bluuebunny/crossref_metadata_2025_split huggingface dataset:
Effect of evidence-based nutrition educational intervention on adherence to dietary guidelines (ADG) and weight management among early-stage breast cancer (EBC) patients (pts): A prospective trial.
Authors: Trestini Ilaria , Sperduti Isabella , Caldart Alberto , Bonaiuto Clelia , Fiorio Elena , Parolin Veronica , Tregnago Daniela , Avancini Alice , Pilotto Sara , Lanza Massimo , Scambia Giovanni , Tortora Giampaolo , Milella Michele , Bria Emilio , Carbognin Luisa 
Published: May 2020

12056 Background: Excess adiposity is linked to an increased risk of worse outcome among EBC pts. Pts undergoing EBC treatment are susceptible to change in nutrition status. However, implementation and assessment of the adherence to lifestyle interventions have been limited. This prospective trial aimed to evaluate the impact of an evidence-based nutrition intervention, according to the ADG, in terms of body composition changes in EBC pts. Methods: Entry criteria: EBC pts candidate to neoadjuvant/adjuvant therapy. At study entry, pts received a nutrition evidence-based tailored intervention. Dietary and anthropometric assessments were evaluated at baseline and after 12-months nutritional intervention. Waist circumference (WC) was assessed as a surrogate measure of fat distribution. ADG was estimated by Med-Diet 14-item questionnaire. Health-Related Quality of Life was analysed with EORTC QLQ-C30. Descriptive statistics was adopted. Associations between variables and groups according to nutritional variables were analysed (Chi-square test). Results: From February 2016 to December 2019, 243 pts were enrolled (median age 49 years): 27.6%/48.6% neoadjuvant/adjuvant treatment. At baseline, 38.3% of pts were overweight and 23.9% were obese. Notably, tumor size was significantly correlated with WC in the whole population (p = 0.003). Moreover, pts with central obesity were more likely to present HER2-negative tumors (57.4% vs. 42.5%, p = 0.03). Most pts reported relevant nutrition impact symptoms and symptoms affected QoL. Particularly, dyspepsia and constipation were more prevalent in overweight and obese pts (p < 0.0001 and p = 0.009, respectively), as well as in pts who gained ≥5% of weight (p = 0.04 and p = 0.02, respectively). At baseline, there was low ADG. After the 12-months intervention, ADG significantly increased (median Med-Diet score: 6 vs.12, p < 0.0001). A high ADG (defines as a Med-Diet score ≥10) significantly correlated with: 1) loss of weight ≥5% from the baseline weight (p = 0.003); 2) change in terms of BMI; 3) prevalence of central obesity. Conclusions: A tailored evidence-based nutritional intervention for EBC pts represents a tool to improve their ADG, weight management and, thus, to potentially influence the disease outcome. [Table: see text]
Lifelong disease burden of chemotherapy in Hodgkin lymphoma (HL): A simulation study from the St. Jude Lifetime (SJLIFE) Cohort and HL International Study for Individual Care (HoLISTIC).
Authors: Parsons Susan K. , Bhakta Nickhill , Rodday Angie Mae , Scharman Carlton , André Marc , Federico Massimo , Friedberg Jonathan W. , Friedman Debra L. , Gallamini Andrea , Hay Annette E. , Kahl Brad S. , Keller Frank G. , Kelly Kara M. , Meyer Ralph M. , Raemaekers John , Robison Leslie L. , Hudson Melissa M. , Cohen Joshua T. , Evens Andrew M. , Wong F. Lennie ,   on behalf of the HoLISTIC Consortium
Published: May 2020

