bluuebunny/crossref_metadata_2025_split huggingface dataset:
“What you're hearing from all of us is simplify the language”: A focus group study on biomarker testing in oncology.
Authors: Smith Anna Jo Bodurtha , Ang Ian Lee , Acharya Rashmi , Moore Tracy , DeFeo Sarah , O'Brien Caroline , Ko Emily Meichun 
Published: May 2024

e13540 Background: In oncology, somatic biomarker testing is increasingly driving treatment decision-making. Exploration of patients’ understanding of, and perspectives on, biomarker testing has been limited, yet these are needed to improve health education and communication about biomarkers. Our objectives were to explore the perspectives of patients with gynecologic cancers on biomarker and genetic testing and to identify factors that influenced their decision-making on testing. Methods: Patients with gynecologic cancer enrolled in the University of Pennsylvania’s Biobank were invited to participate. Of the 82 patients contacted, 7 participated in 3 focus groups in fall 2023. Participants reviewed educational materials (pamphlet, slide set) about biomarker testing based on the Cancer Precision Medicine Commons’ patient education materials, explored understanding and perspectives around biomarker testing, and then discussed barriers and facilitators to testing. Thematic analyses by two researchers were performed using verbatim transcripts. Results: All patients strongly agreed that both genetic and biomarker testing were important after a gynecologic cancer diagnosis and impacted their treatment options. However, patients did not understand what a biomarker was and expressed confusion over terms and testing methods, labeling unknown terms as “jargon.” 85% of participants had received germline genetic testing, and 85% received biomarker testing, with the remaining participants uncertain about testing status. Participants utilized a variety of resources such as the Internet, peer forums, articles on the patient portal, discussions with clinicians, and scientific papers to understand their cancer diagnosis and the role of genetic and biomarker testing. They mentioned fear (i.e., seeing low survival rates for ovarian cancer online as a “death sentence”) and financial circumstances as key barriers to accessing genetic or biomarker testing. Patients desired simple tailored written materials that were relevant from diagnosis to across the disease course. Conclusions: Patients understand the importance of biomarker testing in oncology but reported difficulties understanding existing resources. Current online resources had jargon and induced fear in some participants. Work to develop patient-centered resources on biomarker testing is needed.
Promptable foundation model for automatic whole body RECIST measurement.
Authors: Hérent Paul , Philippe Hélène , Ferreres Elodie , Machado Leo , Dancette Corentin , Khlaut Julien , Manceron Pierre , Tordjman Daniel 
Published: May 2024

e13643 Background: RECIST 1.1 is the gold standard for tumor evaluation in clinical trials and patient care. However, it faces challenges due to the subjective selection and measurement of lesions, notably because of inter-observer variability in the 20-30% range (1), which can potentially result in inaccuracies in therapeutic response classification (2). The main objective of this study is to assess the added value of a radiological foundation model to assist the radiologist to measure RECIST across different lesion topographies, using visual prompting. Methods: We use a promptable segmentation algorithm, based on a visual foundation model, pre-trained on various CT-scans and then trained on a subset of the Medical Segmentation Decathlon (MSD) dataset, covering 538 patients with pancreas, liver, colon and lung lesions. It outputs a 3D segmentation mask of the lesion, using a visual prompt, i.e. a 3D bounding box (BBox) as input. We then measure the capacity of the model to measure RECIST on the MSD validation set and on the KiTS validation set (99 samples), which features a new lesion type (kidney). To simulate inter-reader variability of up to 23%, we provide as inputs BBoxes centered on the lesions but with a varying error (15% variability: +10 pixels, 23% variability: +15 pixels). Results: The model is able to correct variability in BBox input: with all BBox error ranges, it beats the input variability (15% and 23% thresholds in each column) across many organ types, except in the pancreas when using large error BBoxes. Moreover, the model is able to generalize to new lesion types not seen during training, on an external dataset (KiTS - Kidney). Conclusions: Unlike existing supervised machine learning models dedicated to lesion detections in specific organs, our approach is organ and lesion agnostic and offers a more reliable, precise tumor assessment. This is a first step before allowing the longitudinal evaluation of tumors while safeguarding the clinical intuition necessary for selecting the right target lesions. Moreover, we believe that these methods will be crucial in advancing beyond RECIST 1.1, facilitating the identification of new prognostic biomarkers and proxies for tumor burden derived from previously underexplored radiomics features, ultimately refining the efficacy of clinical trial assessments and elevating the standard of patient care. 1. Yoon, S et al. 2015. 2. Kuhl et al. 2018. [Table: see text]
Impact of eligibility criteria discordance on clinical trial accrual in diffuse large B-cell lymphoma (DLBCL).
Authors: Anderson Clare E , Wang Mei , Wuliji Natalie , Patel Anand Ashwin , Lin Chenyu 
Published: May 2024

