bluuebunny/crossref_metadata_2025_split huggingface dataset:
Associations between safety and tolerability and reporting of health-related quality of life in phase III randomized trials in common solid tumors.
Authors: Saleh Ramy , Meti Nick , Ribnikar Domen , Goldvaser Hadar , Ocana Alberto , Templeton Arnoud J. , Seruga Bostjan , Amir Eitan 
Published: May 2020

e19206 Background: Anti-cancer drugs are approved typically on the basis of efficacy and safety as evaluated in phase III randomized trials (RCTs). Health related quality of life (HRQoL) is a direct measure of patient benefit from drugs. Despite this, HRQoL is not reported universally for all anti-cancer drugs. Here we explore associations with reporting of HRQoL data in phase III RCTs in common solid tumors. Methods: We searched ClinicalTrials.gov to identify phase III oncology RCTs evaluating new drugs in adult patients with breast, colorectal, lung, or prostate cancers. We included all completed or active trials that completed accrual between January 1, 2005 and October 31, 2016. Data were extracted from published trials including HRQoL data and toxicity data on toxic death, treatment discontinuation and commonly reported grade 3 or 4 adverse events (AEs). Then, we explored associations between these safety and tolerability measures and the odds of reporting HRQoL data and whether HRQoL were favourable or not. Analysis comprised logistic regression and was performed in SPSS version 25. Results: A total of 377 phase III RCTs were initially identified. After excluding ineligible studies, a total of 143 studies were analysed. All trials (100%) were in the metastatic setting with 79 (55%) being positive trials. 40 (28%) were breast cancer trials, 38 (26%) were focused on evaluating chemotherapy, and 128 (90%) of trials were industry sponsored. 84 (59%) trials reported measuring HRQoL data, however of these, only 47 (56%) reported HRQoL data. In 14 (30%) HRQoL was improved with experimental therapy. There was no association between treatment related death (OR 1.25, 95%CI 0.74-2.12, p = 0.398) or treatment discontinuation (OR 1.12, 95%CI 0.73-1.72, p = 0.61) with reporting of HRQoL data. Associations with grade 3 or 4 AEs are shown in the Table. Conclusions: HRQoL is reported for only around a half of RCTs that collect such data. Reporting of HRQoL is not associated with safety and tolerability of anti-cancer drugs. [Table: see text]
4R Program results: What is the impact of 4R care delivery model on patient self-management and which patients benefited?
Authors: Trosman Julia Rachel , Weldon Christine B. , Makower Della F. , Rapkin Bruce D. , Bozier Moreen , Perez Claudia Beth , Kulkarni Swati , Schaeffer Cathleen M. , Hoskins Kent , Gallagher Christopher , Lo Shelly S. , Grace-Louthen Cathy , Throckmorton Alyssa , Krueger Editha , Van Horn Jennifer , Ravelo Arliene , Yu Elaine , Schapira Lidia , Benson Al Bowen , Gradishar William John 
Published: May 2020

e19211 Background: We previously proposed a 4R model of teamwork and patient self-management (pSM) in cancer care (NCI ASCO Teams Project, Trosman JOP 2016). 4R (Right Info / Care / Patient / Time) enables patient and care team to manage complex care with an innovative 4R Care Sequence plan, including a novel visual feature describing timing and sequence of care. We report final results of a program which tested 4R at 5 safety net and 5 non safety net US centers from 2016 to 2019. Methods: Patients with stage 0-III breast cancer received 4R plans (4R Cohort). We surveyed 4R cohort and a historical control cohort of patients receiving care at same centers pre-4R. We assessed the usefulness of 4R to the 4R cohort and the impact on pSM in 4R cohort compared to historical cohort. Results: Survey response rates: 63%, 422/670 (4R cohort); 47%, 466/992 (control). 4R significantly increased the composite pSM score and 5 of 7 pSM metrics vs control (Table). The increase was not influenced by patient age, stage or whether treated at safety net site. pSM scores increased in 4R vs control cohort to a similar extent for patients < 65 years old (74% vs 51%, p = .0001) as for patients ≥ 65 years old (78% vs 57%, p = .0002). pSM improved similarly for patients with stage 0 or I breast cancer (77% vs 56%, p = .0001) as for patients with stage II or III breast cancer (72% vs 54%, p = .0001). Safety net patients showed pSM increase (77% vs 51%, p = .0001) similar to non safety net patients (74% vs 58%, p = .0002). Within the 4R cohort, 80% found 4R useful for organizing care and 70% found the novel visual feature useful to manage care timing and sequence. Usefulness was similar for age groups and stages, but higher for safety net than non safety net patients (88% vs 74%, p = .0008). Conclusions: 4R markedly improved patient self-management in early breast cancer across age groups and cancer stages, but further enhancements are needed to benefit as many patients as possible. 4R benefits in safety net setting indicate that 4R may reduce disparities. [Table: see text]
Colorectal cancer: Improving screening in rural clinic.
Authors: Le Thuy Thanh Thi , Fleckenstein Lorraine , Jiang Zhaozhi , Davis Shellian , Yarlagadda Lakshmi 
Published: May 2020

