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Cost-Effectiveness Analysis of Lenvatinib plus Pembrolizumab or Everolimus as First-Line Treatment for Advanced Renal Cell Carcinoma Lenvatinib联合派姆单抗或依维莫司作为晚期肾细胞癌一线治疗的成本-效果分析
IF 2.3 3区 医学 Q3 ONCOLOGY Pub Date : 2025-02-01 DOI: 10.1016/j.clgc.2024.102264
Huanrui Zheng , Jin Zhou , Yao Tong , Jinhua Zhang

Background

Recently, due to its promising efficacy against advanced renal cell carcinoma (RCC), the combination therapy with lenvatinib and pembrolizumab or everolimus has been approved as a first-line treatment for patients with advanced RCC in China and the United States. However, the high costs of combination therapies, especially of those new drugs, may limit their viability as clinical treatment options. Thus, our study aimed to evaluate the cost-effectiveness of using lenvatinib plus pembrolizumab or everolimus as a first-line treatment for patients with advanced RCC from the perspective of the Chinese healthcare system and US third-party payers.

Methods

We established a Markov model using TreeAge Pro 2022 software to estimate and compare the cost and effectiveness of the therapy with lenvatinib plus pembrolizumab or everolimus with those of sunitinib therapy for treating advanced RCC based on the clinical data derived from a phase III randomized controlled trial (CLEAR, ClinicalTrials.gov number NCT02811861). Transition probabilities and other data were calculated and obtained by using parametric survival modeling. The direct medical costs, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs) were used as economic indicators in this analysis. The robustness of the model was assessed by performing one-way and probability sensitivity analyses (PSA).

Results

Among the 3 treatment strategies, the sunitinib 1 was the least expensive option. All ICERs were far higher than the thresholds of $38,024 and $100,000 selected for China and the United States, respectively. The ICERs of the therapy with lenvatinib plus pembrolizumab versus sunitinib therapy were 106,749.06 US$/QALY and $414,672.19 US$/QALY in China and the United States, respectively. Thus, among these 2, the former strategy was less cost-effective than the latter. In addition, the ICERs of the lenvatinib plus everolimus treatment vs. sunitinib treatment were $44,353.18 US$/QALY and $292,653.10 US$/QALY in China and the United States, respectively. Thus, among these 2 strategies, the former was less cost-effective than the latter. The total cost of the lenvatinib plus everolimus treatment strategy was lower than that of lenvatinib plus pembrolizumab; however, the former treatment was less effective than the latter.

Conclusion

The treatment with lenvatinib plus pembrolizumab or everolimus is less cost-effective than the sunitinib treatment for patients with advanced RCC in China and the United States.
背景:近年来,由于lenvatinib联合派姆单抗或依维莫司治疗晚期肾细胞癌(RCC)的疗效良好,lenvatinib联合派姆单抗或依维莫司已被批准为中国和美国晚期肾细胞癌患者的一线治疗方案。然而,联合治疗的高成本,特别是那些新药,可能会限制其作为临床治疗选择的可行性。因此,我们的研究旨在从中国医疗系统和美国第三方支付者的角度评估lenvatinib联合派姆单抗或依维莫司作为晚期RCC患者一线治疗的成本-效果。方法:基于一项III期随机对照试验(CLEAR, ClinicalTrials.gov编号NCT02811861)的临床数据,我们使用TreeAge Pro 2022软件建立Markov模型,评估和比较lenvatinib联合派姆单抗或依维莫司与舒尼替尼治疗晚期RCC的成本和有效性。采用参数化生存模型计算并获得转移概率等数据。直接医疗费用、质量调整生命年(QALYs)和增量成本-效果比(ICERs)作为本分析的经济指标。通过进行单向和概率敏感性分析(PSA)来评估模型的稳健性。结果:在3种治疗策略中,舒尼替尼1是最便宜的选择。所有ICERs都远远高于中国和美国分别选择的38,024美元和10万美元的门槛。lenvatinib + pembrolizumab与舒尼替尼治疗的ICERs在中国和美国分别为106,749.06美元/QALY和414,672.19美元/QALY。因此,在这两种战略中,前者的成本效益不如后者。此外,lenvatinib +依维莫司治疗与舒尼替尼治疗在中国和美国的ICERs分别为44,353.18美元/QALY和292,653.10美元/QALY。因此,在这两种策略中,前者的成本效益低于后者。lenvatinib +依维莫司治疗策略的总成本低于lenvatinib + pembrolizumab;然而,前者的治疗效果不如后者。结论:在中国和美国,lenvatinib联合派姆单抗或依维莫司治疗晚期RCC患者的成本效益低于舒尼替尼治疗。
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引用次数: 0
Trends and Disparities in Inpatient Palliative Care Use in Metastatic Renal Cell Carcinoma Patients Receiving Critical Care Therapy 接受重症监护治疗的转移性肾细胞癌患者住院姑息治疗的趋势和差异
IF 2.3 3区 医学 Q3 ONCOLOGY Pub Date : 2025-02-01 DOI: 10.1016/j.clgc.2024.102269
Carolin Siech , Simone Morra , Lukas Scheipner , Andrea Baudo , Mario de Angelis , Letizia Maria Ippolita Jannello , Nawar Touma , Jordan A. Goyal , Zhe Tian , Fred Saad , Shahrokh F. Shariat , Nicola Longo , Luca Carmignani , Ottavio de Cobelli , Sascha Ahyai , Alberto Briganti , Cristina Cano Garcia , Luis A. Kluth , Felix K.H. Chun , Pierre I. Karakiewicz

Purpose

Temporal trends in and predictors of inpatient palliative care use in patients with metastatic renal cell carcinoma (mRCC) undergoing critical care therapy are unknown.

