectives</h3><div>Survival outcomes of patients with metastatic urothelial carcinoma (mUC) are still suboptimal and strategies to enhance response to immune-oncology (IO) compounds are under scrutiny. In preclinical studies, it has been demonstrated that antihistamines may reverse macrophage immunosuppression, reactivate T cell cytotoxicity, and enhance the immunotherapy response. We aimed to evaluate the role of concomitant antihistamines administration on oncological outcomes among patients with mUC.</div></div><div><h3>Materials and Methods</h3><div>We relied on individual patient data from IMvigor210 (phase II single-arm trial on second line atezolizumab for mUC) and IMvigor211 trials (phase III randomized trial on second line atezolizumab vs chemotherapy for mUC). Among individuals treated with IO we identified patients who did and did not receive antihistamines. Multivariable Cox or competing-risks regression models were used to predict progression-free survival (PFS), overall survival (OS), and cancer-specific survival (CSS). The impact of antihistamines on the outcomes was assessed after adjusting for potential confounders.</div></div><div><h3>Results</h3><div>Among 896 patients with locally advanced or metastatic urothelial cancer who had progressed after first-line chemotherapy, 155 (17 %) received antihistamines during the delivery of IO. Patients receiving antihistamines had longer OS (Hazard Ratio [HR]:0.59; 95 % Confidence interval [CI]: 0.47-0.74; <em>P</em> < 0.001), PFS (HR:0.70; 95 %CI: 0.57-0.87; <em>P</em> = 0.001) and CSS [sHR:0.58; 95 %CI:0.45-0.75; <em>P</em> < 0.001)] relative to those who had not used antihistamine drugs. A sensitivity analysis, after the exclusion of patients who experienced adverse events and received antihistamines, yielded similar findings of prolonged CSS (sHR 0.78; 95 %CI: 0.59-0.98, <em>P</em> = 0.031) and OS (HR 0.71; 95 %CI: 0.52-0.94, <em>P</em> = 0.021).</div></div><div><h3>Conclusions</h3><div>Concomitant antihistamines administration was associated with improved OS, CSS, and PFS in patients receiving atezolizumab as second line treatment for mUC. Further mechanistic and clinical investigation is warranted to elucidate the role of antihistamines in IO.</div></div>","PeriodicalId":23408,"journal":{"name":"Urologic Oncology-seminars and Original Investigations","volume":"43 3","pages":"Pages 188.e9-188.e17"},"PeriodicalIF":2.4,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142955740","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}
Pub Date : 2025-03-01DOI: 10.1016/j.urolonc.2024.12.004
Ruij Liu
Introduction
A growing number of studies have shown that Yin Yang 1 (YY1) promotes the development of multiple tumors. Here we aimed to uncover the underlying mechanisms by which YY1 mediates neuroendocrine differentiation of prostate cancer (NEPC) cells undergoing cellular plasticity.
Methods
Bioinformatics analysis was performed to determine the expression of YY1 in different types of prostate cancer. Aberrant YY1 expression was validated in PCa tissues and cell lines via qRT-PCR. In vitro and in vivo functional experiments were performed to evaluate the role of YY1 in PCa malignancy. RNA sequencing, luciferase reporter assay and ChIP-PCR were used to identify the key downstream genes regulated by YY1. Ubiquitination modification and interaction between proteins were detected via Co-IP and western blotting.
Results
Using the TCGA and GEO databases, we bioinformatically analyzed the expression of YY1 in prostate cancer (PCa). Aberrant YY1 expression was validated in different PCa tissues and cell lines via RT qPCR, western blotting, and IHC. In vivo and in vitro functional assays verified the oncogenicity of YY1 in PCa. Bioinformatics analysis revealed aberrant YY1 expression in primary PCa, which was further validated in CRPC and NEPC tissues. Proliferation and metastasis of PCa cells were demonstrated in vitro and in vivo by functional assays. Further functional assays showed that ectopic expression of YY1 promoted cellular plasticity in PCa cells through epithelial-mesenchymal transition (EMT) induction and NE differentiation. Mechanically, androgen deprivation therapy (ADT) induces a decrease in ubiquitination of YY1 protein, enhances its stability, and thus enhances the transcriptional activity of FZD8. Castration enhances the binding of FZD8 to Wnt9A and mediates cellular plasticity by activating the noncanonical Wnt (FZD8/FYN/STAT3) pathway.
