bluuebunny/crossref_metadata_2025_split huggingface dataset:
Avelumab first-line maintenance (1LM) in patients (pts) with locally advanced or metastatic urothelial carcinoma (la/mUC) in the Czech Republic: Interim real-world results from a national reimbursement registry.
Authors: Zemankova Anezka , Studentova Hana , Melichar Bohuslav , Eid Michal , Poprach Alexandr , Kopecky Jindrich , Spacek Jan , Stuhlova Sarka , Dvorak Jan , Vlcek Pavel , Zychackova Katerina , Katolicka Jana , Blazek Tomas , Vrana David , Majkova Petra , Cepa Adam , Fiala Ondrej 
Published: January 2024

557 Background: Avelumab 1LM treatment is recommended by international guidelines as the standard of care for pts with la/mUC that has not progressed with 1L platinum-based chemotherapy (PBC) and has been approved in the EU since Jan 2021. In the Czech Republic, following EU approval, there is a requirement to provide real-world data for “highly innovative medicinal products” such as avelumab 1LM when reimbursement decisions are temporary. Obtaining reimbursement therefore requires the creation of a registry to collect real-world data. We report interim results from a retrospective analysis of a national reimbursement registry for avelumab 1LM in the Czech Republic. Methods: Registry data were collected by the Office of Health Insurance (KZP) for pts with la/mUC receiving avelumab 1LM in the Czech Republic between Oct 2021 and Jan 2023. The primary endpoint was overall survival (OS) from the start of avelumab 1LM (index date); secondary endpoints included progression-free survival (PFS) from the start of avelumab 1LM and safety. Descriptive statistics were used to analyze the data. OS and PFS were estimated using the Kaplan-Meier method. Results: 59 eligible pts with la/mUC were treated and documented. At data cutoff (Jan 3, 2023), median follow-up was 6.1 mo (range, 0-16.5). All pts were White; 43 were male and 16 were female. At the start of avelumab 1LM, median age was 71 y (range, 49-84) and 22 pts (37.3%) had visceral metastases. 1L PBC was cisplatin-based in 30 pts (50.8%), carboplatin-based in 24 (40.7%), and both (switched from cisplatin to carboplatin) in 5 (8.5%). Best response to 1L PBC was complete response in 5 pts (8.5%), partial response in 30 (50.8%), and stable disease in 24 (40.7%). Median time from the end of PBC to the start of avelumab was 4.1 wk (range, 1.0-44.0). Effectiveness data for avelumab 1LM are shown in the Table. OS and PFS data are immature, with only 14 pts (23.7%) having died or had disease progression at the time of analysis. 10 adverse events were reported in 9 pts (15.3%), including grade 3 infusion-related reaction (1 pt), grade 2 diarrhea (2 pts), and grade 2 nephritis, pneumonitis, and Addison disease (1 pt each). At last evaluation, 53 pts were alive, of whom 5 pts had started subsequent treatment. Conclusions: This is the first study of pts with la/mUC treated with avelumab 1LM in a real-world setting in the Czech Republic. These preliminary data agree with the results of the phase 3 JAVELIN Bladder 100 trial and other real-world studies, confirming the effectiveness and manageable safety profile of avelumab 1LM in la/mUC. Follow-up for OS is ongoing. [Table: see text]
Identifying patient profiles and mapping treatment journeys of ARPI-treated, taxane-naive patients with metastatic prostate cancer across three countries in a digital patient survey.
Authors: O'Sullivan Joe M. , Lehmann Reiner , Sievert Henning , Allen Stephen , Carl Ernst-Günther , Wolinsky Howard , Poschenrieder Andreas , Mirante Osvaldo , Morgans Alicia K. 
