bluuebunny/crossref_metadata_2025_split huggingface dataset:
A randomized trial comparing four-weekly versus 12-weekly administration of bone-targeted agents (denosumab, zoledronate, or pamidronate) in patients with bone metastases from either breast or castration-resistant prostate cancer.
Authors: Clemons Mark J. , Ong Michael , Stober Carol , Ernst D. Scott , Booth Christopher M. , Canil Christina M. , Mates Mihaela , Robinson Andrew George , Blanchette Phillip S. , Joy Anil Abraham , Hilton John Frederick , Aseyev Olexiy , Pond Gregory Russell , Hutton Brian , Jeong Ahwon , Vandermeer Lisa , Fergusson Dean 
Published: March 2020

11501 Background: Defining the optimal dosing interval of commonly used bone-targeted agents (BTAs), such as denosumab and bisphosphonates, for patients with bone metastases remains an important clinical question. We performed a pragmatic randomised trial comparing the non-inferiority of 12- versus 4-weekly BTAs in patients with bone metastases from breast and prostate cancer. Methods: Patients with bone metastases, who were either BTA-naïve, or already receiving, denosumab, pamidronate or zoledronate were eligible. They were randomised to receive their chosen BTA every 12- or 4-weeks for one year. The primary endpoint was Health related quality of life (HRQL) (EORTC-QLQ-C30 Functional Domain - Physical Subdomain). Secondary endpoints included: pain (EORTC-QLQ-BM22 - pain domain), Global Health Status (EORTC-QLQ-C30), symptomatic skeletal events (SSE) rates and time to SSEs. Adverse events and toxicity profiles were also compared. Results: Of 263 patients (60.8% breast and 39.2% prostate), 130 (49.4%) were randomised to 12-weekly and 133 (50.6%) to 4-weekly therapy. 138 (52.5%) were bone-agent naïve. The BTAs included; denosumab (n=148, 56.3%), zoledronate (n=63, 24.0%) and pamidronate (n=52, 19.8%). Study-reported outcomes showed no significant difference in; HRQL-physical domain (median [range]: 0 [-86, 40] vs. 0 [-66, 53.3]), pain (median [range]: 0 [-66, 72] vs. 0 [-100, 88]), Global Health Status (median [range]: 0 [-100, 66.7] vs. 0 [-83, 33.3]), SSE rates (N [%]: 24 [18.5%] vs. 22 [16.5%]), 1-year SSE-free rate (median, range; 73.2% [63.6, 80.7] vs. 77.9% [69.1, 84.4]) between the 12- and 4-weekly arms, respectively. Subgroup analyses for BTA naïve and pre-treated patients, and for patients receiving denosumab, zoledronate and pamidronate, showed no significant difference between the 12- and 4-weekly arms. There was no significant difference in reported rates of renal impairment (2.3% vs. 3.0%), symptomatic hypocalcaemia (1.5% vs. 1.5%) or osteonecrosis of the jaw (0.8% vs. 0.8%). Conclusion: The findings of this trial are consistent with those previously reported for de-escalating zoledronate. This trial also included patients receiving de-escalated denosumab and pamidronate. While the results of the Swiss REDUSE trial are awaited, the data presented would suggest that de-escalation of all commonly used BTAs is a reasonable treatment option. Clinical trial information: NCT02721433.
Association of baseline cardiovascular risk factors and health care utilization and costs in elderly breast cancer patients enrolled in SWOG clinical trials.
Authors: Hershman Dawn L. , Till Cathee , Wright Jason Dennis , Accordino Melissa Kate , Vaidya Riha , Barlow William E. , Ramsey Scott , Unger Joseph M. 
Published: March 2020

