bluuebunny/crossref_metadata_2025_split huggingface dataset:
Cardiac risk factors and adverse events among patients receiving first-line CLL treatment in a real-world community practice setting.
Authors: Mato Anthony R. , Tang Boxiong , Azmi Soraya , Yang Keri , Wallis Nicola , Stern Jennifer C , Hedrick Eric , Huang Jane , Sharman Jeff Porter 
Published: June 2021

e24044 Background: First-line (1L) ibrutinib monotherapy (IM) is commonly prescribed for CLL but is associated with cardiovascular adverse events (CVAEs) that may lead to discontinuation. Existing data are largely from clinical trials (both 1L and relapsed/refractory), and real-world evidence is limited. The aim of this study was to compare baseline cardiac risk factors and CVAEs in patients (pts) receiving 1L IM vs intensive therapy (IT; aggressive, less tolerable, majority were bendamustine plus anti-CD20 antibody) or non-intensive therapy (NIT; less aggressive, more tolerable, majority were anti-CD20 antibody alone). Methods: We compared 3 treatment groups (IM, IT, and NIT) in terms of clinical characteristics, baseline CV risk factors, and subsequent CVAEs. Pts were selected from the Flatiron Health database based on the following criteria: aged ≥18 years, CLL/SLL diagnosis, had ≥2 clinic encounters, and initiated 1L treatment between 1/1/2016 and 12/31/2019. Baseline characteristics and subsequent CVAEs were descriptively compared between IM and IT/NIT groups; significance was assumed if p < 0.05. Results: Data on 515 pts were included (IM, 191; IT, 195; NIT, 129). Age at baseline differed significantly between the IM group (mean 71.2 years) and the other 2 groups (IT, 66.2 years; NIT, 74.5 years). The proportion of del(17p) was significantly higher in the IM group vs IT/NIT groups (IM, 26.7%; IT, 3.6%; NIT, 3.1%). Significant differences between IM and IT groups were seen in baseline ECOG (ECOG 0: IM, 28.8%; IT, 43.1%), diabetes mellitus (IM, 56.0%; IT, 44.1%), and hypercholesterolemia (IM, 68.6%; IT, 58.0%). Significant differences between IM and NIT groups were seen in baseline angina/coronary revascularization (2.6% vs 8.5%), atrial fibrillation/atrial flutter (AF; 14.1% vs 26.4%), and cerebrovascular disease (8.9% vs 20.2%). The rate of any CVAE was significantly higher in IM (35.6%) vs IT and NIT groups (IT, 20.0%; NIT, 24.8%) (Table). For IM vs IT treated pts, significant differences were observed in new or worsening (N/W) AF (11.5% vs 5.1%), other arrhythmias (9.4% vs 3.1), and hypertension (HTN; 20.4% vs 8.2%). Conclusions: This is one of the first real-world studies focused specifically on 1L CLL to describe baseline CV risk factors and compare CVAE events in CLL pts treated with IM as compared to IT or NIT. Results show higher CVAE rates of AF, other arrhythmias, and HTN for IM vs IT. [Table: see text]
Visual dysfunction in a mouse model of chemotherapy-related neurotoxicity.
Authors: Anderson David , Kedar Sachin , Van Hook Matthew J , Ghate Deepta A , Fan Shan , Smith Jennie C , Goeser Toni L , Reid Lisa M , Rishi Ekta , Haney Staci L , Holstein Sarah A. 
Published: June 2021