Published: January 2024

56 Background: A fully digital survey of patients with prostate cancer (PCa) was conducted in Germany (DE), the US and the UK to map characteristics, experiences and attitudes. Real-world profiles and treatment journeys, as well as intercountry differences, of taxane-naive patients with metastatic PCa (mPCa) are relatively unknown; data from the survey were leveraged to gain insights into these. Methods: From February 9 to April 10, 2021, DontBePatient Intelligence conducted a survey of patients with PCa. We identified responses from patients with mPCa who were taxane-naive and received at least one androgen receptor pathway inhibitor (ARPI), such as abiraterone or enzalutamide. Demographics, disease characteristics, diagnostic trends and treatments journeys were analyzed, using descriptive and inductive statistics. Results: In total, 458 taxane-naive patients (mean age 68.9 years) had received one ARPI, while 36 had received two. There were differences in time since, mode of, and disease stage at diagnosis between countries (Table). Notably, more US patients were diagnosed through routine screening, yet more had been diagnosed with metastases vs UK/DE. UK patients more frequently reported hospital urologists and oncologists being involved in diagnosis vs DE/US patients. In DE, practice urologists were more frequently reported as being involved vs other specialties throughout the patient journey and these were more involved than in the UK/US. UK patients were more satisfied with radio/brachytherapy and hormone therapy and less satisfied with surgery vs DE/US patients. We uncovered considerable differences in treatment journeys between countries. UK patients had received less surgery vs DE/US patients (9.8% vs 41.5/33.1% patients), driven by less use in 1L. Radio/brachytherapy use was highest in the US (69.4%) and lowest in DE (37.3%), driven by infrequent 1L use in DE. Treatment with bone strengthening agents was less common in the UK (16.4%) vs DE/US (37.3/33.8%). Conclusions: In different countries, taxane-naive patients who received one ARPI have different characteristics at diagnosis and distinct patterns of care. It is important to understand how these differences may affect diagnostic and therapeutic trends to maximally improve patient care in this treatment setting. [Table: see text]
Evaluation of provider preferences in first-line metastatic cisplatin-ineligible urothelial carcinoma in the setting of platinum shortages.
Authors: Weinfeld Michael Seth , Chablani Priyanka Vinod , Reizine Natalie Marie , Stadler Walter Michael , Tawagi Karine 
Published: January 2024

576 Background: Standard of care for patients with metastatic urothelial carcinoma (mUC) who are ineligible to receive cisplatin has been gemcitabine and carboplatin (gem/carbo), and more recently followed by maintenance therapy with avelumab. Combination pembrolizumab (pembro) and the antibody-drug conjugate enfortumab vedotin (EV) has shown very promising results and is now approved for first-line therapy in cisplatin-ineligible patients based on the phase Ib/II EV-103 trial. We were interested in assessing providers’ decision-making between gem/carbo and EV/pembro based on perceived comparative response rates and toxicity profiles, as well as the nationwide platinum chemotherapy shortage in 2023. Methods: We sent a 10-question encrypted electronic survey centered on a scenario of a mUC case to 150 oncologists via email listservs and social media. Results: We received 45 responses: 7 oncologists (15.6%) chose gem/carbo, 15 (33.3%) chose EV/pembro, and a majority, 23 (51.5%) chose to discuss both options with patients. 40 (88.9%) were academic or disease focused and 5 (11.1%) described their practice as general oncology. Of oncologists who chose gem/carbo, the most common reasons were: gem/carbo has more long-term data (86.6%) and lack of phase 3 data for EV/pembro (71.4%). Of oncologists who chose EV/pembro, the most common reasons were: higher response rates (86.7%) followed by the carboplatin shortage (40%). Only 6.7% chose the carboplatin shortage as the main reason while 73.3% chose higher response rates as the main reason. Of oncologists who chose to discuss both, the most common reasons why they would consider EV/pembro were: higher response rates (82.6%), followed by patient preference (56.5%), followed by the carboplatin shortage (43.5%). 60.9% chose higher response rates as the main reason why they would consider EV/pembro. Conclusions: This questionnaire-based study of predominantly academic genitourinary oncologists suggests that the majority would consider EV/pembro as a first-line treatment for cisplatin-ineligible patients with mUC. The primary reason for this choice was the belief that it has higher response rates, as opposed to the national shortage of carboplatin or concerns regarding toxicity. We anticipate that the awaited results of the EV-302 trial in the coming months will also change the treatment landscape of mUC. However, similar issues may be relevant in the future for other treatment decisions in which incomplete information is available or with ongoing chemotherapy shortages.
