bluuebunny/crossref_metadata_2025_split huggingface dataset:
Point-of-care clinical decision support for cancer symptom management: Results of a group randomized trial.
Authors: Cooley Mary E. , Blonquist Traci , Catalano Paul , Lobach David , Braun Ilana , Halpenny Barbara , McCorkle Ruth , Rabin Michael , Johns Ellis , Finn Kathleen , Abrahm Janet , Berry Donna Lynn 
Published: February 2017

1 Background: Integration of palliative care into oncology is recommended for quality care. Clinicians may benefit from assistance in assessing and managing multiple symptoms. Palliative care clinicians have the expertise but may not be available or are not consulted early in the course of a patient’s disease. Clinical decision support (CDS) offers an innovative way to deliver symptom management and trigger palliative care referrals at the point-of-care. Methods: Twenty clinicians and their patients were randomized to usual care (UC) or CDS using the symptom assessment and management intervention (SAMI), which provided tailored suggestions for pain, fatigue, depression, anxiety and/or dyspnea. One-hundred seventy-nine patients completed a Web-based symptom assessment prior to each visit for 6 months. A tailored report provided a longitudinal symptom report and suggestions for management were provided to clinicians in the SAMI arm prior to the visit. Standardized questionnaires were administered to patients at baseline, 2, 4 and 6 months later to measure communication about symptoms and health-related quality of life (HR-QOL). The treatment outcome index (TOI) was the primary outcome for HR-QOL. Management of the target symptoms was assessed through chart review. Linear mixed models and logistic regression were used for analyses. Results: Patient characteristics were: mean age of 63 years, 58% female, 88% white, and 32% had < HS education. No differences were noted in communication between patients and their clinicians. Significant differences were noted in physical well-being (p = 0.007, 0.08 adjusted for baseline) and a clinically significant difference in the TOI (62 vs. 68) at 4 months in SAMI as compared to UC. The odds of managing depression (1.6, 90% CI, 1.0-2.5), anxiety (1.7, 90% CI, 1.0-3.0) and fatigue (1.6, 90% CI, 1.1-2.5) were higher in SAMI as compared to UC. The odds of palliative care consults for pain (3.2, 90% CI, 0.7-13.4) appear to be higher in SAMI as compared to UC. Conclusions: Enhanced HR-QOL was noted among patients in the SAMI arm at 4 months. SAMI increased management of depression, fatigue and anxiety and appeared to increase palliative care consults for pain. Clinical trial information: NCT00852462.
Which patients experience improved quality of life (QOL) and mood from early palliative care (PC)?
Authors: Nipp Ryan David , Greer Joseph A. , Traeger Lara , Gallagher Emily R. , Park Elyse R. , Jackson Vicki A. , Pirl William F. , Temel Jennifer S. 
Published: February 2017

16 Background: Prior research has demonstrated improved patient outcomes with early PC integrated with standard oncology care (SC), but it is not clear if these associations exist in all patient demographic groups. This study examined whether early integrated PC was associated with improvements in QOL and mood in different demographic groups. Methods: This is a secondary analysis of data from a randomized controlled trial of 151 patients with newly diagnosed metastatic non-small-cell lung cancer presenting to an outpatient cancer center from June 2006 to July 2009. Patients received either early PC integrated with SC or SC alone. QOL (Functional Assessment of Cancer Therapy–Lung [FACT-L] and Trial Outcome Index [TOI]) and mood (Hospital Anxiety and Depression Scale depression subscale [HADS-D] and Patient Health Questionnaire 9 [PHQ-9], scored categorically) were assessed at baseline and 12 weeks. Data were analyzed to assess relationships between outcome variables and patient demographic characteristics (age and gender). Results: At baseline, QOL and mood outcomes did not differ significantly between treatment groups for age or gender. At 12 weeks, the PC group showed better QOL and lower rates of depressive symptoms for males and those < age 65. In comparison, QOL and mood did not differ significantly between study groups for females and those ≥ age 65. Conclusions: Males and patients < age 65 experienced improved QOL and mood with early, integrated PC. However, these outcomes did not differ significantly between treatment groups for patients ≥ age 65 or for females. Further research should confirm these findings and tailor interventions to meet the unique needs of all patients with cancer. [Table: see text]
Bone health in prostate cancer patients: A survivorship issue requiring intervention.
Authors: Dawson George A. , Greener Anne , Reyes-Dawson Dalila , Malhotra Sheetal , Weinbrom Sarah , Jain Anudh , Reddy Sadhana , Kelly Maria D. 
Published: February 2017

