bluuebunny/crossref_metadata_2025_split huggingface dataset:
Healthcare utilization and outcomes in testicular cancer with and without HIV.
Authors: Deenadayalan Vaishali , Solipuram Vinod , Gupta Shweta 
Published: March 2023

411 Background: Risk of testicular cancer (TC) was higher in HIV patients before combined antiretroviral therapy (cART) era. However the risk has decreased and outcomes reported to be similar since cART (PMID 17548695, 34592009). We evaluated the characteristics, outcomes, and healthcare utilization of patients with TC with and without HIV from a national sample. Methods: Healthcare Cost and Utilization Project-Nationwide Inpatient Sample database was queried to identify all TC patients with and without HIV from 2016-2019. 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 orchiectomy, sepsis, septic shock, acute kidney injury, UTI, anemia, and protein energy malnutrition. Statistics were performed using t-test, univariate and multinomial logistic regression. Results: A total 265 admissions of HIV-TC and 29,450 non-HIV-TC were identified. HIV-TC patients were more likely to be in middle age group (45-65yrs) (38 vs 19% 40, p = 0.08) than non-HIV-TC who were younger <45yrs (76 vs 62%, p = 0.08). Compared to non-HIV-TC, HIV-TC patients were more likely to be Black (36% vs 5%, p<0.001), on Medicaid (47% vs 33%, p=0.002) or uninsured (12% vs 8%, p=0.002), treated at a teaching hospital (94% vs 84%, p=0.036). HIV-TC had a significantly higher comorbidity burden, prevalence of CKD and coinfection with Hepatitis B/C (all p<0.05). Other comorbidities and secondary outcomes were not significantly different. The overall adjusted all-cause mortality was not significantly different between groups (aOR = 0.6, 95% CI 0.08-4.24, p = 0.61), however on subgroup analysis mortality was significantly increased for blacks (aOR = 1.98, 95% CI 1.07-3.66, p = 0.02) and Asians (aOR = 1.84, 95% CI 1.05-3.21, p = 0.03) compared to Caucasians. Mean LOS (7 vs 6 days, p = 0.49) and THC ($68,766 vs $69,371, p = 0.17) were similar between cohorts. Conclusions: HIV-TC patients were older, in the middle age compared to more younger (<45 years) for non-HIV-TC patients. Although overall mortality and outcomes were similar between the groups, a racial disparity was seen with higher mortality in African American patients, the cause of which should be investigated in future studies.
Validation of AGR2 and KRT19 as specific proteins being significantly and differentially expressed in teratoma compared to necrosis in retroperitoneal lymph node resections after chemotherapy (pcRPLND).
Authors: Nestler Tim , Kremer Lara , von Brandenstein Melanie , Wittersheim Maike , Wagener-Ryczek Svenja , Paffenholz Pia , Mueller Stefan , Quaas Alexander , Hellmich Martin , Odenthal Margarete , Pfister David , Heidenreich Axel 
Published: March 2023

412 Background: Metastatic non-seminomatous testicular tumor patients with residual retroperitoneal tumor masses > 1cm after chemotherapy are treated with pcRPLND. The goal of pcRPLND is to remove viable tumors (V) and teratoma (T), which are present in approximately 10% and 40% of cases, respectively. However, histopathologically, only scar/necrosis (N) is identified in the remaining 50% of patients. In those patients, surgical therapy is not necessary, resulting in a relevant overtreatment. So far, no adequate distinction between the histologies exists preoperatively. Recently, the first biomarker was described with miR371a-3p in serum, which is highly specific for V, but not for T. In 2022 we reported AGR2 and KRT19 to be significantly and differentially expressed in teratoma compared to necrosis in pcRPLND tissue on protein and mRNA level. The aim of this study was to validate these proteins on an independent cohort. Methods: All consecutive pcRPLND patients from 2021 who were treated in the University Hospital of Cologne, Germany, were selected (n=66). All patients had residual masses > 1 cm and normalized or plateaued tumor markers. For immunohistochemistry, the monoclonal antibodies KRT19 and AGR2 were applied to representative Formalin-Fixed Paraffin-Embedded tissue. To quantify the results, the H-score was used. The investigators were blinded to the final pathohistological results. Results: The cohort was composed of 66 patients, 23 patients with T, 24 patients with V and 19 patients with N. Significantly higher H-scores were shown for AGR2 and KRT19 when comparing T vs. N and T vs. V (both p < 0.0001). The discriminatory ability of the two proteins AGR2 and KRT19 was calculated by AUCs for T vs. N and was 1.0 in each case with a corresponding sensitivity and specificity for T of 100%. Conclusions: With AGR2 and KRT19, we could validate the two proteins that are significantly and differentially expressed in the pcRPLND specimen in the clinically relevant groups T vs. N. In perspective, these proteins could be targeted by radiolabeled ligands as a tracer in order to reliably distinguish patients with teratoma from those with necrosis by means of functional imaging. Thus, overtreatment with pcRPLND of patients with N could be safely reduced.