Analysis of a national database to evaluate place-of-death preferences among patients with bladder cancer in the United States of America from 2003 to 2020.
Authors: Jatwani Karan , Sukaina Mahnoor , Khosla Atulya Aman , Patel Riya Jayesh , Muthusamy Kumarasamy Vasanthan , Singh Rohit , Gopalakrishnan Dharmesh 
Published: January 2024

580 Background: Bladder Cancer (BC) is associated with significant treatment related morbidity and mortality risk. End of life care (EOL) and advance care planning are crucial in oncology care of BC patients. Place of Death (PoD) is an important determinant of patient and caregiver preference, access to home-based supportive care, and cost of caregiving at EOL. We evaluate trends in PoD for patients and hospice utilization with BC in the U.S. from 2003 to 2020 based on the CDC WONDER (Centers for Disease Control and Prevention for Wide-ranging Online Data for Epidemiologic Research) database. Methods: We analyzed data using the CDC WONDER database from January 01, 2003, to December 31, 2020. The data for deaths due to bladder cancer was pooled using the International Classification of Diseases-10th (ICD-10) Revision code as C67, C67.1, C67.2, C67.3, C67.4, C67.5, C67.8, C67.9. The inclusion criteria included patients aged >18. The demographic data was obtained to calculate descriptive statistics using age, gender, PoD, census region, and utilization of hospice mortality accordingly over the past two decades. Results: The analysis demonstrated that overall mortality due to BC were 319,229 from 2003-2020. Of these deaths, 27,990 (8.8%) were recorded in hospice facilities. The hospice mortality has steadily increased from 0.3% in 2003 to the highest of 9.10% in 2019, with a sharp decline to 7.3% in 2020. We noticed the PoD differed based on racial subgroups. More than half of African American (AA) population mortality was observed in a medical facility (57.01%) compared to Whites (50.27%). Hospice or death at home in AA were (42.99%) compared to whites (49.73%). Age stratified mortality analysis showed decreased hospice utilization in 25-44 yrs (9.61%) vs 65+ yrs (10.15%). Stratifying the results by the state census showed highest hospice utilization in Florida (25.23%) vs the lowest in Virginia (2.51%). Conclusions: To our knowledge this is the first study utilizing CDC WONDER database to demonstrate PoD preferences in BC related deaths. We observed a steady increase in hospice utilization from 2003-2020 throughout the US with a decline in 2020 possibly related to COVID pandemic. AA had higher mortality in medical facilities compared to whites, whereas the white population has utilized more hospice services or died at home. This study highlights the need for further efforts and policy changes needed to improve hospice utilization across the US with a focus on improved access to EOL care in BC patients.
Analysis of therapy attrition and changes in outcomes over time for patients (pts) with advanced urothelial cancer (aUC) treated at an academic center.