e24059 Background: Chemotherapy-related neurotoxicity (CRNT) poses challenges to long-term outcomes of cancer survivors. Visual function remains relatively unexplored in CRNT. Preliminary clinical work from our group suggests contrast sensitivity may be impaired in patients receiving chemotherapy. Here, we sought to isolate effects of chemotherapy on visual dysfunction in a mouse model. Methods: 10-week old C57BL/6J mice received either 4, 7, or 10 weekly intraperitoneal injections of chemotherapy (CTX group; n=15) or physiologic saline (SAL group; n=12). CTX mice received cyclophosphamide (50 mg/kg) and doxorubicin (2 mg/kg). Contrast sensitivity was assessed using an optomotor response (OMR) chamber. Psychometric functions were fitted to OMR contrast response functions to derive measures of contrast sensitivity (K), stimulus responsivity (Rmax), and stimulus selectivity (n). Electroretinography (ERG) waveforms, which measure light-evoked retinal neural activity, were recorded under scotopic (rod-driven) conditions and decomposed to isolate photoreceptor (a-wave), bipolar cell (b-wave), and interneuron amacrine cell (oscillatory potentials [OP]) activity. OMR and ERG were measured prior to and following treatment. Dependent- and independent-sample t-tests assessed within- and between-group changes, respectively, in outcome measures. Results: Outcome measures are reported in Table 1. SAL relative to CTX mice showed greater weight gain (p=0.004). OMR revealed increases in Rmax (pCTX=0.002; pSAL=0.11) and K (pCTX=0.80; pSAL=0.06) parameters in SAL but not CTX mice. ERG results revealed significant declines in OP peak frequency in CTX relative to SAL mice (p=0.006). Other OMR and ERG measures showed no within- or between-group differences (p>0.10). Decreases in weight were associated with decreases in Rmax (R2=0.25, p=.008) and OP peak frequency (R2=0.20, p=.02). Conclusions: Our animal model showed chemotherapy-related visual dysfunction. Mice receiving chemotherapy showed relative declines in contrast sensitivity, stimulus responsivity, and oscillatory neural activity, suggestive of disrupted neuronal circuits within the visual pathway. Future studies will focus on understanding neuronal mechanisms of visual pathway dysfunction and translating findings to clinical studies. [Table: see text]
GLIM versus ESPEN criteria for the diagnosis of early malnutrition in oncological outpatients.
Authors: Gascon Ruiz Marta , Casas-Deza Diego , Torres Irene , Zapata-Garcia Maria , Alonso Marin Natalia , Sesma Goñi Andrea , Lambea- Sorrosal Julio Jose , Alvarez Maria , Quilez Elisa , Zurera Berjaga Maria , Ocáriz Maitane , Moratiel Pellitero Alba , Ruiz Moreno Ines , Goas Gomez Ana , Marti Pi Maria , Arbonés-Mainar José Miguel , Isla Dolores 
Published: June 2021

e24065 Background: Malnutrition is one of the most prevalent problems among oncological patients. It reduces the response to treatments and negatively impacts survival. In 2019, a consensus criteria for diagnosing malnutrition (GLIM criteria) were proposed by most scientific nutrition societies. The objective of our work is 1) to assess the diagnostic capacity of the GLIM criteria in ambulatory patients with cancer and 2) to compare the GLIM with the ESPEN criteria to evaluate the contributions of these new criteria with respect to the existing ones. Methods: Observational, cross-sectional, and single-center study carried out at the Medical Oncology Department in the Lozano Blesa Clinical Hospital in Zaragoza (Spain). One hundred and sixty-five outpatients with tumors in the upper gastrointestinal tract, head and neck, and colorectal locations were recruited. All of them received the MST, MUST, and Nutriscore screening tools along with the ESPEN and GLIM diagnostic criteria. Results: The prevalence of malnutrition was 46.7% according to the GLIM criteria and 21.2% using the ESPEN tool. Patients diagnosed by GLIM had a higher body mass index (BMI, 24.3 kg/m2) and muscle mass (MM, 16.1 kg/m2) than those diagnosed by ESPEN (21.2 kg/m² and 14.3 kg/m2 respectively, both p = 0.001). The MST, MUST, and Nutriscore tools had a higher degree of concordance with GLIM compared to ESPEN (MST 0.53 vs 0.26; MUST 0.36 vs 0.66; Nutriscore 0.28 vs 0.54). Conclusions: The found prevalence of malnutrition in cancer patients is higher using the GLIM instead of ESPEN criteria. This disparity can be explained at least in part by the difficulty of the ESPEN criteria for malnutrition to diagnose patients with high baseline BMI or MM. The use of criteria with greater sensitivity, such as the new GLIM criteria, could help early diagnosis and thus early intervention in cancer patients. [Table: see text]
Prophylaxis of neutropenia with mecapegfilgrastim in patients with non-myeloid malignancies in a real-world setting.
Authors: Ma Jun , Huang Huiqiang , Fu Peifen , Xu Nong , Mao Chenyu , Cheng Gang , Yan Haijiao , Li Yongqing , Shi Yanxia , Wang Yongsheng , Yao Yumin , Chen Liang , Chen Yong , Zhang Ningling , Zhang Guifang , Ren Zhangxia , Li Zengjun , Song Lihua , Qin Shukui 
Published: June 2021

