bluuebunny/crossref_metadata_2025_split huggingface dataset:
Long-term symptom burden and orodental health of oropharyngeal cancer (OPC) survivors following treatment with chemoradiotherapy (CRT) or sequential therapy (ST).
Authors: Limaye Sewanti Atul , Haddad Robert I. , Partridge Ann , O'Neill Anne M. , Radossi Andrea , Shreenivas Aditya V. , Lorente David , Hanna Glenn J. , Sonis Stephen T. , Shulman Lawrence N. , Posner Marshall R. , Lorch Jochen H. 
Published: March 2020

9530 Background: OPC treatment is associated with significant long-term toxicity. Very little is known about the long-term symptom burden and orodental health in OPC survivors >2 yrs from treatment. Methods: Survivors treated for OPC with CRT/ST (involving definitive RT) at Dana Farber Cancer Institute between 2002-2011 and >2 yrs from treatment completion, were identified by chart review and asked to complete the Vanderbilt Head and Neck Symptom Survey version 2 (VHNSS v2), National Health And Nutrition Examination Survey for Oral Health Questionnaire, health care availability survey. Results: 200 survivors were contacted, 127 responded (RR: 64%). Median age at diagnosis was 54 yrs; 85% males; 85% stage IVA/B, 13% stage III; 56% CRT, 43% ST. HPV status: 47% (+), 10% (-), 43% unknown. Median time from treatment completion: 50 mths (24-135 mths). Residual moderate to severe toxicities reported in VHNSS v2: 71% dry mouth; 59% difficulty chewing/swallowing food; 53% feeling of food becoming stuck in the throat; 53% prolonged time to eat; 31% thick mucus, 6% had difficulty sleeping secondary to this; 16% trouble speaking, 27% trouble hearing;30% limitation of neck/shoulder movement; altered taste/smell - 45%/23%; sensitivity to spicy food and dryness-57%/62%; 30% decreased desire to eat, 11% had moderate weight loss. Orodental health assessment: 13% thermal sensitivity, 21% teeth cracking and chipping, 20% loose teeth, 33% had treatment for gum disease, 42% had lost bone around teeth. 98% survivors had health insurance; only 66% had dental insurance. No statistically significant difference was noted with respect to symptoms between CRT or ST. ST did not affect long-term toxicity compared to CRT alone. Conclusions: OPC is known to correlate with HPV positivity, early age at diagnosis and high rates of long-term survival after appropriate therapy. Our study documents that the OPC survivors have substantial residual long-term head and neck and orodental symptoms directly related to the treatment that significantly impacts their quality of life. A substantial number of patients lack dental health coverage, which likely further impacts symptom burden and QOL.
From Bayesian modeling to genomic mapping: Biologic validity of predictive single nucleotide polymorphism networks for chemotherapy-related side effects.
Authors: Sonis Stephen T. , Schwartzberg Lee Steven , Weidner Susan M , Alterovitz Gil 
Published: March 2020

