bluuebunny/crossref_metadata_2025_split huggingface dataset:
CT abdomen only for active surveillance in patients with stage I germ cell tumor (GCT): A multi-institutional study.
Authors: Ahmadi Hamed , Benidir Tarik , Saoud Ragheed , Anson-Cartwright Lynn , O’Malley Martin , Eggener Scott E. , Hamilton Robert James , Daneshmand Siamak 
Published: February 2022

410 Background: Active surveillance (AS) for stage I germ cell tumor (GCT) typically includes periodic imaging of chest, abdomen and pelvis. Efforts to modify the surveillance protocols aim to minimize radiation exposure in this young patient population. We report our multi-institutional effort to assess the effect of omitting CT pelvis. Methods: Using data from three major referral centers for GCT (University of Southern California, University of Toronto, and University of Chicago), all patients with stage I GCT who experienced recurrence on AS were selected. Clinicodemographic information including recurrence pattern (tumor marker (TM), imaging, physical exam (PE), or a combination of these) were collected. Bifurcation of the common iliac arteries was defined as the anatomic landmark between CT abdomen and pelvis. The location of recurrent nodal disease was determined accordingly. Results: A total of 270 patients were included. 122(45%) patients had non-seminomatous GCT (NSGCT). 17(6%) patients had history of cryptorchidism and 38 (14%) had history of scrotal/inguinal surgery. The median time to recurrence for seminoma and NSGCT was 16 months (IQR 8–27) and 6 months (IQR 4–13), respectively. The most common method for detecting recurrence was imaging-only (49%) followed by combination of TM and imaging (43%). A total of 43/270(16%) patients had pelvic/inguinal nodal recurrence (PNR). Prior hernia repair was significantly higher in patients with pelvic/inguinal nodal disease compared to their counterparts (19%vs2.5%;p=0.01). PNR was detectable only by imaging in 16/270(6%) patients. However, in 11/16(69%) patients, PNRe was either visible on CT abdomen cuts or there was simultaneous retroperitoneal recurrence. Overall, only 5/270(1.8%) patients (4 seminoma, 1 NSGCT) had PNR only detectable on CT pelvis. Conclusions: CT abdomen only, chest imaging, TM and PE detect majority of recurrences in stage I GCT and CT pelvis could be safely omitted during AS. Future modification in AS protocols of stage I GCT may be warranted.[Table: see text]
Nerve sparing retroperitoneal lymph node dissection in clinical stage IIA/B seminoma: The COTRIMS trial.
Authors: Heidenreich Axel , Paffenholz Pia , Nestler Tim , Pfister David A. 
Published: February 2022

418 Background: Retroperitoneal radiation therapy or systemic chemotherapy with 3 cycles PEB represent the guideline recommended treatment options in marker negative clinical stage IIA/B seminoma. Despite a high cure rate of 90% to 94% and 82% to 90% in CS IIA and IIB, respectively, both therapeutic options are associated with significant long-term toxicities. It was the aim of our trial to evaluate the feasibility, oncological efficacy and treatment associated morbidity of primary nsRPLND in stage IIA/B seminoma. Methods: 16 patients with marker negative clinical stage IIA and IIB classical seminoma of the testis were recruited in the prospective trial. Patients with primary metastatic stages IIA/B or patients who developed metastatic during active surveillance for clinical stage I seminoma could be recruited. Metastatic disease following carboplatin therapy for clinical stage I seminoma represented an exclusion criteria. Informed consent was obtained after educational talk about the standard treatment options. Surgery associated complications were classified according to Clavien-Dindo. Progression-free survival and overall survival were calculated by Kaplan-Meier curves. Results: Mean age was 37.2 (21-54) years. Mean follow-up is 21.2 (1-36) months. All patients were treatment-naïve and 9 (56.2%) and 7 (43.8%) patients were diagnosed with stage IIA/B at time of primary diagnosis or during active surveillance for clinical stage I disease, respectively. 13 (81.2%) and 3 (18.8%) patients were diagnosed with stage IIA and IIB disease, respectively. 14 (87.5%) and 2 (12.5%) patients underwent open and robot assisted ns RPLND, respectively. Mean OR time was 131 (105-195) min, mean blood loss was < 150ml and the mean hospitalization time was 4.5 (3-9) days. We did not observe surgery associated complications > Clavien Dindo grade 3a. 14/16 (87.5%) patients preserved antegrade ejaculation. Histology of the resected lymph nodes revealed metastatic seminoma in 12 (75%) patients; 1 and 3 patients demonstrated embryonal carcinoma and inflammatory disease, respectively. 2/16 (12.5%) patients developed an outfield relapse 4 and 6 months postoperatively. Both patients were salvaged by systemic chemotherapy with 4 cycles PEB. Conclusions: NsRPLND results in a high cure rate at midterm follow-up and it is associated with a low frequency of treatment associated morbidities making this approach a feasible alternative to standard radiation therapy or systemic chemotherapy. Clinical trial information: DRKS00025384.