Contemporary analysis of complications after retroperitoneal lymph node dissection: Data from the National Surgical Quality Improvement Program 2006-2018.
Authors: Cahill Ellen , Chua Kevin J , Doppalapudi Sai Krishnaraya , Srivastava Arnav , Patel Hiren V , Balraj Vasundhara , Ghodoussipour Saum , Jang Thomas L 
Published: March 2023

416 Background: Retroperitoneal lymph node dissection (RPLND) offers therapeutic and diagnostic value for patients with testicular cancer. Specific indications for RPLND include management of patients with stage I-II nonseminomatous germ cell tumors (NSGCT), advanced NSGCTs with post-chemotherapy masses, and seminomas with early metastatic disease. While RPLND is an invasive and complex operation, prior research suggests complication rates are relatively low and may vary based on patient characteristics and disease-related factors. We examined the incidence of complications after RPLND and aimed to determine risk factors associated with these complications. Methods: The National Surgical Quality Improvement Program (NSQIP) database from 2006-2018 was queried for RPLND in patients with testis cancer who were identified by ICD 9 and 10 codes. All reported postoperative complications were examined and categorized by type and organ system. Univariable and multivariable logistic regressions were performed to determine risk factors associated with complications. Results: 368 RPLND procedures over the 13 year interval met inclusion criteria. The overall complication rate was 23.91% (n=88). The most common complication was bleeding requiring transfusion (n=59, 16.03%). Risk factors associated with any complication included older age (OR 1.041, p=0.003), longer operative time (OR 1.007, p<0.001), and major concomitant procedure (OR 2.429, p=0.015). As shown in the table, risk factors associated with transfusion included older age (OR 1.040, p=0.019), longer operative time (OR 1.009, p<0.001), and major concomitant procedure (OR 3.296, p=0.004). Higher pre-operative hematocrit was associated with decreased risk of transfusion (OR 0.883, p<0.001). M+ (metastatic) disease and longer operative time were associated with an increased risk for wound, infectious, and respiratory complications. Conclusions: Based on our analysis, almost one in four patients undergoing RPLND experienced a complication. Bleeding requiring transfusion was the most common complication and was associated with patient age, preoperative hematocrit, operative time, and major concomitant procedure. Urologic surgeons may seek to optimize hematocrit prior to surgery, especially when major concomitant procedure may be necessary. [Table: see text]
The role of the size and number of index lesion in the diagnosis of clinically significant prostate cancer in patients with PI-RADS 4 lesions detected by multiparametric MRI of the prostate.