11508 Background: Cardiovascular-disease risk factors (CVD-RFs) increase the risk of cardiac events in women undergoing chemotherapy. Less is known about the impact of CVD-RFs on healthcare utilization and costs. Methods: We examined breast cancer patients treated uniformly on SWOG clinical trials from 1999-2011. We identified baseline diabetes, hypertension, hypercholesterolemia, and coronary artery disease (CAD) by linking trial records to Medicare claims; obesity was identified using clinical records. The outcomes were emergency room visits (ER), hospitalizations and costs. Multivariable logistic and linear regression were used. Results: Among the 708 patients included in the analysis, 160 (22.6%) experienced 234 separate hospitalizations, and 193 (27.3%) experienced 311 separate ER visits. Diabetes, hypertension, hypercholesterolemia, and CAD were all associated with increased risk of hospitalizations and ER visit. Hypertension had the strongest association, with more than a threefold risk of hospitalization for those with hypertension compared to those without (OR [95% CI], 3.16 [1.85-5.40], p<0.001). For those with ≥3 CVD-RFs, the risk of hospitalization was greater compared to 0 or 1 CVD-RFs (OR [95% CI], 2.74 [1.71-4.38], p<0.001). Similar results were seen for ER visits. In the first 12 months after trial registration, patients with diabetes ($38,324 vs $30,923, 23.9% increase, p=0.05), hypercholesterolemia ($34,168 vs $30,661, 11.4% increase, p=0.02), and CAD ($37,781 vs $31,698, 19.2% increase, p=0.04) had statistically significantly higher total healthcare costs. Additionally, those with 2 significant CVD-RFs ($35,353 vs. $28,899, 22.3% increase, p=.005) had higher total healthcare costs. Conclusions: Our study demonstrates that the presence of both CVD-RFs and ER visits and hospitalizations are frequent among elderly BC patients. The risk of ER visits and hospitalizations is higher among patients with CVD-RFs, and increases with the number of RFs. Better management of CVD-RFs and more aggressive symptom management may be required to reduce both physical and financial toxicities to elderly patients undergoing BC therapy.
Randomized trial of a hospice video decision aid for patients with advanced cancer and their caregivers.
Authors: El-Jawahri Areej , Vanbenschoten Olivia , Fenech Alyssa L. , Jankowski Amanda L. , Markovitz Netana , Traeger Lara , Greer Joseph , Volandes Angelo E. , Temel Jennifer S. 
Published: March 2020

11513 Background: Although hospice provides high-quality end-of-life (EOL) care for patients with advanced cancer and their family caregivers, the service remains underutilized in part due to lack of adequate information provided to patients and families about hospice care. Methods: We conducted a single-site randomized clinical trial of a hospice video decision aid versus a verbal description in 150 hospitalized patients with advanced cancer and their caregivers. Patients without an available caregiver were still eligible to participate. Intervention participants (75 patients; 18 caregivers) received a verbal description about hospice plus a six-minute video depicting hospice care. Control participants (75 patients; 26 caregivers) received only the verbal description. The primary endpoint was patient preference for hospice care immediately after the intervention, adjusting for baseline preferences. Secondary outcomes included patient and caregiver knowledge and perceptions of hospice (Hospice Perception and Knowledge Questionnaire). Results: Between 2/2017 and 1/2019, we enrolled 55.7% (150/269) of potentially eligible patients and 44 caregivers. Post-intervention, patients assigned to the video group were more likely to prefer hospice care at the EOL (86.7% vs. 82.7%, OR = 2.85, P = 0.08), but this was not statistically significant. Patients in the video group reported greater knowledge about hospice (B = 0.50, P = 0.024) and were less likely to endorse that hospice care is only about death (6.7% vs. 21.6%, OR = 0.28, P = 0.035). Post-intervention, caregivers assigned to the video were more likely to prefer hospice care for their loved ones (94.4% vs. 65.4%, P = 0.031), reported greater knowledge about hospice (B = 1.94, P < 0.001), and were less likely to endorse that hospice care is only about death (0.0% vs. 23.1%, P = 0.066). Conclusions: Patients with advanced cancer and their caregivers who viewed a hospice video decision support tool were more informed about hospice care and reported more favorable perceptions of hospice. Future work should examine the impact of the video on hospice utilization and length-of-stay among patients with advanced cancer. Clinical trial information: NCT03040102.
Effects of a structured intervention program to improve physical activity (PA) of adolescents and young adult cancer survivors (AYAs): Final results of the randomized Motivate AYA–MAYA trial.
Authors: Salchow Jannike Lisa , Jensen Wiebke , Koch Barbara , von Grundherr Julia , Elmers Simon , Escherich Gabriele , Reer Rüdiger , Bokemeyer Carsten , Mann Julia , Stein Alexander 
Published: March 2020

