bluuebunny/crossref_metadata_2025_split huggingface dataset:
Patients with cancer symptom and physical function reporting by caregivers as predictors of adverse clinical outcomes.
Authors: Neeman Elad , Yunis Reem , Kubo Ai , Aghaee Sara , Shieh Jennifer , Veuthey Tess L , Fonda Stephanie Jo , Liu Raymond , Oakley-Girvan Ingrid 
Published: June 2022

12026 Background: Informal caregivers are essential partners in the delivery of cancer care, and often can accurately identify and report symptoms and physical function of the patients they care for. We assessed whether such reporting by caregivers is predictive of adverse patient outcomes. Methods: In this prospective study, adult solid cancer patients on active intravenous systemic therapies and their informal caregivers were recruited from 18 Kaiser Permanente Northern California cancer centers. Using a study mobile app (TOGETHERCare), caregivers completed weekly surveys for 4 weeks, which were based on normalized NIH-PROMIS scores to report patients’ physical function and PRO-CTCAE to report patients’ symptoms. Patients’ adverse clinical outcomes were abstracted from the medical record and included: emergency department (ED) visits or hospitalizations, grade 3-4 adverse events (AEs), and treatment delays, up to 1 month following the 4-week study period, as well as mortality and hospice referrals up to 6 months following the study period. Simple univariate logistic regressions were used to correlate caregiver reports (either at baseline or most proximal preceding an adverse outcome) with mortality and hospice referrals, and quasi-Poisson regressions were used for the other adverse outcome measures. Results: Fifty-four patient-caregiver dyads were enrolled, and 52 were included in this analysis. A third of patients had breast cancer and almost 75% had stage 3 or 4 disease. Caregivers predominantly identified as male (61.5%), spouse/partner (76.9%), and non-Hispanic White (63.5%). At least one adverse outcome was experienced by 36.5% of the patients. Caregiver-reported PRO-CTCAE consistently predicted ED/hospitalizations and mortality, and caregiver-reported PROMIS scores predicted hospice referrals (see Table). Conclusions: The results suggest that caregiver reporting of patients’ symptoms and physical function could help provide early predictions of adverse patient outcomes.[Table: see text]
Financial stress and burden among caregivers of cancer survivors in the United States.
Authors: Theodoropoulos Nicholas , Xie Hui , Wang Qian , Li Yannan , Wen Chi 
Published: June 2022

12027 Background: United States caregivers perform annual services equating to nearly $500 billion, with three-quarters of family caregivers utilizing personal funds. Nearly a third of all caregivers of cancer survivors report using all or most of their savings to contribute to the cost of cancer care. Prior studies indicate the duration of caregiving is associated with an increase in caregiving burden. This study aims to further describe the financial stress and burden in relation to caregiving duration for people who provide care to cancer survivors. Methods: A retrospective cross-sectional study was conducted using the 2015 and 2020 National Alliance for Caregiving and American Association of Retired Persons survey data. Multivariable logistic regressions were used to examine differences in reporting financial stress between various racial/ethnic groups while adjusting for education, income, and employment. Results: A total of 2,998 caregivers were included, where 208 of them were caring for cancer patients. Caregivers of cancer patients who provided care > 21 hours/week were statistically more likely to be less educated, lower income, single, and unemployed compared to those who provided < 21 hours/week. Caregiving for > 21 hours/week compared to < 21 hours/week is associated with being more likely to report communicating with healthcare professionals about a recipient's care (87.7% vs. 75.9%; p = 0.038). It is borderline significant that caregivers who provided care for > 21 hours/week were more likely to advocate for recipients (68.7% vs. 56.8%; p = 0.086) and monitor condition severity to adjust care needs (84.9% vs. 70.7%; p = 0.100). After controlling for confounders (education, income, and employment), Non-Hispanic Black (odds ratio (OR) = 1.30; 95% CI: 1.02-1.65), Hispanic (OR = 1.39; 95% CI: 1.02-1.89), and Asian (OR = 1.51; 95% CI: 1.02-2.24) cancer caregivers had increased odds of reporting increased financial stress compared to Non-Hispanic White caregivers. Conclusions: Longer duration of caregiving to cancer survivors is associated with a greater burden for caregivers. Financial stress disparities related to caregiving exist between racial/ethnic groups, with non-white caregivers being more likely to report increased financial strain. Special financial programs are needed to assist caregivers of cancer survivors, a growing but understudied population.