Conclusions
We identified YY1 as a novel dysregulated transcription factor that plays an important role in NEPC progression in this study. We hypothesize that an in-depth investigation of the underlying mechanisms of YY1-mediated disease may lead to improved NEPC therapies.
{"title":"THE NONCANONICAL WNT PATHWAY (FYN/STAT3) ACTIVATED BY YY1 PROMOTES THE NEUROENDOCRINE DIFFERENTIATION OF PROSTATE CANCER CELLS.","authors":"Ruij Liu","doi":"10.1016/j.urolonc.2024.12.004","DOIUrl":"10.1016/j.urolonc.2024.12.004","url":null,"abstract":"<div><h3>Introduction</h3><div>A growing number of studies have shown that Yin Yang 1 (YY1) promotes the development of multiple tumors. Here we aimed to uncover the underlying mechanisms by which YY1 mediates neuroendocrine differentiation of prostate cancer (NEPC) cells undergoing cellular plasticity.</div></div><div><h3>Methods</h3><div>Bioinformatics analysis was performed to determine the expression of YY1 in different types of prostate cancer. Aberrant YY1 expression was validated in PCa tissues and cell lines via qRT-PCR. In vitro and in vivo functional experiments were performed to evaluate the role of YY1 in PCa malignancy. RNA sequencing, luciferase reporter assay and ChIP-PCR were used to identify the key downstream genes regulated by YY1. Ubiquitination modification and interaction between proteins were detected via Co-IP and western blotting.</div></div><div><h3>Results</h3><div>Using the TCGA and GEO databases, we bioinformatically analyzed the expression of YY1 in prostate cancer (PCa). Aberrant YY1 expression was validated in different PCa tissues and cell lines via RT qPCR, western blotting, and IHC. In vivo and in vitro functional assays verified the oncogenicity of YY1 in PCa. Bioinformatics analysis revealed aberrant YY1 expression in primary PCa, which was further validated in CRPC and NEPC tissues. Proliferation and metastasis of PCa cells were demonstrated in vitro and in vivo by functional assays. Further functional assays showed that ectopic expression of YY1 promoted cellular plasticity in PCa cells through epithelial-mesenchymal transition (EMT) induction and NE differentiation. Mechanically, androgen deprivation therapy (ADT) induces a decrease in ubiquitination of YY1 protein, enhances its stability, and thus enhances the transcriptional activity of FZD8. Castration enhances the binding of FZD8 to Wnt9A and mediates cellular plasticity by activating the noncanonical Wnt (FZD8/FYN/STAT3) pathway.</div></div><div><h3>Conclusions</h3><div>We identified YY1 as a novel dysregulated transcription factor that plays an important role in NEPC progression in this study. We hypothesize that an in-depth investigation of the underlying mechanisms of YY1-mediated disease may lead to improved NEPC therapies.</div></div>","PeriodicalId":23408,"journal":{"name":"Urologic Oncology-seminars and Original Investigations","volume":"43 3","pages":"Page 1"},"PeriodicalIF":2.4,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143509346","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}
Pub Date : 2025-03-01DOI: 10.1016/j.urolonc.2024.12.028
Madison Krischak, David Elliott, Zach Landis-Lewis, Patrick Lewicki, Gretchen Piatt, Todd Morgan, Geoffrey Barnes, Alex Bryant, Megan Caram, Phoebe Tsao, Molly Harrod, Ted Skolarus, Anne Sales, Kristian Stensland
<div><h3>Introduction</h3><div>Clinical trials advance science and provide innovative care that is sometimes the only treatment option for people with cancer. Some groups do not have access to clinical trials, excluding them from the benefits of trial participation, and could be considered “scientifically underserved”. Specific to Veterans with prostate cancer, it is unclear how frequently and where prostate cancer clinical trials are offered within the VA, and who may be scientifically underserved. Describing these gaps could identify opportunities for improving Veteran access to cancer clinical trials, ensuring Veterans are afforded the benefits of clinical trial enrollment. To understand gaps in access, we assessed VA site inclusion in prostate cancer clinical trials registered on ClinicalTrials.gov.