247 Background: In general, men are not routinely screened for bone health. Prostate cancer patients are at an increased risk because of treatment with androgen deprivation therapy (ADT). Unlike other patients diagnosed with a malignancy, they may survive a long time. Some risk factors include inadequate calcium, vitamin D deficiency, tobacco use and alcohol abuse. We implemented a pre-ADT program to mitigate the effects of ADT on bone health. This study evaluates the pre-existing risk factors and bone health by baseline DEXA scans pre-ADT initiation. Methods: We completed a chart review of 182 veterans referred to Radiation Oncology for curative treatment of prostate cancer from 2009 to 2013. Of those, 160 patients underwent baseline DEXA scans. Clinical variables analyzed were demographics, tobacco and alcohol use, vitamin D levels, incidence of AODM (adult onset diabetes mellitus), and calcium or vitamin D intervention. Descriptive statistics and bivariate analysis including Chi Square tests and odds ratios were carried out. Results: The mean age of the study participants was 66.6 years (range 47-82.8 years). Baseline DEXA scans were abnormal in 63% of patients, showing osteoporosis and/or osteopenia. Vitamin D levels were abnormal in 61% of patients- 26% of whom had normal DEXA scans. Twenty percent had a history of alcohol abuse, and 56% used tobacco; 33% had AODM. Smokers with an abnormal Vitamin D level were at increased risk of bone disease as compared to non smokers (OR 3.23, 95% CI 1.35-7.69 p<0.01). Variables significantly impacting bone health were age (OR 1.087, p=0.012, 95% CI 1.018-1.161) and Tobacco use (OR 0.424, p=0.045, 95% CI 0.183-0.980). Almost 90% of the patients in this study had intermediate risk prostate cancer with an expected cancer specific survival of 85 to 90% at 5 to 10 years. Conclusions: Pre-ADT screening confirms the risk of underlying bone disease in this veteran population with an expectation of long term survival. Guidelines for treatment and prevention of bone disease should be implemented in all patients over age of 50. Particular attention should be paid to patients who underwent ADT. This can affect the quality of life in this group of cancer survivors.
Impact of a nurse practitioner-staffed, symptom-management clinic on emergency department utilization in a large community oncology cancer institute.
Authors: Sivendran Shanthi , Holliday Rachel , De la Torre Kristen , Newport Kristina Braine 
Published: February 2017

58 Background: Emergency department (ED) utilization among oncology patients is a source of patient distress as well as a financial burden to the health care system. Effective outpatient symptom management can potentially reduce ED utilization. In this analysis, we review ED utilization prior to and post the institution of a nurse practitioner staffed symptom management clinic in a large community oncology practice. Methods: In April 2014 a symptom management clinic staffed by a nurse practitioner five days a week was established at our outpatient cancer institute to increase patient access to acute symptom management. ED utilization 6 months prior to and post starting this clinic was measured. Only patients who received chemotherapy within 30 days of an ED visit were included in this analysis. Results: Between October 2013 and September 2014, a total of 420 visits to the ED were documented. A total of 196 visits occurred in the 6 months prior to establishing the clinic. There was an increase in visits to 224 after instituting the clinic. The median number of monthly visits was 34.5 (range 24-38) prior to the clinic and increased to 38 (range 30-43) after establishing the clinic. Conclusions: In our practice, a nurse practitioner led symptom management clinic did not reduce ED utilization in patients receiving chemotherapy. Based on published studies, other factors may need to be incorporated into our cancer institute to effectively reduce ED utilization. These include standardizing symptom assessment and management, patient and caregiver education on how to effectively manage symptoms at home, and improved coordination with supportive services.
Facilitators and barriers to advance care planning in oncology.
Authors: Paladino Joanna , Bernacki Rachelle , Hutchings Mathilde , Billings J. Andrew , Block Susan 
Published: February 2017

