bluuebunny/crossref_metadata_2025_split huggingface dataset:
The impact of F-18 PSMA PET imaging on clinical decision-making in prostate cancer across disease states.
Authors: Arafa Ali , Jain Aditya , Humphrey Brad , Froelich Jerry , Antonarakis Emmanuel S. 
Published: March 2023

63 Background: Piflufolastat F-18 (18F-DCFPyL) PSMA PET imaging was recently approved by the FDA for initial staging, biochemical recurrence (BCR), and restaging of metastatic prostate cancer. Given that the PSMA PET is a next-generation novel imaging modality that carries a higher sensitivity for detecting metastatic disease compared with conventional imaging, we aimed to assess how its integration into clinical care may have impacted the management of patients. Methods: We identified 236 patients who underwent an 18F-DCFPyL PET scan at the University of Minnesota between August 2021 to June 2022. The median PSA at the time of imaging was 1.75 ng/ml (range, 0.02 - 3740 ng/ml). All PSMA PET scans were evaluated by an experienced nuclear medicine physician. Descriptive statistics were used to analyze its impact on the clinical care of 158 patients: 22 for initial staging, 110 with biochemical recurrence, and 26 patients with known metastatic disease. The remaining 78 patients had no information available to assess clinical utility. Results: Metastatic PSMA-avid lesions were detected in 152/236 (64.4%) patients. In patients undergoing initial staging of high-risk prostate cancer, 17/40 (42.5%) patients had metastatic lesions outside the prostate involving 10 regional and 5 non-regional lymph nodes, 1 visceral site, and 10 bone metastases. 17/40 (42.5%) of the scans were unremarkable. 6/40 (15%) had equivocal scan results. For the patients with available clinical information, 12/22 (54.5%) had a change in their treatment plan post-DCFPyL, while 10/22 (45.5%) had no change. In the biochemical recurrence cohort, 93/151 (61.6%) had positive lesions: 28 local recurrences, 47 regional and 22 non-regional lymph nodes, 5 visceral and 28 bone metastases. Equivocal and negative scans accounted for 13/151 (8.6%) and 45/151 (29.8%) cases, respectively. 44/110 (40%) of the patients with clinical information had a change in their treatment plan, while the plan did not change for 66/110 (60%) cases. In patients with known metastatic prostate cancer undergoing restaging, 42/45 (93.3%) had DCFPyL-positive lesions; 12 local recurrences, 20 regional and 16 non-regional, 9 visceral, and 29 bone metastases. Equivocal and negative scans accounted for 2/45 (4.4%) and 1/45 (2.2) of cases, respectively. Only 11/26 (42.3%) of those with clinical information had their tentative treatment plan adjusted post-DCFPyL. No change in the treatment plan was made in 15/26 (57.7%) cases. Conclusions: Integration of the F-18 PSMA PET imaging substantially impacted clinical decision-making, especially for initial staging of high-risk localized disease (treatment change in 55%) and for biochemical recurrence (treatment change in 40%). It remains to be seen if this would translate into superior survival outcomes.
Real world analysis of peritoneal metastasis from renal cell carcinoma: Meet-Uro 27 study.