Authors: Kılıç Mert , Köseoğlu Ersin , Madendere Serdar , Vural Metin , Balbay Mevlana Derya , Esen Tarik 
Published: March 2023

44 Background: This study aimed to evaluate the contribution of the size and number of the sampled lesions to the diagnosis of clinically significant prostate cancer (CSPC) in patients who had PI-RADS 4 lesions detected by multiparametric MRI (mpMRI) of the prostate and underwent in-bore biopsy (IB). Methods: In this retrospective study, data of 295 patients who underwent IB for PI-RADS 4-5 lesions between 2012 and 2021 were analyzed, and a total of 159 patients with only PI-RADS 4 lesions were included. Clinical and radiological data, including age, PSA level, previous biopsy information, and the size and the number of PI-RADS 4 lesions were recorded. Patients with a lesion classified as Grade Group 2 and above were considered to have CSPC. Univariate and multivariate regression analyses were used to evaluate the factors affecting the diagnosis of prostate cancer (PCa) and CSPC. Results: A great majority (86.8%) of the patients had undergone a biopsy for the first time. About three-fourths (71.7%) of the patients had PCa, and half (54.1%) had CSPC. In multivariate analysis, the relationship between PCa and age, index lesion size, low PSA levels, and first biopsy patients were found significant, while CSPC exhibited a significant relationship with age and first biopsy patients. When the patients were divided into three groups according to the index lesion size (<5 mm, 5-10 mm, and >10 mm), the prevalence of PCa was 64.3%, 67.5%, and 82.4% and the prevalence of CSPC was 42.9%, 51.2%, and 64.7% respectively. Conclusions: While the size of PI-RADS 4 lesions was significant in predicting PCa, it had no significance in detecting CSPC. The number of lesions was insignificant in predicting both conditions. However, the prevalence of PCa was high, especially in patients with PI-RADS 4 lesions larger than 10 mm, which in turn increased the probability of the lesion being Grade Group 2 or above. [Table: see text]
Early switching to pembrolizumab (Pe) during first-line platinum-based chemotherapy (PCT) in patients (pts) with metastatic urothelial carcinoma (mUC).
Authors: Endo Yuki , Kimura Go , Akatsuka Jun , Takeda Hayato , Yanagi Masato , Mikami Hikaru , Hasegawa Hiroya , Taniuchi Mami , Katsu Akifumi , Funato Ryota , Toyama Yuka , Kondo Yukihiro 
Published: March 2023

452 Background: With the results of the Javelin bladder 100 trial, PCT followed by ICI has become the standard of care for pts with mUC. While more than half of the pts have progressive disease (PD) by the 4th cycle of PCT, in general, most these pts will receive ICI after 4th cycle of PCT. However, for pts who have PD before 4 cycles, additional PCT will not only be effective, but will also cause side effects and worsen immune environment. However, the outcome of early switching to ICI during 1st-line PCT has not been reported. Here, we investigated whether early switching to Pe may improve prognosis. We also examined the usefulness of serum CYFRA (sCY) as a prognostic marker of 2nd-line Pe in this study. Methods: Seventy pts with mUC received PCT followed by Pe from February 2018 to July 2022 at our institution. Among them 56 pts who had received PCT 3 cycles or less because of PD or unacceptable side effects were included in this study. During PCT, computed tomography (CT) was performed at the end of each cycle and PCT was continued until PD. If PD on CT was confirmed, 2nd-line Pe was initiated. Performance status, metastasis site, neutrophil-lymphocyte ratio, hemoglobin, and serum alkaline phosphatase, C-reactive protein, total protein, albumin, corrected calcium (Ca) and sCY before Pe were examined as possible prognostic factors for overall survival (OS). OS was analyzed by Kaplan-Meier curves and log-rank test. Multivariate analysis on prognostic factors was carried out using the Cox hazards model. Results: Median age was 73 (31-86). Twenty-seven pts (49%) received gemcitabine-cisplatin and 29 (51%) received gemcitabine-carboplatin for PCT. Twelve pts (21%) received 1 cycle of PCT, 2 cycles in 26 (46%) and 3 cycles in 18 (32%). During the median follow-up period of 14.6 (6.2-44.6) months (M), 30 pts (53.5%) had died. The median OS was 15.5M and the 1-year OS rate was 60%. The median PFS was 10.2M and the 1-year PFS rate was 46%. Objective response rate was 25% and 18 pts showed stable disease (32%) and 24 pts (43%) showed PD. On univariate analysis, sCY (p=0.001) and Ca (p=0.003) were the significant factors for OS. On multivariate analysis, sCY (HR 3.2, 95%CI [1.33-7.82], p=0.009) and Ca (HR2.3, (95%CI [1.02-5.22], p=0.046) were the significant factors for OS. Conclusions: Early switching to Pe during 1st-line PCT resulted in PFS of 10.2M and OS of 15.5M, which were longer than those of the KEYNOTE-045 trial (PFS 2M, OS 10M). Early introduction of Pe may be effective in the pts with mUC who are resistant to chemotherapy. sCY and Ca were suggested to be the useful prognostic factors for OS.