84 Background: For seriously ill patients to plan for the end of life, they need to discuss with their clinicians their prognosis, values, and goals, yet such conversations often begin very late in the course of illness. To promote early advance care planning (ACP) in oncology, facilitators and barriers to these conversations need to be identified. Objectives: 1. To determine the effectiveness of “triggers” that remind oncologists to complete ACP discussions with outpatients whom they expect might die within a year. 2. To prospectively evaluate clinician-identified barriers to these conversations. Methods: A cluster-randomized controlled trial. The intervention includes: clinician identification of patients at high risk of death within a year; 2½ hour training program on the use of the Serious Illness Conversation Guide; an email trigger/reminder, immediately before an outpatient visit, for the oncologist to conduct an ACP discussion using the Conversation Guide; clinician reports of why they deferred such conversations. Results: Eighty-eight enrolled oncology clinicians (MDs, NPs, PAs) screened 15,576 patients and identified 1,743 for whom they would not be surprised about death within a year. To date, 332 patients have consented to enrollment; 104 patients and 40 clinicians entered the intervention arm; 124 subsequent visits were triggered, resulting in 62 completed conversations. 79% of the conversations occurred after 1 trigger; 92% by the second trigger. Of the 62 triggered visits that did not result in an immediate conversation, clinicians identified the following reasons: 26% not enough time; 20% clinician attitudes about the impact and timing of such conversations (i.e., they take away hope, patient not sick enough); 46% immediate patient issues making conversation inappropriate (i.e., patient acutely ill, anxious, depressed, or not ready); and 8% “other.” Conclusions: An email trigger in the outpatient oncology clinic is highly effective in promoting ACP conversations for trained clinicians. The majority of clinician-identified barriers to such discussions reflect beliefs about the impact and timing of the discussion and concerns about the patient’s immediate condition; time constraints only account for about a quarter of delays. Clinical trial information: NCT01786811.
Helping cancer-family caregivers with end-of-life home symptom management: Initial evaluation of an automated symptom monitoring and coaching system.
Authors: Mooney Kathi , Berry Patricia , Wong Bob , Donaldson Gary 
Published: February 2017

85 Background: Family caregivers face the task of providing end of life care (EOL) in the home setting and need effective caregiving support. Although not previously tested in EOL care, automated symptom monitoring has shown promise for cancer patients on active treatment. This study tests an automated monitoring and coaching system for family caregivers during home hospice. Methods: Family Caregivers (FC) of hospice cancer patients (PT) (N=243 dyads) were monitored daily using an automated telephone symptom monitoring system, and randomly assigned to receive the symptom care intervention (SC) (N=119) or usual care (UC) (N=124). All FCs called the monitoring system daily, reporting by proxy, past 24 hour presence, severity and FC distress on 11 common PT symptoms (0–10 scale). In addition, FCs reported their own fatigue, sleep, mood and anxiety severity (0-10 scale). The SC intervention FCs received automated tailored symptom care coaching based on reported patterns; in addition symptoms moderate or greater generated alerts to their hospice nurse. Results: Most FCs and PTs were White (95; 94%), 66% of FCs and 48% of PTs were female with the Mean age for FCs 60 and 73 for PTs. Most frequent PT symptoms were fatigue (70%), pain (64%), poor appetite (54%), anxiety (39%), and change in thinking (38%). PT symptom severity levels were highly related to FC distress. Preliminary analyses indicates that FC vitality (FC combined symptoms) improved more in the SC group (p=.003, mixed effects model). Furthermore PT symptom severity, categorized as Mild (<=3), Moderate (4-6), or Severe (>=7), provided strong preliminary evidence of SC intervention benefit in each of the first four weeks in hospice care and overall (p=.003). Rapid onset of the SC benefit was suggested by Kaplan-Meier analysis of time to first all-zero symptom profile (p=.06 log-rank). The benefit of the SC intervention continued throughout the hospice stay until the last several days of life when there was no difference with UC. Conclusions: This is the first reported evaluation of automated symptom monitoring in home EOL care and provides strong preliminary evidence of benefit for cancer family caregivers and patients. Clinical trial information: NCT02112461.
Quantification of HER2 from gastroesophageal cancer (GEC) FFPE tissue by mass spectrometry (MS).
Authors: Hembrough Todd A. , Henderson Les , Rambo Brittany , Liao Wei-Li , Thyparambil Sheeno , Bangali Kathleen , Uzzell Jamar , Darfler Marlene , Krizman David , Xu Peng , Xiao Shu-Yuan , Zhao Lei , Burrows Jon , Catenacci Daniel Virgil Thomas 
Published: February 2017