Authors: Stellato Marco , Buti Sebastiano , Maruzzo Marco , Fotia Giuseppe , Sorarù Mariella , Bassanelli Maria , Maiorano Brigida Anna , Grillone Francesco , Galli Luca , Filippi Roberto , Fanelli Martina , Dionese Michele , Maffezzoli Michele , Vincenzi Bruno , Procopio Giuseppe , Verzoni Elena 
Published: March 2023

638 Background: Peritoneal metastases (PM) have been reported in approximately 1% of patients (pts) with metastatic Renal Cell Carcinoma (mRCC). Outcome data are limited due to the rarity of this metastatic site. Therefore, the aim of our study is to describe RCC pts with PM treated as per clinical practice. Methods: Baseline characteristics and outcome data of pts with PM from RCC were retrospectively collected from 12 Italian oncological referral centers adhering to the Meet-Uro group, from January 2016 to September 2022. Results: We collect 91 RCC pts with PM. 87/91 pts received systemic treatment, 4/87 only best supportive care. First line treatment included TKI and ImmuneOncology(IO)-TKI with different Objective Response Rate(ORR) (41% vs 53.8%, respectively) and Disease Control Rate (DCR) (57.1% and 80.7%, respectively) as well as median PFS (9.9 mo (95%CI 4.5-15.4) for TKI and not reached (NR) for IO-TKI (69.7% pts were free from progression at a median follow up of 13.8 months). Primary refractory (PR) pts were 35.7% for TKI and 7.7% for IO-TKI. According to IMDC score, mPFS was consistent among risk categories, 36.8 mo (95%CI 9.6-63.9) for good risk pts, 13.8 mo (95%CI 8.8-18.8) for intermediate pts and 2.9 mo (95%CI 2.2-3.7) for poor risk pts. Synchronous PM was associated to shorter mPFS 11.0 (95%CI 3.1-19.0) compared to patients with metacronous involvement as well as ORR (31.3%) and DCR (43.1%) whereas PR was higher (34.7%). Only 43/87 pts (45.7%) received a second line treatment that was TKI ( ORR 30.7%; DCR 61.5%; or IO (ORR 20.6%; DCR 41.3%). mOS was 21.8 mo (12.0-31.5) for TKI and NR for pts treated with IO-TKI (80.8 alive at 1 yrs). According to IMDC score, mOS was NR for good risk pts, 24.6 (95%CI 15.8-33.3) and 3.4 (95%CI 2.4-4.3) for intermediate and poor risk, respectively. Conclusions: We report one of the largest case series regarding PM from RCC. Poor risk patients according to IMDC score, sarcomatoid feature and liver metastasis were more represented in our population, compared to historical control, suggesting a more aggressive behavior of PM mRCC. Outcome data suggest that TKI-IO as first line treatment, compared to TKI monotherapy, and TKI as second line, compared to IO, are more active treatment for these pts with dismal prognosis. Nevertheless, synchronous PM has been reported in 57% of pts with poorer outcome and lower response rate. [Table: see text]
Real-world treatment patterns and progression-free survival among patients with metastatic castration-resistant prostate cancer: Examining the benefits of sequential androgen receptor pathway inhibitor use.
Authors: Patel Jeetvan , Sawhney Amrita , Byrne Clare , Tang Jackson , Yu Channing 
Published: March 2023

64 Background: Numerous treatments with different mechanisms of action are approved for metastatic castration-resistant prostate cancer (mCRPC), but real-world studies increasingly indicate that androgen receptor pathway inhibitors (ARPIs) are the most common treatment choice at both first- (1L) and second-line (2L). Nonetheless, robust evidence on the clinical effectiveness of ARPIs when used sequentially is lacking. The aim of this study was to examine the real-world treatment patterns and associated progression-free survival (PFS) among patients with mCRPC in the United States (US). Methods: This retrospective cohort study used Flatiron Health electronic health record data from 01/01/2013 to 06/30/2020. Included patients were male, aged ≥18 years, had a confirmed diagnosis of mCRPC within the study period, and received ≥1 systemic therapy post-mCRPC diagnosis. Three treatment subgroups were examined, with ARPI defined as abiraterone or enzalutamide: all 1L ARPI users; all 2L ARPI users irrespective of 1L therapy; and 1L ARPI users who received another ARPI at 2L. Treatment patterns were evaluated descriptively; time to next therapy (TTNT) was measured from the start of the ARPI of interest to the start of the subsequent line of therapy. The Kaplan-Meier method was used to evaluate PFS from the start of the ARPI therapy of interest until progression or death from any cause. Results: The study included 2,588 patients (mean age 72 years). ARPIs were the most prescribed systemic therapy in both the 1L and 2L settings: 63% (1,634/2,588) and 46% (808/1,760), respectively. Among 1L ARPI patients, 28.9% received 2L ARPI, 14.0% 2L taxane, 14.3% 2L combo therapies, and 32% received no further therapy. The median TTNT was 7.6, 6.2, and 5.1 months for 1L ARPIs, 2L ARPIs among all users, and 2L ARPIs among patients who received 1L ARPIs, respectively. The corresponding median PFS was 6.5 months, 4.5 months, and 3.9 months, respectively. Conclusions: Among real-world mCRPC patients in the US, ARPIs remain the most common therapy at both 1L and 2L. However, sequential ARPI use appeared to provide diminishing returns, with a PFS of <4 months seen at 2L in those who had received 1L ARPIs. [Table: see text]
Utilization of local treatment modalities and surveillance in veterans with early stage renal cell carcinoma.