12068 Background: Current emphasis for childhood and young adults with HL is to maintain high cure rates while concurrently identifying regimens to reduce excess long-term mortality/morbidity. Thus, understanding the late effects (LE) of contemporary clinical trials (CCT) for HL is critical. Methods: We used simulation to estimate the projected life expectancy (LExp), quality adjusted life-expectancy (QALE) & cause of death (COD) in a large cohort of HL CCT patients (pts) in the recently established HoLISTIC consortium by linking long-term risk models from the SJLIFE cohort. Individual patient data (IPD) on bleomycin, alkylating agents and anthracycline were extracted & harmonized for 982 HL pts in 5 prospective CCT (mean diagnosis age 19y, range 3-30y; 51% male; all treated with chemotherapy only; progression-free survival [PFS] >5y) in the HoLISTIC database. LExp, QALE & COD were projected using a previously developed microsimulation model (Bhakta, Blood [Supplement], 2019) that incorporated mortality & incidence of LEs by diagnosis age, sex, race, treatment exposures & attained age estimated from 5,522 adult 10-y survivors of childhood cancers in the SJLIFE cohort (56% male; mean age at last follow-up 35y, range 19-68). Microsimulation was applied to 10,000 randomly selected survivors of HL CCT cohort, from 10y after HL diagnosis until death to project the LExp, QALE & COD. Results: Assuming 10-y PFS, LExp and QALEs projected for the HL CCT cohort using adjusted US general population rates linked with the SJLIFE microsimulation model, COD and trial-specific exposures are shown in the Table. Conclusions: A novel lifetime simulation approach was used to project LExp, QALE & COD by linking together IPD from CCTs with the long-term risk model of the SJLIFE survivorship cohort. Despite differences in PFS, reflecting in part the variation in risk/stage status, the projected long-term outcomes were similar. Our approach highlights a new opportunity to inform future clinical trial design and aid provider & patient decision-making. [Table: see text]
Assessing the roles of inflammation and blood brain barrier permeability in cognitive impairment: A nationwide longitudinal study of patients receiving chemotherapy and non-cancer controls.
Authors: Belcher Elizabeth , Gilmore Nikesha , Kleckner Amber , Kleckner Ian , Culakova Eva , Lotta Louis , Thompson Bryan , Geer Jodi , Hopkins Judith O. , Long Joan , Janelsins Michelle Christine 
Published: May 2020

12070 Background: Cognitive impairment is a prevalent side effect of chemotherapy. We have previously shown that chemotherapy treatment is associated with worse performance on the Rapid Visual Processing test (RVP), an objective measure of sustained attention, over time compared to non-cancer controls. Better understanding of the biologic mechanisms underlying cognitive impairment in cancer patients is needed. The pro-inflammatory cytokine tumor necrosis factor alpha (TNFα) has been implicated in increasing blood brain barrier (BBB) permeability, which in turn is associated with cognitive impairment. This study assessed the relationships of TNFα and S100β, a biomarker of BBB permeability, to each other and to RVP performance over time. Methods: We analyzed a subset of participants (n = 89 patients, n = 52 controls, mean age = 60) from a prospective longitudinal study of women with breast cancer receiving chemotherapy and non-cancer controls. TNFα and S100β were measured in serum pre-chemotherapy (T1, ≤7 days before first treatment) and post-chemotherapy (T2, ≤1 month after last treatment) and at corresponding times for controls. Sustained attention was assessed by total correct rejections on the RVP test at T1 and T2. Separate linear regression models including all participants were used to relate 1) baseline TNFα and S100β levels to change in RVP performance over time, 2) change in TNFα and S100β to change in RVP performance over time, and 3) change in TNFα to change in S100β. Models were adjusted for age. 4) T-tests were used to compare the TNFα and S100β change scores (T1 to T2) of patients vs controls. Results: Greater increase (T1 to T2) in the pro-inflammatory cytokine TNFα was associated with worse cognition, measured by performance on RVP over time (p = 0.02). Higher baseline S100β, a biomarker of BBB permeability, was associated with worse performance on RVP over time (p = 0.09). Increase in TNFα was associated with increase in S100β (p = 0.11). S100β increased from T1 to T2 in patients relative to controls (p = 0.09). Conclusions: These results suggest that higher TNFα may be related to increases in blood brain barrier permeability and worse cognition. Future studies will further define the link between inflammation, blood brain barrier permeability and chemotherapy-related cognitive decline, with the goal of informing the development of new interventions. Funding: R01CA231014, T32CA102618, DP2CA195765, UG1CA189961.
Using digital engagement to proactively manage symptoms in patients on capecitabine.
Authors: Sohal Mandeep , McLarty Sarah , Friend Kayla E , Johnson Kathryn D , Johlie Melissa , Sawicki Christine , Johnson Kjel Andrew 
Published: May 2020