e24072 Background: The prophylaxis of neutropenia has been evolving from short acting granulocyte colony-stimulating factors (G-CSFs) to long acting G-CSFs. The safety and effectiveness of long acting G-CSF in a real-world setting were still lacking. Methods: We performed a multi-center, non-interventional, real-world study to explore the tolerability and effectiveness of mecapegfilgrastim. Different prophylactic strategy (primary or secondary prophylaxis) were compared. The effect of mecapegfilgrastim by means of continuous administration was also explored. Results: This study included 638 patients who had complete the study from May 2019 to November 15, 2020. About half of the participants were breast cancer patients. The mean age of the patients were 56 years. The most frequently reported adverse event possibly related to study drug was white blood cell increase (6.2 %). No unexpected adverse events were reported. Overall, thirty-six (5.6 %) patients experienced grade ≥ 3 neutropenia in chemotherapy cycle one. The patients in the primary and secondary prophylaxis subgroups had incidence of grade ≥ 3 neutropenia of 4.3 % and 9.2 % in chemotherapy cycle one respectively. There was a decreasing trend of neutropenia from cycle one to cycle four when mecapegfilgrastim were administrated continuously. Conclusions: The mecapegfilgrastim was well tolerable and no unexpected adverse events were observed in real-world setting. Primary prophylaxis using mecapegfilgrastim had lower incidence of neutropenia than secondary usage.
Palliative care for cancer in Turkey: A comprehensive review of the literature.
Authors: Kutluk M. Tezer , Ahmed Fahad , Cemaloğlu Mustafa , Aydin Burca , Sengelen Meltem , Kirazlı Meral , Yurduşen Sema , Sullivan Richard , Harding Richard 
Published: June 2021

e24088 Background: Palliative care is patient and family-centered care provided to optimize the quality of life in serious illness, and is an essential health service under Universal Health Coverage. Given the burden of cancer and other chronic disease diseases along with demographic changes, the need for palliative care is growing in Turkey. This study aimed to review of the available scientific literature on palliative cancer care needs, models and outcomes Turkey. Methods: A comprehensive literature review was conducted with English and Turkish keywords in PubMed, Scopus, Embase, ScienceDirect, Web of Science, Google Scholar, The Turkish Academic Network and Information Centre databases, Turkish Ministry of Health documents, Turkish Council of Higher Education’s doctoral thesis, and renowned national and international palliative care as well as cancer conferences 01/ 2000 to 07/ 2020. Results: Out of 27489 papers identified, 320 met the criteria for inclusion. The main focus of these studies was; historical development in palliative care, legislative regulation, professional training, use of opioids, symptom management, care for patients, palliative care centers, public awareness, psychosocial support, and end of life ethics. The majority of this literature used descriptive design, although a few case-control, cohort, and randomized control trials were also found. Our analysis showed that the development of PC in Turkey can be divided into three period. The first (early initiatives, before 2000), the second (dissemination phase, 2000-2010), and the third stage (government & societial engagement, after 2010). Several studies also analyzed the barriers such as low public & professional awareness, disconnection from cancer care, the opioidfobia and the lack of trained palliative care providers. The lack of integration of palliative care to cancer care is a major challenge for palliative care implementation. Conclusions: This review presents the evidence of the significant progress in PC during the last 20 years and the opportunities for further progress. Bringing research into practice is needed for shaping the integration of palliative care to cancer care in Turkey. The stakeholders and policy makers should not neglect the need for PC under the current pressure of COVID-19 pandemic on health and economy.
A network analysis approach to the needs of oncological patients.
Authors: Rossi Alessandro , Marconi Maria , Mannarini Stefania , Minelli India , Verusio Claudio 
Published: June 2021