</div></div><div><h3>Methods</h3><div>In March 2024, using a Python script, we identified all phase 2-3 prostate cancer clinical trial records registered on ClinicalTrials.gov after January 1, 2007, and extracted trial site information. A custom algorithm was used to identify VA sites recorded on ClinicalTrials.gov. We identified the number of unique trials hosted at each VA grouped by trial phase and overall trial status. We manually identified the total number of VA hospitals from the VA directory (va.gov/directory), grouping hospitals by unique address and manually removing duplicates. We then described the proportion of VA sites hosting at least 1 clinical trial, and the proportion of trials with at least 1 VA site. We further identified geographic variation in trial availability by describing the proportion of VA facilities in each census division with at least 1 prostate cancer trial.</div></div><div><h3>Results</h3><div>Of 1,884 registered phase 2 or 3 prostate cancer clinical trials, 118 (6%) included at least one VA site. Of 353 phase 3 trials, 55 (16%) included at least 1 VA site. Of 159 identified VA facilities, 66 (42%) have had at least one phase 2 or 3 prostate cancer clinical trial, while 58 (36%) have had at least one phase 3 trial. As of March 2024, there were 53 VA sites (33%) with a currently active phase 3 prostate cancer clinical trial, 60 (38%) with an active phase 2 or 3 prostate cancer clinical trial, and 8 sites (5%) with >10 currently active prostate cancer clinical trials. Availability of prostate cancer trials at VA sites within census divisions ranged from 3 of 10 VA facilities in the New England census division to 10 of 19 VA facilities in the Pacific census division.</div></div><div><h3>Conclusions</h3><div>Veterans treated at VA facilities have access to only 6% of prostate cancer clinical trials. Further, less than half of VA hospitals are sites for at least one prostate cancer clinical trial, and only a third have had a phase 3 prostate cancer clinical trial. There was some geographic variation in VA trial availability, with a higher proportion of Pacific division VA facilities offering trials than New England o
{"title":"ARE VETERANS WITH PROSTATE CANCER SCIENTIFICALLY UNDERSERVED? DESCRIBING ACCESS TO PROSTATE CANCER CLINICAL TRIALS IN THE VA","authors":"Madison Krischak, David Elliott, Zach Landis-Lewis, Patrick Lewicki, Gretchen Piatt, Todd Morgan, Geoffrey Barnes, Alex Bryant, Megan Caram, Phoebe Tsao, Molly Harrod, Ted Skolarus, Anne Sales, Kristian Stensland","doi":"10.1016/j.urolonc.2024.12.028","DOIUrl":"10.1016/j.urolonc.2024.12.028","url":null,"abstract":"<div><h3>Introduction</h3><div>Clinical trials advance science and provide innovative care that is sometimes the only treatment option for people with cancer. Some groups do not have access to clinical trials, excluding them from the benefits of trial participation, and could be considered “scientifically underserved”. Specific to Veterans with prostate cancer, it is unclear how frequently and where prostate cancer clinical trials are offered within the VA, and who may be scientifically underserved. Describing these gaps could identify opportunities for improving Veteran access to cancer clinical trials, ensuring Veterans are afforded the benefits of clinical trial enrollment. To understand gaps in access, we assessed VA site inclusion in prostate cancer clinical trials registered on ClinicalTrials.gov.</div></div><div><h3>Methods</h3><div>In March 2024, using a Python script, we identified all phase 2-3 prostate cancer clinical trial records registered on ClinicalTrials.gov after January 1, 2007, and extracted trial site information. A custom algorithm was used to identify VA sites recorded on ClinicalTrials.gov. We identified the number of unique trials hosted at each VA grouped by trial phase and overall trial status. We manually identified the total number of VA hospitals from the VA directory (va.gov/directory), grouping hospitals by unique address and manually removing duplicates. We then described the proportion of VA sites hosting at least 1 clinical trial, and the proportion of trials with at least 1 VA site. We further identified geographic variation in trial availability by describing the proportion of VA facilities in each census division with at least 1 prostate cancer trial.