bluuebunny/crossref_metadata_2025_split huggingface dataset:
Patterns of failure with 18F-DCFPyL PSMA PET/CT in the post-prostatectomy setting: A regional cohort analysis.
Authors: Sigurdson Samantha S. , al Salman Khalid , Mesci Aruz , Tsakiridis Theodoros , Dayes Ian S. , Quan Kimmen , Goldberg Mira , Schnarr Kara , Kapoor Anil , Shayegan Bobby , Bauman Glenn , Zukotynski Katherine , Lukka Himu 
Published: March 2023

309 Background: The participants are patients enrolled in the PSMA-PET Registry for Recurrent Prostate Cancer (PREP) who were referred for [18F]-DCFPyL PET/CT at our institution in Hamilton, Canada. The Registry is the only funded access to PSMA PET/CT for patients in Ontario. Methods: Our analysis includes all men who had a PSMA PET/CT on the Registry between April 2019 and December 2021 and are either node positive, or persistently detectable PSA after initial radical prostatectomy (RP), or biochemical failure after initial RP. Results: In total 177 men were enrolled on the Registry who met the above criteria. 170 men had complete pathological information available and were included. The pre-PSMA PET/CT median PSA was 0.27 ng/mL. Overall, the probability of a positive PSMA PET/CT result was 59.4%, and the incidence increased with increasing PSA. Lymph node (LN) and distant metastases (DM) were detected more frequently in patients with Grade groups 3-5 and higher pathologic tumor (pT) and nodal (pN1) disease. Across all 170 patients the most common site for LN recurrence was in the internal iliac chain (15.9%), followed by the external iliac (14.7%), obturator (11.8%), common iliac (10.0%), pre-sacral (8.8%), para-aortic (7.7%), and peri-rectal (5.9%) chains. The PSMA PET/CT recurrence rate, PSA, and pathological tumor stage is reported, with the location of the recurrence indicated. Conclusions: Our prospective study elucidates patterns of failure for prostate cancer patients with biochemical recurrence after RP and could impact management at diagnosis and after RP. There is a significant risk of pelvic LN positivity on PSMA PET/CT, which emphasizes the importance of including pelvic LNs within salvage radiation volumes. [Table: see text]
“It just makes sense to me”: Patient experiences with prostate MRI during prostate cancer active surveillance.
Authors: Sutherland Ryan , Gross Cary Philip , Ma Xiaomei , Jeong Farah , Seibert Tyler M , Cooperberg Matthew R. , Catalona William , Loeb Stacy , Schulman-Green Dena , Leapman Michael 
Published: March 2023

334 Background: Although prostate MRI is commonly used in the diagnosis, staging and active surveillance of prostate cancer, little is known about patient perspectives on MRI imaging. Methods: We performed a qualitative descriptive study consisting of in-depth, semi-structured interviews of patients with low and intermediate risk prostate cancer managed with active surveillance. Interviews focused on experiences with prostate MRI and MRI-ultrasound fusion biopsy during active surveillance monitoring. We purposively sampled patients who received prostate MRI as part of their clinical care, over-sampling Black and Latino men, and conducted interviews until thematic saturation. We performed conventional content analysis to analyze data. Results: The mean sample (n=20) age was 68 years (range 51-79). Fourteen (70%) participants identified as White, 5(25%) as Black, and 2(10%) as Hispanic/Latino. At diagnosis, 17 (85%) had a Gleason grade group 1, and 3 (15%) had a grade group 2 tumor. Overall, participants viewed prostate MRI as a valuable tool that accurately localizes and monitors prostate cancer over time. Prostate MRI was seen as central to active surveillance monitoring. We identified five thematic categories: (1) the experiential aspects of undergoing an MRI scan; (2) the experience of visualizing one’s own prostate and prostate cancer; (3) adequacy of provider explanations of MRI results; (4) confidence in prostate MRI in decision-making; and (5) the role of prostate MRI in longitudinal follow-up during active surveillance, including an interest using MRI to modify the timing of, or replace, prostate biopsy. Conclusions: These findings reveal that patients highly value prostate MRI as a tool that enhances the confidence in the initial diagnosis and monitoring of prostate cancer. This work can inform future studies to optimize the patient experience, education and counseling during active surveillance for prostate cancer.
Comparative cost-effectiveness of alternative imaging and surveillance schedules for testicular seminoma in the TRISST trial.
Authors: Huo Dacheng , Huddart Robert A , Cafferty Fay Helen , Murphy Laura , Rustin Gordon J. S. , Sohaib Syed A , Schiavone Francesca , Kaplan Richard S. , Joffe Johnathan K , Sculpher Mark , Pedro Saramago 
Published: March 2023

