bluuebunny/crossref_metadata_2025_split huggingface dataset:
Effect of treatment of residual disease after immunotherapy-based combinations on complete response rate in metastatic renal cell carcinoma.
Authors: Moinard-Butot Fabien , Oriel Marine , Tricard Thibault , Cazzato Roberto Luigi , Pierard Laure , Gaillard Victor , Werle Pierre , Lindner Veronique , Martin Sophie , Schuster Caroline , Roy Catherine , Burgy Mickael , Anthony Anne , Bigot Cecile , Boudier Philippe , Fritsch Aurelie , Malouf Gabriel G. , Lang Herve , Barthelemy Philippe 
Published: March 2023

601 Background: Immunotherapy (IO) has revolutionized the management of metastatic renal cell carcinoma (mRCC) by improving survival, overall response and complete response (CR) rates. CR is achieved in 11 to 17% with the different PD-1-based IO combinations in first-line setting of mRCC. However, local treatment of residual disease after systemic treatment exposure may improve CR rates. We performed a retrospective study to characterize patients (pts) in CR with systemic therapy alone or combined to an ablative approach of residual disease. Methods: We included all consecutive mRCC pts treated with mRCC in first-line treatment with IO combination with IO or TKI, either alone or with local treatment at the Institut de Cancérologie Strasbourg Europe. Pts were characterized according to IMDC risk group. Radiologic response was defined according to RECIST v1.1. Results: We enrolled 80 pts with mRCC between 5/2015 and 5/2022; median age was 68 (41-89) years; 75% male; 36 pts (45%) had prior nephrectomy; IMDC risk group: 12 favorable (15%), 50 intermediate (63%), 18 poor risk pts (22%), respectively; 47 pts (59%) received IO + IO, 24 (30%) received IO + TKI and 9 pts (11%) received another IO-based therapy; 35 pts (44%) achieved partial response, 23 pts (29%) stable disease, 13 pts progressive disease and 9 pts achieved CR (11%) as best response with systemic therapy alone; 10 pts out of 35 PR pts achieved CR by adding local treatment on residual disease. Among CR pts: 5 out of 19 pts had a component of sarcomatoid histology; median age was 60 years. Characteristics of pts with CR are reported in the table. Median duration of IO exposure before local therapy was 13 months. Residual disease resected sites included kidney (N = 6), lymph node (N = 4), lung metastasis (N = 2) and liver metastasis (N = 1). Local treatment was surgery for 9 pts and liver thermoablation for 1 patient. Conclusions: The resection of residual disease after first line IO-based therapy in mRCC improves CR rates (from 11% up to 24%). This approach should be considered as an option for a selected population. Prospective trials assessing this strategy should be performed in the future. Characteristics of patients in CR. [Table: see text]
Effect of race-free estimated glomerular filtration rate equations (eGFR) on oncology clinical trial eligibility for Black patients.
Authors: Schmeusser Benjamin , Palacios Arnold Raul , Midenberg Eric , Nabavizadeh Reza , Patil Dattatraya H , Harvey R. Donald , Bryksin Janetta , Connor Michael J. , Ogan Kenneth , Bilen Mehmet Asim , Master Viraj A. 
Published: March 2023

611 Background: Race is no longer recommended in estimated glomerular filtration rate (eGFR) equations. The resulting lower eGFR may positively impact black patients, such as with earlier nephrology referral. However, the impact of race-free equations on black oncology patients–a cohort more likely to experience inferior cancer outcomes and underrepresentation in clinical trials–has not been fully examined. Here, we analyze removal of race from eGFR in black patients with cancer, specifically with regards to clinical trial eligibility. Methods: Self-identified black patients undergoing nephrectomy at a referral center from 2009-2021 were identified. Patients with end-stage renal disease were excluded. Using preoperative creatinine, height, and weight, eGFR was calculated with the Chronic Kidney Disease Epidemiology Collaboration creatinine equation with and without race (CKD-EPI-WithRace; CKD-EPI-WithoutRace, respectively), and the Modification of Diet in Renal Disease equation with and without race (MDRD-WithRace; MDRD-WithoutRace, respectively). Distribution of patients and changes within CKD stages with different equations was considered. Theoretical exclusion at commonly observed clinical trial eGFR points was then simulated based on utilization of the race coefficient. Subgroup analysis was completed on patients with stage III-IV disease only. Results: 459 self-identified black patients that underwent nephrectomy at our institution were identified, 135 of which had stage III-IV disease. On average, eGFR decreased around 10-13ml/min/1.73m2 with removal of the race coefficient (Table). 13-22%, 6-12%, and 2-3% more black patients would fall under common clinical trial cutoffs of 60, 45, or 30ml/min cutoffs, respectively, depending on the equation used (Table). Subanalysis of stage III-IV patients only were similar. Conclusions: Race free renal function equations may inadvertently result in increased exclusion of black patients from clinical trials. [Table: see text]
Impact of race and payor status on patterns of utilization of partial and radical nephrectomy in patients with localized renal cell carcinoma (RCC).