e13707 Background: Excessively stringent clinical trial eligibility criteria may hinder trial accrual, differentially exclude racial-ethnic minority groups, and limit generalizability. This study reviewed the association between trial accrual and concordance of eligibility criteria with known drug safety data in DLBCL clinical trials. Methods: Eligibility criteria and accrual of completed phase II/III clinical trials for DLBCL that opened in the US between 2010-2020 were abstracted from ClinicalTrials.gov. Trials missing posted results or studying cellular therapy / transplant were excluded. Concordance with known safety data was assessed by comparing study eligibility criteria for QTc, renal, hepatic, and cardiac function to FDA labels and phase I safety signals of study drugs. Excessively strict discordant criteria (ExSDC) were defined as eligibility criteria without supporting safety signals. Logistic regression +/- dispersion was used for analysis. Results: 58 trials met criteria for inclusion, accruing 6,232 participants. 88% of studies involved a non-FDA-approved agent, 74% were multicenter, 55% were industry sponsored, 66% only accrued in the US, and 86% were phase II. Eligibility criteria were highly variable (Table). Discordance of renal, hepatic, cardiac function, and QTc criteria from known safety data occurred in 31%, 26%, 41%, and 29% of studies, respectively. Race and ethnicity data were not reported in 22% and 45% of studies, respectively. Trials after 2015 were more likely to report race (p=0.04) and ethnicity (p=0.01). In a multivariable model adjusted for international study sites, greater number of ExSDC was associated with a lower proportion of black patients in the trial (OR 0.45, CI 0.29-0.71, p=0.001). ExSDC in cardiac function were most associated with reduced accrual of this minority group (OR 0.17, CI 0.05-0.58, p=0.007). 11 studies (19%) had early termination for lack of accrual (ETLA). In multivariable analysis, greater number of ExSDC was independently associated with ETLA (OR 3.53, CI 1.45-8.64, p=0.006), while multicenter status protected against ETLA (OR 0.05, CI 0.01-0.31, p=0.002). Industry sponsor and concordance of cardiac criteria protected against ETLA in univariable analysis only. Other eligibility criteria were not associated. Conclusions: Eligibility criteria in DLBCL trials varied widely and were often discordant with known safety data. Higher number of ExSDC was associated with lower accrual of black patients and higher risk of ETLA. Optimizing concordance of eligibility criteria with safety data may improve trial accrual and diversity. [Table: see text]
Trends of demographic and clinical traits of young patients with breast cancer from the National Cancer Database: Disproportionate effect on underrepresented underserved populations.
Authors: Mark Cynthia , Pujara Vivek , Boyle Marissa K. , Yuan Yuan , Bitar Jin Sun 
Published: May 2024

e13715 Background: Over the past decade, there has been increasing incidence of young patients diagnosed with cancer. Despite these developments, there is still uncertainty surrounding the factors and patterns contributing to the rising incidence in young age. This study aims to explore the demographic and clinical characteristics of young breast cancer (YBC) patients. Methods: We obtained characteristics and survival data from 206,156 of young patients (≤ 40 years of age) diagnosed with breast cancer between 2005 and 2019 in the National Cancer Database (NCDB). The demographic and clinical data were subdivided the patients into two comparison groups based on year of diagnosis with 10 years interval (2005-2009, Old vs. 2015-2019, New group). The z-score test was employed to measure the changes in the 2 groups. Cox proportional hazards model was used to explore the variables influencing overall survival (OS). Results: Overall, the absolute number of YBC patients have been increasing every year. The comparison between Old (55397 pt) and New groups (67930 pt) showed increase in Hispanic (4,575 (8.3%) vs 6,720 (9.9%), p <0.0001), Black (8,695 (15.7%) vs 11,156 (16.4%), p=0.0005), Asian (2,592 (4.7%) vs 4,512 (6.6%), p<0.0001), and other minority populations. Non-Hispanic White showed no change (p=0.1902). Additionally, there was a reduction in the proportion of patients with private insurance (43,940 (79.3%) vs 51,104 (75.2%), p<0.0001) and an increase in patients with Medicaid (5,893 (10.6%) vs 10,694 (15.7%), p<0.0001). Interestingly, there was a significant increase in hormone positive disease (35,142 (63.4%) vs 49,409 (72.7%), p<0.0001), while no change in hormone negative disease. In New group, the influence of race is evident in the observed variations in OS (Table). Finally, patients with Medicaid or without insurance exhibited a diminished OS compared to those with private insurance, and a lower median income was associated with a negative impact on OS. Conclusions: For YBC patients, the proportion of underrepresented and underserved population is increasing. There is an increasing rate of hormone positive disease. This can cause substantial personal and societal implications, such as family planning and early menopause. Therefore, awareness of these at-risk populations is important for early identification of breast cancer and mitigation of poorer outcomes. [Table: see text]
Ethnicity and health insurance disparities in rectal carcinoma.
Authors: Sankhe Rachel , Cholankeril Michelle , Salinas Flavio Eduardo , Smith Keia 
Published: May 2024