17 Background: Trastuzumab had a survival benefit in ‘HER2 positive’ GEC, determined by IHC/FISH. These companion diagnostics have limitations. IHC is semi-quantitative, subjective, and sensitive to antigen instability in FFPE; FISH is laborious, expensive, and subjective. Gene amplification may not correlate to protein expression. Moreover these are low throughput assays. There is increased recognition of profound interpatient molecular heterogeneity with several putative biomarkers, and only scarce tissue to assess for each one. We sought to evaluate our MS platform on GEC FFPE tissues for HER2 status compared to IHC/FISH. We also applied the “GEC-plex” of 11 other potentially predictive/prognostic markers for GEC. Methods: We utilized trypsin digestion mapping of rHER2 to identify unique peptides for SRM development. Stable isotope-labeled peptides were synthesized as internal standards, and standard curves were generated in a complex eukaryotic matrix (PC3 cells) to determine LOD, LLOQ, accuracy, precision and linearity of the assays. The assay was run on 17 GEC cell lines, in parallel with FISH/IHC, and expression thresholds were established for HER2+/HER2-; the sensitivity/specificity of the established cutoffs were then tested prospectively in FFPE GEC tissues on 10uM FFPE LCM slides (n=121). HER2 stability from FFPE sections was assessed by assaying 33 freshly cut FFPE samples; the adjacent sections were processed one year later. Results: The HER2 peptide chosen (ELVSEFSR) had a LOD of 100 amol and CV<20%. HER2 MS on GEC cell lines revealed concordance with FISH (HER2:CEP17) ratio (R2=0.96). The analysis suggested HER2 expression > 750 amol/ug was indicative of HER2 amplification. The assay was stable in archival FFPE sections (R2=0.76). For GEC FFPE cases, ‘any’ HER2 expression was seen in 69.4% of cases; 8.2% showed HER2 > 750 amol (10/121) - all were HER2 amplified. No cases <550 amol/ug were HER2 amplified. IHC/FISH results for cases with 550-750 amol/ug demonstrated a heterogeneous ‘equivocal’ zone, not unlike ‘IHC 2+’, which may require FISH confirmatory testing. Conclusions: ‘GEC-plex’ has a quantitative, sensitive, and specific HER2 assay that can be multiplexed along with other GEC biomarkers.
Arginine deiminase: A novel radiosensitizer in pancreatic cancer in vitro and in vivo.
Authors: Deorukhkar Amit , Diep Nga , Chatterjee Dev , Diagaradjane Parmeswaran , Bomalaski John S. , Krishnan Sunil 
Published: February 2017

221 Background: The benefits of chemoradiation therapy in patients with locally advanced pancreatic cancer (LAPC) are limited due to the inherent radioresistance of pancreatic cancer (PC) and high systemic toxicity of current radiosensitizers (e.g., gemcitabine). Hence, the search for newer radiosensitizers with unique anticancer properties continues. Single amino acid arginine starvation is a new promising therapeutic approach for solid tumors (e.g., PC), that are auxotrophic for non-essential amino acids. Arginine degrading enzyme, arginine deiminase (ADI), deprives cells of arginine and thereby exerts its anti-proliferative effects, especially in cancer cells deficient in enzyme argininosuccinate synthase (ASS1). Here we evaluate the effects of ADI-polyethylene glycol formulation (ADI-PEG20) as a radiosensitizer in PC. Methods: The toxicity of ADI-PEG20 in vitro was evaluated using XTT. Effect of ADI-PEG20 as radiosensitizer was determined by clonogenic cell survival. For in vivo, mice with PC tumor xenografts (Panc1), randomized into four groups, were treated with vehicle (PBS), ADI-PEG20 (5 IU/mouse; twice weekly), radiation (IR; 2 Gy × 5 times), and ADI-PEG20 with IR. Tumors were measured following treatment and the tumor re-growth delay time for each group was calculated. Immunohistochemical analysis of Ki-67 and VEGF was done on tumor tissues (paraffin sections) by routine immunofluorescence. Results: ADI-PEG20 selectively sensitized ASS1 deficient PC cells to IR at low, non-toxic concentrations (0.04 and 0.08 μg/mL for 72 h; DER at 10% SF for Panc1 was 1.39 and 1.52; for Miapaca-2, 1.09 and 1.25 respectively), but not ASS1 positive cells (L3.6pl). In vivo, ADI-PEG20 profoundly sensitized PC cells to IR. IR treatment alone delayed the tumor doubling time (7.6 ± 1.7 days compared to the non-treated controls); however, combining ADI-PEG20 with IR delayed the tumor growth by an additional 10 ± 1.3 days (p<0.05). Immunohistochemical analysis of tumor tissues suggested that ADI-PEG20 with IR down-regulates the expression of Ki-67 and VEGF. Conclusions: ADI-PEG20 potently radiosensitizes PC cells in vitro and in vivo. The detailed molecular mechanism of this radiosensitization warrants further investigations.
Patient-reported satisfaction with symptom control during lanreotide autogel/depot (LAN) treatment for carcinoid syndrome (CS) in gastroenteropancreatic neuroendocrine tumor (GEP-NET) patients: Symnet, a large multinational, cross-sectional, observational study.
Authors: Ruszniewski Philippe B. , Caplin Martyn E , Valle Juan W. , Lombard Bohas Catherine , Maisonobe Pascal , Atlan Philippe ,   SYMNET Study Group
Published: February 2017