9535 Background: Using proprietary Bayesian network (BN) algorithms, we discovered interacting single nucleotide polymorphism (SNP)-BNs predicting patient-risk for 6 chemotherapy (CT)-induced side effects (SEs): oral mucositis (OM), diarrhea (D), CT-induced nausea and vomiting (CINV), fatigue, cognitive dysfunction (CD) and peripheral neuropathy (PN). To assess biologic validity, SNP-BNs mapped each SE to its gene loci, exploring biologic pathways for those genes. Roles of genes and pathways found in similar phenotypic diseases (e.g., Inflammatory Bowel Disease [IBD] for D, Alzheimer disease [AD] for CD, chronic fatigue syndrome [CFS] for F) were explored. Methods: Via an FDA-cleared DNA extraction kit, saliva was collected from 78 women with breast cancer (dose-dense AC+T) and 57 patients with colon cancer (FOLFOX +/- bevacizumab). We assessed 2.5M SNPs/patient (Illumina OmniQuad bead chip assays). SEs were measured via a validated tool (Patient Care Monitor). Analyzed SNP arrays and SEs discovered SNP-BNs. Final SNP-BNs per SE included gene name, symbol, and loci. Pathways and networks were analyzed for gene function and related genes, querying 6 databases (NLM, NextBio, Weizmann Institute, SPRING, Gene Ontology, AmiGO). Results: Mucosal injury-implicated networks and genes were identified, including oxidative stress, NF-κB, pro-inflammatory cytokines IL-1, IL-6, and TNF, MMPs and fibronectin breakdown (SPOCK3). D networks and genes overlapped with IBD (ERG, IER2, CASK). SNP-BNs for CINV overlapped in both CT regimens with genes for neurotransmitters (serotonin, dopamine, substance P) and nerve impulse transmission. B3GAT1, involved with opioid-induced CINV, was identified. F networks involving genes and pathways for cytokines and skeletal muscle overlapped to CFS. CD networks involve genes in AD. PN networks mapped genes involving myelination, demyelination, inflammation, and toxic neuropathy. Conclusions: SNP-BNs predicting CT-induced SEs mapped to genes associated with known biology of each SE, sharing central traits with other diseases, and are targets for drug discovery in cancer-related SEs and unmet needs, including AD.
Opportunities for improved end-of-life (EOL) care for adult patients with advanced cancer: Results of a longitudinal assessment of care provided by Quality Oncology Practice Initiative (QOPI) participants.
Authors: Dougherty David W. , Kadlubek Pamela , Pham Trang , Earle Craig , Malin Jennifer , Breathwaite Larry , Jacobson Joseph O. 
Published: March 2020

9537 Background: End of life care of patients with advanced cancer has received recent attention because of evidence of widespread variation in utilization of aggressive therapies and interventions and possible suboptimal use of palliative care and hospice services. QOPI, the ASCO sponsored quality assessment program, has been available to all United States physician members since January 2006 and has assessed EOL care since its inception. The current analysis explores whether the increased national focus on EOL and increased availability of palliative care and hospice services has resulted in improvements in EOL care as reported by QOPI participants. Methods: Data was aggregated across all EOL care quality measures for 9 sequential semi-annual QOPI collection periods from 2008 through 2012. Trends were analyzed among rates of eligible patients related to hospice enrollment and timing of enrollment, palliative care referrals, discussions about hospice and palliative care, and chemotherapy administration at the end of life. The Cochran-Armitage trend test was performed to determine the significance of trends and differences in measure performance over time. Results: From Fall 2008 to Fall 2012, the rate of hospice enrollment for appropriate patients improved by 7.4% [51.8% to 59.2%; p<0.0001] and the rate of hospice enrollment or palliative care referral improved by 5.6% [63.3% to 68.9%; p<0.0001]. Modest improvements were seen in the rates of hospice enrollment more than 3 and 7 days before death [2.8%, 2.6%], discussion of hospice or palliative care with patients not referred for these services within the last 2 months of life [2.7% increase; 19% to 21.7%], and chemotherapy administration within the last 2 weeks of life [2.4% improvement from 13.7% to 11.3%]. Conclusions: Despite modest increases in the rate of hospice enrollment and palliative care referrals over time, EOL care for adult patients with cancer associated with QOPI practices remains suboptimal. Opportunities exist to increase more meaningful participation in hospice and palliative care and to reduce exposure to chemotherapy near death.
End-of-life experience of patients with rare cancers and their caregivers.
Authors: Loggers Elizabeth Trice , Prigerson Holly Gwen 
Published: March 2020