Authors: Barragan-Carrillo Regina , Dallas Kai , Tripathi Abhishek , Govindarajan Ameish , Zengin Zeynep Busra , Meza Luis A , Philip Errol James , Castro Daniela V. , Chehrazi-Raffle Alexander , Chawla Neal , Hsu Joann , Dizman Nazli , Eilber Karyn , Bergerot Cristiane Decat , Pal Sumanta Monty 
Published: March 2023

614 Background: Racial minorities experience intersecting forms of marginalization and suffer significant healthcare disparities. Prospective trials have shown similar outcomes with partial and radical nephrectomy among patients with localized RCC (Van Poppel et al Eur Urol 2011), and multiple studies suggest increasing use of the former technique (Breau et al Can J Urol 2020). We hypothesize that patients from minority groups, as well as those with non-private insurance, will have less access to this specialized procedure and therefore have a higher rate of radical nephrectomy. Methods: We utilized the California Office of Statewide Health Planning and Development (OSHPD) database that collects information from all inpatient admissions, emergency room visits and inpatient/outpatient procedures in the state. All patients undergoing nephrectomy (both partial and radical) were identified from Jan 1, 2012 to Dec 31, 2018 using CPT and ICD-9/10 codes to identify patients. Demographic data was collected with specific attention to race and payor status. Univariate and multivariate analyses were conducted to determine the association between demographic data and procedure type. Results: In total, 31,093 patients were identified; 57% were males, with a mean age of 58 years. Among these, 16,142 (51.9%), 8,645 (27.8%), 2,795 (9.0%), 2,032 (6.5%) and 1,479 (4.8%) were characterized as White, Hispanic, Asian, Black and other, respectively. Partial nephrectomy and radical nephrectomy were performed in 15,840 (50.9%) and 15,253 (49.1%) of patients. By race, partial nephrectomy was performed in 8,576 (53.1%), 4,107 (47.5%), 1,286 (46.0%), 1,124 (55.3%) and 747 (50.5%) of White, Hispanic, Asian, Black and other patients, respectively (p<0.001). Use of partial nephrectomy also differed among patients based on payor status, with rates of 6,800 (56.4%), 5,036 (43.9%), 1,817 (38.3%) and 2,187 (77.7%) among patients with private, Medicare, indigent coverage (e.g., MediCal or Medicaid) and other insurance, respectively (p<0.001). On multivariate analysis controlling for age, gender, comorbidities and frailty, race was independently associated with type of nephrectomy procedure. Conclusions: Our study confirms that race and payor status may have an influence on utilization of partial versus radical nephrectomy, with the highest rate of partial nephrectomies among Whites and patients with private insurance. Although there are multiple potential confounders (e.g., latency of diagnosis and resulting tumor size/complexity), it is possible that access to care may be an important driver of these disparities.
Validating the Palacios’ future glomerular filtration rate equation with and without race.
Authors: Schmeusser Benjamin , Ali Adil , Patil Dattatraya H , Palacios Arnold Raul , Armas-Phan Manuel , Ogan Kenneth , Master Viraj A. 