Authors: Kumar Abhishek , Salama Joseph Kamel , Boyer Matthew J 
Published: March 2023

643 Background: Surgery represents the standard treatment for early stage renal cell carcinoma (RCC). For older patients, especially those with comorbidities including chronic kidney disease (CKD), there have been efforts made to spare renal function. The objective of this study was to evaluate the disease and treatment characteristics of Veterans with early stage RCC. Methods: We used the national Veterans Affairs’ Corporate Data Warehouse (CDW) database to identify patients diagnosed between 2000-2018 with early stage (cT1-2N0M0) RCC. Laboratory and diagnosis data were used to calculate creatinine clearance and Charlson comorbidity score. Chronic kidney disease (CKD) was defined as creatinine clearance < 60 milliliters per minute. The odds of receiving surveillance were evaluated with multivariable logistic regression. Results: Overall 19,555 Veterans with early stage RCC were included. The median age at diagnosis was 65, 90% range (48-82). 9,807 patients (50%) had at least 1 comorbidity and 4169 (21%) had multiple. Of 16,514 (84%) patients with available lab data, 1,359 (8%) patients had CKD. The treatments received were radical nephrectomy (RN) (N=4107, 21%), nephron sparing surgery (NSS) (N=5008, 26%), thermal ablation (N=489, 3%), and surveillance (N=9946, 51%). Compared to 2000-2010, from 2011-2018, there was a higher proportion of patients receiving NSS (29% vs. 20%, p < 0.01) and a lower proportion receiving surveillance (49% vs. 54%, p < 0.01). On multivariable logistic regression, predictors of receiving surveillance included older age (Odds Ratio [OR] 1.03 per year, p<0.01), T1 disease (OR 1.18, 95% CI 1.08-1.28), increasing number of comorbidities (OR 1.12 per comorbidity point, 95% CI 1.08-1.16), or CKD (OR 1.25, 95% CI 1.12-1.41). Compared to creatinine clearance before diagnosis, the median change in creatinine clearance at least 1 year after diagnosis was -46 for RN, -9 for NSS, -8 for ablation, and -24 for surveillance (p<0.01). Conclusions: A significant proportion of Veterans with early stage RCC undergo surveillance. Nephron sparing treatments are becoming increasingly common and are associated with more modest reductions in renal function than radical nephrectomy or surveillance. Further studies are warranted to assess the impact of surveillance on survival and cancer related outcomes.
Real-world survival outcomes of patients (pts) treated with 6-weekly pembrolizumab 400mg (pem6w) plus axitinib (axi) for advanced renal cell carcinoma (aRCC).
Authors: Ansel Sonam , Stares Mark , Jones Robert J. , Symeonides Stefan N. , Manson Laura , Ray-Chaudhuri Anirban , Randhawa Manreet , Slater Sarah , Devasar Abeera , Malik Jahangeer , Sundaramurthy Aravindhan , Elliott Tony , Venugopal Balaji 
Published: March 2023

645 Background: The Keynote 426 trial demonstrated 3-weekly pembrolizumab 200mg (pem3w) plus axi twice daily is effective in aRCC. We previously reported real-world experience of pem6w + axi demonstrating a comparable safety profile to pem3w + axi reported in Keynote 426, with the added benefit of less frequent hospital visits. Here we present updated results on progression free survival (PFS) and landmark analyses of overall survival (OS) at 6, 9 and 12-months. Methods: Electronic medical records of pts on pem6w + axi between 1st May 2020 & 1st June 2021 in two large cancer centres in Scotland were analysed retrospectively for pts’ characteristics, efficacy and treatment related adverse events (TRAE). A data cut-off of 1st June 2022 was applied. Results: A total of 93 pts were identified (baseline demographics previously reported). 74 pts (80%) had clear cell histology, 19 pts (20%) had non-clear cell and 11 pts (12%) had sarcomatoid component. Approximately half had previous nephrectomy (46 pts). 