Methods

Relying on the National Inpatient Sample (2008-2019), we identified mRCC patients undergoing critical care therapy, namely invasive mechanical ventilation, percutaneous endoscopic gastrostomy tube insertion, dialysis for acute kidney failure, total parenteral nutrition, or tracheostomy. Estimated annual percentage changes (EAPC) analyses and multivariable logistic regression models addressed inpatient palliative care use.

Results

Of 3802 mRCC patients undergoing critical care therapy, 817 (21.5%) received inpatient palliative care. Overall, inpatient palliative care use increased from 4.9% to 31.5% between 2008 and 2019 (EAPC +9.2%). In subgroup analyses, the highest increase in inpatient palliative care use was observed in the Midwest (EAPC: +11.9%), in the South (EAPC +10.4%), and in teaching hospitals (EAPC +9.0%; all P ≤ .004). In logistic regression models, teaching hospital status (odds ratio [OR] 1.41) and contemporary year interval (OR 2.12; all P < .001) independently predicted higher inpatient palliative care rates. Conversely, hospital admission in the Northeast (OR 0.53) or in the South (OR 0.79; all P ≤ .03) was associated with lower inpatient palliative care rates than in the West.

Conclusion

In mRCC patients, inpatient palliative care rates have improved over time, with the highest increase in hospitals in the Midwest and in the South. Moreover, admission to teaching hospitals or in the West is associated with higher inpatient palliative care rates. In consequence, regional disparities, as well as differences according to teaching hospital status represent targets to achieve comprehensive inpatient palliative care coverage in mRCC patients receiving critical care therapy.
目的:转移性肾细胞癌(mRCC)患者接受重症监护治疗的住院姑息治疗的时间趋势和预测因素尚不清楚。方法:根据2008-2019年全国住院患者样本,我们确定了接受重症监护治疗的mRCC患者,即有创机械通气、经皮内镜胃造口管插入、急性肾衰竭透析、全肠外营养或气管造口术。估计年度百分比变化(EAPC)分析和多变量逻辑回归模型解决了住院姑息治疗的使用。结果:3802例接受重症监护治疗的mRCC患者中,817例(21.5%)接受住院姑息治疗。总体而言,2008年至2019年期间,住院姑息治疗使用率从4.9%增加到31.5% (EAPC +9.2%)。在亚组分析中,住院姑息治疗使用增幅最高的是中西部地区(EAPC +11.9%)、南部地区(EAPC +10.4%)和教学医院(EAPC +9.0%;P均≤0.004)。在logistic回归模型中,教学医院状况(比值比[OR] 1.41)与当代年份间隔(比值比[OR] 2.12;均P < 0.001)独立预测较高的住院姑息治疗率。相反,东北地区(OR 0.53)和南部地区(OR 0.79)的住院率相对较高;所有P≤0.03)与较低的住院姑息治疗率相关。结论:在mRCC患者中,住院姑息治疗率随着时间的推移而改善,中西部和南部医院的增幅最大。此外,在教学医院或在西方入院与较高的住院姑息治疗率有关。因此,地区差异以及教学医院地位的差异代表了mRCC患者接受重症监护治疗时住院姑息治疗全面覆盖的目标。
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引用次数: 0
Development and Validation of Prognostic Model for Metastatic Castration-Resistant Prostate Cancer Patients Treated With First-Line Abiraterone or Enzalutamide 一线阿比特龙或恩杂鲁胺治疗转移性去势抵抗性前列腺癌患者预后模型的建立和验证。
IF 2.3 3区 医学 Q3 ONCOLOGY Pub Date : 2025-02-01 DOI: 10.1016/j.clgc.2024.102265
Orazio Caffo , Umberto Basso , Carlo Cattrini , Paola Ermacora , Marco Maruzzo , Martina Alberti , Cecilia Anesi , Davide Bimbatti , Massimiliano Cani , Veronica Crespi , Giovanni Farinea , Dzenete Kadrija , Stefania Kinspergher , Eleonora Lai , Ludovica Lay , Francesca Maines , Alessia Mennitto , Francesco Pierantoni , Alessandro Samuelly , Susanna Urban , Antonello Veccia

Introduction

Over the years, several prognostic models were developed in patients receiving chemotherapy for metastatic castration resistant prostate cancer (mCRPC), while data on androgen-receptor signaling inhibitors (ARSI) in a real-world setting are limited.

Patients and methods

We compared a consecutive series of 565 mCRPC patients receiving first-line ARSI at 4 high-volume Italian Centers (development set) to an external series of 180 patients receiving the same treatment at another Italian high-volume Center (training set), between 2011 and 2022.
Sixteen clinical and baseline laboratory variables were selected to develop a prognostic model. Patients were categorized into risk groups according to the number of independent factors positively associated with overall survival (OS).

Results

In the development cohort, after a median follow-up of 21.1 months, the median OS was 30.4 months (95% CI 27.5-33.4). At the multivariate analysis, 7 variables [age, prostate specific antigen (PSA) doubling time, baseline levels of hemoglobin, PSA, time to castration resistance, ECOG PS and bone metastases number) were included into the final model.
The median OS was 13.4, 25.7 and 46.4 months in poor (0-2 factors), intermediate (3-4 factors) and good (≥ 5 factors) prognosis group, respectively.
The application of the model to the validation set confirmed its ability to prognosticate for OS. The model c-indexes were 0.68 (95% CI 0.64-0.72) and 0.75 (95% CI 0.68-0.81) in the development and validation cohort, respectively.