273^ Background: Somatostatin analogs are used to reduce the incidence and severity of symptoms of CS in GEP-NET patients. How this impacts on patients’ satisfaction needs further investigation. Methods: At routine clinic visit, GEP-NET patients with CS-related diarrhea and > 3 months LAN treatment completed questionnaires (including Likert scales) on satisfaction with diarrhea control (primary endpoint) and other symptoms following treatment. Investigators also recorded, based on chart reviews, demographic parameters, disease history, diarrhea characteristics and symptom changes for analysis of predictive factors for satisfaction. NCT01234168. Results: Of the study population (n=273), 56% were male, 57% were aged >60 yrs, mean time since diagnosis was 4.4 yrs, 66% had small bowel primary tumor, and 80% had liver metastases. Within the prior 3 mo, 66% had surgery and 23% other anti-tumor therapy. Mean LAN treatment duration was 21.7 mo and median dose on visit day 120 mg/mo. The study showed most patients (76%) were “completely” or “rather satisfied” with their diarrhea control. Similar satisfaction (73%) with flushing control was also reported. Most patients (79%) reported an overall improvement in their diarrhea with LAN treatment, and more had no or mild impact on daily activities during treatment (75%) than before (33%). Investigators identified a clinically relevant decrease in daily stool frequency from treatment initiation to current visit (median of 4 to 2). Furthermore, statistically significant decreases (McNemar paired tests, p<0.001) were seen in no. of patients with urgency (73-41%), leakage (21-9%), and associated pain (37-14%). Baseline stool leakage and localization of primary outside small bowel were factors associated with satisfaction with diarrhea control. Conclusions: Patient-reported information indicates that LAN-treated GEP-NET patients achieve good and sustained control of CS symptoms. Analyses of predictive factors could help identify patients who may benefit the most of LAN. Clinical trial information: NCT01234168.
Tolerability and efficacy of modified FOLFIRINOX (mFOLFIRINOX) in patients with borderline-resectable pancreatic cancer (BRPC) and locally advanced unresectable pancreatic cancer (LAURPC).
Authors: Blazer Marlo A. , Wu Christina Sing-Ying , Goldberg Richard M. , Phillips Gary S. , Schmidt Carl Richard , Muscarella Peter , El-Dika Samer S , Walker Jon P , Krishna Somashekar Gopala , Groce J. Royce , Wuthrick Evan John , Williams Terence M , Efries David , Smith Yahna T. , Mathey Kris , Wagner Mandy , Reardon Josh , Ellison Edwin Christopher , Bloomston Mark , Bekaii-Saab Tanios S. 
Published: February 2017

275 Background: FOLFIRINOX exhibits a meaningful improvement in outcome measures in metastatic pancreatic cancer, making it an interesting regimen for BRPC and LAURPC. However, its use remains prohibitive due to toxicity. In this study, we examine the outcomes of mFOLFIRINOX as a neoadjuvant strategy for patients with BRPC and LAURPC. Methods: This is a retrospective analysis of a prospectively maintained database of patients who received mFOLFIRINOX for BRPC or LAURPC at Ohio State University. mFOLFIRINOX is as follows: irinotecan at 165 mg/m2; oxaliplatin at 85 mg/m2; 5-fluorouracil (5FU) at 2,400 mg/m2 over 46 hours and pegfilgrastim on day 4 of each 2-week cycle. Cases were thoroughly reviewed by a multidisciplinary team prior to initiation of therapy and at each restaging scan. The primary outcomes of this analysis were resection rate and grade 3/4 (G3/4) toxicities. Results: Since 1/1/2011, 43 patients (20 BRPC; 23 LAURPC) have received mFOLFIRINOX. Patients received gemcitabine-based chemoradiation (36 Gy in 15 fractions) only if their best response was stable disease after 4 months of mFOLFIRINOX. At the time of this abstract, 39 patients are evaluable for primary outcome. Overall resection rate was 53.8% including 45% of patients with initially unresectable disease. R0 resection was achieved in 85.7% of the surgeries. See table for more results. The rate of G3/4 toxicity was remarkably low with no episodes of febrile neutropenia, G3/4 neutropenia or thrombocytopenia. Toxicities lead to dose reductions in 46% of patients. Conclusions: Neoadjuvant mFOLFIRINOX is an effective, well-tolerated regimen as part of an integrated, multimodality strategy in BRPC and LAURPC leading to high resection rates and high R0 resection frequency. [Table: see text]