15 (16%), 46 (50%) and 32 (34%) pts respectively were classified as favourable, intermediate, and poor risk group as per international metastatic renal cell carcinoma database consortium (IMDC) criteria. The median follow-up was 13 months (inter-quartile range [IQR] 8-17). At data cut off, 59 (63%) had progressed or died, with median PFS of 10.7 (IQR: 4.6-not reached) months. At landmark time-points of 6, 9 and 12 months 63 (68%), 50 (54%) and 42 (45%) of pts were progression free (Table). The median OS was not reached and follow up continues. At landmark time-points of 6, 9 and 12 months 88 (95%), 69 (74%) and 65 (70%) of pts were alive (Table). Clinician assessed radiological response was evaluable in 87 pts. Overall response rate (ORR), including partial response and complete response, was noted in 51 pts (59%). Clinical benefit rate including pts with ORR and stable disease was seen in 74 pts (85%). 82 pts (88%) had any grade and 28 pts (30%) had grade 3/4 TRAE. Any grade immune related AE (irAE) occurred in 62 pts (67%) and grade 3/4 in 19 pts (20%); g3/4 transaminitis (10%), colitis (8%), nephritis (2%) and skin (2%). Any grade AE due to axi occurred in 69 (74%) and grade 3/4 AE in 14 pts (15%). 25pts (27%) on Pem and 19pts (20%) on axi discontinued treatment due to TRAE. Conclusions: Our real-world experience demonstrates that pem6w + axi appears to have comparable efficacy and safety profile to pem3w + axi reported in Keynote 426 study. [Table: see text]
Adjuvant immunotherapy for patients with renal cell carcinoma at increased risk of recurrence following resection: A National Cancer Database analysis.
Authors: Garg Harshit , Bhandari Mukund , Noel Onika , Dursun Furkan , Liss Michael A. , Kaushik Dharam , Pruthi Deepak K , Svatek Robert S. , Ramamurthy Chethan , Mansour Ahmed M 
Published: March 2023

649 Background: Radical nephrectomy is the standard management for locoregional renal cell carcinoma (RCC); however, patients with adverse pathological features are at increased risk of recurrence. IMmotion010 and KeyNote 564 trials investigated the adjuvant role of immune checkpoint inhibitors (ICI) for high-risk clear cell RCC (ccRCC) and have yielded conflicting results. We aimed to investigate real-world survival outcomes associated with the adjuvant use of ICI in high-risk ccRCC using the National Cancer Database Methods: In this nationwide contemporary cohort study, patients with newly diagnosed non-metastatic high-risk clear cell RCC undergoing radical nephrectomy between 2015-2019 were included. High-risk RCC was defined as cT2 with Fuhrman grade 4 or cT3a with Fuhrman grade 3/4 or cT3b/T3c/T4 with any grade, or TxN+ any grade. Patients receiving adjuvant ICI were classified as Group A and patients who did not receive adjuvant ICI were classified as Group B. Inverse probability weighting (IPW)-adjusted Kaplan Meier curves were utilized to compare overall survival (OS) between the groups and cox proportional hazard models were utilized to identify the predictors for OS. Results: Overall, 768 patients met the inclusion criteria; 270 patients in Group A and 498 patients in Group B. The mean age was 60.5(10.6) years, and 70.8% of patients were males (Table). The use of ICI in the adjuvant setting for high-risk RCC increased from 17.4% in 2015 to 61.8% in 2019. The unadjusted and IPW-adjusted Kaplan Meier 5-year overall survival was similar in the two groups [Unadjusted: 36.8% in Group A vs 50.1% in Group B, p=0.30 and adjusted: 39.5% in Group A vs 47.9% in Group B, p=0.17]. The use of adjuvant ICI did not appear to be an independent predictor for OS on multivariable cox regression analysis (HR=1.14, p=0.31) Conclusions: Adjuvant ICI therapy in non-metastatic high-risk ccRCC might not be associated with a benefit in overall survival. [Table: see text]
Impact of systemic therapy (ST) on deferred cytoreductive nephrectomy (CN) perioperative outcomes: A National Surgical Quality Improvement Program (NSQIP) analysis.
Authors: Dason Shawn , Sheetz Tyler , Ray Shagnik , Zimmerman Danielle Elise , Yin Ming , Folefac Edmund , Mortazavi Amir , Gong Michael , Shabsigh Ahmad , Singer Eric A. 