11518 Background: Major cardiovascular (CV) events are the most common late toxicities among AYAs. Although regular PA of vigorous intensity (≥ 9 metabolic equivalent [MET]-hours/week) lowers the risk for CV events and mortality, no larger randomized controlled trials on interventions are available. Our aim was to assess whether a 12-week structured intervention increases the vigorous PA of AYAs. Methods: AYAs aged 15 to 39 years, after curative intent cancer treatment with at least one CV risk factor, were randomized to usual-care control group (CG) and to intervention group (IG). The CG received standard recommendations, and the IG participated at a semi-structured interview and phone consulting focusing on PA and behavioral change. At baseline, post-intervention (12 wks), and at follow-up (52 wks), participants completed the International Physical Activity Questionnaire (IPAQ) and quality of life assessment (EORTC QLQ-C30). Primary endpoint was the rate of AYAs with ≥ 9 MET-hours/week of vigorous activity (IPAQ) at 12 weeks. This single center trial was registered (DRKS00009453). Results: Among 115 screened AYA 89 eligible patients were randomized; 69 (77.5%) completed the intervention and the endpoint assessment; 36 (52.2%) were in the IG and 33 (47.8%) in the CG. Median age was 24.3 years (range, 18 to 39). CV risk factors were use of anthracyclines (94.2%), chest radiation (47.8%), or both (44.9%). At baseline 49.2% of all AYAs reported to perform vigorous PA with at least 9 MET-hours/week, although reporting was individually biased. Post-intervention this rate significantly increased in the IG from 45.7% to 69.7% (p = 0.007), whereas in the CG only a modest non-significant increase was noted (53.3% to 65.6%, p = 0.134). Notably, upon long-term follow up (52 wks) AYAs did not keep their increased vigorous PA, whereas improved moderate PA was achieved (MET score in IG p = 0,044). Also, both groups reduced significantly the time they spent sitting from 6.5 (SD, 2.9) to 5.4 (SD, 2.7) hours/day (p = 0.001). Conclusions: Intensified PA counseling improves short term vigorous PA and long term moderate PA of AYAs and, should thus be part of survivorship programs. Further studies with AYAs will be required to establish reliable PA screening methods and to confirm the results in larger cohorts. Clinical trial information: DRKS00009453.
Goals of care designation associated with improved survival and indicators of quality end-of-life care in pancreatic cancer (PC) patients (pts) undergoing palliative chemotherapy.
Authors: Anaka Matthew , Spratlin Jennifer L. , Cheung Winson Y. , Ghosh Sunita , Lee Minji 
Published: March 2020

11532 Background: Discussion of goals of care (GoC) is a key part of quality care for pts with palliative cancer. Numerous studies have shown that documentation of GoC in this population remains low. Here we describe changes in GoC documentation and other indicators of quality end-of-life care in PC pts undergoing palliative chemotherapy during a health-system wide initiative to improve advanced care planning (ACP). Methods: This is a retrospective cohort analysis of 106 pts with locally advanced or metastatic PC treated with palliative chemotherapy from 2012-2015 in Northern Alberta (Canada). In 2014, an initiative was launched to provide pts with hard copies of their GoC designation intended to be available at all health-system interactions. Data were obtained from outpatient medical oncology (MO) and palliative care (PAL) notes and the provincial cancer registry. Survival analysis used a multivariate Cox-regression. All other tests were Chi-squared. Results: 50% (53/106) of pts had a documented GoC discussion, with 45% (48/106) receiving a specific GoC designation. In 2012, 31% (6/19) of pts had a GoC designation, which increased to 61% (20/33) in 2015. Of 84 individual GoC discussions documented, 34% (29/84) were by MO, 62% (52/84) were by PAL, and at least 8% (7/84) referenced prior discussions with a family physician or discussion while admitted to hospital. Pts with a GoC designation had increased median overall survival (287 vs 216 days; HR = 0.62; p = 0.041), and were less likely to receive chemotherapy in the last two weeks of life (p = 0.016). Conclusions: Rates of GoC discussions for PC pts undergoing palliative chemotherapy increased during a health-system wide ACP initiative. Having a GoC designation was associated with greater overall survival and indicators of higher quality end-of-life care.
Economics of using telehospice to supplement hospice care in rural areas.
Authors: Lomenick Adam , Kuhlman Sandy , Gurley-Calvez Tami , Barnes Joe , Krebill Hope , Spaulding Ashley , Doolittle Gary C. 
Published: March 2020