e24128 Background: In recent years, an ever greater importance is given to the needs of cancer patients which could impact medical treatments, adherence and compliance, and patients’ quality of life (Teo et al. 2019; NCCN, 2015). However, recognizing and addressing the needs of patients may not be enough. Indeed, on one hand, needs that clinicians might consider as 'important' could play a marginal role, and – on the other hand – needs that clinicians may perceive as 'unimportant' may be central for patients. An innovative approach – psychometric network analysis (PNA; Epskamp, 2017) – was used to assess the network among needs ( nodes). Notably, the more a central node (need) is modified (addressed), the more a cascade change will occur in all the other nodes (needs). This study aimed to evaluate: (A) the structure of relationships among needs ( edges) of cancer patients, (B) which needs ( nodes) are the most relevant ( central), and (C) play a key role in the network. Methods: Patients ( n = 511; mean age = 65.95, SD = 12.72; 280 males) were enrolled at the Oncology Day Hospital at the “Presidio Ospedaliero” of Saronno, ASST Valle Olona, Italy. Patients were tested with the Need Evaluation Questionnaire (NEQ) which is composed of 23 items that investigate as many needs – divided into 4 areas: (1) information about diagnosis/prognosis, (2) information about exams and treatment, (3) communicative, and (4) relational needs. Results: Preliminary analysis revealed that all of the items were informative (SDitem < 2.5SDall_itemsSD) and there was no redundancy between items (redundancy index < 0.25). An Ising model (5,000 nonparametric bootstraps) with LASSO regularized nodewise logistic regression was performed. PNA showed a high accuracy: CS-coefficient = 0.56. On one hand, PNA showed that item#2 ( “I need more information about my future condition”; z = 2.039), item#17 ( “I need to speak with a psychologist”; z = 1.209), and item#13 ( “I need to be reassured more by the doctors”; z = 1.201) were the strongest (central) nodes. On the other hand, item#14 ( “ I need the hospital to provide better services”; z = -2.261) was the weakest node in the network. Conclusions: These findings show useful implications for clinical practice. Clinical interventions should address the needs showing the strongest connections in the network. These central nodes can influence all the other connected needs, thus representing important needs to be targeted by clinicians – allowing to tailoring more targeted and efficient therapeutic approaches to meet patients’ needs, with beneficial effects for medical treatments and quality of life.
A randomized phase II trial of second-line treatment for advanced soft tissue sarcoma comparing trabectedin, eribulin and pazopanib (2ND-STEP, JCOG1802).
Authors: Endo Makoto , Tanaka Kazuhiro , Matsumoto Yoshihiro , Hiraga Hiroaki , Iwata Shintaro , Tsukushi Satoshi , Watanuki Munenori , Akiyama Toru , Yonemoto Tsukasa , Nakayama Robert , Ae Keisuke , Kawashima Hiroyuki , Tsuchiya Hiroyuki , Katagiri Hirohisa , Nagano Akihito , Takenaka Satoshi , Kataoka Tomoko , Machida Ryunosuke , Fukuda Haruhiko , Ozaki Toshifumi ,   Bone and Soft Tissue Tumor Study Group of the Japan Clinical Oncology Group
Published: June 2021

TPS11580 Background: Soft tissue sarcomas (STS) are a rare type of malignancy, which comprises of a variety of histologies. Chemotherapy is the standard treatment for patients with advanced STS. Doxorubicin alone or in combination with ifosfamide is widely accepted as the first-line chemotherapy for advanced STS. While a combination with gemcitabine and docetaxel is regarded as a standard regimen of the second-line chemotherapy after failure of doxorubicin-based first-line regimen, the efficacy is not sufficient. Trabectedin, eribulin, and pazopanib are the candidates of the second-line chemotherapy for advanced STS, although there is no clear evidence showing which is better among those agents. The purpose of this clinical trial conducted by Bone and Soft Tissue Tumor Study Group of Japan Clinical Oncology Group (JCOG) is to determine the most promising regimen among trabectedin, eribulin and pazopanib as the test arm regimen in the future phase III trial of the second-line treatment for patients with advanced STS. Methods: The study, JCOG1802, is a multicenter, selection design, randomized phase II trial comparing trabectedin (1.2 mg/m2 IV, every 3 weeks), eribulin (1.4 mg/m2 IV, days 1 and 8, every 3 weeks) and pazopanib (800 mg PO, everyday) for patients with unresectable or metastatic STS refractory to doxorubicin-based first-line chemotherapy. Eligibility criteria include 16 year-old or older, unresectable and/or metastatic STS, an exacerbation within 6 months prior to registration, histological diagnosis of STS other than Ewing sarcoma, well-differentiated liposarcoma and myxoid liposarcoma, a history of chemotherapy for STS other than doxorubicin-based regimen, ECOG (Eastern Cooperative Oncology Group) performance status 0 to 2, and sufficient organ function. Primary endpoint is progression-free survival (PFS), and secondary endpoints include overall survival, disease-control rate, response rate, and adverse events. To select the most promising regimen in median PFS (3 months in the worst regimen and 4 months in the best regimen) with a probability of at least 80%, a total of 120 patients will be enrolled from 37 institutions in Japan. After JCOG1802, a subsequent phase III trial comparing the winner of this study and a combination of gemcitabine and docetaxel will be planned. The study was activated at December 5, 2019 and 22 of planned 120 patients have been enrolled as of February 15, 2021. Clinical trial information: jRCTs031190152.
Exploring the role of digital health coaching for men with prostate cancer.
Authors: Handley Nathan , Wen Kuang-Yi , Gomaa Sameh , Brassil Kelly Jean , Jackson Lindsey , Dicker Adam P. 
Published: June 2021