Authors: Reyes Kevin R , Jindal Tanya , Deshmukh Prianka , Zhu Xiaolin , Ding Chien-Kuang Cornelia , Wong Anthony C. , Chu Carissa E , Porten Sima P. , Chou Jonathan , Friedlander Terence W. , Koshkin Vadim S 
Published: January 2024

590 Background: Despite recent advances in treatment (Tx) options for pts with aUC, real world data suggest that <50% of pts starting Tx receive 2nd line Tx and <15% receive 3rd line Tx. We hypothesized that aUC pts treated at an academic center would have lower Tx attrition rates which would translate into improved outcomes for pts treated more recently. Methods: We identified pts with aUC treated since 2011 and analyzed pts who received systemic Tx for metastatic disease, including baseline characteristics, Tx lines and outcomes. Date of 1/1/2019 for Tx start was used to divide pts into earlier vs later Tx groups. Overall survival (OS) from Tx start was assessed using Kaplan Meier Method in pts who started Tx >1 year before censor date of 12/31/2022 for survival. Chi-square test and Wilcoxon rank sum test were used to compare proportions and numerical data, respectively. Results: Among 360 pts with aUC, 237 received 1st line Tx from 09/2011-08/2022. Of 237 pts, 133 (56%) received 2nd line Tx, 61 (26%) 3rd line Tx, 30 (13%) 4th line Tx, and 10 (4%) > 4 Tx. Pts with Tx in the later group (start after 1/2019) had higher ORR with 1st and 2nd line Tx (Table) and more NGS testing (87% vs 54%, p<0.001) relative to earlier group. With median follow-up of 29.5 mos, median OS was 24.2 mos (95% CI: 17.4 – 29.7) for all pts. Pts in the later group (Tx started 1/2019-12/2021, n=94) had improved mOS relative to the 134 pts in the earlier group (30.6 vs 17.4 mos, p=0.02) despite similar number of average Tx lines (2.4 vs 2.5). Conclusions: During a decade when significant changes occurred in the aUC Tx landscape, pts treated at an academic center had lower Tx attrition rates than those described in real world settings during a similar timeframe. Notably, pts who started Tx after 1/2019 had improved OS relative to pts who started Tx earlier, despite similar number of average Tx lines. This finding may be driven by higher ORR to 1st and 2nd Tx lines in pts treated more recently. Validation in other academic centers and larger cohorts is needed. [Table: see text]
A phase II study of tislelizumab (T) monotherapy as neoadjuvant treatment for cisplatin-ineligible high risk upper tract urothelial carcinoma (UTUC).
Authors: Huang Jiwei , Cai Xinyun , Kong Wen , Zhang Jin , Chen Yonghui , Chen Haige , Xue Wei 
Published: January 2024

591 Background: Platinum-based chemotherapy is standard of care after radical nephroureterectomy for patients with high risk UTUC. However, more than half of UTUC patients may suffer from severe renal function loss which limits the use of cisplatin. Here we report the efficacy and safety results of T in the neoadjuvant treatment of patients with high risk UTUC who are ineligible for cisplatin-based chemotherapy. Methods: Eligible patients had high risk UTUC defined as pathological high-grade UTUC (either by endoscopic biopsy or urinary cytology) and/or invasive aspect on radiological examination(cT2-T4a N0/X M0) and/or hydronephrosis, ECOG PS 0-2, no prior systemic therapy and ineligible for cisplatin. Patients with variant histology on biopsy were included. Patients were given T 200mg IV every 3 weeks for at most 4 cycles followed by surgery (radical nephroureterectomy or ureteral resection or endoscopic ablation). CTU or contrast enhanced MRI examination was performed before the third dose and another before the surgery. The primary endpoint was pCR(pT0N0). The secondary endpoint included PaR(＜pT2N0) and safety. Results: 16 patients were recruited between Mar 2021 and Sep 2022: median age was 65 years(46-71), 13(81.3%) male, 14(87.5%) cT3-cT4, 4(25%) cN+. All patients received at least 2 doses of T but 7 patients didn't accept all 4 doses as planned. 9 patients received radical nephroureterectomy, 1 patient received endoscopic ablation, 3 patients received segmental ureteral resection. 3 patients declined surgery due to disease progression or adverse events. Best radiological tumor response before surgery were 6(37.5%) cPR, 7(43.8%) cSD and 3(18.7%) cPD. Overall, 4 patients achieved pCR(25%) after surgery, among which 3 patients received radical nephroureterectomy. 1 patient received endoscopic ablation with no residual disease observed in specimens and was assessed as pCR after surgery with no recurrence observed 1 year after surgery. 7 patients were evaluated as ＜pT2N0. Grade 3/4 TRAE was 18.8%. No new safety signals were observed. Conclusions: The trial demonstrated a promising pCR rate of neoadjuvant tislelizumab in patients with high risk UTUC who were ineligible for cisplatin-based chemotherapy. Further exploratory analysis is ongoing to investigate underlying correlation between tumor immune microenvironment and treatment response. Clinical trial information: NCT04672330 .