12079 Background: Adherence to oral chemotherapy is a challenge due to the toxic adverse events (AEs) patients’ experience. Capecitabine (CAP) may cause patients to experience AEs such as diarrhea and hand and foot syndrome (HFS), leading to therapy non-adherence. Digital patient engagement has successfully improved patient adherence and has been used to monitor AEs in a variety of cancer types. We used proprietary secure messaging to engage specialty patients receiving CAP and to message them at the expected onset of diarrhea and HFS; nurse care management was deployed for patients reporting an AE. The objective of this study was to determine whether nurse engagement using digital tools to manage oncology AEs resulted in improved medication adherence. Methods: CAP patients were sent outgoing SMS branching logic messages during November 2019, and respondents reporting AEs were engaged by nurses using a proprietary secure messaging platform. Nurses made clinical interventions in these patients by either making a pharmacologic or non-pharmacologic recommendation or referring the patient to an oncologist. The number of patients responding to outgoing SMS and secure messaging, nurse interventions, and medication fill history were measured. We compared 30-day post-intervention proportion of days covered (PDC) in the intervention group (those that engaged with nurses and received digital adherence and clinical messages) to standard of care (those who received digital adherence and clinical messages but did not engage) using the Student’s t-test. Results: 1,421 outgoing messages were sent to utilizers of CAP; 95 patients replied indicating the occurrence of either diarrhea or HFS. Nurse care managers reached 49 (52%) unique patients resulting in 54 interventions where care coordination was provided. The majority of engaged patients reached (74%) had symptom resolution as a result of nurse intervention. PDC was 79.3% in the intervention group and 68.8% (p = 0.038) in the standard of care group. Conclusions: SMS and secure messaging patients with AEs on CAP resulted in clinical interventions by nurse care managers. Nurse intervention resulted in the majority of patients having symptomatic resolution and therapy continuation. PDC indicated greater medication adherence in the engaged group. These results for one drug suggest that nurse digital engagement can be effective in increasing adherence for patients treated with oral oncolytics suffering from AEs. Proactive symptom tracking supports the early identification of potential AEs and effective nurse care coordination.
Quality of life in patients with locally advanced head and neck cancer undergoing chemoradiation with once-a-week versus once-every-three-weeks cisplatin.
Authors: Menon Nandini Sharrel , Noronha Vanita , Joshi Amit , Patil Vijay Maruti , Bhattacharjee Atanu , Kalra Devanshi , Mathrudev Vijayalakshmi , Bhelekar Arti , Prabhash Kumar 
Published: May 2020

12092 Background: This trial was conducted to compare the efficacy of low dose once-a-week cisplatin with once-every-3-weeks cisplatin with radiation in locally advanced head and neck squamous cell carcinoma (LAHNSCC). The current analysis focuses on the quality of life (QoL) of patients in this trial. Methods: In this phase III randomized trial, patients with stage III or IV non-metastatic LAHNSCC were randomized to receive cisplatin 30 mg/m2 once a week or cisplatin 100 mg/m2 once every 3 weeks concurrently with curative intent radiotherapy. The primary endpoint was locoregional control. QoL was a key secondary endpoint. QoL was assessed using the EORTC QLQ-C30 (v.3) and EORTC QLQ-H&N35 (v.1). QoL data were assessed at baseline and days 22 and 43 during treatment; at the end of chemoradiation and at each follow-up. The linear mixed effects model was used for longitudinal analysis of QoL domains to determine the impact of treatment (arm) and time on QoL scores. Results: Three hundred patients were enrolled, 150 in each arm. QoL data from 283 patients with at least one assessable questionnaire were analyzed. The pretreatment QoL scores were similar in both the arms in all domains. There was no significant difference in the global health status/QoL with respect to the treatment arm ( P =0.608) or time ( P=0.0544 ). There was no significant difference in the longitudinal QoL scores between the two treatment arms in all domains except the physical function ( P= .0074), constipation ( P= .0326), trouble with social contact ( P= .0321) and sexuality ( P= .0004). There was a decline in the QoL scores in all domains in both arms during treatment. After completion of treatment, the QoL scores started improving steadily up to 1 year and plateaued thereafter in both arms. Conclusions: The use of once-every-three weeks cisplatin significantly improved the locoregional control without adversely impacting the quality of life as compared to once-a-week cisplatin in combination with radical radiotherapy in locally advanced HNSCC. Clinical trial information: CTRI/2012/10/ 003062. .
CIFeR: A novel Clinician-lead Intervention to address Fear of cancer Recurrence (FCR) in breast cancer survivors.
Authors: Liu Jia , Bui Kim Tam , Serafimovska Anastasia , Kiely Belinda Emma , Hui Mun Ngah , Goodwin Annabel , McNeil Catriona M. , Costa Daniel SJ , Butow Phyllis , Beith Jane McNeil 
Published: May 2020