e13732 Background: Ethnicity and insurance coverage affect healthcare delivery in rectal carcinoma (RC). RC pts (pts) with Medicaid or no insurance are more likely to present with distant stage RC compared to Medicare/private insurance pts, and have a worse prognosis even when stage is accounted for. To combat such issues, federal law requires that non-profit hospitals, which make up 58% of all community hospitals, to provide charity care, or financial assistance, to those eligible. As insurance status, ethnicity and race have been found to independently affect colon cancer care, we expect similar results for RC in our limited but diverse cohort. Methods: Trinitas Medical Center RWJBH is an urban, community hospital that predominantly treats a minority population and provides financial assistance to eligible underinsured pts. Due to this assistance, or Charity Care, we can provide access to cancer care for many who would not ordinarily have such means. With institutional IRB approval, we completed a retrospective chart review of 59 pts diagnosed with Stage I-IV RC from 2017-2023. We assessed ethnicity, insurance carriers and treatment choices. Results: We reviewed 59 pts with the following ethnic distribution: 22 Hispanic (H), 21 White (W), 11 Black (B) and 5 Asian (A) pts. The median age at diagnosis with RC was 57 in H, 64 in B, 71 in W and 71 in A pts. B pts were found to be diagnosed with more advanced disease: 36% at Stage III and 45% at Stage IV, with none diagnosed at Stage I or II. H pts had comparatively fewer distant stage diagnoses (23% at Stage III, 18% at Stage IV). Neoadjuvant chemotherapy and radiation therapy to 20 of 59 pts treated at our center, 15 of whom subsequently received surgery. Four of five of these declined surgical intervention post neoadjuvant therapy. H pts had the following primary insurance carriers: 36% Medicaid, 36% Medicare, 27% Charity care. 62% of W pts had Medicare and 14% Medicaid. 27% had B pts had Medicare, 27% Medicaid and 9% had Charity care. 50% of the 59 pts had Charity care, with most pts in this group being H. Conclusions: Research suggests that immigrants utilize healthcare facilities less than U.S. citizens and programs like Charity care may be underutilized. In our RC cohort, 38 of 59 (64%) pts were racial minorities, of these 50% received Charity care. Most did not receive screening prior to a diagnosis of rectal cancer and many applied for Charity Care only after their diagnosis. Despite offering significant financial assistance to our pts, we suggest education to immigrants regarding insurance coverage, broader screening efforts and the ability to offer improved subspecialty care to RC pts. In particular, we look to target B and H who present at younger ages and are not Medicare eligible. We believe this will lead to earlier staging of RC, which should lead to improved survival for minority pts.
Disparities in patients with HER2-positive breast cancer receiving optimal treatment: Analysis of the real-world ASCO CancerLinQ dataset.
Authors: Kantor Olga , Jones Alyssa N , Mayer Erica L. , Chavez-MacGregor Mariana , King Tari A. , Mittendorf Elizabeth A. 
Published: May 2024

