bluuebunny/crossref_metadata_2025_split huggingface dataset:
Safety of using hormone replacement therapy in breast cancer survivors: A systematic review and metanalysis.
Authors: Poggio Francesca , Del Mastro Lucia , Bruzzone Marco , Ceppi Marcello , Razeti Maria Grazia , Fregatti Piero , Cosso Maurizio , Pronzato Paolo , Massarotti Claudia , Franzoi Maria Alice B , Lambertini Matteo , Tagliamento Marco 
Published: June 2021

12067 Background: Improvements in breast cancer (BC) care have led to increased survival of patients; hence, more attention to long-term treatment-related adverse events and quality of life (QoL) is required. Symptoms of spontaneous and treatment-induced menopause significantly affect the QoL and adherence to endocrine therapy among BC survivors, with potential negative implications on outcome. Use of systemic hormone replacement therapy (HRT) to mitigate menopause-associated symptoms is not recommended to reduce the burden of these side effects being historically associated with an increased risk of disease recurrence. This systematic review and metanalysis aimed to estimate the effect of HRT on risk of disease recurrence in BC survivors. Methods: A systematic search of Pubmed and Embase libraries up to January 15, 2021, was conducted in order to identify randomized controlled trials (RCTs) investigating the risk of disease recurrence with the use of HRT in BC survivors. We used the random-effect model to calculate the overall risk of recurrence, reported as pooled hazard ratio (HR) with 95% confidence intervals (CI). Moreover, we performed a subgroup analysis to estimate the risk of recurrence according to hormone receptor status. The Higgins I2 index was computed to assess the heterogeneity between studies. The likelihood of publication bias was assessed by Egger’s test. Results: Four RCTs were found and three were included in the metanalysis (n = 3.973 patients); one study (n = 100 patients) was excluded due to the impossibility to extract the HR for disease recurrence. Overall, 1.990 patients were randomized to receive HRT (estrogen-progesteron combination or tibolone), while 1.983 patients were included in control groups (placebo or no HRT). As compared to control group, HRT significantly increased the risk of BC recurrence (HR 1.49, 95% CI 1.15-1.93, p = 0.002). The heterogeneity between the studies was low (39%, p = 0.194), and no publication bias was found ( p = 0.537). Two studies reported the HR according to hormone receptor status. At the subgroups analysis, the risk of BC recurrence with the use of HRT was significantly increased in hormone receptor-positive patients (HR 1.8, 95% CI 1.15-2.82, p = 0.010) but not in those with hormone receptor-negative tumors (HR 1.25, 95% CI 0.83-1.88, p = 0.290). Conclusions: Use of HRT significantly increases the risk of recurrence in BC survivors, particularly in those with hormone receptor-positive disease. Therefore, this approach remains contraindicated in this setting. Alternative interventions to mitigate menopause-related symptoms should be proposed to these patients.
Comparison of inpatient outcomes of pathological fractures in metastatic breast cancer and osteoporosis.