Published: March 2023

616 Background: Accurate prediction of future glomerular function rate (fGFR) following nephrectomy in renal cell carcinoma (RCC) patients is of interest. A postoperative estimated glomerular filtration (eGFR) rate ≥ 45 mL/min/1.73m2 is considered favorable, with guidelines reflecting these findings. Though nephron sparing surgery is preferable, radical nephrectomy is often the preferred oncologic surgery. Various models to predict postoperative renal function have been proposed, with a new 2021 equation by Palacios et al. exhibiting strong performance in predicting fGFR. We aim to validate this fGFR equation in a large institutional cohort using both the Chronic Kidney Disease Epidemiology (CKD-EPI) 2009 equation with race, used in the creation of the formula, as well as the CKD-EPI 2021 equation without race, which is currently the recommended CKD-EPI creatinine equation. Methods: Using an institutional database, patients that underwent partial or radical nephrectomy for RCC from 2005-2021 were identified. Patients with creatinine values preoperatively and 3-12 months postoperatively were included, with end stage renal disease serving as exclusion criteria. Correlation/bias/accuracy/precision of the fGFR equation (fGFR=35+ [preoperative eGFR x 0.65]- 18 [if radical] - [age x 0.25]+ 3 [if tumor >7cm]-2 [if diabetes]) with observed postoperative eGFR was determined by both the CKD-EPI-2021 and CKD-EPI 2009 equations. Results: 1,443 patients were included in our analysis. 71% (1,024) and 22.9% (331) patients were white and black, respectively. A majority of patients underwent radical nephrectomy (60.3%). 40% of patients had T3-T4 RCC, with 14.8% of patients having M1 disease. Median observed vs predicted fGFR was 58.0 vs 58.7 ml/min/1.73m2 for CKD-EPI 2021 and 56.0 vs 57.5 for CKD-EPI 2009. The correlation/bias/accuracy/precision of the fGFR equation was 0.805/-0.5/81.7/7.9-9.0 for CKD-EPI 2021 and 0.809/-0.8/81.3/-8.1-8 for CKD-EPI 2009 equations (Table). Conclusions: The fGFR equation accurately predicted renal function in our large and diverse institutional cohort using both the CKD-EPI 2009 including race and CKD-EPI 2021 excluding race equations. [Table: see text]
Natural history of patients with muscle metastases from renal cell carcinoma: Results of the French national ARTEMIS study.
Authors: Wespiser Mylene , Carril-Ajuria Lucia , Ilfad Blazevic , Thibault Constance , Flechon Aude , Martin Sophie , Laramas Mathieu , Borchiellini Delphine , Simon Camille , Mahammedi Hakim , Linassier Claude , Goujon Morgan , Zaibet Sonia , Rolland Frederic , Albiges Laurence , Meurisse Aurelia , Falcoz Antoine , Thiery-Vuillemin Antoine 
Published: March 2023

618 Background: Muscle metastases (MM) are among rare secondary locations in renal cell carcinoma (RCC). Current guidelines do not provide specific advice on the management of these patients. There is a lack of scientific literature on the subject, mainly based on case reports or small retrospective monocentric cohorts. To date, therefore, there remains uncertainty about the clinical history, prognosis, and appropriate management of patients with MM. Methods: ARTEMIS is an ambispective national French multicenter, non-interventional study. It was opened to patients with metastatic RCC who had MM. The study was designed to assess overall survival (OS), progression-free survival (PFS), describe diagnostic and treatment modalities, and treatment-related serious adverse events in case of local treatments (TR-SAEs). Results: Median follow-up was 74.4 months IC95% [38.7-84.1]. The 146 enrolled patients were 73.6% male, with a median age of 57.6 years at diagnosis. They were initially diagnosed with stage IV RCC for 40.4% of them and had a favorable (36.2%), intermediate (45.7%), or poor (18.1%) IMDC risk score at the onset of metastases. Initially, metastases were mainly located in the lungs (55.5%), lymph nodes (26.7%), and bones (24.0%). Patients had a history of partial or total nephrectomy in 78.8% of cases. There were 30.0% of patients with synchronous MM. The median times from initial diagnosis or metastatic status to MM discovery were 25.5 [16.8-35.7] months and 8.4 [5.0-13.5] months, respectively. The majority (69.0%) of MM were discovered on conventional injected CT scans, whereas 8.3% were diagnosed clinically. Survival data are displayed on the table. Thirty-seven (25.3%) patients received local treatment of their MM which consisted of: external radiotherapy (48.6%), surgery (27.0%), cryotherapy (27.0%), stereotactic radiotherapy (5.4%), embolization (2.7%). Among them, local treatments prevented local relapse of MM in 28 patients (75.7%). Local TR-SAEs were seen in two patients (5.4%). Conclusions: ARTEMIS is the largest published cohort describing the disease history of patients with RCC suffering from MM. To our knowledge, this is the first study reporting the diagnostic and treatment modalities, also survival data. Despite its low incidence, the issue of these patients is not so rare in physicians’ practice. This work thus allows a greater understanding of clinical features and treatment of this pathology. [Table: see text]
Predictive accuracy of computer-generated C-index nephrometry scores compared with human-generated scores in predicting oncologic and perioperative outcomes.