e19215 Background: Colorectal cancer (CRC) is the second leading cause of cancer-related deaths in the United States. From 2010 to 2014, CRC was also the second leading cause of cancer deaths in North Carolina (NC). Between 2012-2016, the age adjusted mortality rate was 18-25 per 100,000 persons in Robeson County, NC. During this timeframe, it is estimated that if all people aged 50 and older in NC were routinely screened, 40 out of 100 deaths from late stage CRC can be prevented. A chart review in a rural primary care clinic identified patients not being appropriately screened for targeted intervention. Methods: Retrospective chart review at Lumberton Medical Clinic, a rural outpatient Internal Medicine Clinic, reviewed 1622 records from adults 50-75 years old during the timeframe September 2017 - August 2018 for phase I and 1588 records from September 2018-August 2019 for phase II. Patients with history of CRC or status-post colectomy for other reasons were excluded from this study. Patient records were assessed for compliance with USPTF CRC screening guidelines – adults aged 50 to 75 years receive screening as follows: 1) Fecal occult blood testing (FOBT) annually 2) Flexible sigmoidoscopy every 5 years 3) Colonoscopy every 10 years OR 4) Combined FOBT (every 3 years) + flexible sigmoidoscopy (every 5 years). Following data analysis in phase I, interventions to increase screening rates were initiated – provider education, posters hung in exam rooms, and individualized letters mailed to patients found deficient. The success of this effort was measured in phase II. Results: For phase I, the review showed 56% of patients received appropriate screening and 44% were found with no documentation of screening. Following interventions, 76% received appropriate screening and 24% with no documentation. Thus, there is ~35% improvement in screening rate. Conclusions: The mortality rate from CRC is higher in Robeson County compared to the NC state rate. Additionally, 40% of deaths from late-stage CRC may be prevented by doing a routine screening. It is the responsibility of providers to emphasize the importance of proper screening. This retrospective review showed ~ 35% improvement in screening rates following interventions. The result might not be as high as expected due to several factors: 1) new resident physicians and faculty 2) few posters were taking down due to disagreement with the guidelines by one of the 3 main providers 3) patients might not receive the letters. To further increase the screening rate, we are implementing the “Preventive Maintenance” tab in our electronic medical record system at the end of clinic visits.
Plant-based diet trends in oncology patients.
Authors: Webster Bradley R , Ton-That Matthew V , Hashemi-Sadraei Neda , Shah Satyan K 
Published: May 2020