</div></div><div><h3>Results</h3><div>Of 1,884 registered phase 2 or 3 prostate cancer clinical trials, 118 (6%) included at least one VA site. Of 353 phase 3 trials, 55 (16%) included at least 1 VA site. Of 159 identified VA facilities, 66 (42%) have had at least one phase 2 or 3 prostate cancer clinical trial, while 58 (36%) have had at least one phase 3 trial. As of March 2024, there were 53 VA sites (33%) with a currently active phase 3 prostate cancer clinical trial, 60 (38%) with an active phase 2 or 3 prostate cancer clinical trial, and 8 sites (5%) with >10 currently active prostate cancer clinical trials. Availability of prostate cancer trials at VA sites within census divisions ranged from 3 of 10 VA facilities in the New England census division to 10 of 19 VA facilities in the Pacific census division.</div></div><div><h3>Conclusions</h3><div>Veterans treated at VA facilities have access to only 6% of prostate cancer clinical trials. Further, less than half of VA hospitals are sites for at least one prostate cancer clinical trial, and only a third have had a phase 3 prostate cancer clinical trial. There was some geographic variation in VA trial availability, with a higher proportion of Pacific division VA facilities offering trials than New England o","PeriodicalId":23408,"journal":{"name":"Urologic Oncology-seminars and Original Investigations","volume":"43 3","pages":"Page 11"},"PeriodicalIF":2.4,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143509708","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}
Pub Date : 2025-03-01DOI: 10.1016/j.urolonc.2024.12.030
John Pfail, Alain Kaldany, Rachel Passarelli, Melinda Fu, Benjamin Lichtbroun, Kevin Chua, Vignesh Packiam, David Golombos, Thomas Jang, Saum Ghodoussipour
Introduction
Historically, outcomes have been similar among patients undergoing continent and incontinent diversion at time of radical cystectomy, with no difference in complication rates. Given the decreasing rates of continent diversion, we sought to examine postoperative complication rates based on type of diversion in a contemporary cohort.
Methods
Data was extracted from the National Surgical Quality Improvement Program (NSQIP) database including all patients from 2019-2021 who underwent radical cystectomy. Patients were stratified based on diversion type. Statistical endpoints included thirty-day complications, length of stay (LOS), and readmissions. Optimal RC outcome was defined as absence of any postoperative complication, reoperation, prolonged LOS (75th percentile, 8 days) with no readmission. Multivariable analyses with Bonferroni correction were performed to assess the association between urinary diversion and postoperative outcomes in patients undergoing RC.
Results
A total of 4375 patients were identified, including 3780 (86.4%) who underwent incontinent diversion and 595 (13.6%) who underwent continent diversion. Compared to patients with continent diversion, those with incontinent diversion were more likely to be older, female, have higher ASA, worse renal function, robotic/laparoscopic approach, history of radiation or pelvic surgery, and higher stage (Table 1). On multivariable analysis, after Bonferroni adjustment, patients with continent diversion had increased odds of high grade complications (OR 1.58; 99% CI [1.15-2.15]) and readmission (OR 1.7 [1.28-2.27]) as well as lower odds of an optimal outcome (OR 0.74 [0.58-0.95]) compared to incontinent diversion (Figure 1).
Conclusions
In a contemporary cohort of patients undergoing radical cystectomy, odds of adverse postoperative outcomes were increased among those undergoing continent diversion compared to incontinent diversion, despite more favorable baseline characteristics in this cohort.
{"title":"A COMPARATIVE ANALYSIS OF COMPLICATION RATES IN URINARY DIVERSIONS: EXPLORING THE IMPACT OF CONTEMPORARY SURGICAL TRENDS","authors":"John Pfail, Alain Kaldany, Rachel Passarelli, Melinda Fu, Benjamin Lichtbroun, Kevin Chua, Vignesh Packiam, David Golombos, Thomas Jang, Saum Ghodoussipour","doi":"10.1016/j.urolonc.2024.12.030","DOIUrl":"10.1016/j.urolonc.2024.12.030","url":null,"abstract":"<div><h3>Introduction</h3><div>Historically, outcomes have been similar among patients undergoing continent and incontinent diversion at time of radical cystectomy, with no difference in complication rates. Given the decreasing rates of continent diversion, we sought to examine postoperative complication rates based on type of diversion in a contemporary cohort.