12115 Background: FCR affects 50-70% of cancer survivors. There are no validated oncologist-delivered FCR interventions. This multicentre, single-arm study sought to determine the helpfulness, feasibility and efficacy of an oncologist-delivered FCR intervention. Methods: Women were invited to participate if they had completed local treatment, chemotherapy and/or HER2 targeted therapy for early stage breast cancer and had a FCR score >0 on the 42-item FCR Inventory. The brief intervention, delivered by their medical oncologist at routine follow-up, entailed 1) FCR normalisation; 2) provision of personalised prognostic information; 3) take-home education sheet on recurrence symptoms; and 4) advice on managing worry. Consultations were audio-recorded. FCR, need for help, depression and anxiety were assessed before the intervention (T0), and at one week (T1) and three months (T2) after the intervention. Satisfaction with the intervention was assessed at T1. The primary outcome was participant-rated helpfulness. Secondary outcomes included feasibility (response rate, time taken for intervention) and efficacy. Results: Five oncologists delivered the intervention to 61 women (255 women invited; response rate 24%). The mean age was 57 ± 13 years. The mean time since breast cancer diagnosis was 2.5 ± 1.3 years. Forty-three (72%) were on adjuvant hormonal therapy. Overall, 58 women (95%) found the intervention helpful and 59 (98%) would recommend it to others. FCR severity, and the proportion of women with clinically significant FCR decreased significantly over time. There were no significant changes in unmet need, depression, or anxiety. Forty (66%) of consultations were recorded. Mean consultation length was 22 minutes (range 12-37 minutes) and mean intervention length was 9 minutes (3-20 minutes). The intervention was perceived as useful and feasible by oncologists, all of whom have used components of the intervention to help manage FCR in other breast cancer patients. Conclusions: A brief oncologist-delivered intervention to address FCR is helpful and feasible, and has shown preliminary efficacy in reducing FCR. Plans for an implementation study amongst oncologists in Australia are underway. Clinical trial information: ACTRN12618001615279 . [Table: see text]
Video conference intervention for distance caregivers (DCGs) of patients with cancer: Improving psychological outcomes.
Authors: Douglas Sara L , Mazanec Polly , Lipson Amy R , Blackstone Eric , Day Kim , Bajor David Lawrence , Krishnamurthi Smitha S. 
Published: May 2020

12123 Background: Family caregivers are increasingly involved in providing care and support for patients with cancer. Approximately 20% of caregivers live > 1 hour away from the patient and are considered DCGs. DCGs report higher distress and anxiety than local caregivers—often due to lack of first hand information and a high degree of uncertainty regarding the patient’s condition. Methods: This RCT was conducted at a large, urban comprehensive cancer center. Patients of all cancer types were eligible if they had monthly oncologist appointments and were receiving treatment. DCGs were randomized to one of three arms. Arm 1 received 4 monthly videoconference coaching sessions with a nurse practitioner or social worker focused upon information and support, participated in patient’s appointments with the oncologist via videoconference over the 4 month study period, and had access to a website designed for DCGs. Arm 2 did not receive the coaching sessions but received the other 2 components of Arm 1. Arm 3 received access to the DCG website only. Primary variables of interest were DCG distress and anxiety. DCGs completed online surveys prior to randomization and at the completion of the intervention period. PROMIS Anxiety and the NCCN distress thermometer were used. Results: Between November, 2016 and October, 2019, 441 patient-dyads were enrolled. Mean DCG age was 47 years; 71% were female, 65% Caucasian, 63% were the child of the patient and 81% were employed. Mean patient age was 65 years, 60% were female, 30% had GI cancer and 18% had hematologic cancer. For patients with solid tumor cancers, 59% were Stage IV. RMANOVA was used to examine the change in anxiety t-scores over time by arms of the intervention, controlling for DCG age, race, and gender. There was a significant anxiety by group interaction (p = .03) with Arm 1 being the only group that showed a significant reduction in anxiety over time (21.2% improved, ES = .57). Distress followed a similar pattern with a significant distress by group interaction (p = .02) with Arm 1 demonstrating the greatest improvement in distress over time (54.3%). Conclusions: These data suggest that the use of a coaching videoconference intervention made significant and clinically meaningful differences in anxiety and distress for these important members of the family caregiving team. Clinical trial information: NCT02666183 .
Discovery of a core-panel of markers for a blood-assay for cancer detection utilizing cfDNA methylation changes.
Authors: Seneviratne Lasika , Evans Steven , Pulicharam Juvairiya , Arber Nadir , Kuint Jacob 
Published: May 2020