408 Background: Risk of radiation exposure from standard computed tomography (CT) surveillance is a major concern in the management of stage I seminoma testis patients. The TRISST randomized trial (NCT00589537) demonstrated that effective monitoring could be achieved with a reduced scan schedule or using Magnetic Resonance Imaging (MRI) instead of CT. Here, TRISST data is used to evaluate the economic consequences and health outcomes of different surveillance schedules in seminoma patients in the UK. Methods: 669 men were randomized to 4 surveillance groups undergoing 7 CTs over 5 years, 3 CTs over 3 years, 7 MRIs, or 3 MRIs of the retroperitoneum. Resource use (including investigations, scans, hospitalisations and treatment for relapse) and health outcomes data (EQ-5D 3L) on each patient were collected at baseline and over a period of 6 years after randomization. Health resources were costed using publicly available national unit costs. Within-trial mean total costs and quality-adjusted life years (QALYs) were estimated for each alternative schedule. Under the perspective of the UK health system, cost-effectiveness was evaluated using a cost per QALY gained framework. Probabilistic sensitivity analysis was used to reflect parameter uncertainty and evaluate results robustness. Results: Since only 82 men (12%) relapsed, most health resource consumption (76%) happened during the disease-free period. Patients undergoing 7 MRIs yielded, on average, slightly higher health benefits (5.20 QALYs) but at higher costs (GBP £6,632, see table). Compared to 7 CTs, 7 MRIs was estimated to have 63% probability of being cost-effective at a system willingness to pay threshold of £20k/QALY. 3 MRIs had similar costs and benefit to 7 CTs, whereas 3CTs was more expensive than 7 CTs and 3 MRIs, providing marginal additional benefits. Conclusions: Overall, small differences exist in total costs and total QALYs between different strategies. A 7 scan MRI schedule yielded more health benefits than other strategies, but at higher costs. Considering possible capacity constraints with MRI, the reduced radiation exposure relative to CT, and non-inferiority for clinical outcomes in the primary analysis, a 3 scan MRI schedule may be the best option to replace current CT-based longer surveillance practice. Clinical trial information: NCT00589537 . [Table: see text]
Geographic variation in utilization of doublet therapy for metastatic prostate cancer.
Authors: Washington Samuel L. , Cowan Janet E. , Zhao Shoujun , Rider Jennifer , Taylor Nicholas , Whyte Warren , Carroll Peter , Cooperberg Matthew R. 
Published: March 2023

41 Background: Clinical trials for men with metastatic prostate cancer have supported the use of combination therapies to improve survival outcomes, with recent work showing increased benefit of triplet regimens. However, real-world utilization of doublet therapy ( i.e., androgen deprivation therapy (ADT) plus a novel hormonal therapy (NHT)) and variation in use according to geographic region have not been evaluated in detail. With recent data supporting the use of triplet regimens we must understand what factors already impact doublet therapy utilization before we can intensify treatment further. Using data aggregated from a national cohort of community and academic medical oncology practices, we characterized real-world utilization of doublet therapy and examined factors associated with its use, including geographic region. Methods: Using ConcertAI RWD, clinical data of men with metastatic prostate cancer was linked with state-level measures of socioeconomic factors and healthcare resources from the Area Health Resources File. Logistic regression was used to evaluate associations between clinical and community characteristics and receipt of doublet therapy (vs ADT alone) within 90 days of diagnosis; models were adjusted for clinical factors, state level factors (excluding hospital beds, poverty, and education due to collinearity), and geographic region. Odds ratios (ORs) with 95% confidence intervals were reported. Results: A total of 1,763 men with M1 disease were eligible, with a mean age of 68.6 years at diagnosis. Nearly half (48%) lived in the Southern region, 9.3% in North East, 18.6% in West, and 23.7% in Midwest. Roughly 13.8% were Black, and 1.3% American Indian, and 1.1% Asian. One-third received ADT alone (37.8%). Regression analysis for ADT+NHT vs. ADT included 1,604 men, of which 84.6% received doublet therapy. Geographic region [vs Southern: Midwest, OR 0.6, 95% CI 0.4-0.9; Northeast, OR 0.4, 95% CI 0.2-0.7], larger state population [(log-transformed) OR 0.09, 95 % 0.02-0.3], prior surgery or radiation (vs none, OR 1.7, 95% CI 1.3-2.3), greater urologist density [(log-transformed), OR 0.1, 95% CI 0.02-0.8] and radiation oncologist density [(log-transformed), OR 12.9, 95% CI 2.8-60.2] were significantly associated with receipt of doublet therapy compared to ADT alone. Conclusions: Receipt of doublet therapy was impacted by geographic region and regional availability of specialty care (i.e. urologist and radiation oncologist density), emphasizing the relationship between regional medical expertise and care implementation. As the drive to improve care grows, our study highlights how treatment remains influenced by where you live and the need for identifying actionable targets for intervention and organizational change at the regional level.
Gender specific differences in health-related quality of life for patients with bladder cancer following radical cystectomy.
Authors: Westhofen Thilo , Buchner Alexander , Schlenker Boris , Becker Armin , Stief Christian G. , Kretschmer Alexander 
Published: March 2023