Impact of HIV-HPV co-infection on inpatient penile cancer outcomes.
Authors: Olafimihan Ayobami Gbenga , Deenadayalan Vaishali , Fawehinmi Praise , Gupta Shweta 
Published: January 2024

6 Background: HPV (human papillomavirus) and HIV (Human Immunodeﬁciency Virus) are risk factors for Penile cancer (PC); HIV-HPV co-infection heightens the risk of anogenital dysplasia (PMID: 19706632, 19082746, 35630489). However, there is paucity of data on the impact of HIV-HPV co-infections on PC outcomes. We evaluated the characteristics, outcomes, and healthcare utilization of patients with PC with and without HIV-HPV co-infection (HHC) from a national sample. Methods: Healthcare Cost and Utilization Project-Nationwide Inpatient Sample database was queried to identify all PC patients with (HIV-HPV-PC) and without HIV-HPV co-infection (non-HIV-HPV-PC) from 2016-2020. The groups were compared for socio-demographic differences, medical comorbidities, inpatient mortality, length of stay (LOS), and total hospital charges (THC). Secondary outcomes included rates of sepsis, septic shock, and UTI. Statistics were performed using t-test, univariate and multivariate logistic regression. Results: Out of 11,320 PC admissions, 255 had HIV, 205 had HPV, and 30 had HIV-HPV co-infection. Patients without the co-infection were older with a mean age of 65.6 years as compared to those with HIV-HPV co-infection, who had a mean age of 52.7 years (p = 0.002). Compared to non-HIV-HPV-PC, HIV-HPV-PC patients were more likely to be Black (66.7% vs 11.3%, p<0.001). The prevalence of comorbidities was similar between both groups. HIV-HPV co-infection in penile cancer patients was associated with a ten-fold higher adjusted all-cause mortality compared to those without the co-infection (adjusted odd ratio (aOR) = 10.2, p = 0.035). Mean LOS (6.0 vs 5.7 days, p = 0.8) and THC ($65,472 vs $64,627, p = 0.32) were similar between cohorts. Conclusions: HIV-HPV co-infection in penile cancer is associated with younger age, black race, and a ten-times higher adjusted all-cause inpatient mortality. [Table: see text]
Trends over time in the proportion of sequential treatment and overall survival in patients with metastatic urothelial carcinoma in real-world practice.
Authors: Yamamoto Shoma , Kato MInoru , Matsue Taisuke , Yukimatsu Nao , Takeyama Yuji , Otoshi Taiyo , Yamasaki Takeshi , Kuratsukuri Katsuyuki , Uchida Junji 
Published: January 2024

606 Background: New approaches involving immune checkpoint inhibitors (ICIs) and antibody-drug conjugates prolong overall survival (OS) in patients with metastatic urothelial carcinoma (mUC). However, the access to such systemic therapy in clinical practice is suboptimal, and whether these agents improve OS in patients with mUC over time remains unclear. In the present study, we investigated the OS trend from the initiation of first-line therapy with these agents to identify changes due to the medication and time of treatment initiation. Methods: We retrospectively evaluated 195 patients who received platinum-based chemotherapy as a first line treatment. The patients were treated with chemotherapy, pembrolizumab, avelumab, or enfortumab vedotin (EV) sequentially and were divided into the following three groups: chemotherapy period (April 2009–June 2017; P1), pembrolizumab period (July 2017–December 2020; P2), and avelumab and EV period (January 2021–August 2022; P3) based on the regulatory approval. Data cutoff was set at July 31, 2023. Results: OS was prolonged over time by the new therapeutic agents, and median OS was 11, 25, not reached, and 35.5 months for patients who were treated with chemotherapy, pembrolizumab, avelumab, or EV, respectively. However, median OS was 14, 18 months, and not reached in P1, P2 and P3, respectively. Analysis by periods showed that OS was significantly longer in P2 than in P1 (HR = 0.62, 95% CI: 0.43–0.89, P = 0.009) and in P3 than in P1 (HR = 0.47, 95% CI: 0.28–0.78, P = 0.015). No difference was observed in OS between P2 and P3 (HR = 0.66, 95% CI: 0.36–1.20, P = 0.21). Overall, the proportion of patients who received ICIs increased over time, as indicated by the fact that 77 and 95 patients received ICIs (pembrolizumab or avelumab) in P2 and P3, respectively. However, the prevalence of the treatment with EV was only 24%, and 43% of patients who received pembrolizumab received best supportive care. Conclusions: This study showed an improvement in OS over time in patients with mUC in real-world practice and may indicate the importance of not missing the appropriate opportunity to receive sequential treatments.