e19224 Background: Plant-based diets are beneficial in several cancers such as colorectal and prostate. However, their adoption among oncology patients is not well studied. We report trends in plant-based diet selection among medical and surgical oncology patients at a comprehensive cancer center. Methods: An IRB-approved retrospective review of all patients admitted to the University of New Mexico Hospitals between October 2009 and October 2017 was conducted. Inclusion criteria included: 1) vegetarian Ovo-Lacto (dairy and eggs ok) or vegan (no animal-derived foods) inpatient diet request and 2) age >= 18 years. For each individual, the dietary orders and discharge summaries were reviewed. Patients with cancer diagnosis principally related to admission and/or admission to an oncology inpatient service were defined as oncology patients. Surgical oncology services included 8 different surgical branches. Results: A total of 181 oncology patients ordered plant-based diets. Median age was 62 years (range 18 to 90) and 69% were female. Vegetarian Ovo-Lacto (66%) was requested more than vegan diet (34%). The services on which the greatest number of these patients were treated were Medical Oncology (31%), General Surgical Oncology (23%), and Gynecology-Oncology (20%). Comparing medical and surgical oncology patients, there was no difference in terms of median age (63 vs. 62 years, p=0.62), nor in the % requesting vegan diet (30 vs. 35%, p=0.50), respectively. However, females comprised 95 of 124 (77%) surgical patients, but only 29 of 57 (51%) medical patients (p<0.001). The number of patients requesting a plant-based diet grew from 81 in the first half of the study period to 100 in the second half (a 23% increase). During this time period, vegetarian diet became more popular than vegan with an increase from 48 patients (59%) in the first half to 72 (72%) in the second half (p=0.05). Conclusions: Oncology patients are increasingly requesting plant-based diets. Most are female and prefer vegetarian over vegan meals. These findings can help cancer centers improve quality of care by tailoring nutritional offerings.
Changes in intravenous immunoglobulin (IVIG) usage for hypogammaglobulinemia (HG) after implementation of a stewardship program.
Authors: Derman Benjamin Avi , Schlei Zachary , Mullane Kate M. , Parsad Sandeep , Knoebel Randall W 
Published: May 2020

e19225 Background: IVIG is used to replenish immunoglobulins in HG due to hematologic malignancies (HM) or their treatment (stem cell transplantation (ASCT) and chimeric antigen receptor T-cell therapy (CAR-T)), in an effort to reduce the risk of infections. There is limited high-level evidence to support this use, and IVIG supplies are limited with a recent shortage leading to restricted allotments. We report the results of a stewardship program designed to safely reduce IVIG usage. Methods: An IVIG stewardship plan (ISP) was implemented with the following requirements for IVIG administration: IgG level < 400 mg/dL (corrected for paraprotein) for post-ASCT and post-CAR-T patients, or IgG < 400 mg/dL with evidence of a bacterial infection within the last 3 months that required hospitalization or an emergency department encounter for those with HM. We evaluated the amount of IVIG administered, the incidence of infections, and antibiotic administration before and after implementation of an ISP. Results: In the 3 months pre-ISP, HG accounted for 38% (72/188) of total IVIG orders. 86 pts received IVIG for HG in the 3 months pre-ISP. The amount of IVIG given decreased from 1907 g/month pre-ISP to 670 g/month post-ISP; estimated cost savings in IVIG was $57,561/month. The pre-ISP median IgG level prior to dosing of IVIG was 550 (range 40-1189) mg/dL. Compared to pre-ISP, pts who stopped receiving IVIG post-ISP had lower median pre-dose IgG (444, range 93-819 mg/dL, p<0.05), infections/patient-months (14/141 vs 56/255, p<0.001), antibiotic usage (12/47 vs 44/86, p<0.05), and hospitalization rate for infection (4/55 vs 21/86, p<0.05); no deaths occurred. For those receiving IVIG post-ISP, adherence to guidelines was 64%. Compared to pre-ISP, median pre-dose IgG was lower (328, range 51-1011 mg/dL, p<0001), infections/patient-months decreased (27/163 vs 56/255, p<0.001), and antibiotic usage, hospitalization rate for infection, and deaths from infection all remained stable. Conclusions: An ISP for HG led to a dramatic and sustainable decrease in IVIG usage, primarily by selecting out patients who are low risk for infection after discontinuation of IVIG. Such an ISP is replicable and warrants adoption.
Implementation of the Institute of Medicine treatment plan in oncology practice.
Authors: Sivendran Shanthi , Wilfong Lalan S. , Horenkamp Elizabeth , Rocque Gabrielle Betty 
Published: May 2020