Authors: Ahuja Kriti , Lingamaneni Prasanth , Weir Catherine , Elsebaie Maha A.T. , Rodriguez Alarcon Pierre Alexander , Aguilera-Astudillo Maria , Tamkus Deimante 
Published: June 2021

12115 Background: In the United States, an estimated 1 in 8 women will be diagnosed with breast cancer during her lifetime. Of those with metastasis, over half have bone metastases leading to risk for pathological fractures. Further, approximately 1 in 4 women over 65 years have osteoporosis of the femur neck or lumbar spine. We performed a retrospective analysis on outcomes in pathological fractures secondary to breast cancer metastasis in comparison to osteoporosis, including disposition at discharge. Methods: The Nationwide Inpatient Sample (NIS) database was queried to include all adult women admitted with osteoporotic fractures and pathological fractures due to metastatic breast cancer between 2016 and 2018. T-test was used to compare means of continuous variables and chi-square test to compare proportions of categorical variables. Multivariate analysis of predictors of pathological fractures in women with breast cancer metastatic to bone, as well as mortality, resource utilization and disposition in this group were performed. Results: A total of 91,494 fractures, combining osteoporosis and pathological fractures secondary to metastatic breast cancer were identified, of which the latter accounted for 4.9%. Patients with pathologic fractures secondary to metastatic breast cancer were younger (mean age 62.8 vs 79.5 years, p < 0.0001) and were more likely to be black (14.6% vs 3.1%, p < 0.0001) or Hispanic (8.3% vs 4.7%, p < 0.0001). Adjusting for demographic variables and comorbidity burden, pathological fractures secondary to metastatic breast cancer were not associated with a significant increase in inpatient mortality (aOR 1.57, 95% CI 0.84-2.95, p = 0.16), but were independently associated with increased length of hospital stay by 0.7 days per admission (p = 0.01) and higher hospitalization costs by $3,381 USD per admission (p < 0.01). Regarding disposition, patients with pathological fractures secondary to breast cancer were less likely to be discharged to a nursing facility (aOR 0.57, 95% CI 0.48-0.68, p < 0.001) and were more likely to be transitioned to home health care (aOR 1.46, 95% CI 1.20-1.78, p < 0.001). Conclusions: In adult women, pathological fractures secondary to breast cancer are less frequent than osteoporotic fractures and were not independent predictors of inpatient mortality. They do however prolong length of stay and increase healthcare costs. Further efforts should focus on risk prediction and prophylactic management of high risk bone lesions in order to enhance patient’s quality of life, decrease hospitalization admissions, stay and cost.
Documentation of goals of care (GOC) by medical oncologists is associated with improved oncology patient end-of-life (EOL) care outcomes.
Authors: Xiao Han , Riley Michael , Donopria Richard , Martin Steven , Nelson Judith Eve , Epstein Andrew S. 
Published: June 2021

1507 Background: Documenting GOC is integral to patient care and quality performance but has been underutilized by oncologists due to many barriers. As oncologists play a key role in initiating GOC discussions, we implemented a clinical initiative to improve their GOC documentation and evaluated the impact of such documentation on patient care during the EOL (last 30 days of life). Methods: We launched the initiative among 270 medical oncologists in an academic cancer center in 4/2020. A newly formulated GOC note to ease documentation was embedded in oncology outpatient and inpatient notes. Oncologists completed components in the GOC note that applied to their communication about GOC with the patient: 1) cancer natural history, 2) patient goals, and 3) EOL discussion: patient resuscitation preferences and, when pertinent, receptivity to hospice referral. GOC notes were pulled to a centralized location in the electronic health record (EHR) that displays documents relevant to patients’ values, goals and preferences. A dashboard allowed continual monitoring of documentation performance. We evaluated the association between GOC notes and outcomes of patient care at EOL. We further analyzed the impact of EOL discussion on EOL care. Results: The GOC note completion rate steadily rose after implementation. GOC notes were present in EHR for 46% of 10,006 patients who were either seen in outpatient clinic or discharged from hospital during the 1st week of January 2021. Among 1790 patients who died between 7/1/20 and 12/31/20 and had either at least an outpatient visit or hospitalization during EOL, the median days from first GOC note and first EOL discussion to the patient’s death were 71 days and 24 days, respectively. Linear regression analysis demonstrated that patients who had GOC note 60 days before death spent less time as inpatient during EOL (0.4 day less/patient, from 8.1 to 7.7, P = 0.01). When EOL discussion was documented 30 days before death, patients also spent less time in the hospital (1.2 days less/patient, from 9.7 to 8.5, P < 0.001) and in the ICU (0.3 days less/patient, from 1.7 to 1.4 ICU days, P = 0.04), and were 4% less likely to receive chemotherapy (from 38% to 34%, P = 0.004) at EOL. During the same period, among 1,009 patients with hospital admission in the last 30 days of life, those with a prior documented EOL discussion had shorter inpatient stay (7.7 vs 13.1 days, P < 0.001) and were more likely to be discharged to hospice (34% vs 22%, P = 0.003). Conclusions: During the COVID-19 pandemic, we successfully implemented GOC documentation by medical oncologists that is easily visible by the full care team. Documentation of GOC including EOL discussion was associated with fewer days in the hospital and ICU, increased hospice referral, and lower likelihood of receiving chemotherapy during patients’ last 30 days of life.