Clinical applications of urine- and blood-based genome wide copy number study from 1,000 patients with bladder and prostate cancer.
Authors: Dai Chao , Zheng Tiantian , Mo Wei , Bonora Giancarlo , Wang Amy , Luo Shujun , Zhou Kemin , Jia Shidong , Du Pan 
Published: March 2023

459 Background: Liquid biopsy has become increasingly important in cancer diagnosis and disease progression monitoring. Copy number variation is an important characteristic for genitourinary cancer and many other cancer types, where bladder cancer was shown to have the largest copy number alternation among 33 human cancer types from TCGA. We developed PredicineCNB, a companion LP-WGS assay to robustly estimate genome-wide copy number burden (CNB) from plasma and urine clinical samples, which can provide longitudinal disease monitoring in a cost-effective way. Methods: By integrating both fragments coverage and fragments length from LP-WGS data, and quantifying copy number deviation at chromosome arm level, we greatly increase both sensitivity and specificity for CNB based cancer detection. Analytical evaluation was performed based on clinical plasma titration samples, and PredicineCNB has demonstrated high cancer detection sensitivity (LOD is 1%) with high specificity (> 99%), using DNA input amounts as low as 1ng. We also validated CNB using Predicine panel-based tumor fraction for more than 200 clinical samples, results demonstrated both are highly concordant with correlation coefficient 0.84. Results: We performed clinical evaluation of PredicineCNB on 700 patients with prostate cancer and 300 patients with bladder cancer. For clinical patients with longitudinal samples under different disease stages or drug treatments, we demonstrated a promising potential using PredicineCNB for monitoring dynamic changes in ctDNA, that are caused by copy number variation. For 12 different bladder cancer patients, each with at least two longitudinal samples, we observed that CNB declines as early as two weeks after treatment initiation, providing an early signal of molecular response to therapy. In addition, when comparing conventional radiology-based imaging with CNB, we found that an increase in CNB preceded clinical progression of disease in majority of patients; and CNB shows a positive correlation between cancer stage revealed by CT scan. Conclusions: We conducted a comprehensive clinical study using PredicineCNB in 1,000 patients with prostate and bladder cancers, demonstrating the promising clinical application of liquid biopsy-based genome-wide copy number changes in therapy monitoring.
The impact of blue light cystoscopy use among patients with non-muscle invasive bladder cancer in an equal access setting.
Authors: Das Sanjay , Gu Lin , Trustram Eve Claire , Parrish Joshua , De Hoedt Amanda Marie , McKee Chad , Aronson William , Freedland Stephen J. , Williams Stephen B. 