e13739 Background: Racial/ethnic disparities in locoregional second breast cancer events (SBCE) in patients (pts) with HER2-positive (HER2+) breast cancer (BC) are not well defined. We examined rates of SBCE and overall survival (OS) by race and ethnicity in the ASCO CancerLinQ Discovery (CLQD) real-world dataset in HER+ BC pts receiving optimal and not-optimal treatment. Methods: CLQD was used to identify pts undergoing surgery for stage I-III HER2+ BC from 2005-2022. Race/ethnicity were self-reported. Optimal treatment was defined as HER2-directed therapy for stage II-III HER2+ BC starting in 2008, adjuvant endocrine therapy for hormone-receptor positive (HR+) HER2+ BC, radiation after lumpectomy, and regional nodal irradiation for N2-N3 disease. The primary endpoint was SBCE defined as a second event in the ipsilateral or contralateral breast or axilla, with OS as a secondary endpoint. Kaplan-Meier analysis was used to estimate SBCE-free survival and OS. Results: Of 8,795 stage I-III HER2+ BC pts, 5,487 (62.4%) were Non-Hispanic White (NHW), 1,083 (12.3%) Non-Hispanic Black (NHB), 418 (4.7%) Hispanic, 323 (3.7%) Asian or Pacific Islander (API), and 1,484 (16.9%) other/unknown. Overall, 39.2% had HR-HER2+ and 60.7% had HR+HER2- BC. NHW pts were the most likely to present with stage I disease (40.2% vs 31.9%, 29.0%, and 30.3% of NHB, Hispanic, and API pts, respectively, p<0.01) and less likely to be age <50 at diagnosis (26.1% vs 32.3%, 41.0%, and 36.6% in NHB, Hispanic, and API, p<0.01). Overall, 54.2% of HER2+ BC pts received optimal treatment: 54.1%, 60.2%, 60.5%, and 58.8% of NHW, NHB, Hispanic, and API pts (p<0.01). Neoadjuvant HER2-therapy was given in 42.4%, 46.3%, 53.8%, and 51.2% of NHW, NHB, Hispanic, and API pts (p<0.01) and endocrine therapy in 64.7%, 56.8%, 59.3%, and 54.7%, respectively (p<0.01). 5-yr SBCE-free survival and OS are shown (Table). SBCE-free survival was not statistically different by race and ethnicity in optimally or non-optimally treated pts. Optimal treatment increased OS by 4.1% and 0.9% in NHW and NHB pts with HR-HER2+ BC and 2.4% and 8.9% in NHW and NHB pts with HR+HER2+ BC. Conclusions: Differences in OS, but not SBCE, were seen by race/ethnicity in HER2+ BC. OS differences were not completely mitigated by receipt of optimal treatment. [Table: see text]
Assessing the feasibility and cost-effectiveness of all oral adjuvant chemotherapy (cyclophosphamide, methotrexate, capecitabine) in high-risk hormone receptor positive breast cancer.
Authors: Ibraheem Abiola Falilat , Gadi VK , Hoskins Kent , Chaudhry Amina 
Published: May 2024

TPS616 Background: Women with high-risk HR+/HER2- breast cancer (BCA) receive additional chemotherapy to reduce disease recurrence. Preferred Taxane and Anthracycline based chemotherapy regimens have debilitating side effects such as cardiotoxicity, leukemia, peripheral neuropathy, severe fatigue, alopecia, downtime which are more common in black women thereby necessitating dose reductions. Metronomic cyclophosphamide, methotrexate, 5-fluourouracil (CMF) is an option but less preferred due to frequent dosing and longer therapy duration. Head-to-head comparison of CMF to anthracycline-based chemotherapy conducted 3 decades ago in early-stage BCA showed anthracycline benefit was driven by HER2+ disease with no benefit for HR+/HER2- BCA. Head-to-head comparison trials of CMF and Taxane-based regimen have not been conducted but single institution data suggest similar disease-free and similar overall survival but different toxicity profiles favoring CMF. In our ongoing trial, we converted all three chemotherapy drugs in CMF regimen to an all-oral regimen namely oral Cyclophosphamide, oral Methotrexate, oral Capecitabine (CMC) with the potential benefit of increased patient convenience, decreased costs (oral agents are generic; no chair time; no growth factors), and improved toxicity profile (low rates of grade III neutropenia, no port complications, no alopecia). This trial in progress aims to evaluate the feasibility of oral CMC by measuring the relative dose intensity in addition to the safety and tolerability of oral CMC. We hypothesize that 80% of patients will receive >85% of the intended dose of oral CMC. Methods: This is a Phase II, single arm, non-randomized study enrolling 25 patients with high-risk early-stage HR+ HER2- breast cancer to receive oral CMC regimen based on dose conversion equivalent bioavailability with conventional metronomic CMF chemotherapy. Enrolled patients will receive adjuvant therapy of oral cyclophosphamide 60 mg/m2 PO days 1-21 continuously, Methotrexate 15 mg/m2 PO Day 1, 8, and 15 and Capecitabine 650 mg/m2 PO BID Day 1- 14 to be given every 21 days for 8 cycles. The primary objective is to assess feasibility which is defined as 80% of patients (greater than 20 patients) maintaining a relative dose intensity (RDI) > 85%. The RDI is calculated as the ratio of the actual dose intensity/standard dose intensity; the average RDI for oral CMC regimen is the sum of RDI for each drug divided by 3. This study will be stopped if >25% of patients report Grade 4+ toxicity on oral CMC. The secondary objectives will assess quality of life as reported by the patients and report adverse effects. Clinical trial information: NCT06085742 . [Table: see text]
LACC Trial: Final Analysis on Overall Survival Comparing Open Versus Minimally Invasive Radical Hysterectomy for Early-Stage Cervical Cancer
Authors: Ramirez Pedro T. , Robledo Kristy P. , Frumovitz Michael , Pareja Rene , Ribeiro Reitan , Lopez Aldo , Yan Xiaojian , Isla David , Moretti Renato , Bernardini Marcus Q. , Gebski Val , Asher Rebecca , Behan Vanessa , Coleman Robert L. , Obermair Andreas 
Published: May 2024

Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported. The aim of this study was to compare overall survival between open and minimally invasive radical hysterectomy with participants followed for 4.5 years. The primary objective was to evaluate whether minimally invasive surgery was noninferior in disease-free survival (DFS) to abdominal radical hysterectomy. Secondary outcomes included overall survival. Sample size was based on DFS of 90% at 4.5 years and 7.2% noninferiority margin for minimally invasive surgery. A total of 631 patients were enrolled: 319 assigned to minimally invasive and 312 to open surgery. Of these, 289 (90.6%) patients underwent minimally invasive surgery and 274 (87.8%) patients open surgery. At 4.5 years, DFS was 85.0% in the minimally invasive group and 96% in the open group (difference of –11.1; 95% CI, –15.8 to –6.3; P = .95 for noninferiority). Minimally invasive surgery was associated with lower rate of DFS compared with open surgery (hazard ratio [HR], 3.91 [95% CI, 2.02 to 7.58]; P < .001). Rate of overall survival at 4.5 years was 90.6% versus 96.2% for the minimally invasive and open surgery groups, respectively (HR for death of any cause = 2.71 [95% CI, 1.32 to 5.59]; P = .007). Given higher recurrence rate and worse overall survival with minimally invasive surgery, an open approach should be standard of care.
Beyond Clinical Trials: Understanding Neurotrophic Tropomyosin Receptor Kinase Inhibitor Challenges and Efficacy in Real-World Pediatric Oncology
Authors: Vince Carolina Sgarioni Camargo , Brassesco Maria Sol , Mançano Bruna Minniti , Gregianin Lauro Jose , Carbone Edna Kakitani , do Amaral e Castro Adham , Dwan Viviane Sayuri Yamachira , Menezes da Silva Roberta Zeppini , Mariano Cassia Silvestre , da Mata Juliana França , Silva Marcelo Oliveira , Caran Eliana Maria Monteiro , Macedo Carla Donato , Alves da Costa Gildene , Esteves Tereza Cristina , Silva Luciana Nunes , Ferman Sima Esther , Martins Flavia Delgado , Cristófani Lilian Maria , Odone-Filho Vicente , Silva Marcelo Milone , Reis Rui Manuel , Pianovski Mara Albonei Dudeque , Campregher Paulo Vidal , Kunii Mayara Satsuki , de Sá Rodrigues Karla Emilia , Carvalho Filho Neviçolino Pereira , Valera Elvis Terci ,   The Brazilian Committee of Precision Medicine in Pediatric Oncology (BC-PMPO)—the Brazilian Society of Pediatric Oncology (SOBOPE)
Published: May 2024

PURPOSE Our study aimed to explore real-world treatment scenarios for children and adolescents with neurotrophic tropomyosin receptor kinase (NTRK)–fused tumors, emphasizing access, responses, side effects, and outcomes. PATIENTS AND METHODS Pooled clinical data from 17 pediatric cases (11 soft-tissue sarcomas, five brain tumors, and one neuroblastoma) treated with larotrectinib and radiologic images for 14 patients were centrally reviewed. Testing for gene fusions was prompted by poor response to treatment, tumor progression, or aggressiveness. RESULTS Six different NTRK fusion subtypes were detected, and various payment sources for testing and medication were reported. Radiologic review revealed objective tumor responses (OR) in 11 of 14 patients: Complete responses: two; partial responses: nine; and stable disease: three cases. Grades 1 or 2 Common Terminology Criteria for Adverse Events adverse effects were reported in five patients. Regarding the entire cohort's clinical information, 15 of 17 patients remain alive (median observation time: 25 months): four with no evidence of disease and 11 alive with disease (10 without progression). One patient developed resistance to the NTRK inhibitor and died from disease progression while another patient died due to an unrelated cause. CONCLUSION This real-world study confirms favorable agnostic tumor OR rates to larotrectinib in children with NTRK-fused tumors. Better coordination to facilitate access to medication remains a challenge, particularly in middle-income countries like Brazil.