</div></div><div><h3>Methods</h3><div>Data was extracted from the National Surgical Quality Improvement Program (NSQIP) database including all patients from 2019-2021 who underwent radical cystectomy. Patients were stratified based on diversion type. Statistical endpoints included thirty-day complications, length of stay (LOS), and readmissions. Optimal RC outcome was defined as absence of any postoperative complication, reoperation, prolonged LOS (75th percentile, 8 days) with no readmission. Multivariable analyses with Bonferroni correction were performed to assess the association between urinary diversion and postoperative outcomes in patients undergoing RC.</div></div><div><h3>Results</h3><div>A total of 4375 patients were identified, including 3780 (86.4%) who underwent incontinent diversion and 595 (13.6%) who underwent continent diversion. Compared to patients with continent diversion, those with incontinent diversion were more likely to be older, female, have higher ASA, worse renal function, robotic/laparoscopic approach, history of radiation or pelvic surgery, and higher stage (Table 1). On multivariable analysis, after Bonferroni adjustment, patients with continent diversion had increased odds of high grade complications (OR 1.58; 99% CI [1.15-2.15]) and readmission (OR 1.7 [1.28-2.27]) as well as lower odds of an optimal outcome (OR 0.74 [0.58-0.95]) compared to incontinent diversion (Figure 1).</div></div><div><h3>Conclusions</h3><div>In a contemporary cohort of patients undergoing radical cystectomy, odds of adverse postoperative outcomes were increased among those undergoing continent diversion compared to incontinent diversion, despite more favorable baseline characteristics in this cohort.</div></div>","PeriodicalId":23408,"journal":{"name":"Urologic Oncology-seminars and Original Investigations","volume":"43 3","pages":"Pages 11-12"},"PeriodicalIF":2.4,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143509710","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}
Pub Date : 2025-03-01DOI: 10.1016/j.urolonc.2024.12.024
Madison Krischak, Alice Semerjian, Gretchen Piatt, Zach Landis-Lewis, Geoffrey Barnes, Patrick Lewicki, Todd Morgan, Megan Caram, Lindsey Herrel, Anne Sales, Ted Skolarus, Kristian Stensland
Introduction
Clinical trials should reflect the population affected by the disease under study. While urologic cancers occur more frequently in men, there is still a significant incidence in women. Whether women are proportionately represented in urologic oncology clinical trials is not known. Ensuring representative enrollment is crucial for the generalizability of trial outcomes and addressing potential gender disparities in treatment efficacy and safety. This analysis examines enrollment of women in urologic oncology clinical trials compared to the estimated incidence of these cancers among women.
Methods
Enrollment demographics were extracted from the Aggregate Analysis of ClinicalTrials.gov database for bladder and kidney cancer trials registered since 1/1/2007. Trials with results reported were included. The proportion of female enrollees in each trial was calculated from aggregate result tables. Trials were then coded by cancer type, and descriptive statistics were calculated for proportion of women enrolled for trials of each cancer type. These proportions were compared to the proportion of incident cancers estimated by the American Cancer Society.
Results
There were 590 cancer trials included in the analysis, with 414 kidney and 176 bladder trials. The median proportion of women in kidney cancer trials was 29% (IQR 23-37%), with a mean of 31%. The expected proportion based on estimated proportional incidence of kidney cancer in women is 36%. Among bladder cancer trials, the median proportion of women was 22% (IQR 16-30%), with a mean of 25%, which is similar to the estimated proportional incidence of bladder cancer in women (24%).
Conclusions
The proportion of women enrolled in kidney cancer clinical trials is below what is expected based on annual incident proportions, falling short by approximately 1 in 14 women with kidney cancer. Meanwhile, bladder cancer trials enrolled the expected proportion of women with bladder cancer. Further work is needed to ensure adequate representation of women in kidney cancer trials, especially for advanced and metastatic settings. While women are not currently underserved in bladder cancer trials, efforts should continue to maintain representative enrollment of women to ensure equitable and effective urologic cancer treatment across sexes and genders.
