bluuebunny/crossref_metadata_2025_split huggingface dataset:
Tislelizumab combined with gemcitabine and cisplatin (GC) as adjuvant therapy in patients with high-risk upper urothelial carcinoma (UTUC) after surgery: A 2-year follow-up, real-world study.
Authors: Quan Penghe , Hou Haozhong , Yang Xiaojian 
Published: June 2024

e16548 Background: In China, the prevalence of upper tract urothelial carcinoma (UTUC) among patients (pts) with urothelial carcinoma (UC) ranges from 9.3% to 19.9%, which is higher compared to the 5%-10% observed in Caucasoid populations. Following radical nephroureterectomy (RNU), UTUC pts with high-risk factors (e.g., local , pT3-4a, ypT2-4a, or N+) still have a poor prognosis and require adjuvant therapy. Immune checkpoint inhibitor as adjuvant therapy has been previously demonstrated improved disease-free survival (DFS) for UC pts, but the data from UTUC studies is limited.This real-world study aimed to evaluate the efficacy and safety of tislelizumab (Tisle) plus gemcitabine and cisplatin (GC) in high-risk UTUC pts. Methods: Pts who were diagnosed with T1N1 or T2-T4aN0-1M0 UTUC, tolerated surgery, and had adequate renal function reserve after surgery and Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1 were retrospectively enrolled from the Department of Urology, Xijing Hospital of Air Force Military Medical University between January 2020 and March 2023. Within 90 days following the RNU surgery, pts received adjuvant therapy of 200 mg Tisle on day 1 every 3 weeks plus 0-6 cycle GC chemotherapy (1000 mg/m2 gemcitabine on days 1 and 8; 70 mg/m2 cisplatin on day 2). Tisle was continued until disease progression or intolerable toxicity. The primary endpoint was 3-year DFS rate. Secondary endpoints were 5-year DFS rate, overall survival (OS), cancer-specific survival (CSS), and safety. Results: A total of 53 pts were enrolled in this study for efficacy evaluation. As of the cut-off date , median follow-up time was 26 (5-46) months, and of the pts were followed up for >24 months. The 2-year DFS rate was 75.56% (95% confidence intervals [CI], 57.87%-86.63%), and the 2-year OS rate was 79.63% (95% CI, 61.50%-89.88%). Compared to GC < 3 cycles, GC ≥ 3 cycles significantly improved DFS (hazard ratio [HR], 0.125; 95% CI, 0.034-0.461; p=0.019) and OS (HR, 0.147; 95% CI, 0.037-0.589; p=0.037), indicating a long tail in survival with the addition of Tisle to GC. Conclusions: In this real-world setting, adjuvant therapy with Tisle plus GC demonstrated encouraging efficacy and well-tolerated safety among high-risk UTUC pts. The final results will reported in further studies.
Costs associated with novel first-line (1L) treatments in patients (pts) with locally advanced or metastatic urothelial carcinoma (la/mUC) from a United States (US) Medicare and commercial payer perspective.
Authors: Ike Chiemeka , Kongnakorn Thitima , Tichy Eszter , Sanchez Alvarez Javier , Kearney Mairead 
Published: June 2024

e16552 Background: Recent drug approvals in the 1L treatment (tx) setting have expanded options for pts with la/mUC. It is important to understand the economic burden of these novel therapies within the current tx landscape. This study estimated first-year cost of care in the US from a Medicare and commercial payer perspective for pts with la/mUC treated with the following 1L tx: enfortumab vedotin (EV) + pembrolizumab (PEM) in platinum-eligible pts, nivolumab (NIV) + platinum-based chemotherapy (PBC) in cisplatin-eligible pts, and 1L PBC with or without avelumab (AVE) 1L maintenance (1LM). Methods: A cost of care model was developed to estimate direct medical care costs in the first year of tx with EV + PEM, NIV + PBC, and PBC with and without AVE 1LM in pts with la/mUC who are eligible for 1L PBC; pts treated with NIV + PBC were eligible for cisplatin. The latest available costs (2023 USD)—including drug acquisition and administration, disease management, adverse event (AE) management, and subsequent therapy (second-line or later line) costs—were calculated based on tx duration, progression-free survival, overall survival, and AE incidence with various therapies. Efficacy and safety data were sourced from key published trials (EV-302, CheckMate-901, JAVELIN Bladder 100) and product prescribing information. Results: Estimated first-year costs per treated pt are shown in the Table. Cost per treated pt was estimated to range between $56,952 to $438,660 and $90,918 to $457,390 for Medicare and commercial payers, respectively, with the highest cost for EV+PEM and the lowest for PBC only. Drug acquisition costs in the 1L represented the majority of the costs except PBC, for which subsequent tx and administration costs represented the largest cost component. Conclusions: Costs per treated pt were lower for PBC with AVE 1LM than for EV+PEM and NIV+PBC. As value-based oncology care is becoming increasingly important in the US, comprehensive understanding of costs across different tx options and sequences can facilitate informed tx choice. [Table: see text]
Treatment and outcomes of bladder cancer in Armenia.
Authors: Bardakhchyan Samvel , Gharadaghyan Hovsep , Zohrabyan Davit , Safaryan Liana , Avagyan Armen , Harutyunyan Lilit , Sargsyan Amalya , Mailyan Mariam , Harutyunyan Martin , Rushanyan Marine , Mkrtchyan Gohar , Karapetyan Nune , Mkhitaryan Sergo , Arakelyan Jemma 
Published: June 2024