Published: March 2023

650 Background: Management of metastatic renal cell carcinoma (mRCC) is highly individualized and often involves cytoreductive nephrectomy (CN) and systemic therapy (ST). The optimal sequencing of CN and ST is uncertain. A difference in perioperative outcomes based on sequence of CN and ST could influence decision-making. We conducted this NSQIP analysis to assess whether preoperative systemic therapy adversely impacted perioperative outcomes in patients receiving deferred CN. Methods: This analysis was conducted using the American College of Surgeons NSQIP Participant Use Data File for years 2019 and 2020. These years were selected because data on receipt of preoperative therapy is only available since 2019. Inclusion criteria were i) CPT code consistent with nephrectomy, ii) urologist operating surgeon & iii) presence of disseminated cancer. All cases with ICD-10 diagnosis codes not consistent with mRCC were excluded. Groups were stratified by their receipt of preoperative systemic therapy within 90 days before CN and we assessed 46 preoperative and perioperative outcomes. Results: The study cohort included 505 patients with 115 (23%) who received preoperative ST. No differences were noted in perioperative outcomes (Table). Patients receiving preoperative ST were more likely to be on steroids (23% vs. 7%, p<0.01) and develop urinary tract infections (4.3% vs. 0.5%, p<0.01). There were no significant differences noted in other related variables like surgical site infections, wound dehiscence, sepsis, septic shock, pneumonia, cardiovascular complications, preoperative hypertension, or preoperative diabetes (p>0.05). Conclusions: Because preoperative ST did not have an appreciable impact on deferred CN perioperative outcomes, decision making for ST and CN sequencing should not be influenced by perioperative outcomes. Those who undergo deferred CN are unlikely to experience delayed time to surgery or perioperative complications from their ST. [Table: see text]
An evaluation of current practice patterns for patients with renal cell carcinoma.
Authors: Boehmer Leigh , Wood Laura S. , Mohs Jocelyn , Liatis Andrea Ines , Vogel Wendy , Matta Maria , Shivakumar Latha 
Published: March 2023

655 Background: First-line immunotherapy and tyrosine kinase inhibitor (TKI) treatment combinations have significantly improved clinical outcomes for patients with renal cell carcinoma (RCC). To maximize clinical benefit of these regimens, risk stratification should guide treatment selection and treatment-related adverse events (AEs) should be appropriately managed. The goal of this project was to identify current practice patterns regarding treatment selection, guideline-based management of AEs, care coordination, and patient education for individuals with RCC treated in community oncology programs and practices. Methods: In July-September 2022, ACCC administered an online survey to evaluate current practice patterns for patients with RCC treated in community cancer programs. To maximize participant engagement, the survey was also shared with advanced practitioner, pharmacist, and oncology nurse members of the Advanced Practitioner Society for Hematology and Oncology (APSHO) and the Kidney Cancer Association who provide care to patients with RCC. Results: Respondents (n=104) were mainly surveyed from community cancer care programs or private/physician practices (69%) in urban/suburban settings (90%) who average 25-75 patients with RCC annually (77%). Most respondents (89%) reported using a combination of an immunotherapeutic and a TKI as initial treatment for advanced clear cell RCC while only 61% of respondents reported frequently using risk scores for newly diagnosed patients. 45% of regimen-specific patient education happens as a separate visit, usually conducted by the oncologist (23%) or the infusion nurse (22%), and 37% of respondents conduct this education on the first day of treatment. The responsibility of providing comprehensive patient education seems to vary by program with the oncologist being the most reported (23%), followed by infusion nurse (22%), clinic nurse (20%), advanced practice provider (18%), and pharmacist (16%). The frequency of monitoring AEs differed based on the given regimen. Respondents mainly (54%) monitored on day 1 of the cycle and again mid-cycle in patients receiving immunotherapy, while 40% monitor only on day 1 of the cycle in patients receiving single-agent TKIs. Clinic nurses are primarily responsible (40%) for monitoring treatment adherence in patients receiving TKIs and also triage for associated AEs. Conclusions: This survey has identified real-world practice patterns related to the management and monitoring of patients with RCC prescribed immunotherapy and tyrosine kinase inhibitor combinations. Opportunities exist to increase utilization of risk assessments, create patient education materials for the multidisciplinary cancer care team, and address the optimal frequency of adverse event monitoring.