Veterans on anticancer medications in rural and community environment support (VA CARES) program: A pharmacist-led telemedicine medication management program for veterans receiving oral antineoplastic therapies through the MISSION Act.
Authors: Healy Regan , Passey Deborah , Pinnell Derek , Qualls Joshua , Hamilton Clayton , Burningham Zach , Tilley Elizabeth , Hood Tanya , Sauer Brian C , Halwani Ahmad Sami 
Published: June 2021

1545 Background: Cancer therapies are leveraging oral targeted treatments over traditional cytotoxic chemotherapy (CT) at an increasing rate. Compared to CT, use of oral antineoplastic treatments (OATs) shift some of the burden of medication management onto patients. To address these challenges, several health systems have developed multidisciplinary OAT management teams or ‘clinics’ whereby an Oncology Clinical Pharmacist (OCP) collaborates with oncology teams to ensure optimal use of these agents. Through the VA MISSION Act of 2018, Veterans can be prescribed treatments in the community which are dispensed by VA. These Veterans often live in rural areas and may lack access to comprehensive medication management resources. Methods: The VA CARES Program is a telemedicine medication management ‘clinic’ and care delivery model for patients receiving OATs leveraging custom designed health information technology (HIT) tools to remotely coordinate OAT related care. Veterans are automatically enrolled in the program if they have OATs prescribed by community providers which are to be dispensed by VA. An OCP provides telemedicine medication management services. The OCP performs a screening assessment, ensures appropriate indication and dosing, reviews baseline laboratory results, and performs a thorough drug-drug interaction analysis. The OCP then provides OAT education. Throughout the duration of therapy the OCP ensures necessary therapeutic monitoring, and regularly follows up with the Veterans. Subsequent encounters are to assess knowledge, adherence, toxicities, new drug-drug interactions, and need for OAT refills. The outcome measures for the VA CARES Program include safety (number and type of pharmacist interventions), economic benefits (cost savings or cost avoidance), and patient satisfaction. Results: In the initial 13 months, the VA CARES Program screened N = 78 and enrolled N = 64 (82%) Veterans from three VA medical facilities in VISN-19 from January 2020 to January 2021. The CPS performed n = 342 telemedicine visits and n = 80 interventions leading to improved safety, effectiveness, and/or an economical benefit. The most common interventions included detection and/or prevention of drug-drug interactions (n = 45) and adverse events (n = 18), drug not indicated (n = 13), alternative therapy suggested (n = 7), and limited-quantity dispensed (n = 7). The CPS interventions saved an estimated $210,864 in medication-related costs or avoidance. The Veterans surveyed were highly satisfied with the program services. Conclusions: Telemedicine delivery of oncology medication management by an OCP across systems is feasible, and provides clinical and economic benefits.
A natural language processing tool for automatic identification of new disease and disease progression: Parsing text in multi-institutional radiology reports to facilitate clinical trial eligibility screening.