Final results of a multicenter prospective phase II clinical trial of gemcitabine and cisplatin as neoadjuvant chemotherapy in patients with high-grade upper tract urothelial carcinoma.
Authors: Yip Wesley , Coleman Jonathan , Wong Nathan Colin , Sjoberg Daniel D. , Bochner Bernard H. , Dalbagni Guido , Donat S. Machele , Herr Harry W. , Pietzak Eugene J. , Hakimi A. Ari , Kim Kwanghee , Al-Ahmadie Hikmat A. , Vargas Hebert Alberto , Meraney Anoop M. , Baccala Angelo Angelino , Apolo Andrea B. , Iyer Gopa , Teo Min Yuen , Rosenberg Jonathan E. , Bajorin Dean F. 
Published: February 2022

440 Background: Neoadjuvant chemotherapy (NAC) has proven survival benefits for invasive urothelial carcinoma of the bladder, yet its role in upper tract urothelial carcinoma (UTUC) remains undefined. We conducted a phase II multicenter trial of NAC with gemcitabine and cisplatin (GC) in patients with high-risk UTUC prior to extirpative surgery to evaluate major outcomes of response, survival, and tolerability. Methods: Eligible patients with defined criteria for high-risk localized UTUC received four cycles of GC prior to surgical resection and lymph node dissection. The primary study endpoint was pathologic response rate (defined as < pT2N0). Patients with progressive disease prior or unable to proceed to surgery were considered treatment failures. Secondary endpoints included time to disease progression (PFS), overall survival (OS), and safety and tolerability. Results: Among 57 patients evaluated, 36 (63%) demonstrated pathologic response, meeting the primary endpoint of the study. A complete response was noted in 11 patients (19%), defined as pT0N0. Forty patients (70%) tolerated all four cycles of GC, and all patients proceeded to surgery. The 90-day ≥ grade 3 surgical complication rate was 7.0%. With a median follow up of 42.3 months among survivors, six patients succumbed to disease. Two and five-year PFS were 76% (95% CI 66, 89) and 61% (95% CI 47, 78). Two and five-year OS were 93% (95% CI 86, 100) and 79% (95% CI 67, 94). Patients demonstrating pathologic response had improved PFS and OS compared to those who did not (two-year PFS 91% vs 52%, log-rank p < 0.001, two-year OS 100% vs 80%, log-rank p < 0.001). Conclusions: NAC for high-risk UTUC demonstrates outcomes of favorable pathologic response, is well tolerated requiring minimal delay to surgery without significant perioperative complication risk, and thus should be considered a new standard of care option for patients with high-risk UTUC. Better survival outcomes in patients with favorable pathologic features after NAC indicate a potential clinical benefit to this approach. Clinical trial information: NCT01261728.
E-cigarette use and the risk of bladder and lung cancer.