9540 Background: Cancers are defined as rare if fewer than 35,000 cases are diagnosed per year. Rare cancers represented 23% of incident cancer cases and 33% of cancer deaths in 2008. However, little is known about the end-of-life (EOL) experience of patients with rare cancers or their caregivers. Methods: From September 2002 to August 2008, 618 advanced cancer patients (195 with rare and 423 with common stage IV cancers following failure of first line chemotherapy) and their caregivers participated in a U.S. multi-site, prospective, interview-based cohort study (Coping with Cancer). Patients were interviewed about EOL preferences, planning, and care at study entry. Interviews with caregivers at baseline assessed caregiver mental and physical health, while post-mortem surveys assessed EOL patient care. Descriptive statistics (t-test, chi-square) were used to characterize the study sample; logistic regression tested the association between cancer type and care received, controlling for confounders. Results: Rare cancer participants were more likely to be younger (57.7 vs 60.7 years, p=.01), Hispanic (19% vs 9%, p=.002) and have fewer co-morbidities (Charlson comorbidity index, mean 5.9 vs 6.5, p=.004), than their common-cancer counterparts. Rare cancers patients were four times more likely to be receiving both radiation and chemotherapy at study entry than common cancer patients (10.3% versus 3.3%, OR 4.31, p=0.003), but equally as likely to acknowledge their illness was terminal, have EOL discussions, and participate in advance care planning as common cancer patients. Caregivers of patients with rare cancers were more likely than common cancer caregivers to report declining health during the prior year of care-giving (22.1% versus 15.7%, p=0.05) and marginally more likely to prefer the patient choose treatment focusing on extending life rather than pain relief (22.3% vs 16.5%, p=0.08). Conclusions: Patients with advanced-stage, rare cancers may be treated more aggressively following failure of first line chemotherapy than individuals with common cancers. Future research should investigate patterns and quality of care for terminally ill patients with rare cancers and caregiver burden.
Health behaviors (HB) and geriatric assessment (GA) in older women with breast cancer (BC).
Authors: Jolly Trevor Augustus , Deal Allison Mary , Alston Shani Malia , Gordon Brittaney-Belle Elizabeth , Dixon Samara Ann , Williams Grant Richard , Muss Hyman Bernard 
Published: March 2020

9543 Background: Physical inactivity (PI), alcohol (A) and tobacco (T) abuse are associated with poor health outcomes in older adults, however, little is known about the prevalence of these HB and their associations with GA domains in older cancer patients (pts). This study explores the relationship between HB and GA in older BC pts. Methods: Between 03/2010-01/2013, 111 pts ≥65 yrs completed a predominantly self-administered GA (Hurria et al. Cancer 2005) comprising measures of comorbidity, polypharmacy, cognitive, functional, psychosocial and nutritional status as well as a nine-item HB questionnaire based on the 2006/7 National Health Interview Survey ( www.cdc.gov/nchs/nhis.htm ) assessing PI, A and T use. Fisher’s Exact and Wilcoxon Rank sum test were used to evaluate associations with GA measures. Results: Median age was 72 (range 65-94). Most pts were white (89%), married (61%), retired (86%) and at least high school graduates (96%). 51% never smoked while 45% were former and 4% current smokers. Former/current smokers were more likely than never smokers to have slower gait speeds (Timed “up and go” >14 second; 32 vs 14%; p=.04) and took more daily prescription medications (mean 5 vs. 4; p=.04). 52% of pts consumed at least one alcoholic drink per week (median 3.5). Modest alcohol consumption was associated with less activity of daily living (ADL) impairment (p=.03), lower mean BMI (29 vs. 26 kg/m2 p=.03) and greater non-prescription medication use (p=.04). 48% never performed vigorous activity and these pts were more likely than those exercising to have one or more functionally impairing comorbidities (p=.03); mainly arthritis. PI correlated with more impairment in both ADL (p<.0001) and instrumental ADL (p=.004). HB were not associated with demographic factors, treatment phase, weight loss, falls, sensory impairment, social activity, anxiety or depression in this dataset. Conclusions: PI, T and A use were common in this cohort of older BC pts and were associated with significant impairments in several GA domains. These findings reinforce the need for interventions to improve HB in older BC pts. Support: Breast Cancer Research Foundation, New York, NY and Lineberger Comprehensive Cancer Center, Chapel Hill, NC.
Population-based patterns of palliative systemic therapy use in elderly patients with metastatic colorectal cancer (mCRC).
Authors: Chan Matthew , Gresham Gillian , Cheung Winson Y. 
Published: March 2020