Conclusions

Our model, based on clinical and laboratory variables readily assessable in clinical practice, might prognosticate the OS of mCRPC patients receiving first-line ARSI.
多年来,在接受转移性去势抵抗性前列腺癌(mCRPC)化疗的患者中建立了几种预后模型,而在现实环境中,雄激素受体信号抑制剂(ARSI)的数据有限。患者和方法:我们比较了2011年至2022年间在4个意大利大容量中心(开发组)接受一线ARSI治疗的565名mCRPC患者连续系列和在另一个意大利大容量中心(训练组)接受相同治疗的180名患者的外部系列。选择16个临床和基线实验室变量来建立预后模型。根据与总生存期(OS)呈正相关的独立因素数量将患者分为危险组。结果:在开发队列中,中位随访21.1个月后,中位OS为30.4个月(95% CI 27.5-33.4)。在多因素分析中,将年龄、前列腺特异性抗原(PSA)翻倍时间、基线血红蛋白水平、PSA、去势抵抗时间、ECOG PS和骨转移数等7个变量纳入最终模型。预后不良组(0-2个因素)、中预后组(3-4个因素)和预后良好组(≥5个因素)的中位OS分别为13.4、25.7和46.4个月。该模型在验证集上的应用证实了其预测OS的能力。在开发和验证队列中,模型c指数分别为0.68 (95% CI 0.64-0.72)和0.75 (95% CI 0.68-0.81)。结论:我们的模型基于临床实践中易于评估的临床和实验室变量,可以预测接受一线ARSI的mCRPC患者的OS。
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引用次数: 0
Complex Decision Making for Individual Patients With Penile Cancer: Benchmarking Divergent Practices in European High-Volume Reference Centers: Results From eUROGEN Survey 阴茎癌个体患者的复杂决策:欧洲大批量参考中心的基准不同实践:来自eUROGEN调查的结果。
IF 2.3 3区 医学 Q3 ONCOLOGY Pub Date : 2025-02-01 DOI: 10.1016/j.clgc.2024.102275
Laura Elst , Darren Shilhan , Michelle Battye , Jure Murgić , Ana Frӧbe , Maarten Albersen , Marija Miletić

Background and objectives

Penile cancer (PeCa) remains a challenge due to its rarity and the lack of prospective studies, leading to treatment challenges and controversies. Guidelines offer recommendations, but discrepancies with clinical practice persist. This study analyzed treatment practices among specialists managing high-risk PeCa in European reference centers.

Methods

A cross-sectional survey included 39 PeCa specialists from 13 European countries representing high-volume centers. Descriptive analysis assessed (neo)adjuvant therapy preferences, systemic regimen choices, immunotherapy use, and next-generation sequencing (NGS) integration.

Key findings and limitations

Variations in managing high-risk PeCa, especially in (neo)adjuvant therapy utilization, were noted among participants. The differences highlight the influence of professional backgrounds and variations in treatment approaches between participants. Systemic regimen preferences and immunotherapy utilization also varied. Limited NGS integration indicated gaps in precision medicine adoption. Limitations included sample size, self-reported data, and cross-sectional design.

Conclusions and clinical implications

This study offered insights into PeCa management by specialists in high-volume European reference centers, stressing the need for evidence-based recommendations, guideline adherence, and collaboration to enhance PeCa care.