e19233 Background: Participation in the Center for Medicare and Medicaid Services (CMS) value-based payment reform, The Oncology Care Model, requires that every beneficiary has a documented 13-point Institute of Medicine (IOM) treatment plan (TP) when commencing antineoplastic therapy. The intent of this document is to enhance shared decision making between the patient and care team by providing transparent treatment recommendations and engaging patients and caregivers in meaningful discussion. There is limited discussion in the literature on how to adapt the CMS recommendations to diverse practice settings while maintaining fidelity to the intent of the TP. Methods: We compare how three clinically and geographically unique OCM participating institutions implemented the TP in their respective institutions within the domains of the Consolidated Framework for Implementation Research (CFIR). Settings include a community cancer institute in the northeast, an academic hospital setting in the southeast, and a large community cancer network in the southern United States. Results: We identified similar themes in implementation including engaging stakeholders, leveraging information technology, structuring the TP, development of clinic processes and considering scalability. We also describe adaptations unique to the culture and setting of each site. Conclusions: Although studies have shown patients do not feel informed of their diagnosis, there are currently many approaches to improving shared decision making including utilizing the 13 points of the IOM TP as mandated by the OCM. We provide practical strategies for incorporation of the TP into clinical care with lessons from diverse settings. As shown by the wide variability in implementing shared decision making, further research is needed to optimize illness understanding. Additionally, optimal implementation of CMS’s IOM TP would ideally include concrete metrics measuring impact on shared decision making, illness understanding, or patient satisfaction.
Physician perceptions about goals of care of hospitalized patients with malignancies.
Authors: Balanchivadze Nino , Slota Alexander Antoni , Mangano Andrew , Kudirka Adam , Alkhatib Yaser 
Published: May 2020

e19234 Background: More sophisticated treatment techniques in cancer management have led to increased complexity in patient care. The perception of cancer outcomes is different between physicians and may result in premature hospice referral in hospitalized patients with or without cancer-related acute illness. We created a clinical scenario-based survey to assess perceptions of goals of care choices of inpatient primary providers while caring for patients with malignancies. Methods: A survey was developed and sent to all internal medicine and primary care residency programs nationwide via “Survey Monkey” online platform. Cases were adapted from real patient encounters. A total of 8 cases were presented and physicians were asked to determine level of care. Two cases represented potentially curable disease, three described patients with treatable but incurable malignancies, and the remainder described patients with advanced malignancies appropriate for hospice care. Physicians were also questioned about patterns of consulting hematology/oncology (HO) and their opinions regarding barriers in providing care to patients with malignancies. Results: Of 269 physicians who took the survey, 184 physicians (68%) fully completed it. 37% reported consulting HO for every patient with underlying malignancy, while 2% of the providers do not have access to HO consultants. In curable cancers, 65% of physicians would request inpatient oncology consultation while 11% would initiate hospice referral. There was a significant variation in choices for care in treatable cancer cases. In case 1, 13% of surveyed physicians thought that patients were hospice appropriate, while a higher percentage felt the same for the 2nd and 3rd cases with 18% and 52%, respectively. For hospice-appropriate patients, 25% of providers felt that further cancer treatment should be performed in younger patients, while the majority agreed on hospice referral (91%) for older patients. The most reported barrier to providing care to hospitalized patients with malignancies was a disconnect between the perception of goals of care of the primary treating oncologist/hematologist and patient’s actual condition. Conclusions: Perceptions about goals of care in hospitalized patients with malignancies varies and is affected by patient age and perceived severity of disease, which doesn’t necessarily translate into outcome statistics reported in literature. A multidisciplinary approach and treating oncologist involvement might be warranted when patient goals of care change is planned in hospital setting.
Real-world clinical and economic burden associated with hospitalization in metastatic triple-negative (ER-/PR-/HER2-) breast cancer.
Authors: Tan Amie , Han Xu , Near Aimee , Tse Jenny , Preger Luciana 
Published: May 2020