437 Background: Previous studies have shown pronounced gender specific differences regarding diagnosis and oncological outcome for patients with bladder cancer (BC). Current literature lacks evidence on gender specific differences in health-related quality of life (HRQOL) outcomes for patients with BC following radical cystectomy (RC). We aimed to assess those gender specific differences by providing HRQOL data from a large prospective propensity score-matched cohort of patients undergoing RC with a systematic follow-up of up to 10 yrs. Methods: 1498 consecutive patients [n=421 women, n=1077 men] who underwent RC at a large tertiary care center were included. A propensity-score matched analysis of 794 patients [n=397 women, n=397 men] was conducted applying the matching- variables “patient age”, “BMI”, “pT-stage” and “type of urinary diversion”. Exclusion criteria encompassed age <30 yr and RC due to benign diseases. HRQOL was assessed preoperatively, at 3 mo, then annually until a maximum follow-up of 120 months applying the validated EORTC QLQ-C30- as well as the bladder cancer-specific QLQ-BLM30- and FACT-BL-questionnaires. Separate modeling of longitudinal HRQOL for women and men was performed. Spearman’s rank correlation was applied to identify gender specific factors influencing HRQOL. Results: At baseline women and men showed no significant difference in general HRQOL assessed by the global health status domain (GHS) (p=.162). Women presented with worse mean emotional (p=.001) and cognitive (p=.007) functioning subscale. In the longitudinal analysis, a similar natural course of the GHS for women and men could be observed up to 36mo after RC (p-range: .107 - .856). Between 48mo and 96mo after RC, general HRQOL was significantly higher for men compared to women (p-range: .002-.045). At 12month a significant correlation between physical functioning or urinary continence and increased general HRQOL could equally be observed for men and women (each p< .05). No significant correlation was found between sexual functioning and increased general HRQOL. While a strong correlation between Social/Family wellbeing and increased general HRQOL was found for women (p=.001), no correlation was found for men (p=.103). Conclusions: The current study provides prospective data from a unique propensity score-matched contemporary patient cohort, which displays gender specific differences in the natural course of general HRQOL and its subdomains. Those data are important to guide gender specific treatment decision-making for patients with BC.
Uptake of maintenance immunotherapy and changes in upstream treatment selection in patients with advanced urothelial cancer (aUC).
Authors: Mamtani Ronac , Zhang Hanxi , Parikh Ravi Bharat , Cohen Aaron B. , Patel Khilna , Homet Moreno Blanca , Li Haojie , Imai Kentaro , Galsky Matt D. , Hubbard Rebecca A. 
Published: March 2023