TPS1586 Background: Toxicity leading to impaired quality of life is common among men receiving treatment for Prostate Cancer (PCa). Digital interventions may be beneficial in enhancing health self-efficacy in managing symptom burden. This study evaluates the feasibility and preliminary outcomes of digital health coaching intervention on men with PCa. Methods: This pilot study aims to recruit up to 100 adult, English-speaking men with PCa who in the last 2 years have required active treatment, defined as cancer management via active surveillance, surgery, radiation, androgen deprivation, chemotherapy, hormonal therapy, immunotherapy or a combination of these modalities. Men will be enrolled across the catchment area of Jefferson Health using social media and a variety of other outreach tools approved by the Institutional Review Board. Consented patients are enrolled in a 3-month digital health coaching program which combines weekly calls with up to 4 nudges of evidence-based content delivered via text or email weekly. The program focuses on a weekly health topic, such as physical, mental, social, or financial health, and managing symptoms, and empowers participants to set health goals of importance to them. Primary endpoints include feasibility, defined as 60% of participants completing the 3-month program. The main secondary endpoints measured are health self-efficacy as measured by the Cancer Behavior Inventory-Brief (CBI-B), quality of life, as measured by the Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP), financial toxicity as measured by the Comprehensive Score of Financial Toxicity (COST) and physical and mental health as measured by the Patient Reported Outcomes Measurement Information System-Global Health 10 (PROMIS-10). Outcomes are captured on enrollment and monthly through program completion for a total of 4 data points. Summary statistics will be used to describe patient demographic and clinical characteristics of the study population. Summary statistics will also be used to describe CBI, EPIC-CP, PROMIS and COST by assessment time. The change in CBI-B scores from baseline to 3 months will be calculated along with 95% confidence intervals. Additional LMMs will be created to assess the relationship between self-efficacy (CBI) and quality of life (EPIC-CP), financial toxicity (COST) and global health (PROMIS- SF10).
Phase 2 trial of newly diagnosed high-grade glioma treated with concurrent radiation therapy, temozolomide, and BMX-001.
Authors: Peters Katherine B. , Villano John L. , Butowski Nicholas A. , Cohen Adam Louis , Mendez Joe Sammy , Giglio Pierre , Zhang Chi , Raza Shahzad , McGranahan Tresa , Lobbous Mina , MacLeod David , Gad Shayne , Penchev Sara , Silberstein David , Crapo James 
Published: June 2021

TPS2069 Background: High-grade gliomas (WHO grade III-IV) patients experience marked morbidity and mortality. While the standard of care for newly diagnosed high-grade glioma patients is surgery followed by concurrent chemotherapy and radiation therapy (RT), the outcomes remain poor. BMX-001 (MnTnBuOE-2-PyP5+) is a metalloporphyrin with differential action in response to radiation therapy and chemotherapy-induced oxidative stress. As shown in preclinical evaluations, BMX-001, when used with radiation, can protect normal, healthy tissues and augment cell kill in malignant cancer cells, notably, human glioblastoma xenografts. We evaluated the safety of BMX-001 in combination with concurrent RT and temozolomide (TMZ) in a phase 1 study of newly diagnosed high-grade glioma patients and we found that BMX-001 is safe and well-tolerated in this population. The maximum tolerated dose of BMX-001 during concurrent RT and TMZ was determined to be 28 mg delivered subcutaneously (SC) followed by 16 biweekly SC doses at 14 mg (Peters et al., Neuro-Oncology 2018). Methods: For this multi-site, open-label, phase 2 study (NCT02655601), we will randomize approximately 160 patients 1:1 to concurrent RT and TMZ with BMX-001 versus concurrent RT and TMZ alone. Key eligibility criteria include newly diagnosed histologically confirmed high-grade glioma (WHO III-IV), 18 ≥ years, and Karnofsky performance status ≥ 70%. The primary endpoint is overall survival. Secondary endpoints are objective cognitive performance, bone marrow protection, safety and tolerability, progression-free survival, overall tumor response rate, and plasma pharmacokinetics. Exploratory endpoints are patient-reported outcomes of health-related quality of life (as assessed by Functional Assessment of Cancer Therapy–Brain, Functional Assessment of Cancer Therapy-Cognition, and Functional Assessment of Chronic Illness Therapy-Fatigue), qualitative hair loss, and white matter integrity (as measured by MRI diffusion tensor/susceptibility imaging). Since November 2018, this phase 2 study has enrolled 147 of 160 high-grade glioma patients at nine sites in US. Clinical trial information: NCT02655601.