e16574 Background: Bladder cancer is the fifth most common cancer by incidence in Armenia with around 450 new cases diagnosed every year. Methods: For this retrospective hospital-based study we have collected data from three main oncology centers in Armenia: Yeolyan Hematology and Oncology Center, Mikaelyan Institute of Surgery, and Muratsan Hospital Complex of Yerevan State Medical University. Data of patients with bladder cancer who were treated at these three centers during 01/Jan/2010 - 01/Jan/2023 period was collected from the medical records. Statistical analysis was conducted by 01/Nov/2023. Results: Eighty-seven patients with bladder cancer treated during mentioned period in these three hospitals were included in the final analysis. Male to female ratio was 8.6:1. 70% of patients were smokers. Median age at diagnosis was 65 years (range 37-82 years). 5.7% of patients had stage I, 17.2% stage II, 47.1% stage III, 25.3% stage IV bladder cancer, and for 4.6% of patients' stage was unknown. 9.2% of patients had grade 1, 18.4% grade 2 and 60.9% grade 3 tumors. Among stage IV patients the most common metastasis sites were lungs (36.4%), followed by non-regional lymph nodes (31.8%). Median overall survival (OS) was 31 months for the entire cohort. Median OS was 31 months for stage I, 62 months for stage II, 40 months for stage III and 14 months for stage IV patients. While OS for non-metastatic bladder cancer was higher than for metastatic stage, this difference was not statistically significant (39 vs 14 months; p=0,088). About 61% of patients received 1st line chemotherapy with Cisplatin and 33.3% with Carboplatin. Only 9% of patients received immunotherapy during their course of treatment. In non-metastatic setting median OS was significantly better for those treated with Cisplatin containing regimens, compared with those treated with Carboplatin containing regimens (40 vs 23 months; p=0,021), while in stage IV this difference was not statistically significant (30 vs 14 months; p=0,269). Conclusions: Bladder cancer is one of the most common cancers in Armenia. Treatment with Cisplatin in non-metastatic patients was associated with better OS compared with Carboplatin. Patients diagnosed in metastatic setting have really poor prognosis with median OS slightly surpassing 1 year. While new treatment modalities with immunotherapy and targeted therapy are showing promising results worldwide, they are not widely available in Armenia.
Tumor immune microenvironment analysis and MRI results of a phase II trial investigating tislelizumab (T) in the neoadjuvant treatment of high-risk upper tract urothelial carcinoma (UTUC).
Authors: Huang Jiwei , Cai Xinyun , Ng Cheoklong , Luo Yuansheng , Wang Zaoyu , Kong Wen , Zhang Jin , Chen Yonghui , Wu Guangyu , Chen Haige , Xue Wei 
Published: June 2024