9547 Background: Elderly cancer patients are consistently under-represented in clinical trials, which may lead to under-treatment. Our aims were to 1) determine the impact of advanced age on use of palliative systemic therapy in mCRC, 2) examine the reasons for treatment choices and 3) compare adverse events and treatment discontinuations in elderly vs young patients. Methods: All patients diagnosed with mCRC from 2006 to 2007 and referred to any 1 of 5 regional cancer centers in British Columbia, Canada were reviewed. Summary statistics were used to describe treatment patterns between elderly patients (EP; >/=70 years) and young patients (YP; <70 years). Cox regression models that adjusted for age and confounders were used to determine the effect of systemic therapy on overall survival (OS). Results: We identified 1,013 patients: median age was 67 years (range 23-93); 42% were elderly and 58% were young; 57% were men; and 66% had ECOG 0/1. Compared to YP, fewer EP were offered systemic therapy (46 vs 76%, p<0.001). Among those treated, EP were less likely than YP to be given combination chemotherapy (47 vs 81%, p<0.001) and bevacizumab (19 vs 47%, p<0.001). Most common reasons for no treatment were similar in EP and YP: patient choice (32% for both), poor ECOG (18% of EP and 16% of YP), and significant comorbidities (11% for both). Advanced age alone was also cited as a reason among EP (7%) for not receiving therapy. In the subset that was treated, risk of adverse events (24 vs 14%, p=0.24) and early treatment discontinuations (14 vs 13%, p=0.88) were comparable between EP and YP, respectively. Receipt of systemic therapy was associated with improved OS in both the elderly (HR for death 0.45, 95% CI 0.37-0.56, p<0.001) and the young (HR for death 0.43, 95% CI 0.35-0.53, p<0.001), regardless of age (p interaction of age and treatment >0.05). Conclusions: In this population-based cohort of mCRC, EP were more likely to receive no treatment, monotherapy rather than combination therapy, or a regimen without bevacizumab. In carefully selected EP, however, it appears that rate of adverse events, frequency of early treatment discontinuations, and magnitude of survival benefit from systemic therapy were comparable to YP.
Efficacy and safety data from elderly patients with pretreated advanced melanoma in the Italian cohort of ipilimumab expanded access programme (EAP).
Authors: Chiarion-Sileni Vanna , Pigozzo Jacopo , Ascierto Paolo Antonio , Maio Michele , Danielli Riccardo , Del Vecchio Michele , Ridolfi Laura , De Galitiis Federica , Testori Alessandro , Cocorocchio Emilia , Cognetti Francesco , Ferraresi Virginia , Bernengo Maria Grazia , Guida Michele , Antonuzzo Andrea , Mandala Mario , Parmiani Giorgio , Vanella Vito , Aglietta Massimo , Queirolo Paola 
Published: March 2020

9548 Background: Ipilimumab was the first agent approved for the treatment of unresectable or metastatic melanoma that showed an overall survival benefit in randomised phase III trials. Here we evaluate the safety and efficacy of ipilimumab treatment outside of clinical trials in elderly (>70 years old) patients (pts) enrolled in the EAP in Italy. Methods: Ipilimumab was available upon physician request for pts aged ≥16 years with unresectable stage III/IV melanoma who had either failed systemic therapy or were intolerant to ≥1 systemic treatment and for whom no other therapeutic option was available. Ipilimumab 3 mg/kg was administered intravenously every 3 weeks for 4 doses. Disease evaluation was performed at baseline and after completion of induction therapy using immune-related response criteria. Patients were monitored for adverse events (AEs), including immune-related AEs, using Common Terminology Criteria for Adverse Events v.3.0. Results: Out of 855 Italian pts participating in the EAP from June 2010 to January 2012 across 55 centres, 193 (22.6%) were over 70 years old (median 75; 70-88). Of these, 132 pts (68.4%) received all 4 doses of ipilimumab, 24 (12.4%) 3 doses, 17 (8.8%) 2 doses and 20 pts (10.4%) received 1 dose. With a median follow-up of 7.6 months (range 1-26), the disease control rate among 188 pts evaluable for response was 38.3%, including 4 pts (2.1%) with a complete response, 24 (12.8%) with a partial response and 44 (23.4%) with stable disease. As of December 2012, median progression-free survival and overall survival were 3.7 months and 8.9 months respectively, with 1-year survival rate of 38%. In total, 96 pts (49.7%) reported an AE of any grade, which were considered treatment-related in 69 pts (35.7%), with a safety profile comparable to the general population. Grade 3/4 AEs were reported by 19 pts (9.8%) and drug-related in 11 pts (5.7%). AEs were generally reversible with treatment as per protocol-specific guidelines with a median time to resolution of 2.0 weeks. Conclusions: Based on the data from EAP, ipilimumab is a feasible treatment in the elderly population; efficacy and safety results were similar to those observed in the general population.
Identification of comprehensive geriatric assessment based risk factors for malnutrition in elderly Asian patients with cancer.
Authors: Tan Tira Jing Ying , Ong Whee Sze , Koo Khai-Nee , Tan Iain B. , Poon Donald , Kanesvaran Ravindran 
Published: March 2020