Published: March 2023

461 Background: Prior studies suggest that white light cystoscopy (WLC) alone can fail to detect cases of non-muscle invasive bladder cancer (NMIBC) compared to blue light cystoscopy (BLC). We describe bladder cancer outcomes and the impact of BLC among NMIBC patients in an equal access setting. Methods: A total of 378 NMIBC patients within the Veterans Affairs system that had a CPT code for BLC from December 1, 2014 to December 31, 2020 were assessed. We determined recurrence rates and time to recurrence prior to BLC (i.e. after previous WLC if available) and following BLC. We used the Kaplan-Meier method to estimate event-free survival and Cox regression to determine the association between race and recurrence, progression, and overall survival. Results: Of 378 patients with complete data, 43 (11%) were Black and 300 (79%) White. Median follow-up was 40.7 months from bladder cancer diagnosis. There were 194 (51%) patients with either TaHG or T1 without CIS; 52 (14%) had CIS with or without TaHG or T1; and 127 (34%) had TaLG only. A total of 239 (63%) patients received BCG at any point during the study. Median time to first recurrence following BLC was longer compared to WLC alone (40 (33-NE) vs. 26 (17-39) months). The risk of recurrence was significantly lower following BLC (Hazard Ratio (HR) 0.70; 95% Confidence Interval (CI) 0.54-0.90). There was no significant difference in recurrence (Hazard Ratio (HR) 0.83; 95% Confidence Interval (CI) 0.48-1.43), progression (HR 1.46; 95% CI 0.45-4.74), and overall survival (HR 0.69; 95% CI 0.29-1.65) following BLC by Black vs. White race. Conclusions: In this study from an equal access setting in the VA, we observed significantly decreased risk of recurrence and prolonged time interval to recurrence following BLC compared to WLC alone. There was no difference in any bladder cancer outcomes by race.
Baseline characteristics from a retrospective, observational, US-based, multicenter, real-world (RW) study of avelumab first-line maintenance (1LM) in locally advanced/metastatic urothelial carcinoma (la/mUC) (PATRIOT-II).
Authors: Grivas Petros , Barata Pedro C. , Moon Helen , Hutson Thomas E. , Gupta Shilpa , Sternberg Cora N. , Dave Vaidehi , Downey Chad , Shillington Alicia C. , Devgan Geeta , Kirker Melissa , Thakkar Sheena , Katzenstein Howard M. , Bhanegaonkar Abhijeet , Liu Frank , Brown Jason , Sonpavde Guru P. 
Published: March 2023

465 Background: The JAVELIN Bladder 100 clinical trial demonstrated a significant overall survival and progression-free survival benefit with avelumab 1LM + best supportive care (BSC) vs BSC alone for la/mUC not progressing on platinum-based chemotherapy (PBC). PATRIOT-II aims to describe RW data for avelumab 1LM treatment (tx) of patients (pts) with la/mUC. Methods: PATRIOT-II collected data from pts with la/mUC treated in 37 geographically dispersed oncology practices/communities and academic centers in the US. Pts who initiated avelumab 1LM following PBC were retrospectively enrolled and will be followed up via medical record review for 52 weeks post avelumab 1LM initiation. This analysis focused on pt characteristics and tx data from la/mUC diagnosis through the PBC period and at avelumab 1LM initiation. Disease and PBC tx characteristics, as well as response to PBC, were assessed. All analyses were descriptive. Results: A total of 160 pts were enrolled (Table), 118 (74%) were white, non-Hispanic, 16 (10%), were Black, Asian, or Hispanic, and the rest unknown; 102 (64%) were current or former smokers. 77 (48%) were tested for PD-L1 via various assays, with 44 (57%) of those tumor samples reported as positive. 1L PBC was cisplatin-based in 100 (63%) of pts and carboplatin-based in 60 (38%). Pts received a median of 4 PBC cycles (interquartile range [IQR], 3-6) for a median of 13 weeks (IQR, 10-17). 31 (19%) discontinued PBC due to unacceptable side effects/toxicity. Best observed response was complete response in 21 (13%), partial response in 109 (68%), and stable disease in 17 (11%), with the remainder unknown. Median time to first imaging was 10 weeks (IQR, 5-14) after PBC initiation. 23 (14%) were hospitalized while receiving PBC, and 25 (16%) were seen in the emergency department. Pts proceeded to avelumab 1LM at a median of 4 weeks (IQR, 3-6) following PBC completion. Avelumab was administered at 800 mg every 2 weeks in 130 (81%), 10 mg/kg in 15 (9%), <800 mg in 8 (5%), and >800 mg in 7 (4%) pts. Conclusions: This ‘RW’ study offers valuable insights into characteristics and outcomes of pts with la/mUC treated in the US. Baseline factors, tx patterns and response to PBC were consistent with usual therapy paradigms in the 1L induction setting. Ongoing trials are evaluating the optimal number of PBC cycles and predictive biomarkers. Limitations include the retrospective nature, lack of randomization and central review, potential selection and confounding biases. [Table: see text]
Multi-center, retrospective study of first-line systemic therapy ± immune checkpoint inhibition for metastatic neuroendocrine carcinoma of the urinary tract.