e16582 Background: Although PD-1/L1 checkpoint inhibitors have shown promising efficacy results in the neoadjuvant treatment of urothelial carcinoma, part of patients may have disease progression during the treatment. Up to now, there is no definitive biomarker to predict the response of neoadjuvant immunotherapy. We have formerly reported the preliminary results of T, a PD-1 checkpoint inhibitor, in the neoadjuvant treatment of UTUC. Herein, we report the tumor immune microenvironment analysis and contrast-enhanced MRI results to explore possible pathological and radiological characteristics in correlation with treatment response. Methods: Patients were given T 200mg IV every 3 weeks for at most 4 cycles followed by surgery (radical nephroureterectomy, ureteral resection or endoscopic ablation). The primary endpoint was pCR rate (ypT0N0). The secondary endpoints included pathological response rate (≤ypT1N0), objective response rate and safety. Contrast-enhanced MRI examination was performed before the third dose and another before the surgery and the apparent diffusion coefficient(ADC) was calculated. The infiltrating immune cells pattern within tumor microenvironment was analyzed using multiplexed immunofluorescence (mIF) staining on pretreatment samples. Results: Between Mar 2021 and Sep 2022, 16 patients were enrolled. 4 patients (25%) patients achieved pCR and 7 patients (43.8%) were re-staged as ≤ypT1N0 at specimens. Best of response was cPR in 6 patients, cSD in 7 patients and cPD in 3 patients. The density of PD-L1+CD68+ cells in the stromal region was significantly higher in cPR patients compared to cSD or cPD patients before neoadjuvant treatment (p=0.002). Additionally, the density of PD-1+CD8+ cells in the stromal region of cPR patients was also higher, although the significance was borderline (p=0.065). The average value of ADC showed no statistically significant difference between cPR patients and cSD or cPD patients (p=0.997). However, a significant higher entropy of ADC was found in cPR patients compared with cSD or cPD patients (p=0.002). Conclusions: The elevated ADC entropy on MRI and the enrichment of PD-L1+CD68+ cells within tumor microenvironment before treatment were observed in cPR patients. Both characteristics might help to identify UTUC patients who can benefit from neoadjuvant immune therapy. Clinical trial information: NCT04672330 .
Nimotuzumab, a novel anti-EGFR with concurrent chemoradiotherapy in muscle invasive bladder cancer: A real-world experience from India.
Authors: Rawat Shyam , Jain Rajesh 
Published: June 2024

e16592 Background: Muscle invasive bladder cancer (MIBC) shows 55-75% EGFR overexpression. Radical cystectomy (RC) with/without neoadjuvant chemotherapy is mainstay of treatment. Targeting with anti-EGFR therapy would be potential treatment option to preserve the organ in MIBC. Methods: Evaluation of medical records of patients with transitional cell carcinoma of urinary bladder who received concurrent cisplatin (40 mg/m2) and radiotherapy (60 Gy) (CRT) with Nimotuzumab (200 mg) between 2012 and 2020 was done with prior consent of patients. Results: Medical records of 21 patients were analyzed of which 86% of male with average age of 64.6 years. Tobacco addiction was reported in 76% patients. Eighty-six percent of patients had locally advanced disease, of which 71% with grade III lesions. Treatment with CRT + Nimotuzumab was completed by all patients. Objective response rate was 100% (complete response 95% and partial response 5%) at 6-months post treatment. At the of follow-up was 59 months median overall survival (OS) and disease-free survival (DFS) was not reached. OS and DFS rates at 3-years were 100% and 90.4% respectively. Only two RC were performed subjecting to 90% organ preservation rate. There were no grade 3 or 4 adverse events, however grade 1-2 AEs Included neutropenia (28%), loose motion (76%) and skin reactions (47%). Conclusions: Concurrent CRT with Nimotuzumab could be a possible treatment option for organ preservation with improved outcomes and tolerable safety profile in patients with MIBC, and it can be evaluated further. Keywords: bladder cancer, MIBC, organ preservation, nimotuzumab, chemoradiation. Acknowledgment: We thank you Dr. Amit Y Jadhav for editorial support for this research project.
Effect of patient-derived tumor-like cell clusters on personalized medicine of patients with non-muscle invasive bladder cancer.
Authors: Xi Jianzhong , Yin Shenyi , He Yang , Ye Buqing 
Published: June 2024