Authors: Herriges Michael Joseph , Pinkhasov Ruben , Shapiro Oleg , Jacob Joseph M , Basnet Alina , Bratslavsky Gennady , Goldberg Hanan 
Published: February 2022

443 Background: Electronic cigarette smoking and similar novel smoking modalities have raised questions about their impact on various cancers compared with traditional forms of tobacco smoking. Tobacco smoking has been concretely proven to increase the risk of many cancers, including lung (LCa) and bladder (BCa) cancer. To date, there is little data on how e-cigarette smoking impacts the incidence of these cancers. We investigated whether any disparities exist in the prevalence of LCa and BCa between various smoking histories using a US nationally representative data source. Methods: This cross-sectional survey-based US study included men and women aged 18+ from the National Health Interview Survey (NHIS) database between 2016-2018. Primary endpoint was self-reported occurrence of LCa and BCa diagnosis. Multivariable logistic regression analyses assessed possible association of various covariates with diagnosis of these cancers. Results: Prevalence of BCa and LCa was higher in all smoking histories compared to never smokers. Patients with a history of e-cigarette smoking vs. no history of e-cigarette smoking were significantly younger at BCa diagnosis (56.87 [±9.86] vs. 65.00 [±12.60] years, p=0.001). Multivariable logistic regression models showed that a history of cigarette smoking and e-cigarette smoking individually was associated with increased ORs of 2.476 (p≤0.001) and 1.577 (p≤0.001) for BCa diagnosis, respectively, and 4.589 (p≤0.001) and 1.614 (p=0.007) for LCa diagnosis, respectively. Conclusions: Compared to never smokers, history of e-cigarette smoking was associated with increased risk of LCa and BCa development and earlier BCa diagnosis. Additional studies are needed to better define the public health effects of these novel and unregulated products.
The association of FDG PET/CT and NaF PET/CT with survival outcomes in patients (pts) with metastatic genitourinary malignancies (mGU) treated with cabozantinib + nivolumab +/- ipilimumab (CaboNivo +/- Ipi).
Authors: Simon Nicholas I. , Lei Katherine , Verdini Nicholas Peter , Lin Jeffrey , Vega Andy , Niglio Scot Anthony , Mortazavi Amir , Pal Sumanta K. , Kempf Jeffrey , Becker Murray , Knopp Michael V. , Wright Chadwick , Jung Alex , Choyke Peter L. , Steinberg Seth M. , Mena Esther , Lindenberg Liza , Apolo Andrea B. 
Published: February 2022

452 Background: This study determined the association of functional imaging parameters obtained on FDG PET/CT and NaF PET/CT with OS for pts with mGU malignancies treated on a phase I study with CaboNivo +/- Ipi. Methods: Pts on this phase I study underwent sequential (1-hour apart) FDG PET/CT and NaF PET/CT imaging at baseline and at first-restaging (8 weeks follow up). Scan semi-quantitative parameters measures included: maximum standardized uptake value (SUVmax), metabolic tumor volume (MTV), and total lesion glycolysis (TLG) for FDG and MTV for NaF. Total lesion number was captured for all scans. The association of imaging parameters and survival was determined with Kaplan-Meier curves. Baseline values and percent change values were calculated. Results: 81 pts were included in the analysis. 67 (83%) were males; Median age was 63 (range 25-86); Histologically, 30 pts had urothelial carcinoma, 15 clear cell renal cell carcinoma, 9 germ cell tumors, 8 urachal/adenocarcinoma, 8 prostate cancer, 3 penile cancer, 3 squamous cell carcinoma, 3 renal medullary carcinoma, and 2 small cell (1 bladder, 1 prostate). All 81 had a baseline FDG PET scan, 78 pts received baseline NaF PET scans; 66 received both FDG PET and NaF PET baseline and follow up scans. 957 total lesions were detected on FDG PET across all histologies, 87 liver (9%), 252 lung (26%), 152 bone (16%), 411 lymph node (43%), and 55 other visceral metastases (6%). 414 total lesions were detected on NaF imaging. Low vs high baseline FDG MTV (31 vs 11 months, p = 0.0002), TLG (30 vs 11 months, p = 0.0004), Lesion number (49 vs 15 months, p = 0.0005), and SUVmax (25 vs 12 months, p = 0.025), FDG lesion number decrease or no change vs increase (24 vs 12 months, p = 0.0068), and low vs high baseline NaF MTV (26 vs 16 months, p = 0.007), and lesion number (26 vs 16 months, p = 0.007) showed the strongest associations with OS. A multivariable Cox analysis demonstrated that baseline FDG MTV (HR = 2.87, 95% CI 1.62-5.08, p = 0.0003) and FDG lesion number percent change (HR = 2.71, 95% CI 1.40-5.24, p = 0.0031) were jointly associated with OS. Conclusions: Baseline functional imaging parameters and percent change seen on follow imaging with FDG PET and NaF PET are prognostic in mGU pts treated with CaboNivo +/- ipi. Additional parameters and histologic subsets will be presented.