11535 Background: Hospice care in rural areas is often characterized by provider shortages and vast geographical service areas to cover, making access to quality end-of-life care challenging. Telehospice, the utilization of interactive video (ITV) technology to provide health services over a distance for hospice patients, has been proposed as a solution to address access issues. In 2017, the University of Kansas Medical Center (Kansas City, Kansas) partnered with Hospice Services, Inc. (HSI) (Phillipsburg, Kansas) to augment traditional, in-person hospice care with hospice care delivered via mobile tablets.This work examines the costs of Telehospice when compared with the costs of in-person hospice services. Methods: Detailed administrative data from July 1, 2018 to December 31, 2018 was analyzed to estimate the costs of service after Telehospice use was inculcated into routine practice. Results: Hospice Services, Inc., which averages a daily census of 34 patients, conducted 257 calls, averaging 28 hours a month. The average time for a Telehospice call was 21 and 18 minutes for nursing and medical director calls, respectively. Through various hospice functions, including administrative, patient, and non-patient related connections, HSI saved over $115,000 in staff travel time and mileage reimbursement. Administratively, by hosting their weekly 14-member interdisciplinary meeting via ITV, HSI saved $29,869 of staff travel time and mileage reimbursement. Conclusions: Our estimates indicate substantial cost saving potential with the use of Telehospice services. Further research is needed to assess the effects of Telehospice utilization on the experiences and subsequent cost of hospice care. Additional cost data specifics will be presented in poster form. [Table: see text]
Variation in the intensity of end-of-life care, hospice enrollment, and the cost of care by cancer site.
Authors: Uppal Shitanshu , Pleasant Versha , Bell Sarah , Reynolds R. Kevin , Rice Laurel , Spencer Ryan J. 
Published: March 2020

11539 Background: To compare end-of-life (EOL) care intensity across multiple cancer sites and its impact on the cost of care during the last 30-days of life. Methods: Cross-sectional retrospective study using Surveillance, Epidemiology, and End Results Program (SEER)-Medicare linked database from 2008-2013. Utilization of the following in the EOL period (last 30 days of life prior to death) was examined: 2 or more visits to the Emergency Department (ED), hospitalizations, receipt of any life-extending procedures, admission to intensive care unit, any hospice use, hospice used ≤3 days, death in hospital, or receipt of chemotherapy (last 14 days). We tallied the claims made during the EOL period for each patient. Median expenditures during the EOL period were tabulated by cancer site and stratified by receipt of hospice care. Results: EOL care utilization varied widely between cancer sites. The rates of any hospice utilization were the highest for breast cancer (48.2%) compared to ovarian (17.4%) (p < 0.001). Chemotherapy during the last two weeks of life was the highest for ovarian cancer (1.7%) and the lowest for colorectal cancer (0.5%). The median cost of care during the EOL period for patients who received hospice care was $7,547.84 (Interquartile range [IQR] $5,422-$17,293) compared to $17,179 (IQR $10,323 - $30,824) for those never received hospice care (p < .0001). There was no significant variation in median cost by cancer site for those who received hospice services (range $7,317 - $9,816). However, the cost of care varied for those who did not receive hospice care. Median costs for this subgroup was the lowest for pancreatic cancer ($14,635) and the highest for colorectal cancer ($24,324) (p < 0.001). Conclusions: Despite increasing acceptance of palliative care services and hospice in cancer care, there continues to be intensive and costly care administered during the EOL period. These costs vary considerably across cancer sites when patients do not receive hospice care, but costs are relatively similar when patient are enrolled in hospice Further research to investigate the causes of this variation should be undertaken to design interventions aimed at improving timely hospice enrollment at the EOL and reducing costly care in the EOL period.
Guided geriatric interventions (GI) in older adults with cancer: What, how, and for whom? The French PACA EST Cohort Experience.
Authors: Boulahssass Rabia , Gonfrier Sebastien , Ferrero Jean-Marc , Champigny Noemie , Rambaud Cyrielle , Largillier Remy , Chauviere Damien , Barranger Emmanuel , Bereder Jean Marc , Benizri Emmanuel , Borchiellini Delphine , Durand Matthieu , Baque Patrick , Delotte Jerome , Barriere Jerome , Hannoun-Levi Jean-Michel , Guigay Joel , Piche Thierry , FRANCOIS Eric , Guerin Olivier 
Published: March 2020