Patient summary

Managing PeCa is complex due to its rarity and treatment controversies. This study examined practices among specialists in European reference centers, revealing treatment variations. The findings emphasize the importance of evidence-based care and collaboration in optimizing PeCa management.
背景与目的:阴茎癌(PeCa)由于其罕见性和缺乏前瞻性研究,导致治疗挑战和争议,仍然是一个挑战。指南提供了建议,但与临床实践存在差异。本研究分析了欧洲参考中心管理高危PeCa的专家的治疗实践。方法:横断面调查包括来自13个欧洲国家的39名PeCa专家,代表了高容量中心。描述性分析评估了(新)辅助治疗偏好、系统方案选择、免疫治疗使用和新一代测序(NGS)整合。主要发现和局限性:高危PeCa管理的差异,特别是(新)辅助治疗的使用,在参与者中被注意到。这些差异突出了专业背景的影响和参与者之间治疗方法的差异。系统方案偏好和免疫疗法的使用也各不相同。有限的NGS整合显示了精准医疗采用的差距。局限性包括样本量、自我报告数据和横断面设计。结论和临床意义:本研究为欧洲大量参考中心的专家提供了PeCa管理的见解,强调了以证据为基础的建议、指南遵守和合作的必要性,以加强PeCa护理。患者总结:由于其罕见性和治疗争议,PeCa的治疗是复杂的。这项研究调查了欧洲参考中心的专家的做法,揭示了治疗的差异。研究结果强调了循证护理和协作在优化PeCa管理中的重要性。
{"title":"Complex Decision Making for Individual Patients With Penile Cancer: Benchmarking Divergent Practices in European High-Volume Reference Centers: Results From eUROGEN Survey","authors":"Laura Elst ,&nbsp;Darren Shilhan ,&nbsp;Michelle Battye ,&nbsp;Jure Murgić ,&nbsp;Ana Frӧbe ,&nbsp;Maarten Albersen ,&nbsp;Marija Miletić","doi":"10.1016/j.clgc.2024.102275","DOIUrl":"10.1016/j.clgc.2024.102275","url":null,"abstract":"<div><h3>Background and objectives</h3><div>Penile cancer (PeCa) remains a challenge due to its rarity and the lack of prospective studies, leading to treatment challenges and controversies. Guidelines offer recommendations, but discrepancies with clinical practice persist. This study analyzed treatment practices among specialists managing high-risk PeCa in European reference centers.</div></div><div><h3>Methods</h3><div>A cross-sectional survey included 39 PeCa specialists from 13 European countries representing high-volume centers. Descriptive analysis assessed (neo)adjuvant therapy preferences, systemic regimen choices, immunotherapy use, and next-generation sequencing (NGS) integration.</div></div><div><h3>Key findings and limitations</h3><div>Variations in managing high-risk PeCa, especially in (neo)adjuvant therapy utilization, were noted among participants. The differences highlight the influence of professional backgrounds and variations in treatment approaches between participants. Systemic regimen preferences and immunotherapy utilization also varied. Limited NGS integration indicated gaps in precision medicine adoption. Limitations included sample size, self-reported data, and cross-sectional design.</div></div><div><h3>Conclusions and clinical implications</h3><div>This study offered insights into PeCa management by specialists in high-volume European reference centers, stressing the need for evidence-based recommendations, guideline adherence, and collaboration to enhance PeCa care.</div></div><div><h3>Patient summary</h3><div>Managing PeCa is complex due to its rarity and treatment controversies. This study examined practices among specialists in European reference centers, revealing treatment variations. The findings emphasize the importance of evidence-based care and collaboration in optimizing PeCa management.</div></div>","PeriodicalId":10380,"journal":{"name":"Clinical genitourinary cancer","volume":"23 1","pages":"Article 102275"},"PeriodicalIF":2.3,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142848700","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}
引用次数: 0
Comparison of Outcomes Between African American and European American Patients With Metastatic Clear Cell Renal Cell Carcinoma Receiving Immune Checkpoint Inhibitors
IF 2.3 3区 医学 Q3 ONCOLOGY Pub Date : 2025-01-15 DOI: 10.1016/j.clgc.2025.102304
Jasmeet Kaur , Jill S. Hasler , Elizabeth A. Handorf , Matthew R. Zibelman , Fern Anari , Daniel M. Geynisman , Pooja Ghatalia

Background and Objective

Immune checkpoint inhibitors (ICIs) and ICI/tyrosine kinase inhibitor (TKI) (ICI-based) combinations are standard first-line treatment (tx) options for patients with metastatic clear cell renal cell carcinoma (mRCC). However, only 1% of patients enrolled in trials studying these agents were Blacks.

Methods

Patients with mRCC who received front-line ICI-based tx or sunitinib after 2011 were included from the Flatiron Health electronic record-derived database. We analyzed progression-free survival in African American (Black) and European American (White) patients and tested the interaction between treatment type and race. Multivariable Cox proportional hazards models were used to assess associations with outcomes.

Key Findings and Limitations

Of 2,592 eligible pts, 2,379 (91.8%) were White, and 213 (8.2%) were Black. Of these, 1453 (56%) received ICI-based tx and 1139 (44%) received sunitinib. IMDC favorable, intermediate/poor and unknown risk was noted among 6%, 77.5% and 16.4% of White patients and 3.3%, 86.8% and 9.9% of Black patients. Median age was 64 years. There was no significant difference in PFS between Black and White patients receiving ICI-based treatment compared to sunitinib [hazard ratio (HR) for interaction between treatment type and race was 1.063 (0.78-1.45, P = .7)]. The interaction term between race and treatment type showed that there was no evidence of a differential treatment effect by race in the first 10 months (HR = 0.931 (0.79-1.10); P = .40), however significantly improved after 10 months (HR = 0.697 (0.56-0.87); P = .001). The retrospective nature of the study is a limitation

Conclusions and Clinical Implications

The study found no significant difference in treatment effects between White and Black patients receiving ICI-based first-line treatment and should be the standard of care for both Black and White patients.