1522 Background: Cancer screening is limited to several cancers despite improved outcome A screening test should be acceptable, safe, and relatively inexpensive1 Tumors shed cfDNA to the blood where abundant tumor-specific methylation changes can be detected 1https://www.who.int/cancer/detection/variouscancer/en/. Methods: This is a prospective, multicenter, observational study under two protocols NCT04264767, NCT04264754. Plasma was collected from 1,255 subjects: 586 treatment-naïve cancer patients and 639 controls, in 21 sites and biobanks. Training set I (211 cases/99 controls) was used to select the 6 final markers for the core panel, training set II (200 controls) was used to lock the algorithm, and set the threshold to a score yielding specificity of 95%. The validation set (342 cases/310 controls) was performed utilizing the pre-specified algorithm and threshold. Plasma was separated from a single EDTA tube within 4 hours of blood draw. EpiCheck’s reagents and methylation-sensitive enzymes (Nucleix, Israel) were used for DNA extraction, digestion, and amplification in real-time PCR (ABI 7500 Fast Dx, Applied Biosystems). Results: Age was comparable but sex and smoking history were different (more women in cases, more smokers in controls). In the validation cohort twelve cancer types were included, with prominent representation of major cancer types (19% Breast, 14% colorectal and 21% lung) and stages I&II (56%). Specificity and sensitivity were maintained high at 94% and 62%. Highest sensitivity was demonstrated in GI cancers (77% colorectal, 83% esophageal, 100% gastric) and non-solid malignancies (83%). Sensitivity in early stage cancers (stages I, II & IIIA) was 71%, led by Sarcoma (83%) esophageal (76%) and colorectal (61%). Conclusions: This 6-marker blood-based methylation assay is a promising initial component in a future cancer screening test, generating significant signal in early cancers and utilizing simple and inexpensive PCR technology. Clinical trial information: NCT04264767, NCT04264754. [Table: see text]
Comprehensive molecular assessment of mismatch repair deficiency in Lynch-associated ovarian cancers using next-generation sequencing (NGS) panel.
Authors: Kim Rachel Soyoun , Oldfield Leslie E. , Tone Alicia , Pollett Aaron , Van de Laar Emily , Pedersen Stephanie , Wellum Johanna , Clarke Blaise , Pugh Trevor J , Ferguson Sarah 
Published: May 2020

1523 Background: Abnormalities in mismatch repair (MMR) gene may be the result of pathogenic germline (Lynch syndrome) and somatic mutations as well as epigenetic events. Abnormalities in MMR have been described in non-serous/non-mucinous ovarian cancer (OC) but few studies have examined the causes of these MMR defects (MMRd). To address this, we have completed targeted mutational and methylation sequencing on MMRd OC cases. Methods: Women with newly diagnosed non-serous/mucinous OC (N = 215) were prospectively recruited from three cancer centers in Ontario, Canada between 2015-18. Tumors were reflexively assessed for MMR protein expression by immunohistochemistry. Tumor DNA was extracted from macrodissected MMRd cases and MMR-intact (MMRi) controls following pathology review. Matched tumor-normal samples were run on a custom NGS panel to identify germline and somatic mutations, copy number variants, rearrangements and promoter methylation in MMR and associated genes. Results: Of the 215 women enrolled in our study, 185 (86%) had OC alone and 30 (14%) had synchronous OC and endometrial cancer. Twenty-eight (13%) cases were MMRd, 11 of which were synchronous. The MMRd cohort had median age of 52.5 years, with mostly stage I (N = 14; 50%), grade 1 or 2 disease (N = 18; 64%) with endometrioid histotype (N = 18; 64%). One patient had recurrence after median follow-up of 33.6 months (13.2-93.6). There was no significant difference in overall/progression-free survival between the MMRd and MMRi patients. Using the NGS panel, Lynch syndrome (LS) was detected in 39% of MMRd cases (11/28; 7 OC and 4 synchronous): 7 MSH6, 2 MLH1, 1 PMS2, and 1 MSH2. Clinical germline sequencing was performed on all cases and verified panel findings. An explanation for the observed MMR phenotype was available for 18/20 deficient cases, including 9/10 MLH1−/PMS2− (7 somatic methylation, 1 bi-allelic somatic deletion, 1 germline mutation), 0/1 PMS2−, 6/7 MSH6− (6 germline mutations) and 2/2 MSH2−/MSH6− (1 germline mutation, 1 bi-allelic somatic mutation). Concordance between clinical and research panel sequencing results was 90%. None of the germline mutations were missed by the panel. Conclusions: Use of our custom NGS panel allows for the streamlined assessment of hereditary and somatic causes of MMR deficiency in OC and may be an attractive screening strategy for LS in this population.