11548 Background: Some previous studies in geriatric oncology have described the GI and their adherence. Today’s challenge is to screen patients needing specific GI and repeated Comprehensive Geriatric Assessments (CGA). We recently analyzed a phenotype of patients requiring more GI (Boulahssass et al, Cancers 2019). The main purpose of the present study is to compare types of GI implemented, according to patient frailty levels, in order to better understand the necessary care plan. Methods: Between April 2012 and May 2018, 3530 consecutive patients with solid tumors were enrolled in this multicentric, prospective cohort. 3140 patients (mean age:82y) were finally included and a CGA was performed at Baseline. Twelve GI were standardized, individualized or based on experience if no guidelines were available. Within 1 month, geriatricians including patients in the cohort received standardized training. Logistic regression was performed to compare types of GI in the 3 groups using the Balducci Score (B1/B2/B3). Results: 8819 GI were implemented for the 3140 patients. On average, fit patients had 1.5 GI (n = 146), vulnerable patients 2.4 GI (n = 1568) and frail patients 3.3 GI (n = 1426). We observed no significant differences between the 3 groups concerning specific pain management (Fit vs B2: p = 0.19; Fit vs B3: p = 0.57) and psychological care (Fit vs B2:p = 0.03; Fit vs B3:p = 0.24). In vulnerable and frail patients, we recorded more significant GI for nutritional care, delirium prevention, comorbidity management, nursing interventions, social worker interventions, treatment modifications for optimization or iatrogenic disorders and physiotherapy, with the highest Odds Ratio for nursing interventions (Fit vs B2 OR:2.9 p = 0.011; Fit vs B3 OR:9 P < 0.001) and physiotherapy (Fit vs B2:OR 4.3 p < 0.001; Fit vs B3:OR:9 p < 0.001). B3 patients had significantly more GI on care pathways modifications (OR:3.1, p = 0.002) and caregiver care (OR:2, p = 0.049). Conclusions: Fit patients also needed GI. We observed differences in types of GI between the groups. However, the aims and levels also seemed to differ and need further studies to analyze their impact.
Predicting severe toxicity of targeted therapies in elderly patients with cancer (PreToxE): A multicenter, prospective, and retrospective study.
Authors: Lebreton Coriolan , Cantarel Coralie , Toulza Emilie , Desgrippes Romain , Bozec Lemoal Laurence , Saada Esma , Ducoulombier Agnes , Tardy Magalie Pascale , Paillaud Elena , Lalet Caroline , Mathoulin-Pélissier Simone , Italiano Antoine 
Published: March 2020

11550 Background: It is crucial that targeted therapies are also studied in senior patients to establish predictive factors of severe toxicity. Methods: The PRETOXE study includes 3 multicentric independent cohorts of patients ≥70 years old with advanced solid tumor (2 retrospectives and one prospective) and treated with a tyrosine/threonine kinase inhibitor (TKI) as per drug label. Data on clinical and biological characteristics of the patient, disease and treatment were centrally collected at the beginning of the treatment. Primary endpoint is severe toxicity defined as treatment-related death, persistant or significant disability/incapacity, hospitalization or discontinuation of treatment for more than three weeks. Predictive factors of severe toxicity were first identified in a training retrospective cohort by multivariate analysis. Two independent cohorts ( retrospective and prospective) will be used for external validation. Results: 371 patients entered the study (training retrospective cohort n = 171, 46.1 %; validation retrospective cohort: n = 160, 43.1%, validation prospective cohort: n = 40, 10.8%). Median age was 74.0 (range 70.0-88.0) in the training retrospective cohort. 73 patients (42.7%) were male. The most frequent solid tumors were lung 64 (37.4%), breast 50 (29.2%), sarcomas 27 (15.8%), colon 10 (5.8%) and kidney 8 (4.7%). The five most frequent prescribed TKIs were everolimus 51 (29.8%), erlotinib 43 (25.1%), pazopanib 18 (10.5%), gefitinib 17 (9.9%) and regorafenib 14 (8.2%). The prescribed dose was lower than that recommended in the drug label in 32.1% of cases. 46 (26.9%) patients had a severe toxicity as per protocol definition in retrospective cohort: hospitalization 5 (10.9%), discontinuation of treatment more than 3 weeks 4 (8.7%), definitive discontinuation of treatment 38 (82.6%), persistent or significant disability/incapacity 14 (30.4%). On multivariate analysis, female gender, ≥3 concomitant medications and anti-angiogenic activity of TKI were independent predictive factors of severe toxicity. External validation on the other two independent cohorts (retrospective and prospective) will be presented at the meeting. Conclusions: One in four cancer patient ≥ 70 years old and treated with a TKI has severe toxicity impacting treatment outcome. The role of geriatric intervention to prevent such toxicities should be considered particularly in female patients, patients with ≥3 concomitant medications or when the TKI targets the VEGF receptors family. Clinical trial information: NCT02751827.