Patient Summary

We reviewed Flatiron databases of patients with mRCC from both Black and White populations, finding that ICI-based therapy should be considered the standard of care for patients from both racial backgrounds.
{"title":"Comparison of Outcomes Between African American and European American Patients With Metastatic Clear Cell Renal Cell Carcinoma Receiving Immune Checkpoint Inhibitors","authors":"Jasmeet Kaur ,&nbsp;Jill S. Hasler ,&nbsp;Elizabeth A. Handorf ,&nbsp;Matthew R. Zibelman ,&nbsp;Fern Anari ,&nbsp;Daniel M. Geynisman ,&nbsp;Pooja Ghatalia","doi":"10.1016/j.clgc.2025.102304","DOIUrl":"10.1016/j.clgc.2025.102304","url":null,"abstract":"<div><h3>Background and Objective</h3><div>Immune checkpoint inhibitors (ICIs) and ICI/tyrosine kinase inhibitor (TKI) (ICI-based) combinations are standard first-line treatment (tx) options for patients with metastatic clear cell renal cell carcinoma (mRCC). However, only 1% of patients enrolled in trials studying these agents were Blacks.</div></div><div><h3>Methods</h3><div>Patients with mRCC who received front-line ICI-based tx or sunitinib after 2011 were included from the Flatiron Health electronic record-derived database. We analyzed progression-free survival in African American (Black) and European American (White) patients and tested the interaction between treatment type and race. Multivariable Cox proportional hazards models were used to assess associations with outcomes.</div></div><div><h3>Key Findings and Limitations</h3><div>Of 2,592 eligible pts, 2,379 (91.8%) were White, and 213 (8.2%) were Black. Of these, 1453 (56%) received ICI-based tx and 1139 (44%) received sunitinib. IMDC favorable, intermediate/poor and unknown risk was noted among 6%, 77.5% and 16.4% of White patients and 3.3%, 86.8% and 9.9% of Black patients. Median age was 64 years. There was no significant difference in PFS between Black and White patients receiving ICI-based treatment compared to sunitinib [hazard ratio (HR) for interaction between treatment type and race was 1.063 (0.78-1.45, <em>P</em> = .7)]. The interaction term between race and treatment type showed that there was no evidence of a differential treatment effect by race in the first 10 months (HR = 0.931 (0.79-1.10); <em>P</em> = .40), however significantly improved after 10 months (HR = 0.697 (0.56-0.87); <em>P</em> = .001). The retrospective nature of the study is a limitation</div></div><div><h3>Conclusions and Clinical Implications</h3><div>The study found no significant difference in treatment effects between White and Black patients receiving ICI-based first-line treatment and should be the standard of care for both Black and White patients.</div></div><div><h3>Patient Summary</h3><div>We reviewed Flatiron databases of patients with mRCC from both Black and White populations, finding that ICI-based therapy should be considered the standard of care for patients from both racial backgrounds.</div></div>","PeriodicalId":10380,"journal":{"name":"Clinical genitourinary cancer","volume":"23 2","pages":"Article 102304"},"PeriodicalIF":2.3,"publicationDate":"2025-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143101028","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}
引用次数: 0
Investigating the Potential to Offer Reproductive Organ Preserving Radical Cystectomy to More Female Bladder Cancer Patients
IF 2.3 3区 医学 Q3 ONCOLOGY Pub Date : 2025-01-13 DOI: 10.1016/j.clgc.2025.102303
Nina Pappot, Sophia Liff Maibom, Maja Vejlgaard, Ulla Nordström Joensen

Introduction

Traditional radical cystectomy (tRC) in female bladder cancer (BC) patients includes removal of the ovaries, uterus, and anterior vaginal wall. Reproductive organ preserving radical cystectomy (ROPRC) offers less invasive surgery with comparable survival and better functional outcomes for selected patients. The objective of this study is to investigate the current number of ROPRC at our institution and the potential for increased adoption of the procedure based on precystectomy assessment criteria.

Patients and methods

A retrospective cohort study of female patients treated with radical cystectomy between 2017 and 2021 at a single high volume academic center in Denmark. Suspicion of stage T4 was assessed based on precystectomy CT, transurethral resection of bladder tumor with bimanual palpation, and intraoperative assessment at cystectomy. Median follow-up was 36 months for both tRC and ROPRC. The primary outcome was number of ROPRC. The secondary outcome was potential for ROPRC in the tRC population. Frequencies and predictive values were calculated.

Results

A total of 118 female BC patients were included. Four patients underwent ROPRC, all with non–muscle-invasive BC. None had local recurrence. In tRC (n = 114), stage T4 BC was suspected in 31% (35/114) and 14% (16/114) had pT4 at final pathology. There was no suspicion of stage T4 BC in 83 patients, and 82 of these had <pT4 at final pathology, providing a negative predictive value for identifying stage T4 BC before pathology of 99%. The potential for ROPRC in the tRC population was 69% (79/114). Limitations were the retrospective single center study and limited number of ROPRC.

Conclusions

Only 4 women over a 5-year period underwent complete or partial ROPRC. The preoperative prediction of stage T4 was accurate, which could reflect a potential to offer ROPRC to more than two thirds of female cystectomy patients currently undergoing tRC.
{"title":"Investigating the Potential to Offer Reproductive Organ Preserving Radical Cystectomy to More Female Bladder Cancer Patients","authors":"Nina Pappot,&nbsp;Sophia Liff Maibom,&nbsp;Maja Vejlgaard,&nbsp;Ulla Nordström Joensen","doi":"10.1016/j.clgc.2025.102303","DOIUrl":"10.1016/j.clgc.2025.102303","url":null,"abstract":"<div><h3>Introduction</h3><div>Traditional radical cystectomy (tRC) in female bladder cancer (BC) patients includes removal of the ovaries, uterus, and anterior vaginal wall. Reproductive organ preserving radical cystectomy (ROPRC) offers less invasive surgery with comparable survival and better functional outcomes for selected patients. The objective of this study is to investigate the current number of ROPRC at our institution and the potential for increased adoption of the procedure based on precystectomy assessment criteria.</div></div><div><h3>Patients and methods</h3><div>A retrospective cohort study of female patients treated with radical cystectomy between 2017 and 2021 at a single high volume academic center in Denmark. Suspicion of stage T4 was assessed based on precystectomy CT, transurethral resection of bladder tumor with bimanual palpation, and intraoperative assessment at cystectomy. Median follow-up was 36 months for both tRC and ROPRC. The primary outcome was number of ROPRC. The secondary outcome was potential for ROPRC in the tRC population. Frequencies and predictive values were calculated.</div></div><div><h3>Results</h3><div>A total of 118 female BC patients were included. Four patients underwent ROPRC, all with non–muscle-invasive BC. None had local recurrence. In tRC (n = 114), stage T4 BC was suspected in 31% (35/114) and 14% (16/114) had pT4 at final pathology. There was no suspicion of stage T4 BC in 83 patients, and 82 of these had &lt;pT4 at final pathology, providing a negative predictive value for identifying stage T4 BC before pathology of 99%. The potential for ROPRC in the tRC population was 69% (79/114). Limitations were the retrospective single center study and limited number of ROPRC.</div></div><div><h3>Conclusions</h3><div>Only 4 women over a 5-year period underwent complete or partial ROPRC. The preoperative prediction of stage T4 was accurate, which could reflect a potential to offer ROPRC to more than two thirds of female cystectomy patients currently undergoing tRC.</div></div>","PeriodicalId":10380,"journal":{"name":"Clinical genitourinary cancer","volume":"23 2","pages":"Article 102303"},"PeriodicalIF":2.3,"publicationDate":"2025-01-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143076511","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}
引用次数: 0
Enzalutamide and Docetaxel in Combination With Androgen Deprivation for Men With Metastatic Hormone-Sensitive Prostate Cancer: ENZADA, a Phase II Trial
IF 2.3 3区 医学 Q3 ONCOLOGY Pub Date : 2025-01-08 DOI: 10.1016/j.clgc.2025.102302
Earle F. Burgess , Claud M. Grigg , Danielle Boselli , James T. Symanowski , AliReza Golshayan , David L. Graham , Kwabena Osei-Boateng , Nagajyothi Gavini , Jiang Zhu , Landon C. Brown , Sarah Norek , Xhevahire J. Begic , Derek Raghavan