Authors: Clayton Eric J. , Banerjee Imon , Ward Patrick J. , Howell Maggie D , Lohmueller Beth , Pierson Sunita , Hall Rachel , Harrison Peter B , Waterhouse David Michael 
Published: June 2021

1555 Background: Screening every patient for clinical trials is time-consuming, costly and inefficient. Developing an automated method for identifying patients who have potential disease progression, at the point where the practice first receives their radiology reports, but prior to the patient’s office visit, would greatly increase the efficiency of clinical trial operations and likely result in more patients being offered trial opportunities. Methods: Using Natural Language Processing (NLP) methodology, we developed a text parsing algorithm to automatically extract information about potential new disease or disease progression from multi-institutional, free-text radiology reports (CT, PET, bone scan, MRI or x-ray). We combined semantic dictionary mapping and machine learning techniques to normalize the linguistic and formatting variations in the text, training the XGBoost model particularly to achieve a high precision and accuracy to satisfy clinical trial screening requirements. In order to be comprehensive, we enhanced the model vocabulary using a multi-institutional dataset which includes reports from two academic institutions. Results: A dataset of 732 de-identified radiology reports were curated (two MDs agreed on potential new disease/dz progression vs stable) and the model was repeatedly re-trained for each fold where the folds were randomly selected. The final model achieved consistent precision (>0.87 precision) and accuracy (>0.87 accuracy). See the table for a summary of the results, by radiology report type. We are continuing work on the model to validate accuracy and precision using a new and unique set of reports. Conclusions: NLP systems can be used to identify patients who potentially have suffered new disease or disease progression and reduce the human effort in screening or clinical trials. Efforts are ongoing to integrate the NLP process into existing EHR reporting. New imaging reports sent via interface to the EHR will be extracted daily using a database query and will be provided via secure electronic transport to the NLP system. Patients with higher likelihood of disease progression will be automatically identified, and their reports routed to the clinical trials office for clinical trial screening parallel to physician EHR mailbox reporting. The over-arching goal of the project is to increase clinical trial enrollment. 5-fold cross-validation performance of the NLP model in terms of accuracy, precision and recall averaged across all the folds.[Table: see text]
Continuous unobtrusive assessment of meaningful change in older adults with cancer: The Pacific Aging & Cancer Study Collaborative—PACS collaborative.
Authors: Wu Chao-Yi , Tibbitts Deanne , Beattie Zachary , Dodge Hiroko H. , Beer Tomasz M. , Marks Daniel , Shannon Jackilen , Kaye Jeffrey , Winters-Stone Kerri M. 
Published: June 2021

1569 Background: Knowledge of changes in health that precede a cancer diagnosis is challenging because of a lack of longitudinal, objective measurement techniques. Current approaches rely on periodic assessment via self-report which may miss when and how health changes, particularly when changes may appear subtly over time. Remote-monitoring technologies provide a mechanism to continuously, passively, and unobtrusively monitor changes in health so that trajectories of change in relation to a life event (i.e., cancer diagnosis, treatment) can be detected and described. We examined the changes in digital indicators of health and life events 1 year before and after a self-reported cancer diagnosis in community-dwelling adults aged 65 and older. Methods: This is a secondary, retrospective data analysis of older adults who self-reported a new cancer diagnosis in the Oregon Center for Aging & Technology (ORCATECH) cohort. Ten older adults (age = 71.8±4.9 years, 30% women) were included with various cancer types (esophageal, prostate, uterine, pancreatic, b-cell follicular lymphoma, multiple myeloma, basal cell melanoma, basal and/or squamous cell carcinoma). Daily physical activity was measured using step counts derived from an actigraph watch. Weekly health and life events (pain severity, loneliness, hospitalization/emergency room (ER) visits, days away from home overnight) were self-reported from weekly online surveys. Results: A total of 3,624 days of actigraphy data (210 ± 88 days pre-cancer; 153 ± 81 days post-cancer) and 750 weeks of self-reported online survey data (36 ± 12 weeks pre-cancer; 39 ± 14 weeks post-cancer) were collected. Longitudinal linear mixed-effects models revealed that the trajectory of step counts was different pre- and post-cancer (β = -1.52, p <.001), with a gradual decrease in step counts before a cancer diagnosis. The trajectory of pain severity was different pre- and post-cancer (β = 0.01, p <.001), with a gradual increase in pain severity before a cancer diagnosis. There was a gradual increase in the occurrence of hospitalization/ER visits (OR = 1.07, p = 0.02) and days away from home overnight (OR = 1.04, p = 0.01) before a cancer diagnosis. Feelings of loneliness increased over time, regardless of pre- or post-cancer (OR = 1.04, p <.001). Conclusions: Changes in health and life events 1-year before a cancer diagnosis in older adults with varying cancer types and severity were unobtrusively observed. This study suggests that a remote-monitoring technology platform deployed in homes can detect meaningful intra-individual changes before and after a cancer diagnosis. Future studies can employ this technology as a pathway for improving the timeliness of detection and more effective therapeutic follow-up for older adults.