Criteria used to determine platinum eligibility and first-line (1L) treatment (tx) patterns among platinum-eligible (PE) and -ineligible (PI) patients (pts) with metastatic urothelial cancer (mUC) in France, Germany, Spain, Italy, and the United Kingdom (Eu5).
Authors: Milloy Neil , Kirker Melissa , Berry Mia , Kostikas Michael , Montgomery Rachel , Kearney Mairead , Costa Nuno Matos , Chang Jane 
Published: February 2022

457 Background: European Society for Medical Oncology (ESMO) guidelines recommend tx for mUC based on cisplatin and platinum eligibility. To date, most real-world analyses have not included physician-confirmed eligibility status. This study collected mUC patient data in Eu5 and summarized the criteria used in the real-world setting to determine PE and 1L tx prescribed based on PE. Methods: Data were drawn from the Adelphi mUC Disease-Specific Programme, a real-world point-in-time study conducted from November 2020 to April 2021. Oncologists and urologists were enrolled in the study and recruited the next 8 eligible pts who came for a consultation. Demographic, clinical characteristics, platinum eligibility, and tx patterns were collected. Results: Physicians provided data on 1,868 mUC pts who were receiving or had completed 1L tx and had a known PE status as determined by a physician prior to 1L tx. Renal function contributed to physicians’ platinum eligibility decisions for 72% of pts; ECOG score and age were used in 59% and 38% of pts, respectively. The mean (SD) age was 69.1 (7.88) years and 73% were men. At initial mUC diagnosis (dx), 25% were PD-L1–positive, 17% were PD-L1–negative, and 58% had either unknown PD-L1 status or were not tested. 87% of pts were PE (55% were eligible for cisplatin and carboplatin; 31% were cisplatin ineligible), and 13% were PI. PE pts who were eligible for cisplatin and carboplatin were younger than cisplatin ineligible and PI pts (66.6, 71.9 and 73.1 years, respectively). The percentage of pts with ECOG 0 or 1 at dx was 92%, 79%, and 67% for cisplatin and carboplatin eligible, cisplatin ineligible, and PI pts respectively. Conclusions: Only a small proportion of pts were classified as PI. The majority of PE pts received guideline-recommended tx with platinum-based regimens in the 1L. Overall, there was limited use of immune checkpoint inhibitor tx in the 1L, with use observed primarily among PI pts. Some guideline deviations were observed, including pts deemed PI who still received platinum-based chemotherapy. Recently, ESMO guidelines were updated to include avelumab for 1L maintenance tx in PE pts. Future studies should evaluate concordance with updated guideline recommendations in PE pts and rationale for guideline deviations.[Table: see text]
Impact of COVID-19 on cancer caregivers: Results from the Global Carer Well-being Index.
Authors: Turpin Karen V.L. , Foland Elizabeth , Patton Taylor , Guterl Jeremy , Zapakin Marni , Greenamyer Jasmine 
Published: February 2022

460 Background: Caregiver burden has been intensified by the COVID-19 pandemic. The Carer Well-being Index is a global research study commissioned by Embracing Carers, a partnered initiative with nine global caregiving organizations. The study sought to explore and delineate the impact of the pandemic on the health and well-being of caregivers across the globe, including those caring for persons with cancer. Methods: The survey was conducted via online and phone methodologies in September and October 2020, with over 9,000 unpaid carers across 12 countries, including the United States and Canada. Unpaid carers were defined as those who care for someone with a long-term illness (e.g., cancer), physical disability (e.g., spinal cord injury), or cognitive/mental condition (e.g., Alzheimer’s). The base sample size for cancer caregivers from the global surveyed population was n=1035. Statistically significant differences between cancer carers and non-cancer carers were evaluated using the Chi-square test with p ≤ 0.05. Results: 63% of all caregivers were women, with a 60/40 female to male split in the cancer carer group. While the average age of started caregiving was 37.2 years, and 39.0 in cancer carers, caregivers caring for someone with cancer were more likely than the average caregiver to be in the 60+ age group. Compared to non-cancer caregivers surveyed, a higher percentage of cancer caregivers became carers in the last year (26 vs 13% of non-cancer caregivers). Providing emotional support, managing doctor appointments, preparing meals, home maintenance and housekeeping, transportation, and giving/managing medications were more likely to be among cancer caregivers' primary responsibilities, compared to non-cancer caregivers. Cancer carers were significantly more likely than non-cancer carers to have reported negative impacts because of COVID on their emotional/mental, physical, and financial health, and paid work responsibilities. Overall, cancer caregivers were significantly more likely to report that COVID has made caregiving harder than non-cancer caregivers (71 vs 63%), and were more likely to report never receiving support from a variety of organizations, such as insurance organizations (71 vs. 66% non-cancer caregivers) and local/state government (73 vs. 66%). Of note, cancer carers were more likely to report a positive impact on the relationship with the person being cared for (61 vs. 56%). Conclusions: These results highlight the burdens that have been intensified for cancer carers. Actions are needed to help with health and well-being such as offering and promoting mental health services, respite care; providing financial support to take leaves from paid work, access to equipment and services such as housecleaning. By working together with health care providers, organizations, and government on these types of initiatives, the burden upon cancer caregivers can be lessened.