Background

Androgen receptor pathway inhibitors (ARPI) in combination with docetaxel (Doc) and androgen deprivation therapy (ADT) has improved outcomes for men with metastatic hormone sensitive prostate cancer (mHSPC). We hypothesized that combining ADT with Doc and enzalutamide (Enz) would improve the 52-week prostate-specific antigen (PSA) complete response (CR) rate compared to a historical control with ADT + Doc.

Methods

In a single arm phase II trial, treatment-naïve patients with mHSPC received ADT + Doc every 3 weeks up to 6 cycles and Enz daily until progression. The primary endpoint was 52-week PSA CR. Secondary endpoints included safety/toxicity, best PSA response, time to castration resistance and overall survival (OS).

Results

Between Sep 2017 and Aug 2021, 40 patients were enrolled and 36 evaluable for the primary endpoint. At data cutoff, median follow up was 56.1 months. Thirty patients (75%) had high-volume disease. Median age was 64.5 years. Median pretreatment PSA was 129.5ng/ml. 52-week PSA CR occurred in 22/36 (61.1%) patients compared to historical control (P < .001). Median OS was not reached. Patients who did not achieve a 52-week PSA CR had shorter OS (HR, 4.67; 95% CI 1.41-15.55; P = .006). Treatment-related Grade 3 to 5 adverse events occurred in 17/40 (42.5%) patients.

Conclusion

ADT+Doc+Enz improved 52-week PSA CR compared to historical control with ADT+Doc. Achieving a PSA CR after 1 year of therapy correlated with improved OS. These results are consistent with recent phase III studies and support using triplet regimens that combine ADT+Doc+ARPI for newly diagnosed mHSPC.
{"title":"Enzalutamide and Docetaxel in Combination With Androgen Deprivation for Men With Metastatic Hormone-Sensitive Prostate Cancer: ENZADA, a Phase II Trial","authors":"Earle F. Burgess ,&nbsp;Claud M. Grigg ,&nbsp;Danielle Boselli ,&nbsp;James T. Symanowski ,&nbsp;AliReza Golshayan ,&nbsp;David L. Graham ,&nbsp;Kwabena Osei-Boateng ,&nbsp;Nagajyothi Gavini ,&nbsp;Jiang Zhu ,&nbsp;Landon C. Brown ,&nbsp;Sarah Norek ,&nbsp;Xhevahire J. Begic ,&nbsp;Derek Raghavan","doi":"10.1016/j.clgc.2025.102302","DOIUrl":"10.1016/j.clgc.2025.102302","url":null,"abstract":"<div><h3>Background</h3><div>Androgen receptor pathway inhibitors (ARPI) in combination with docetaxel (Doc) and androgen deprivation therapy (ADT) has improved outcomes for men with metastatic hormone sensitive prostate cancer (mHSPC). We hypothesized that combining ADT with Doc and enzalutamide (Enz) would improve the 52-week prostate-specific antigen (PSA) complete response (CR) rate compared to a historical control with ADT + Doc.</div></div><div><h3>Methods</h3><div>In a single arm phase II trial, treatment-naïve patients with mHSPC received ADT + Doc every 3 weeks up to 6 cycles and Enz daily until progression. The primary endpoint was 52-week PSA CR. Secondary endpoints included safety/toxicity, best PSA response, time to castration resistance and overall survival (OS).</div></div><div><h3>Results</h3><div>Between Sep 2017 and Aug 2021, 40 patients were enrolled and 36 evaluable for the primary endpoint. At data cutoff, median follow up was 56.1 months. Thirty patients (75%) had high-volume disease. Median age was 64.5 years. Median pretreatment PSA was 129.5ng/ml. 52-week PSA CR occurred in 22/36 (61.1%) patients compared to historical control (<em>P</em> &lt; .001). Median OS was not reached. Patients who did not achieve a 52-week PSA CR had shorter OS (HR, 4.67; 95% CI 1.41-15.55; <em>P</em> = .006). Treatment-related Grade 3 to 5 adverse events occurred in 17/40 (42.5%) patients.</div></div><div><h3>Conclusion</h3><div>ADT+Doc+Enz improved 52-week PSA CR compared to historical control with ADT+Doc. Achieving a PSA CR after 1 year of therapy correlated with improved OS. These results are consistent with recent phase III studies and support using triplet regimens that combine ADT+Doc+ARPI for newly diagnosed mHSPC.</div></div>","PeriodicalId":10380,"journal":{"name":"Clinical genitourinary cancer","volume":"23 2","pages":"Article 102302"},"PeriodicalIF":2.3,"publicationDate":"2025-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143101080","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}
引用次数: 0
Trends and Disparities in Prostate Cancer Mortality in the United States (1999–2020)
IF 2.3 3区 医学 Q3 ONCOLOGY Pub Date : 2025-01-03 DOI: 10.1016/j.clgc.2024.102298
Nouman Aziz , Waseem Nabi , Muzamil Khan , Abu Huraira Bin Gulzar , Shree Rath , Muhammad Ansab , Danisha kumar , Adnan Bhat