466 Background: In July 2020, the FDA approved avelumab, an immune checkpoint inhibitor (ICI), for maintenance treatment of aUC that has not progressed with first-line (1L) platinum-containing chemotherapy (chemo). Availability of avelumab may have influenced upstream treatment selection between 1L chemo and 1L ICI (pembrolizumab or atezolizumab). We described avelumab use in real-world practice and determined whether 1L treatment choice changed following its approval. Methods: This cohort study used Flatiron Health’s nationwide de-identified EHR-derived database. Included patients started 1L therapy for aUC in the US before (April 1 2017 to June 30 2020) or after (July 1 2020 to May 31 2022) avelumab approval. We calculated the proportion of patients initiating 1L chemo (carboplatin- or cisplatin-based) or ICI during the pre- and post- avelumab approval periods. Time trends were estimated using multinomial logistic regression for 1L treatment choice regressed on time modeled via a natural cubic spline, allowing for a discontinuity in the time trend at the time of FDA approval. Differences in probabilities of 1L treatment in July 2020 (immediately following approval) compared to June 2020 (immediately prior to approval) were calculated. Maintenance avelumab use was described among patients treated with 1L chemo in the post-approval period, and in a sensitivity analysis, among ‘maintenance eligible’ patients defined as those who were progression-free 28 weeks after 1L chemo start. Results: Among all 1L treatment initiators (n=3,507), the FDA approval of maintenance avelumab was followed by increased use of 1L carboplatin-based chemo (+9.9%; 95% CI 1.1-17.2%) but no significant changes in the use of ICI (-5.8%; 95% CI -15.9-4.4%) or cisplatin-based chemo (-4.2%; 95% CI -12.7-5.2%) (Table). Among patients treated with 1L platinum-chemo (n=485), probability of initiating maintenance avelumab increased over time. In the 22 months after approval, approximately 20.4% (n=99/485) of all 1L chemo-treated patients and 24.3% (n=78/321) of maintenance eligible patients received maintenance avelumab. Conclusions: We found modest uptake of maintenance avelumab for aUC after FDA approval. Potential reasons include limited clinician awareness of maintenance immunotherapy and/or patient preferences against long-term treatment after response to initial chemo. Our finding of higher treatment starts with carboplatin-based chemo in the post-maintenance period suggests increasing preference by clinicians of a strategy that provides patients an opportunity for two effective treatment options. Real-world data can provide important insights on community response to regulatory approvals. [Table: see text]
Assessment of treatment patterns and real-world outcomes following changes in the treatment paradigm for locally advanced/metastatic urothelial carcinoma (la/mUC) in the US.
Authors: Kirker Melissa , Abraham Anup , Vlahiotis Anna , Bhanegaonkar Abhijeet , Benjumea Darrin , Kim Chai , Sun Haiyan , Kearney Mairead , Chandrasekar Sanjana , Li Benjamin , Thakkar Sheena , Moon Helen H 
Published: March 2023

468 Background: The standard-of-care first-line (1L) treatment for la/mUC is platinum-based chemotherapy (PBC) followed by avelumab 1L maintenance (1LM) in those who have not progressed following 1L PBC. This study aims to understand treatment patterns and real-world outcomes in patients with la/mUC in the US, including the early adoption of avelumab 1LM since its FDA approval in June 2020. Methods: Patients aged ≥18 years diagnosed with la/mUC between Jan 2015 and Jul 2021 were identified using electronic health records from the Flatiron Health database. Patient characteristics at baseline (la/mUC diagnosis) and clinical outcomes were described by 1L treatment received using the Kaplan-Meier method. Results: Of 4,387 patients included in this study, 3,706 (84.5%) received systemic treatments. Cisplatin-based therapy was the most common 1L therapy (33.3%), followed by carboplatin-based (30.9%) and immuno-oncology (IO) therapies (28.0%). Patients treated with cisplatin-based therapies had longer median progression-free survival compared with patients treated with carboplatin-based and IO therapies (8.0, 6.4, and 6.1 months, respectively). Median overall survival (mOS) in the treated cohort was 14.6 months from the initiation of 1L therapy. Patients treated with 1L cisplatin-based therapies had the longest mOS (18.3 months), followed by 1L IO therapies (14.6 months), and 1L carboplatin (13.2 months). Since July 2020, 89 patients received avelumab 1LM; the median follow-up time from the start of 1LM avelumab was 6.0 months and clinical outcomes data were immature. Of 1L-treated patients, 50.6% (n=1,874) moved onto second-line (2L) therapy during the study period. Notably, the cohort with the lowest 2L treatment rates were patients treated with 1L IO. The table demonstrates treatment sequences for this population. Conclusions: In this real-world cohort, most patients received standard-of-care platinum-based chemotherapy in 1L, with those on cisplatin-based therapy demonstrating the best outcomes. Early uptake of avelumab as 1LM was observed, and future analysis should examine the clinical outcomes of patients who received avelumab 1LM following 1L PBC. [Table: see text]
Comparative analysis of contemporary and past PSMA PET/CT results for recurrent prostate cancer in a high-volume Brazilian center.
Authors: Lages Dr. Paulo Sergio , Monteiro do Prado Junior Luciano , Fonseca Monteiro do Prado Leonardo , Carvalho Oliveira Bruno , Ramos Barra Renato , Silva Barbosa Michelle , Vargas Pivato de Almeida Daniel ,   Latin American Cooperative Oncology Group Genitourinary Tumors Division, LACOG-GU
Published: March 2023