e16610 Background: Non-muscle invasive bladder cancer (NMIBC) has a high recurrence and progression rate, and the intravesical instillation chemotherapy drugs is diverse. To optimize patient prognosis, patient-derived tumor-like cell clusters (PTC) for drug testing seeks to identify an effective drug for individual patient. Methods: A prospective, single-center, parallel-group, randomized phase II clinical trial was conducted from December 2020 to December 2023 in Department of Urology of the Second Hospital of Tianjin Medical University (ClinicalTrials.gov: ChiCTR2000040996). This study enrolled a total of 120 patients who had been diagnosed as NMIBC. Patients who met the inclusion and exclusion criteria were randomly assigned to either the control group or the PTC drug-screening group. In the control group, chemotherapy drugs (gemcitabine, pirarubicin, epirubicin and hydroxycamptothecin) were selected for intravesical instillation according to the doctor's experience. In the PTC group, chemotherapy drugs were administered according to PTC drug screening results. Results: The PTC group was associated with significantly lower 1-year Relapse-Free Survival (RFS) rate (10.0 %; 95% CI, 2.4%-17.6%,) compared with the control (31.7%; 95% CI, 19.9%-43.4%), (HR=0.2264; 95% CI, 0.0845-0.6068; p = 0.0013). Similarly, the PTC group was associated with significantly lower 2-year RFS rate (18.3%; 95% CI, 8.5%-28.1%) compared with the control (48.3%; 95% CI, 35.7%-61.0%), (HR=0.3730; 95% CI, 0.1756-0.792; p = 0.0075). Conclusions: PTC drug screening significantly reduced the recurrence rate of postoperative NMIBC. Clinical trial information: ChiCTR2000040996 .
Clinical characteristics, oncologic outcome, and survival in patients with urothelial cancer with pure and partial squamous cell differentiation.
Authors: Brandt Maximilian Peter Johannes Karl , Lache Nina , Duwe Gregor , Fischer Nikita , Frey Lisa Johanna , Haferkamp Axel 
Published: June 2024

e16612 Background: In bladder cancer (BC) patients, pure (SCC) and partial (PSCC) squamous cell carcinomas belong to the most common histologic subtypes with approximately 5% of cases. They are highly aggressive and curative treatment in a local disease stage is typically radical cystectomy (RC). In case of tumor progression or metastatic disease, only limited data on the optimal treatment algorithm and its efficacy exists. In this study, we present clinical characteristics and oncologic outcome in a large patient cohort of SCC and PSCC. Methods: Between 2003 and 2021, we extracted data from patients with SCC and PSCC histology who received RC due to invasive bladder cancer. Clinical characteristics, treatment patterns, progression free- and overall survival were the primary outcome parameters. Kaplan-Meier curves were calculated for PFS and OS and a log rank test was applied to compare survival curves. Results: Overall, 770 patients were screened of which 26 men and 28 women with a mean age of 68.4 (SD 11.7) and 67.9 years (SD 14) years were identified. Twenty-three patients had SCC and 31 PSCC. No neo-adjuvant treatment was applied compared to 16 adjuvant chemotherapy regimens. Urinary diversion was ileal-conduit in 30 cases, Mainz-pouch in nine, ureterocutaneostomy in eleven, ileal neo-bladder in three and transverse conduit of the colon in one patient. The mean number of extirpated lymphnodes were 22.8 (SD 17.7) with a mean positivity of three (SD 8.3) lymphnodes. Mean follow-up was 11.5 months with a PFS of 5.9 and 8.7 mo. and OS of 13.3 mo. (SD 12.2) and 7.5 (SD 7.8) in men and women, respectively. There was no statistically significant survival difference for men and women as well as SCC and PSCC. Conclusions: This contemporary data demonstrated the aggressive nature of SCC of the bladder with IC being the most common urinary diversion. Compared to data from transitional cell carcinoma, PFS and OS was shorter and application of adjuvant Cx was overall low. Structured novel treatment modalities are urgently needed in this highly aggressive bladder cancer population.
Artificial intelligence and identifying prognostic patterns in upper tract urothelical carcinoma (UTUC).
Authors: Staehler Michael , Ivanova Troja , Blajan Iulia , Aydogdu Can , Graser Annabel , Hofmann Marina , Schulz Gerald Bastian 
Published: June 2024