Changes in body composition during neoadjuvant platinum-based chemotherapy associations prior to radical cystectomy: Implications for chemotherapy-associated adverse events and oncologic outcomes.
Authors: Maldonado Reno , Fintelmann Florian J. , Marquardt Jan Peter , O'Malley Ryan Blair , Holt Sarah K. , Ngo Steven , Diamantopoulos Leonidas Nikolaos , Laidlaw Grace , Schade George R. , Lin Daniel W. , Wright Jonathan L. , Gore John L. , Nyame Yaw A. , Grivas Petros , Yu Evan Y. , Montgomery Robert B. , Hsieh Andrew Caleb , Yezefski Todd , Schweizer Michael Thomas , Psutka Sarah P. 
Published: February 2022

476 Background: Low skeletal muscle index (SMI) is associated with an increased risk of mortality in muscle-invasive bladder cancer (MIBC) and chemotherapy-related adverse events (AE) across numerous other malignancies. Small case series suggest neoadjuvant chemotherapy (NAC) is associated with a significant decline in SMI in patients with MIBC. However, limited data exists regarding changes in fat mass during NAC. Herein, we examine changes in SMI, visceral fat index (VFI), and subcutaneous fat index (SFI) in patients receiving NAC for MIBC before radical cystectomy (RC). We describe associations between body composition changes and NAC-associated AE and all-cause mortality (ACM) in patients with MIBC. Methods: Retrospective review of patients with MIBC (≥pT2 N0/x/1 M0) who received NAC (2006-2019). Patients with digitized abdominal computed tomography scans (CT) within 75 days prior (T1) and 75 days following completion (T2) of NAC were included. We segmented and calculated the indices (cm2/m2) for SMI, VFI, and SFI at the third lumbar vertebra level at T1 and T2 using validated methodology. Associations with AE during NAC and ACM were evaluated with multivariate logistic regression and Cox proportional hazards models. Results: Included 170 patients, median age 63 years receiving a median of 4 (IQR 3-5) cycles of Gemcitabine/Cisplatin (52%), MVAC (28%), or other NAC (20%). Absolute and relative changes in SMI, VFI, and SFI over a median of 112 days (IQR 94-146) between measurements are presented in the Table. 117 (69%) patients experienced grade ≥3 chemotherapy-related AE. No associations between baseline body composition or change in body composition during NAC with chemotherapy-related AE. T1 SMI (HR: 0.98; 0.97-0.99, p = 0.008), as well as T2 SMI (HR: 0.98; 0.96-0.99, p = 0.003), T2 VFI (HR: 0.99; 0.99-1.0, p = 0.05) and T2 SFI (HR: 0.99; 0.98-1.0, P = 0.03) were associated with ACM after adjusting for age, clinical T and N stage, and performance status. Conclusions: Patients undergoing NAC prior to RC experienced a 6.4% decrease in SMI and a 5.2% decrease in VFI during an average of 112 days. Chemotherapy-related AE were not associated with a change in body composition. Baseline SMI and T2 SMI, SFI, and VFI were associated with ACM on multivariable analysis. Future work is needed to understand the mechanisms underpinning such changes and the extent to which potentially detrimental changes in body composition may be mitigated before surgery.[Table: see text]