51 Background: PSMA PET/CT scan (68Ga-PSMA PET/CT) has emerged as a highly accurate tool when assessing disease staging both for newly diagnosed localized high-risk prostate cancer and for recurrent disease, with treatment plan modification in up to two-thirds of patients. PSMA PET/CT is commercially available in Brazil since last decade and growing experience with this test has led to a more accurate analysis of the results over the years. Methods: We retrospectively reviewed the PSMA PET/CT scans results of patients undergoing the exam in all disease stages in a single institution in Brasilia, Brazil, between October 2015 and July 2022 and analyzed the results correlated with clinicopathological information (when available) in two separated timeframes for those in the recurrent disease setting. Results: Overall, more than 2,500 PSMA PET-CT scans were performed since October 2015. Between 2015 and 2019, 351 exams were performed, of which 303 in the setting of recurrent disease, while 297 tests were executed between 2021 and 2022, with 283 of them being done in the recurrent disease setting. Any clinicopathological information was available for 648 patients, of whom 586 underwent the test in the setting of recurrent disease following treatment of primary disease. Conclusions: There was a similar positivity rate among the clinicopathological characteristics analyzed in an indirect comparison of the two timeframes. It is remarkable the increased positivity rate among patients with lower levels of PSA in the contemporary dataset, which may reflect the learning curve of this image method. Among patients selected by Gleason grade, no definitive information can be extracted given the distinct PSA levels between patients in the two selected timeframes. [Table: see text]
Clinical results of a phase 1 study of intravesical EG-70 in patients with BCG-unresponsive NMIBC.
Authors: Steinberg Gary D. , Kalota Susan J. , Lotan Yair , Warner Loraine , Dauphinee Shauna , Mazanet Rosemary 
Published: March 2023

512 Background: enGene is developing non-viral gene therapy platforms to deliver nucleic acids (plasmids) to epithelial mucosal tissues such as urothelium of urinary bladder. EG-70 is a nanoparticle formulation of plasmids that activates both innate and adaptive immune responses to activate the immune system within the bladder. The plasmid encodes both IL-12 and activators of the innate immune receptor RIG-I. EG-70 is administered intravesically to elicit local stimulation of anti-tumor immune responses providing durable efficacy in high grade non-muscle invasive bladder cancer (NMIBC) while avoidingsystemic toxicities. Methods: In the Phase 1 study(LEGEND; NCT04752722), escalating doses of EG-70 were administered intravesically to patients with BCG-unresponsive Carcinoma in situ (CIS) NMIBC on weeks 1 and 2 or weeks 1, 2, 5, 6 of 12-week treatment cycle. At the week 12 assessment, patients with stable disease (SD) or complete response (CR), as assessed by urine cytology, cystoscopy, and bladder biopsy, were allowed electively to remain on EG-70 for up to 3 additional 12-week cycles. Results: To date, 19 patients have been treated. There have been no DLTs. AEs (48 GR1, 17 GR 2 and 1 GR3) have been largely consistent with urinary tract instrumentation, and were not dose related. Eighteen patients have completed one cycle of EG-70, and 67% have achieved CR. Fifteen patients with CR or SD at the end of cycle 1 elected to receive additional treatment cycles (continuation rate of 15/18 ( 83%)). Durable CRs were seen at all dose levels. Patients who receive additional cycles are followed for durability of response (Table). Complete Response. Conclusions: These results demonstrate the safety, tolerability and durable therapeutic potential of intravesical EG-70 in patients with BCG-unresponsive CIS. A Phase 2 study will proceed in 2023. Clinical trial information: NCT04752722 . [Table: see text]