Comparative outcomes of radical nephroureterectomy and kidney-sparing surgery in the treatment of high-grade upper tract urothelial carcinoma.
Authors: Gao Helen , Moore Kyle , Delgado Jennifer , Kulkarni Anirudh , Lichtbroun Benjamin , Chua Kevin J. , Pfail John , Packiam Vignesh T. , Golombos David , Jang Thomas L. , Ghodoussipour Saum 
Published: January 2024

607 Background: Patients with upper tract urothelial carcinoma (UTUC) can be managed with either radical nephroureterectomy (RNU) or kidney sparing surgery (KSS) depending on the pathology and patient specific characteristics. Due to the rarity of this disease, high-level evidence is lacking with regard to clinical and oncologic outcomes after surgery. This study aims to compare outcomes of RNU with KSS for patients with high-grade (HG) UTUC. Methods: We retrospectively reviewed patients with >1 year follow-up who were treated for HG UTUC at our institution from 2015-2021. Oncologic and clinical outcomes were recorded. Procedure-related burdens, including total number of procedures under anesthesia, anesthesia time, and days hospitalized were collected. Results: 65 patients were analyzed, with 46 patients treated via RNU and 19 treated via KSS. There were no differences in the ASA or CCI between patients in the two groups. The 5-year overall survival (OS) was 65.2% (95% CI, 52.8%-80.5%) for RNU and 44.4% (95% CI, 26.5%-74.5%) for KSS. The 3-year metastasis-free survival was 78.3% for RNU and 78.9% for KSS. The 3-year recurrence-free survival, including recurrences in the bladder, was 47.8% (95% CI, 35.4%-64.7%) for RNU and 43.8% (95% CI, 25.1%-76.3%) for KSS. A decline of GFR <10 2 years after surgery occurred in 97.1% of patients treated with RNU and 100.0% of those treated with KSS. The total number of procedures under anesthesia was higher for KSS than RNU at 3.4 +/- 1.7 vs 2.1 +/- 1.7, respectively (p = 0.0155). The total number of TURBTs for KSS and RNU was similar at 0.6 +/- 0.7 vs 1.1 +/- 1.7, respectively (p = 0.9538). The total number of days hospitalized for KSS was similar to RNU at 5.5 +/- 4.3 vs 6.8 +/- 4.6, respectively (p = 0.3579). The total anesthesia time for KSS was 400 +/- 218 min and was 474 +/- 185 min for RNU (p = 0.2561). Conclusions: There were similar oncologic and clinical outcomes in patients with HG UTUC treated with either KSS or RNU. Patients treated with KSS saw a higher procedural load. There was a trend towards lower OS for patients treated with KSS but this was not statistically significant, likely due to the small sample size. Larger datasets are needed to further evaluate outcome and treatment burdens of RNU vs KSS as treatment options for patients with HG UTUC. [Table: see text]