Authors: Wood Andrew , Benidir Tarik , Abdallah Nour , Heller Nicholas , Isensee Fabian , Tejpaul Resha , Suk-ouichai Chalairat , Curry Caleb , You Alex , Remer Erick M. , Haywood Samuel , Campbell Steven , Papanikolopoulos Nikolaos , Weight Christopher J. 
Published: March 2023

623 Background: The Centrality index (C-index) score is a validated nephrometry scoring system that requires precise measurements and mathematical calculations of cross sectional imaging. Like other nephrometry scores, its implementation has been slowed by required time investment and interobserver variability. We sought to automate this score on preoperative computerized tomography scans by developing an artificial intelligence-generated C-index score. We then aimed to evaluate its ability to predict meaningful oncologic and perioperative outcomes as compared to human-generated C-index nephrometry scores. Methods: 300 patients with preoperative computerized tomography with early arterial contrast phase were identified from a cohort of 544 consecutive patients undergoing surgical extirpation for suspected renal cancer. A deep neural network approach was used to automatically segment kidneys and tumors, and then programed to generate the measurements and calculate C-index score. Human C-index scores were independently calculated by medical personnel blinded to AI-scores. AI- and Human score agreement was assessed using bivariate linear regression correlation and their predictive abilities for both oncologic and perioperative outcomes were assessed using logistic regression and compared with receiver operating characteristic (ROC) curve analyses with measurements of areas under the curve (AUC). Results: Median age was 60 years (IQE 51–68), and 40% were female. Median tumor size was 4.2 cm and 91.3% had malignant tumors. 27% were high stage, 37% high grade, and 63% underwent partial nephrectomy. There was significant agreement between Human scores and AI-scores on linear regression analysis (R2 = 0.738, p <0.0001). Both AI- and Human generated C-index scores similarly predicted meaningful oncologic outcomes, with lower levels of either C-index score associated with increased risk of malignant histology (H-score p = 0.018, AI score p =0.014) high-grade disease (both p <0.0001), and high stage disease (both p <0.0001). Lower levels of either AI or human generated C-index scores also predicted a radical nephrectomy rather than partial nephrectomy surgical approach (both p <0.0001). AUC measurements (Table) were similar but consistently superior for AI generated C-index scores. Conclusions: Fully automated AI-generated C-index scores are comparable to human-generated C-index scores and predict a wide variety of meaningful patient-centered outcomes. Once validated in additional populations, our results suggest that our AI generated C-index could be delivered automatically from a preoperative CT scan to a clinician and patient at the point of care to aid in decision making. [Table: see text]
Clinical outcomes of patients with metastatic renal cell carcinoma who discontinued nivolumab +/- ipilimumab therapy electively or due to toxicity.