Early patient-reported outcomes are a promising predictive factor of cancer progress and outcome in older patients: The EPROFECY study.
Authors: Helissey Carole , Riviere Clémentine , Parnot Charles , Duverger Claire , Becheriat Selma , Vuagnat Perrine , Schernberg Antoine , Picchi Hugo , Le Roy Audrey , Vanquaethem Hélène , Brureau Laurent 
Published: June 2022

12045 Background: Contrary to commonly-held beliefs, older patients (OPs, aged 70 or more) in oncology are compliant with the use of a telemonitoring digital platform. Such a tool allows the medical team to gain detailed knowledge of the tolerance profile of patients, and help monitor and maintain their quality of life, which is a particularly important goal for older patients. The EPROFECY study assesses the predictive power of the patient health status in the first month of treatment, evaluated with the digital telemonitoring platform Cureety, on survival. Methods: This prospective study was conducted at the Military Hospital Bégin on OPs. Patients were allowed to respond to a symptomatology questionnaire based on CTCAE v.5.0, personalized to their pathology and treatment. An algorithm evaluated the patient status based on reported adverse events: correct (A), compromised (B), to be monitored (C) and critical state (D). For A/B (good health status), the patient received therapeutic advice to help manage each of the reported adverse events. For C/D (poor health status), the patient was invited to call the hospital. To assess the early tolerance of patience to their treatments, we determined the health status in the 1st month after initiation of treatment, which was classified as “Good health” (GH, majority of A/B reports) or “Poor health” (PH, majority of C/D reports). The primary endpoint was to assess if the first-month tolerance is a predictive factor of progression free-survival (PFS). The secondary endpoint was to assess if the first-month tolerance is a predictive factor of overall survival (OS). Results: Sixty-one patients were enrolled between July 1st, 2020 and September 30th, 2021. The median age was 78.0 years (range 70.0 – 99.0), with 81% presenting a metastatic stage, and the most represented cancer being prostate cancer. The median follow-up was 8.2 months. Overall, 2299 ePRO were completed, 89% (n= 2036) corresponding to a "correct" or a "compromised" state and only 11% (n=263) corresponding to a state "to be monitored" or "critical". Based on the first month of questionnaires, 62% of the patients were classified in the GH group, and 38% in the PH group. The PFS ratio at 6 months was 64.6 % in GH vs 23.4 % in PH (HR = 0.1980, 95% CI = 0.04431–0.8845, p = 0.0339). The OS ratio at 6 months was 100% in GH versus 95.5 % in PH (HR: 0.69, 95 % CI = 0.06 – 8.29, p = 0.77). Conclusions: This is the first study that assesses the use of PRO-based tolerance as a predictive factor of treatment response in older individuals. We demonstrated here a significant 80% reduction in the risk of progression in OPs that exhibited a good first-month tolerance. This suggests that e-PRO follow-up might be an effective predictor of response and a tool to treatment plan.
Cardiovascular disease in testicular cancer survivors: Identification of risk factors and impact on quality of life.
Authors: Lubberts Sjoukje , Groot Harmke J. , De Wit Ronald , Mulder Sasja F. , Witjes Alfred Alfred , Kerst Jan M. , Groenewegen Gerard , Lefrandt Joop D. , Van Leeuwen Flora , Nuver Janine , Schaapveld Michael , Gietema Jourik A. 