{"title":"ARE WOMEN UNDERREPRESENTED IN UROLOGIC ONCOLOGY CLINICAL TRIALS?","authors":"Madison Krischak, Alice Semerjian, Gretchen Piatt, Zach Landis-Lewis, Geoffrey Barnes, Patrick Lewicki, Todd Morgan, Megan Caram, Lindsey Herrel, Anne Sales, Ted Skolarus, Kristian Stensland","doi":"10.1016/j.urolonc.2024.12.024","DOIUrl":"10.1016/j.urolonc.2024.12.024","url":null,"abstract":"<div><h3>Introduction</h3><div>Clinical trials should reflect the population affected by the disease under study. While urologic cancers occur more frequently in men, there is still a significant incidence in women. Whether women are proportionately represented in urologic oncology clinical trials is not known. Ensuring representative enrollment is crucial for the generalizability of trial outcomes and addressing potential gender disparities in treatment efficacy and safety. This analysis examines enrollment of women in urologic oncology clinical trials compared to the estimated incidence of these cancers among women.</div></div><div><h3>Methods</h3><div>Enrollment demographics were extracted from the Aggregate Analysis of ClinicalTrials.gov database for bladder and kidney cancer trials registered since 1/1/2007. Trials with results reported were included. The proportion of female enrollees in each trial was calculated from aggregate result tables. Trials were then coded by cancer type, and descriptive statistics were calculated for proportion of women enrolled for trials of each cancer type. These proportions were compared to the proportion of incident cancers estimated by the American Cancer Society.</div></div><div><h3>Results</h3><div>There were 590 cancer trials included in the analysis, with 414 kidney and 176 bladder trials. The median proportion of women in kidney cancer trials was 29% (IQR 23-37%), with a mean of 31%. The expected proportion based on estimated proportional incidence of kidney cancer in women is 36%. Among bladder cancer trials, the median proportion of women was 22% (IQR 16-30%), with a mean of 25%, which is similar to the estimated proportional incidence of bladder cancer in women (24%).</div></div><div><h3>Conclusions</h3><div>The proportion of women enrolled in kidney cancer clinical trials is below what is expected based on annual incident proportions, falling short by approximately 1 in 14 women with kidney cancer. Meanwhile, bladder cancer trials enrolled the expected proportion of women with bladder cancer. Further work is needed to ensure adequate representation of women in kidney cancer trials, especially for advanced and metastatic settings. While women are not currently underserved in bladder cancer trials, efforts should continue to maintain representative enrollment of women to ensure equitable and effective urologic cancer treatment across sexes and genders.</div></div>","PeriodicalId":23408,"journal":{"name":"Urologic Oncology-seminars and Original Investigations","volume":"43 3","pages":"Page 9"},"PeriodicalIF":2.4,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143509782","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}
Pub Date : 2025-03-01DOI: 10.1016/j.urolonc.2024.12.011
Vatsala Mundra, Susan Xu, Renil Titus, Eusebio Luna, Carlos Riveros, Sanjana Ranganathan, Brian Miles, Dharam Kaushik, CJ Wallis, Raj Satkunasivam
<div><h3>Introduction</h3><div>Prostate cancer is the second most common cancer in men worldwide and accounts for</div><div>3.8% of all cancer deaths in men. Treatment of localized prostate cancer includes radical prostatectomy (RP) with or without pelvic lymph node dissection (PLND). Multiple guidelines recommend PLND for staging purposes and there may also be a therapeutic benefit. However, PLND is not without complications and nomograms predicting risk of LN metastasis may be employed to optimize selection. There remains, however, a paucity of real-world data assessing the morbidity of contemporary robot assisted PLND. We therefore sought to use the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) targeted prostatectomy database to quantify the rates of real-world 30-day post-operative outcomes of patients undergoing PLND at the time of RP for prostate cancer, quantify the incremental morbidity by comparing to those who underwent RP without PLND.</div></div><div><h3>Methods</h3><div>We conducted a retrospective cohort study using the ACS-NSQIP database of adult patients undergoing radical prostatectomy from 2019-2022. The primary outcome was a composite of any of the following 30-day major postoperative outcomes: mortality, reoperation, cardiac event, and neurologic event. Secondary outcomes were composed of individual complications of the composite primary outcome as well as infectious and venous thromboembolic complications, unplanned intubation and ventilation, transfusion, readmission, and prolonged length of stay (LOS). We also assessed the rates of procedure specific outcomes such as rectal injury, ureteral obstruction, and lymphocele. PLND and non-PLND groups were balanced using propensity score matching (PSM) with a 1:1 ratio with a caliper of 0.01 using demographic characteristics (age, race, BMI, modified frailty index etc.), prior medical history (prior pelvic radiotherapy or operations), and cancer staging (pathologic T stage). Likelihood of complications was assessed by conditional logistic regression.