9552 Background: Elderly patients with cancer are at increased risk for poor nutrition. Malnutrition is associated with increased morbidity and mortality. There is limited information on the clinical risk factors for malnutrition in elderly Asian cancer patients. We aim to identify comprehensive geriatrics assessment (CGA) based clinical factors in elderly Asian cancer patients associated with an increase in malnutrition risk. Methods: CGA data was collected from 249 Asian patients aged 70 years or older who attended the outpatient oncology clinics at the National Cancer Centre Singapore. Nutritional status, one of the seven domains of CGA, was assessed based on the DETERMINE nutritional risk index. Univariate and multivariate logistic regression analyses were applied to assess the association between patient clinical factors together with domains within the CGA and moderate to high nutritional risk. Goodness of fit was assessed using Hosmer-Lemeshow test and discrimination ability assessed based on the area under the receiver operating characteristics curve (AUC). Internal validation was performed using simulated datasets via bootstrapping. Results: Among the 249 patients, 184 (74%) had moderate to high nutritional risk. Multivariate logistic regression analysis identified stage 3–4 disease (Odds Ratio [OR] 2.54; 95% CI, 1.14-5.69), ECOG performance status of 2-4 (OR 3.04; 95% CI, 1.57–5.88), presence of depression as measured by geriatric depression scale (OR 5.99; 95% CI, 1.99-18.02) and haemoglobin levels <12 g/dL (OR 3; 95% CI 1.54-5.84) as significant independent factors associated with moderate to high nutritional risk. The model achieved good calibration (Hosmer-Lemeshow test’s p = 0.17) and discrimination (AUC = 0.80). It retained good calibration and discrimination (bias-corrected AUC = 0.79) under internal validation. Conclusions: Having advanced stage of cancer, poor performance status, depression and anaemia were found to be independent predictors of moderate to high nutritional risk. Early identification of patients with these risk factors will allow for nutritional interventions which may improve treatment tolerance, quality of life and survival outcomes.
Best supportive care (BSC) in published clinical trials.
Authors: Abernethy Amy Pickar , Nipp Ryan David , Currow David , Cherny Nathan , Strasser Florian , Zafar Yousuf 
Published: March 2020

9560 Background: BSC as a control arm in clinical trials is poorly defined. A systematic review was conducted to evaluate clinical trial concordance with published, consensus-based framework for BSC delivery in trials. Methods: A consensus-based Delphi panel previously identified 4 key domains of BSC delivery in trials: multidisciplinary care; supportive care documentation; symptom assessment at least as often as the intervention arm; and guideline-based symptom management. A systematic review of trials including BSC control arms assessed BSC concordance to the consensus-based domains. Databases were searched from 2002-2012 using search strings: “cancer”; “best supportive care”; “randomized” or “random allocation”; and “supportive” or “palliative.” Exclusion criteria were: no BSC arm, non-human trial, not randomized, not English, not advanced cancer, or not including anticancer therapy. Data were independently extracted by 2 reviewers and scored by 4 reviewers for conformance with consensus-based BSC framework. Results: 373 articles were retrieved, 17 retained after applying exclusion criteria. Overall, trials conformed to <18% of the consensus-based BSC standards. 35% of articles offered a detailed description of BSC. 65% reported baseline and regular symptom assessment, and 47% reported using validated symptom assessment measures. 35% reported symptom assessment at identical intervals in both experimental and BSC arms. None listed an evidence-based guideline for symptom management. None of the multicenter trials reported standardization of BSC across sites. No studies reported educating patients on symptom management or goals of anti-cancer therapy. No studies reported offering access to palliative care specialists, social workers, financial or spiritual counseling. Conclusions: Reporting of BSC in trials is incomplete, resulting in uncertain internal and external validity. Such poorly defined interventions and variation between sites is unacceptable for other aspects of a clinical trial. Unless it is truly best supportive care, such studies may risk systematically over-estimating the clinical effect of the comparator arms. Standardization of a BSC delivery framework is needed to improve trial design and data generalization.