Published: June 2022

12070 Background: Testicular cancer (TC) treatment has been associated with cardiovascular disease (CVD) development. To facilitate development of preventive strategies, this study assessed risk factors associated with CVD in TC survivors. Methods: Incidence of coronary artery disease, myocardial infarction and heart failure was assessed in a multicenter cohort comprising 4,748 TC survivors treated at ages of 12-50 years between 1976-2007. Patients who developed CVD and a random sample from the cohort received a questionnaire on cardiovascular risk factors (CVRF) and quality of life (QoL, measured with SF-36). A subgroup (n=304) of responders in the cohort additionally underwent clinical evaluation of CVRF. Results: After a median follow-up of 16 years, 272 patients developed CVD. Compared to orchidectomy only, platinum-based chemotherapy was associated with increased CVD risk (Hazard Ratio (HR) 1.8, 95% Confidence Interval(CI) 1.3-2.5). CVD risk was increased among patients who were obese or a smoker at diagnosis (HR 4.7, 95%CI 2.4-9.3 and HR 1.5, 95%CI 1.1-2.2, respectively) and patients with Raynaud's phenomenon (HR 1.9, 95%CI 1.1-3.6) or a family history of CVD (HR 2.7, 95%CI 1.6-4.5). TC survivors with CVD reported inferior QoL on physical domains (table). In TC survivors who underwent clinical evaluation for CVRF (median age at assessment 51 years), 86% had dyslipidemia, 50% hypertension and 35% metabolic syndrome, irrespective of treatment. Conclusions: TC survivors treated with platinum-based chemotherapy, who were obese or smoking at diagnosis, had family history of CVD and who developed Raynaud’s phenomenon are at risk to develop CVD, which affects QoL. Many TC survivors carry undetected CVRF. We advocate early lifestyle adjustments and lifelong follow-up with low-threshold treatment of CVRF, especially in obese and smoking patients treated with platinum-based chemotherapy. [Table: see text]
Polymorphism rs4673 and plasma paraoxonase 1 level for prediction and early diagnosis of anthracycline-mediated cardiotoxicity in patients with breast cancer.
Authors: Gvaldin Dmitry Yu. , Timoshkina Natalya N. , Vashchenko Larisa N. , Ausheva Tatiana V. , Sagakyants Aleksandr B. , Shulgina Oksana G. , Dashkova Irina R. , Kechedzhieva Emma E. , Vladimirova Liubov Yu 
Published: June 2022

12077 Background: Anthracyclines are highly effective chemotherapeutic agents, used for a wide variety of malignancies. Despite their antitumor efficacy there is a risk of cardiotoxic manifestations that reduce the time and quality of life of patients. The purpose was to study the effectiveness of molecular genetic tests based on rs4673 CYBA genotyping (c.242C > T) and measurement of plasma paraoxonase 1 (PON1) level in patients with breast cancer (BC) for predicting and diagnosing anthracycline-mediated cardiotoxicity (AMC). Methods: The study included 256 Caucasian patients (median age - 55 years) with a diagnosis of breast cancer normal cardiovascular system parameters at baseline, who were treated with anthracyclines in 2019-2020. For rs4673 genotyping, DNA was extracted from the blood by using DNA-sorb-B (AmpliSens, Russia). HRM-PCR was performed on a CFX96 amplifier (Bio-Rad, USA). The presence of polymorphism was confirmed by the Sanger method on a Genetic Analyzer 3500 (ABI, USA). The concentration of PON1 in blood plasma was measured at baseline and after 4 course of chemotherapy with anthracyclines using ELISA kits (Cloud-Clone Corp., China/USA). Results: During the follow-up period 21 (8.2%) patients developed signs of subacute (changes developed within several weeks after the last course of therapy) or early chronic AMC (changes developed within a year after completion of anthracycline therapy). In the group of patients without AMC the frequency of the minor allele rs4673 (c.214C > T CYBA) was 0.38, the frequency of genotypes C/C was 0.4, C/T - 0.43, and T/T - 0.17. The risk of AMC increased by 6.49 times in the presence of the rs4673 polymorphic allele (p = 0.002). The area under the ROC curve of the test based on rs4673 genotyping was 71.9%. The concentration of PON1 after the 4 courses of chemotherapy increased by 19.57% in the group of patients without cardiotoxic manifestations (p = 0.018) and in the group of patients with AMC by 20.23% (p = 0.007) as compared to the initial level. Besides, after 4 courses of chemotherapy the PON1 level was higher in patients with AMC by 25.08% (p = 0.026) than in patients without cardiovascular complications. The sensitivity of the test based on the measurement of the PON1 level in the blood plasma after 4 courses of chemotherapy was 100%, the specificity was 70.8% with a cut-off value of 2.9 ng/ml. Conclusions: This study has showed that genotyping of patients for the rs4673 polymorphism allows pre-stratification of the risk group white determination of the PON1 level in blood plasma after 4 courses of chemotherapy gives the opportunity to identify patients with AMC and promptly correct the chosen treatment.