Background

Prostate cancer is a leading cause of cancer-related mortality among men in the United States. Over the past two decades, the observed decline in prostate cancer mortality can be attributed to advancements in screening, early detection, and treatment. However, persistent disparities related to race, geography, and age highlight the need for targeted interventions to improve outcomes.

Methods

This study evaluated trends in prostate cancer mortality among men aged 45 years and older in the United States, using data from CDC WONDER (1999-2020). Age-adjusted mortality rates (AAMRs) per 100,000 individuals were analyzed using a log-linear regression model to calculate annual percentage changes (APCs) and 95 % confidence intervals. Crude rates were utilized to calculate APCs within specific age subgroups.

Results

The AAMR related to prostate cancer significantly declined from 89.87 per 100,000 in 1999 to 52.92 in 2020. A steeper decline was noted from 1999 to 2013 (APC = −3.44), followed by a slower reduction thereafter (APC = −0.61), which coincided with changes in PSA screening guidelines introduced in 2012. African American men had the highest mortality rates but also experienced the most significant decline, decreasing from 199.91 per 100,000 in 1999 to 104.42 in 2020. Regional disparities evolved over time, with the West overtaking the South in mortality rates by 2020. Non-metropolitan areas consistently exhibited higher mortality rates compared to metropolitan regions. Age-stratified data indicated that AAMR increased with age, with the most notable declines seen in men aged 85 years and older.

Conclusion

Prostate cancer mortality in the United States has significantly decreased over the past 2 decades; however, the rate of progress has slowed in recent years. It is crucial to address racial, geographic, and age-related disparities to further reduce mortality and enhance equity in health outcomes.
背景:前列腺癌是美国男性癌症相关死亡的主要原因。过去二十年来,前列腺癌死亡率的下降主要归功于筛查、早期检测和治疗方面的进步。然而,与种族、地域和年龄有关的差异依然存在,这凸显了采取有针对性的干预措施来改善治疗效果的必要性:本研究利用美国疾病预防控制中心 WONDER(1999-2020 年)的数据,评估了美国 45 岁及以上男性前列腺癌死亡率的变化趋势。使用对数线性回归模型分析了每 10 万人的年龄调整死亡率 (AAMR),以计算年度百分比变化 (APC) 和 95 % 置信区间。利用粗略比率计算特定年龄亚群的 APCs:与前列腺癌相关的急性前列腺癌死亡率从 1999 年的每 10 万人 89.87 例显著下降至 2020 年的 52.92 例。1999 年至 2013 年期间的降幅较大(APC = -3.44),此后降幅放缓(APC = -0.61),这与 2012 年推出的 PSA 筛查指南的变化相吻合。非裔美国男性的死亡率最高,但下降幅度也最大,从 1999 年的每 10 万人 199.91 例降至 2020 年的 104.42 例。随着时间的推移,地区差异也在逐渐扩大,到 2020 年,西部地区的死亡率将超过南部地区。与大都市地区相比,非大都市地区的死亡率一直较高。年龄分层数据表明,前列腺癌死亡率随着年龄的增长而增加,85 岁及以上男性的死亡率下降最为明显:结论:美国的前列腺癌死亡率在过去 20 年中显著下降,但近年来下降速度有所放缓。解决与种族、地域和年龄相关的差异问题对于进一步降低死亡率和提高健康结果的公平性至关重要。
{"title":"Trends and Disparities in Prostate Cancer Mortality in the United States (1999–2020)","authors":"Nouman Aziz ,&nbsp;Waseem Nabi ,&nbsp;Muzamil Khan ,&nbsp;Abu Huraira Bin Gulzar ,&nbsp;Shree Rath ,&nbsp;Muhammad Ansab ,&nbsp;Danisha kumar ,&nbsp;Adnan Bhat","doi":"10.1016/j.clgc.2024.102298","DOIUrl":"10.1016/j.clgc.2024.102298","url":null,"abstract":"<div><h3>Background</h3><div>Prostate cancer is a leading cause of cancer-related mortality among men in the United States. Over the past two decades, the observed decline in prostate cancer mortality can be attributed to advancements in screening, early detection, and treatment. However, persistent disparities related to race, geography, and age highlight the need for targeted interventions to improve outcomes.</div></div><div><h3>Methods</h3><div>This study evaluated trends in prostate cancer mortality among men aged 45 years and older in the United States, using data from CDC WONDER (1999-2020). Age-adjusted mortality rates (AAMRs) per 100,000 individuals were analyzed using a log-linear regression model to calculate annual percentage changes (APCs) and 95 % confidence intervals. Crude rates were utilized to calculate APCs within specific age subgroups.</div></div><div><h3>Results</h3><div>The AAMR related to prostate cancer significantly declined from 89.87 per 100,000 in 1999 to 52.92 in 2020. A steeper decline was noted from 1999 to 2013 (APC = −3.44), followed by a slower reduction thereafter (APC = −0.61), which coincided with changes in PSA screening guidelines introduced in 2012. African American men had the highest mortality rates but also experienced the most significant decline, decreasing from 199.91 per 100,000 in 1999 to 104.42 in 2020. Regional disparities evolved over time, with the West overtaking the South in mortality rates by 2020. Non-metropolitan areas consistently exhibited higher mortality rates compared to metropolitan regions. Age-stratified data indicated that AAMR increased with age, with the most notable declines seen in men aged 85 years and older.</div></div><div><h3>Conclusion</h3><div>Prostate cancer mortality in the United States has significantly decreased over the past 2 decades; however, the rate of progress has slowed in recent years. It is crucial to address racial, geographic, and age-related disparities to further reduce mortality and enhance equity in health outcomes.</div></div>","PeriodicalId":10380,"journal":{"name":"Clinical genitourinary cancer","volume":"23 2","pages":"Article 102298"},"PeriodicalIF":2.3,"publicationDate":"2025-01-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143048658","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}
引用次数: 0
Association of Prehabilitation in the Precystectomy Pathway in Patients With Bladder Cancer on Postoperative Outcomes
IF 2.3 3区 医学 Q3 ONCOLOGY Pub Date : 2024-12-30 DOI: 10.1016/j.clgc.2024.102297
Sasha E. Knowlton , Alexis C. Wardell , Angela Smith , Marc Bjurlin , Matthew Nielsen , Hung-Jui Tan