Alliance A071601: Phase II trial of BRAF/MEK inhibition in newly diagnosed papillary craniopharyngiomas.
Authors: Brastianos Priscilla Kaliopi , Twohy Erin , Geyer Susan Michelle , Gerstner Elizabeth Robins , Kaufmann Timothy J. , Ruff Michael , Bota Daniela Annenelie , Reardon David A. , Cohen Adam Louis , De La Fuente Macarena Ines , Lesser Glenn Jay , Campian Jian Li , Agarwalla Pankaj , Kumthekar Priya , Cahill Daniel P. , Shih Helen Alice , Brown Paul D. , Santagata Sandro , Barker Frederick G. , Galanis Evanthia 
Published: June 2021

2000 Background: Craniopharyngiomas, a rare brain tumor along the pituitary-hypothalamic axis, can cause significant clinical sequelae. Surgery and radiation, the only effective treatments, can cause significant morbidity. Genetic analysis of craniopharyngiomas revealed that 95% of papillary craniopharyngiomas (PCP) have BRAF V600E mutations (Brastianos et al. Nature Genetics 2014). We evaluated the efficacy of BRAF/MEK inhibition in patients (pts) with previously untreated PCP. Methods: Eligible pts without prior radiation whose PCP screened positively for BRAF mutations were treated with oral vemurafenib/cobimetinib in 28-day cycles. The primary endpoint of response rate (RR) based on centrally determined volumetric data was evaluated in 16 pts, where a partial response was defined as >20% decrease in volume. This single arm, Simon two-stage phase 2 trial had 89% power to detect a true RR of at least 30% (vs. the null RR 5%; alpha=0.04). In this design, 3 or more observed volumetric responses in 16 evaluable pts would be considered promising activity. Results: In the 16 pts evaluated, 56% were female, and the median age was 49.5 years. Median follow-up was 22 months (95% CI: 16-26.5) and median number of treatment cycles was 8. Three patients progressed after therapy was discontinued and none have died. Based on volumetric response criteria, 14 of 15 pts with volumetric data available for central review had response to therapy (93%; 95% CI: 68% to 99.8%). Of 16 patients evaluable based on local review, 15 had response to therapy (93.75%; 95% CI: 70% to 99.8%). The median tumor reduction was -83% (range: -52% to -99%). The one nonresponder received 2 days of treatment before coming off therapy due to toxicity. Median progression-free survival was not reached. Grade 3 toxicities at least possibly related to treatment occurred in 12 pts (rash in 6 pts). Grade 4 toxicities were observed in two pts: hyperglycemia (n=1) and increased CPK (n=1). Three pts discontinued treatment for adverse events. Conclusions: Vemurafenib/cobimetinib resulted in an objective response in all pts who received 1 or more cycles of therapy. Our study indicates that BRAF/MEK inhibitors could be a powerful tool in the treatment of previously untreated PCP and warrants further evaluation in larger studies. A second arm of this study is enrolling pts with progressive PCP after prior radiotherapy. Support: U10CA180821, U10CA180882; U24CA196171, U10CA180868 (NRG); Genentech; https://acknowledgments.alliancefound.org. Clinical trial information: NCT03224767.