Hair Safe Study: Effects of scalp cooling on hair preservation and hair regrowth in breast cancer therapy—A prospective interventional study.
Authors: Brunner Christine , Kofler Ricarda , Egle Daniel , Wieser Verena , Ritter Magdalena , Abdel Azim Samira , Lehmann Marlene , Emmelheinz Miriam Elisabeth , Marth Christian 
Published: June 2022

12093 Background: Chemotherapy (CT) is a frequent and well established treatment in women with breast and gynecological tumors. Alopecia is one of the most common side effects of CT seriously impairing patient quality of life and body image. While other CT associated side effects can be controlled by supportive treatment strategy, adequate preventive measures for alopecia have been lacking. New evidence supports the efficacy of scalp cooling for alopecia prevention during CT. The aim of this study was to investigate preventive scalp cooling (SC) for chemotherapy-induced-alopecia in breast cancer patients undergoing standard adjuvant or palliative chemotherapy. We also analysed the impact of SC on hair regrowth after chemotherapy-induced-alopecia. Methods: This was a non-randomized, 2-arm interventional study conducted at the Department of Obstetrics and Gynecology, Medical University Innsbruck. Breast cancer patients receiving any chemotherapy associated with alopecia (i.e. taxane or anthracycline-based chemotherapy) were allocated either to an intervention group receiving SC or to a control group (no SC). SC during chemotherapy was applied by the Paxman scalp cooling system. The primary endpoint was hair preservation (HP) which was assessed by experts and patients using the CTCAE score and analysed during and after completion of chemotherapy. The secondary endpoint was hair regrowth (HR) after 3 and 6 to 9 months post chemotherapy. Results: The study population included 128 patients. The majority, namely 88 (69%) patients were assigned to the intervention group (CAP) and received SC, 40 patients were allocated to the control group (NCAP). HP was significantly higher in the group receiving SC than in the NCAP by patients’ self-evaluation (24% vs. 0%; P = 0.001) and experts’ assessment (72% vs. 0%, P ≤ 0.001). HR was comparable between both groups. Using the patients’ evaluation 50% of patients with taxane monotherapy had a grade 1 alopecia compared to 17% of patients with an anthracycline-taxane CT (50% vs 17%, P = 0.018). Drop-out rate was 13% in CAP and 5% in NCAP group. Main reasons for drop-out were hair loss and patients’ requests. Conclusions: Our study demonstrates that SCsignificantly reduced or avoided chemotherapy-induced-alopecia in breast cancer patients undergoing chemotherapy, especially in patients who received taxane-monotherapy. SC was a safe procedure without severe adverse events. Therefore, SC can be highly beneficial for patients receiving specific chemotherapy and the option should be made available to as many patients as possible. No significant effect was noted regarding regrowth after chemotherapy in the SC group.
Physical performance limitations and participation restrictions among cancer survivors: A population-based study from NHANES data 2015-2018.
Authors: Myers Samantha A. , Finch Emily R , Ness Kirsten K. , Campbell Kristin L. 