Purpose

Prehabilitation in patients with bladder cancer recommended for cystectomy has the potential to improve functional status and outcomes after cystectomy. Prior research has shown that increasing exercise preoperatively can improve strength and quality of life, but research has not yet investigated the impact on length of stay, readmissions, complications and mortality.

Methods

We compared historical controls (2021-2022) for patients with bladder cancer who underwent radical cystectomy at a major academic center to those referred for prehabilitation consultation (2023) on postoperative outcomes, namely hospital length of stay, 30 and 90 day readmission rates, postoperative complications and 90-day mortality.

Results

In total, 16 patients received prehabilitation consultation and were compared to 175 patients who did not receive consultation. There were no significant differences in hospital length of stay or 30 or 90 day readmission rates. There were differences in the incidences of some postoperative complications, although not statistically significant.

Conclusions

In this study, prehabilitation consultation did not improve length of stay, 30 or 90 day readmission rates or some postoperative complications, but was limited by low rate of referral. Further research is needed regarding the implementation of prehabilitation programs for bladder cancer.
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引用次数: 0
CIRCULATING miR-1-3p, miR-96-5p, miR-148a-3p, and miR-375-3p Support Differentiation Between Prostate Cancer and Benign Prostate Lesions
IF 2.3 3区 医学 Q3 ONCOLOGY Pub Date : 2024-12-30 DOI: 10.1016/j.clgc.2024.102294
Rafał Osiecki , Piotr Popławski , Dorota Sys , Joanna Bogusławska , Alex Białas , Marek Zawadzki , Agnieszka Piekiełko-Witkowska , Jakub Dobruch

Introduction

microRNAs (miRNAs) are small noncoding RNAs and promising cancer biomarkers. Prostate-specific antigen (PSA) testing revolutionized prostate cancer (PCa) diagnostics and monitoring. However, PSA testing also contributes to PCa overdiagnoses that are detrimental on patients’ health and may lead to overtreatment. Here, we searched for circulating miRNAs that could serve as biomarkers facilitating differentiation between PCa and benign prostate hyperplasia (BPH).

Patients

66 patients with PCa or BPH were investigated (33 patients in each cohort). Men with PCa underwent minimally invasive radical prostectomy (RP), whereas men with BPH underwent either holmium laser enucleation of the prostate (HOLEP), transurethral resection of the prostate (TURP) or simple prostatectomy.

Methods

We performed RNAseq of PCa and BPH serum samples, integrated our data with TCGA-PRAD cohort, followed by qPCR validation using independent cohort of PCa and BPH patients.

Results

RNAseq detected 295 miRNAs in serum samples, including 283 miRNAs that were both expressed by PCa tissues and present in PCa sera. 10 miRNAs were selected for qPCR validation. Expression of serum miR-1-3p, miR-96-5p, miR-148a-3p, and miR-375-3p was decreased in PCa patients when compared to BPH samples. Diagnostic accuracy of combinations of PSA with geometric means of [miR-1-3p, miR-148a-3p], [miR-148a-3p, miR-375-3p], and [miR-375-3p, miR-96-5p] exceed diagnostic value of PSA alone, with the top AUC 0.97 for [miR-1-3p, miR-148a-3p]/PSA (cut-off < 0.002893, sensitivity 95.83 %, specificity 91.30 %).

Conclusions

In conclusion, we found a miRNAs that can support PCa diagnosis.
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引用次数: 0
期刊
Clinical genitourinary cancer
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