Authors: Yoo Jessica Heejin , Hussey Duncan , Gross Evan , Psutka Sarah P. , Tykodi Scott S. , Thompson John A. , Hall Evan Thomas 
Published: March 2023

625 Background: Immune checkpoint inhibitor (ICI) based regimens are the standard of care for patients with metastatic renal cell carcinoma (mRCC). In other tumor types such as melanoma, there is evidence that cancer control can persist long after discontinuation of ICI therapy. Outcomes after ICI discontinuation for mRCC are less characterized. Our aim is to characterize the durability of treatment response in mRCC patients who discontinued ICI therapy electively or due to toxicity. Methods: We identified patients with mRCC who responded to nivolumab +/- ipilimumab and then discontinued ICI therapy either for elective reasons or due to toxicity. Patients who discontinued therapy due to progressive disease or who died within 3 months of their last ICI dose were excluded. Complete response (CR) duration was calculated from last ICI dose to the most recent documentation of CR status. Time to progression was defined as the time from last ICI dose to documentation of disease progression or initiation of next-line therapy. Durability of treatment response was calculated from the date of last ICI dose to the most recent follow up date at which sustained response was noted. Results: We identified a total of 56 patients treated with nivolumab +/- ipilimumab therapy who discontinued treatment for toxicity (n=30) or for elective reasons (n=26) and achieved CR or partial response/stable disease (PR/SD). Of the entire cohort, 19 patients (34%) achieved CR, and the majority (95%) were still alive and disease-free with a median follow up of 906 days (range 86-2143 days). Among all patients who discontinued treatment with best response of PR/SD, 49% experienced disease progression, with a median progression-free survival of 382 days (range 77-1267). 42% of patients who stopped ICI electively achieved CR and all (100%) were still alive with sustained CR (median follow-up = 735 days) at data collection. Among those with best response of PR/SD after elective discontinuation, about half (53%) maintained disease control while the rest had disease progression or death (47%). Conclusions: Patients with mRCC who achieve CR with nivolumab +/- ipilimumab and then subsequently discontinue therapy for reasons other than disease progression have excellent long-term cancer outcomes. Recurrence and subsequent progression are rare in this group. These results are similar to the durability of ICI treatment response observed in complete responders in melanoma. Outcomes were less favorable for patients who obtained PR/SD as best response prior to ICI discontinuation, although some patients had ongoing and durable cancer control for up to several years. More research is indicated to ascertain which disease/patient features predict long-term disease control after ICI discontinuation in patients who respond favorably to ICI therapy.
Cabozantinib + nivolumab in adult patients with advanced or metastatic renal cell carcinoma: A retrospective, non-interventional study in a real-world cohort.
Authors: Hilser Thomas , Darr Christopher , Niegisch Guenter , Schnabel Marco Julius , Foller Susan , Haeuser Lorine , Zschaebitz Stefanie , Lewerich Jonas , Anders-Meyn Merle , Ivanyi Philipp , Schlack Katrin , Grünwald Viktor 
Published: March 2023

628 Background: Standard treatment for 1st-line mRCC are IO-combinations. Data from real-world collectives are rare. In this multicenter study, we therefore evaluated safety and effectiveness of cabozantinib/nivolumab in Germany. Methods: Data were collected retrospectively from eight GU cancer centres in Germany. Patients (pts) with advanced or metastatic renal cell carcinoma (mRCC) were eligible. Treatment with cabozantinib 40 mg orally + nivolumab 240 or 480 mg i.v. was mandatory and administered according to routine care. Adverse events (AEs) were reported according to CTCAE 5.0. Objective response rate per RECIST 1.1 and Progression Free Survival (PFS) were calculated from start of treatment to progression or death. Descriptive statistics and KM-plots were utilized, where appropriate. Results: 67 suitable pts (62.7% male) with median age of 67.6 years were included. The most common histology was clear cell RCC (ccRCC) in 67.2% (n=45). Nephrectomy was performed in 56.7% (n=38). ECOG 0-1 was 76.1% (n=51). IMDC scores were: 0 in 11 (16.4%), ≥ 1 in 45 (67.1%), missing in 11 pts (16.4%). 29.9% (n=20) required dose reductions or interruptions. Partial response was documented in 46.3% (n=31), stable disease in 32.8% (n=22), and progressive disease in 4.5% (n=3) as best overall response. Data were missing in 14.9% (n=10). Median Follow-up was 8.3 mo, median treatment duration was 6.0 months, PFS rate at 6 month was 81.9% overall (79.3% for ccRCC; 85.9% for non-ccRCC). AEs (all grades) were reported in 82.1% (n=55) and 47.8% (n=32) for grade 3-5. Elevated liver enzymes (40.3%), diarrhea (22.4%) and hand-foot-syndrome (20.9%) were the 3 most frequent AEs of any grade and causality. Conclusions: In this real-world cohort of mRCC pts. cabozantinib + nivolumab was shown to be safe and feasible. While no new safety signals were reported, a reduced dose was frequently utilized. Our data support the use of cabozantinib + nivolumab as a first-line standard. Major limitations were the retrospective data capture and short follow-up of our study.