</div></div><div><h3>Results</h3><div>There were 13,413 patients identified between 2019 and 2022 who underwent prostatectomy: 11,341 (85%) had PLND while 2,072 (15%) did not. After PSM, our cohort included 2,071 matched pairs of patients with and without PLND. In PLND cohort, the detectable prevalence of PLND related complications included lymphocele or lymphatic leak (1.8%), urinary leak or fistula (1.4%), ureter obstruction (0.29%) and rectal injury (.38%). In the non-PLND cohort, the prevalence of complications was: lymphocele or lymphatic leak (0.43%), urinary leak or fistula (1.3%), ureter obstruction (0.20%), and rectal injury (0.30%). There were no significant differences between the two groups in primary outcome (OR 0.84; 95% CI 0.48, 1.48). Receipt of PLND was associated with higher rates of deep vein thrombosis (DVT, OR 2.51; 95% CI 1.10, 5.74) as well as lymphocele or other lymphatic
{"title":"COMPLICATIOMS OF ROBOTIC PELVIC LYMPH NODE DISSECTION FOR PROSTATE CANCER: AN ANALYSIS OF THE NATIONAL SURGICAL QUALITY IMPROVEMENT PROGRAM TARGETED RADICAL PROSTATECTOMY DATABASE","authors":"Vatsala Mundra, Susan Xu, Renil Titus, Eusebio Luna, Carlos Riveros, Sanjana Ranganathan, Brian Miles, Dharam Kaushik, CJ Wallis, Raj Satkunasivam","doi":"10.1016/j.urolonc.2024.12.011","DOIUrl":"10.1016/j.urolonc.2024.12.011","url":null,"abstract":"<div><h3>Introduction</h3><div>Prostate cancer is the second most common cancer in men worldwide and accounts for</div><div>3.8% of all cancer deaths in men. Treatment of localized prostate cancer includes radical prostatectomy (RP) with or without pelvic lymph node dissection (PLND). Multiple guidelines recommend PLND for staging purposes and there may also be a therapeutic benefit. However, PLND is not without complications and nomograms predicting risk of LN metastasis may be employed to optimize selection. There remains, however, a paucity of real-world data assessing the morbidity of contemporary robot assisted PLND. We therefore sought to use the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) targeted prostatectomy database to quantify the rates of real-world 30-day post-operative outcomes of patients undergoing PLND at the time of RP for prostate cancer, quantify the incremental morbidity by comparing to those who underwent RP without PLND.</div></div><div><h3>Methods</h3><div>We conducted a retrospective cohort study using the ACS-NSQIP database of adult patients undergoing radical prostatectomy from 2019-2022. The primary outcome was a composite of any of the following 30-day major postoperative outcomes: mortality, reoperation, cardiac event, and neurologic event. Secondary outcomes were composed of individual complications of the composite primary outcome as well as infectious and venous thromboembolic complications, unplanned intubation and ventilation, transfusion, readmission, and prolonged length of stay (LOS). We also assessed the rates of procedure specific outcomes such as rectal injury, ureteral obstruction, and lymphocele. PLND and non-PLND groups were balanced using propensity score matching (PSM) with a 1:1 ratio with a caliper of 0.01 using demographic characteristics (age, race, BMI, modified frailty index etc.), prior medical history (prior pelvic radiotherapy or operations), and cancer staging (pathologic T stage). Likelihood of complications was assessed by conditional logistic regression.</div></div><div><h3>Results</h3><div>There were 13,413 patients identified between 2019 and 2022 who underwent prostatectomy: 11,341 (85%) had PLND while 2,072 (15%) did not. After PSM, our cohort included 2,071 matched pairs of patients with and without PLND. In PLND cohort, the detectable prevalence of PLND related complications included lymphocele or lymphatic leak (1.8%), urinary leak or fistula (1.4%), ureter obstruction (0.29%) and rectal injury (.38%). In the non-PLND cohort, the prevalence of complications was: lymphocele or lymphatic leak (0.43%), urinary leak or fistula (1.3%), ureter obstruction (0.20%), and rectal injury (0.30%). There were no significant differences between the two groups in primary outcome (OR 0.84; 95% CI 0.48, 1.48). Receipt of PLND was associated with higher rates of deep vein thrombosis (DVT, OR 2.51; 95% CI 1.10, 5.74) as well as lymphocele or other lymphatic ","PeriodicalId":23408,"journal":{"name":"Urologic Oncology-seminars and Original Investigations","volume":"43 3","pages":"Pages 3-4"},"PeriodicalIF":2.4,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143509845","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}
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