Authors: Collier Katharine A. , Simon Nicholas I. , Taylor Amy K , Hemenway Gregory , Rose Tracy L , Eule Corbin Jeffrey , Tripathi Nishita , Rodman Christopher , Kalluri Uttam , Farooq Muhammad Zain , McKay Rana R. , Jain Rohit K. , Sonpavde Guru P. , Sweis Randy F. , Agarwal Neeraj , Lam Elaine T. , Zibelman Matthew R. , Emamekhoo Hamid , Apolo Andrea B. , Mortazavi Amir 
Published: March 2023

467 Background: Neuroendocrine, small cell, or large cell carcinoma originating from the urothelium (uro-NE/SCC/LCC) is rare. Outcomes for metastatic disease are dismal. Treatment is extrapolated from small cell lung cancer, for which immune checkpoint inhibitors (ICIs) have modest activity. Preliminary activity has been reported with ICI for uro-NE. We aimed to compare real-world progression-free survival (PFS) and overall survival (OS) between ICI-containing and non-ICI-containing regimens in the first line (1L) metastatic setting for uro-NE/SCC/LCC. Methods: We performed a retrospective study at 11 cancer centers. Patients (pts) who received systemic therapy (2011-2021) for biopsy confirmed metastatic uro-NE/SCC/LCC were included. Pts with metastasis within 6 months of (neo)adjuvant chemotherapy (CT) (n=16) were excluded from 1L analyses. Results: 102 pts with metastatic uro-NE/SCC/LCC were evaluable. 17 (16.7%) had NE histology, 81 (79.4%) SCC, and 4 (3.9%) LCC. NE/SCC/LCC was mixed with urothelial histology in 19 (18.6%). Primary tumors were most often in the bladder (84.3%, n=86), less frequently upper tract (11.8%, n=12) or urethra (3.9%, n=4). 42 pts (41.2%) were previously treated for localized disease, the rest were de novo metastatic (n=60, 58.8%). Pts who received an ICI in any line (n=61) had significantly longer OS (p=0.038) than pts that never received an ICI (n=41). As shown in the table, in the 1L, ICI-containing regimens (n=33) resulted in significantly longer PFS, but not OS or ORR compared to non-ICI regimens (n=53). Subdividing 1L regimens into ICI without CT (n=14), CT without ICI (n=53), or ICI + CT (n=19), both PFS and OS were significantly different with similar ORR. ICI w/o CT had the longest median PFS and OS with an ORR 57.1% comparable to CT regimens. Of 61 pts that received ICI in any line, 14 (23.0%) had an immune-related adverse event of any grade; 11 (18.0%) received steroids. Conclusions: This is the largest ever report of ICI for metastatic uro-NE/SCC/LCC. ICIs were associated with improved outcomes with expected added toxicity. Further prospective investigation of ICI regimens is warranted. [Table: see text]