Published: June 2022

12096 Background: Anti-cancer therapies have improved survival outcomes in cancer survivors; however, therapy-related toxicities may impact organ structure and function and interfere with physical performance and participation in life roles. This analysis aimed to estimate the prevalence of physical performance limitations (PL) and participation restrictions (PR) among recent (< 5 years since diagnosis), and long-term (≥ 5 years) cancer survivors. Methods: Data from the 2015-2018 National Health and Nutrition Examination Survey (NHANES) were analyzed using multivariable logistic regression, accounting for age, sex, race, and income, and incorporating survey sampling methodology. Odds ratios compared proportions of PL and PR among 663 (weighted population estimate 14,319,219) recent and 341 (weighted population estimate 7,261,088) long-term survivors, and 10,284 (weighted population estimate 215,042,155) persons with no reported cancer history. Two-sided two sample z-tests were used to compare proportions to a previous publication of data from 1999-2002 NHANES data. Results: Physical performance limitations were 1.5-1.7 times (63% vs 29%) and PR 1.5-1.6 times (38% vs 18%) more prevalent in cancer survivors than in those with no cancer history. Long-term cancer diagnosis was associated with increased prevalence of PL and PR, particularly in survivors aged 20-39 years. Proportions increased by 7% for PL and by 10% for PR compared to 1999-2002 values (p-values <0.001). Conclusions: Over 60% of cancer survivors reported PL and nearly 40% reported PR. Despite an interim increase in evidence of the benefits of exercise to manage therapy-related toxicities, these values are a significant increase when compared to 1999-2002 NHANES data. Targeted education for providers and exercise interventions aimed to improve physical function and performance in early cancer survivors should be considered to address the physical sequelae from anti-cancer therapies. [Table: see text]
Phase 2, randomized, double-blind trial of EC-18 versus placebo to mitigate the development and time course of oral mucositis from concomitant chemoradiation for head and neck cancer.
Authors: Henson Christina , Clayburgh Daniel , Lee Arielle Shebay , Wong Deborah J.L. , Kudrimoti Mahesh R. , Adkins Douglas , Lee Steve P. , Kalman Noah , Oppelt Peter John , Rao Krishna A. , Park Ji Sun , Oh Sookyung , Kim Koeun , Yoon Sun Young , Sohn Ki Young , Sonis Stephen T. 
Published: June 2022

12106 Background: Oral mucositis (OM) is a debilitating side effect of concomitant chemoradiotherapy (CRT) for head and neck cancer (HNC). EC-18 may effectively mitigate OM by minimizing the CRT-induced innate immune response. This Phase II, 2-stage trial evaluated safety, tolerability, and efficacy of EC-18 in reducing the duration, incidence, and trajectory of severe OM (SOM) in HNC patients. Methods: Patients (n = 105) with pathologically confirmed oral cavity, oropharynx, hypopharynx, or nasopharynx squamous cell cancers who received intensity-modulated radiation therapy (IMRT; with ≥ 55 Gy on ≥ 2 oral sites) and weekly or tri-weekly cisplatin were studied. In Stage 1, 24 patients were randomized (n = 6 per arm) to receive 500, 1000, or 2000 mg of EC-18, or placebo. Following independent Data Safety Monitoring Board review, 81 patients in Stage 2 received EC-18 2000 mg (n = 41) or placebo (n = 40) throughout CRT. WHO OM grade was assessed twice weekly during IMRT and then once weekly for up to 6 weeks post-IMRT. The primary efficacy endpoint was duration of SOM during the active and short-term follow-up (STFU) periods in the compliant per-protocol population (PP). Much of Stage 2 was conducted during peak periods of the COVID-19 pandemic which measurably impacted patient compliance relative to test medication dosing and planned radiation. Consequently, to assess efficacy most accurately, the PP population was analyzed (with at least 4 weeks of study drug dosing, minimum cumulative radiation of 55 Gy, 80% study drug compliance in the first 28 days of dosing, and without using not-allowed-therapy). Results: Patient demographics and baseline characteristics were balanced between groups. Adverse events (AEs) were comparable amongst cohorts without drug-related severe AEs. In the PP, the median duration of SOM from baseline through STFU was 0 day in the EC-18 group (n = 22) v 13.5 days in the placebo group (n = 20). SOM incidence through STFU (45.5% v 70%) and opioid use (time to onset: 32.3 v 26.0 days; and duration: 32.8 v 37.5 days) favored EC-18 v placebo. Results of the covariates analyses suggested that EC-18 favorably impacted SOM incidence in patients who experienced SOM treated with weekly low-dose cisplatin (n = 26; 37.5% v placebo 70.0%) and HPV+ tumors (n = 29; 35.3% v placebo 66.7%; Table). One-year long-term follow-up for tumor outcomes is ongoing. Conclusions: EC-18 safely mitigated the development and the time course of SOM in CRT-treated HNC patients. In addition, EC-18 may provide substantial benefits to subpopulations of HPV+ HNC patients treated with low dose cisplatin. Clinical trial information: NCT03200340. [Table: see text]