e19236 Background: Metastatic triple-negative breast cancer (mTNBC) is associated with poorer disease prognosis and higher healthcare utilization and costs compared with other breast cancer subtypes, with hospitalizations being a major cost driver. This study aimed to understand reasons for hospitalization and describe the clinical and economic burden associated with hospitalizations in mTNBC patients following 1L treatment initiation. Methods: mTNBC patients were identified in the IQVIA Real-World Data Adjudicated Claims-US database (Jan. 2012 – Jan. 2019) and indexed on the day of 1L treatment initiation. Women ≥18 years of age with mTNBC who had continuous enrollment for ≥12 months before (baseline) and ≥30 days after (follow-up) index and no evidence of other primary cancers during baseline were included. Patient baseline characteristics and all-cause hospitalizations during follow-up were described. Results: 4,617 mTNBC patients were identified (mean age 54 years; 99.7% with chemotherapy as IL); 1,595 (35%) had ≥ 1 hospitalization during follow-up (mean duration 17 months). More hospitalized patients had ≥2 metastasis sites (25% vs. 15%, p < 0.01) as well as visceral (15% vs. 7%, p < 0.01) or bone metastases (15% vs. 8%, p < 0.01) than non-hospitalized patients. The average time from index to first hospitalization was 7.4 months and hospitalized patients had a mean of 2.4 hospitalizations per patient per year (PPPY), with mean length of stay of 6 days. 25% of hospitalized patients were admitted from the ED. Reasons for hospitalization included chemotherapy-related adverse events (AEs; 76%), followed by disease progression (72%), breast-related surgeries (6%), and others (4%). Common chemotherapy-related AEs included infection or pyrexia (46%), anemia (35%), and neutropenia (17%). Total cost associated with hospitalization was $57,115 PPPY, with the annual out-of-pocket cost averaging $3,659 per patient; mean out-of-pocket cost per hospitalization was $1,840. The proportion of patients with hospitalization was similar between metropolitan and rural patients (35% vs. 37%, p = 0.51), yet metropolitan patients had slightly longer hospital stays (mean 6 vs. 5 days, p = 0.03). Conclusions: Approximately one-third of mTNBC patients were hospitalized following 1L treatment initiation and in turn, bear a high economic burden. New therapies are needed to mitigate the clinical and economic burden associated with hospitalizations in this population.
Similar negative emotional impact on hair loss in neoadjuvant endocrine therapy compared to neoadjuvant chemotherapy in young women with breast cancer from patient reported outcomes.
Authors: Gwark Sung-chan , Ahn Sei Hyun , Noh Woo Chul , Lee Eun Sook , Jung Yongsik , Kim Lee Su , Han Wonshik , Nam Seok Jin , Gong Gyungyub , Kim Seon-Ok , Kim Hee Jeong 
Published: May 2020

e19242 Background: We aimed to evaluate patient-reported outcomes (PROs) in the NEST phase III trial, in which neoadjuvant endocrine therapy (NET) compared to conventional neoadjuvant chemotherapy (NCT) for hormone-responsive lymph node-positive premenopausal breast cancer. Methods: Premenopausal women with estrogen receptor (ER)-positive, HER2-negative, and lymph node-positive premenopausal breast cancer patients were enrolled. Patients were randomized to either 24 weeks of neoadjuvant chemotherapy with doxorubicin plus cyclophosphamide followed by taxane (T) or neoadjuvant endocrine therapy with goserelin and tamoxifen. PROs were assessed at day 1 (baseline) and at the end of treatment, using the breast cancer module of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 23 (EORTC QLQ BR23). ClinicalTrials.gov: NCT01622361. Results: 187 patients were randomly assigned to chemotherapy (n=95) or endocrine therapy (n=92), and 174 patients completed the 24 weeks of neoadjuvant treatment period (n=87, both). Baseline scores were similar between arms. No statistically significant between-treatment differences were observed for the function scales including body image, sexual functioning, and sexual enjoyment although endocrine treatment showed significant improvement in future perspective (HR=8.3, 95% CI:1.72-18.38; P=0.021). Even though no alopecia was reported in NET group, no statistically significant difference between both arms in the “upset by hair loss” was observed, in which NET group showed even worse score. Conclusions: Patients who received NET had significant improvement in a future perspective, however, a similar emotional negative impact on hair loss was observed compared with NCT despite no reported alopecia. Key words: breast cancer, patient-reported outcomes, quality of life, hair loss, EORTC QLQ-BR 23. Clinical trial information: NCT01622361 .