e16616 Background: Artificial intelligence tools (AI) are increasingly used in all scientific fields. UTUC is rare form of kidney cancer and prognostic factors seem unclear. We sought to understand if AI could help identify prognostic parameters for overall survival in UTUC and aid in the development of a prognostic score. Methods: n=231 consecutive patients who underwent surgery for UTUC between 2005 and 2020 were included. De-personalized data included were age, gender, ECOG performance status, smoking habits, baseline creatinine and platelets, histology, laterality, pathological and clinical T-stage, grading, cis, TNM stage, necrosis, lymphovascular invasion, vascular invasion, resection margin, tumor size, duration of surgery, surgeon, surgical approach, blood loss, complications (graded by Clavien-Dindo), complete removal of the ureter including bladder cuff, duration until recurrence and duration until death and reason of death. Several publicly accessible AI tools (chatGPT, Tableau, Julius AI, Microsoft Power BI, Polymer) were asked to first identify prognostic parameters and develop a prognostic score for RCC outcome. Statistical analysis was done using chi-square test, cox regression and Kaplan-Meier survival estimation. AI was asked to analyze the data set based on Kaplan-Meier survival analysis and cox proportional log rank testing was performed to estimate score accuracy. Results: Median age was 70.9 years (43.7-81.8). 61% (n=160) were male. ECOG performance stats was 0 in 42.1% (n=82), 1 in 27.2% (n=52). 53.6% (n=105) were non-smoker and 24.5% (n=48) smoker and 21.9% (n=43) were former smokers. 10.3% (n=12) had synchronous bladder cancer. 60.4% (n=131) suffered from gross hematuria and 19.7% (n=42) had flank pain. Median follow-up was 34.5 months (0-174). Median overall survival (OS) was 58.9 months (95% CI 46.2-71.5). Bellmunt risk factors, BMI and baseline creatine and CRP levels correlated significantly with adverse overall survival (p>0.001). Tumors localized in the ureter, larger than 5cm, carcinoma in situ and high grade had a significant worse OS. Resecting a bladder cuff improved OS to 86.7 months (95% CI 65-108.4) compared to 39.9 months (95% CI 27.9-51.9, p=0.012) without. AI revealed ECOG performance status, nodal status, grade, surgical expertise and resecting a bladder cuff to be prognostic factors and did not identify conventional prognostic factors to be relevant for a scoring system to predict OS and PFS. Conclusions: AI can help identify parameters to predict overall survival outcomes in patients with UTUC based on clinical factors. Human adjustment still is necessary. Interestingly, surgeon, complete resection of the ureter including a bladder cuff are factors that can be influenced and should be considered in future evaluations of prognostic models besides tumor characteristics like histology, grading and nodal status that can’t be medically influenced.
Racial and gender disparities in the incidence of bladder cancer: A nationwide analysis.
Authors: Li Vivian , Javaid Saad , Frasier Kelly , Vinagolu-Baur Julia , Ortega Yaguachi Nataly , Rodriguez Evadne , Del Castillo Olivia , Batista Raquel , Jonas Kenlee , Palma Laura 
Published: June 2024

e16623 Background: Several studies have been conducted to examine racial and gender disparities in various common malignancies. However, there remains a notable lack of comprehensive data addressing ethnic and gender disparities, specifically in relation to patients with Bladder cancer. This study sought to evaluate these disparities and their potential impact on the risk of developing bladder cancer. Methods: Using the National Inpatient Sample 2020, we identified patients diagnosed with Bladder cancer as their primary condition (local/regional and advanced metastatic).We analyzed disparities in the baseline characteristics, including age, gender, insurance status, income, comorbidities, and the risk associated with Bladder cancer. We utilized a log Binomial regression model to determine the risk ratios after adjusting for any confounding variables. Results: A total of 6,471,165 patients were analyzed, and it was found that 24,400 of them (0.4%) had bladder cancer. Among these patients, 76% were male, and 23% were female, p<0.001.The mean age of patients with and without Bladder cancer was 72(SD +/- 11.39) vs. 49(SD+/- 27.18) years, respectively, p<0.001. Female patients demonstrated a lower risk of developing bladder cancer than males (RR=0.31(0.24-0.27); p<0.001). Compared to white females, white and black males exhibited an increased risk of bladder cancer (RR=3.45(3.20-3.73); p<0.001 and RR=1.71(1.48-1.98); p<0.001, respectively). Hispanic males also showed an increased risk (RR=2.20(1.88-2.58); p<0.001), while Hispanic females demonstrated a decreased risk (RR=0.72(0.56-0.94); p=0.016). Males of other races had a higher risk of bladder cancer (RR=2.95(2.36-3.70); p<0.001), and no significant difference was observed in the risk of bladder cancer in Asian males and females (RR=1.39(0.66-2.92); p=0.384 and RR=0.83(0.34-2.01); p=0.694, respectively). The risk of bladder cancer increased with age (36-45: RR=4.45(2.21-8.96),p<0.001,46-64: RR=10.94(5.67-21.12),p<0.001, >65: RR =21.02(10.87-40.63), p<0.001). Conclusions: Disparities in healthcare access and understanding of specific challenges faced by high-risk groups deeply impact patients with bladder cancer. Gaining a deeper knowledge of these disparities can better support this vulnerable patient population and illuminate effective preventive measures for reducing the incidence of bladder cancer among high-risk demographic segments.