bluuebunny/crossref_metadata_2025_split huggingface dataset:
A randomized trial of a nurse-led decision aid to inform patients with advanced cancer about palliative chemotherapy.
Authors: Ottevanger P. B. , Oostendorp Linda JM , Van Der Graaf Winette T.A. , Stalmeier Peep FM 
Published: March 2020

e20583 Background: There is a lack of decision aids (DAs) for patients with advanced cancer considering palliative treatment. In this randomized study, we evaluated nurse-led DAs about second-line palliative chemotherapy for patients with advanced breast (BC) or colorectal cancer (CRC). Methods: Patients with advanced BC or CRC considering second-line treatment were randomized to receive only usual care (control group) or usual care plus a DA from a nurse (intervention group) (1:2 ratio). Using the DA, a nurse offered information on adverse events, tumor response, and survival. Patients completed a baseline questionnaire and two follow-up questionnaires 1 week and 8 weeks after the treatment-related information was provided. Outcome measures were well-being, coping, knowledge, and information and decision-related outcomes. Intent-to-treat analyses were performed using Chi Square tests, independent samples t-tests, and linear mixed models to examine differences between groups over time. Results: In all,128 patients participated in the study; median age 62 years (range 32-81), 37% male, 73% CRC. Of the 83 patients assigned to the intervention group, 77 received a DA. At the first follow-up, more patients receiving a DA preferred chemotherapy (96% vs. 84%; p=0.067). Seven weeks later, 88% of patients in the intervention group and 84% of patients in the control group had started chemotherapy (p=0.746). The only statistically significant effect was the stronger treatment preference of patients in the intervention group (3.0 vs. 2.5; p=0.030). The DAs did not negatively impact anxiety, depression, cancer worries, and hopelessness. Conclusions: It is possible to offer a DA with explicit information to patients with advanced cancer without negative impact on patients' well-being. Unexpectedly, this study did not show consistent effectiveness of the DAs. Our interpretation is that most patients receiving the DA had already decided to start chemotherapy. Clinical trial information: NTR1113.
Palliative benefit of novel cell-free and concentrated ascites reinfusion therapy (CART) for refractory ascites associated with cancerous peritonitis.
Authors: Matsusaki Keisuke , Yoshizawa Akitaka , Ohta Keiichiro 
Published: March 2020

e20591 Background: Refractory ascites associated with cancerous peritonitis causes severe abdominal distention, dyspnea and appetite loss, resulting in loss of patients’ activities of daily living (ADL) and discontinuation of their treatment for cancer such as chemotherapy. To improve the symptoms, we have developed a novel cell-free and concentrated ascites reinfusion therapy (CART) which is modified from a conventional CART approved by the Ministry of Health, Labor and Welfare in Japan and examined the efficacy in a pilot study. Methods: 87 patients with cancerous ascites were enrolled and subjected to novel CART from April 2012 to November 2012. The response was assessed by improvement of their ADL. Patients were asked in the form of questionnaires about general malaise, abdominal distention, abdominal pain, nausea, dyspnea, sleep disturbance, appetite loss, disturbance in gait, discomfort and frustration before and after treatment and each point was scored on a scale of zero to ten (ten being severe). Abdominal and thigh circumferences were also examined before and after treatment to evaluate efficacy. This study was approved by the ethics review committee of Kaname-cho hospital. Results: On average, 8.3 ± 4.4 L (range 2.3-27.0) of cancerous ascites was filtrated and concentrated to 0.69 ± 0.28 L (range 0.2-1.6) by novel CART. Any severe adverse events except fever were not observed. After treatment, the scores of all points were significantly improved. For example, abdominal distention was improved by 8.1 ± 2.4 vs. 2.0 ± 2.4 (p<0.0001), dyspnea by 3.7 ± 3.3 vs. 1.3 ± 2.1 (p<0.0001), and appetite loss by 5.3 ± 4.3 vs. 3.1 ± 3.4 (p<0.0001). Abdominal and thigh circumferences were also decreased by -13.3 ± 7.5 cm (p<0.0001) and -2.7 ± 2.6 cm (p<0.0001), respectively. Conclusions: This novel CART system is capable to process over 20 L of cancerous ascites and immediately improve their ADL and edematous lesions. Some patients also restarted anticancer treatment such as chemotherapy. Taken together, this CART is safe and effective for palliative care of patients with cancerous ascites.
Clinical experience with uridine triacetate for 5-FU overexposure: An update.
Authors: Bamat Michael K. , Tremmel Robert , von Borstel Reid , Helton Joan 
Published: March 2020

e20592 Background: 5-Fluorouracil (5-FU) is broadly used to treat solid tumors. It is typically administered by IV infusion, at or near its maximum tolerated dose, over several days. The use of infusion pumps increases the possibility of life-threatening or lethal toxicity due to errors in pump programming, infusion reservoir errors and dosage miscalculations. Partial or total dihydropyrimidine dehydrogenase (DPD) deficiency, which predisposes patients (up to 3% of the population) to impaired 5-FU elimination, can also result in serious or lethal toxicity, Uridine triacetate is an orally bioavailable direct biochemical antagonist of 5-FU toxicity that has been used successfully to treat patients in emergency overdose situations as well as patients with known or suspected overexposure to 5-FU due to DPD deficiency or other causes. Approximately 100 patients at excess risk of 5-FU toxicity due to 5-FU overdose, accidental Xeloda (capecitabine) ingestion, or possible DPD deficiency (rapid onset of severe toxicities) have been treated with uridine triacetate using a common treatment regimen and protocol. More than 80 of these cases have occurred since uridine triacetate data were presented at ASCO in 2009. Methods: Uridine triacetate was provided under emergency IND provisions or an expanded access protocol when requested by qualified clinical sites following 5-FU overexposures, most due to infusion pump errors. Patients received uridine triacetate (10g q6h for 20 doses) as soon as possible after recognition of the overdose or possible clearance defect. Clinical outcomes, including safety and resumption of chemotherapy, were monitored. Results: To date, 98 patients overexposed to 5-FU have been treated with uridine triacetate. 96 of these 98 patients recovered fully. Reductions in or absence of GI, hematologic, and other toxicities associated with 5-FU poisoning were observed. Adverse events attributable to urdine triacetate were infrequent and mild in severity. Conclusions: Uridine triacetate appears to be a safe and effective life-saving antidote for 5-FU overexposure in emergency situations.
Are validated symptom assessment instruments comprehensive? “Orphan” and “champion” symptoms.
Authors: Thomas Shirley , Walsh Declan , Aktas Aynur 
Published: March 2020

e20597 Background: Cancer patients experience multiple symptoms which vary in prevalence, severity, distress and negative impact on life. Comprehensive assessment is essential. Many validated assessment tools are used. They have limitations; varied content, clinical utility, completion rates, and acceptability. The objectives of this study were: Compare common cancer multisymptom assessment instruments to a comprehensive checklist. Identify commonly assessed (“champions”) and frequently neglected (“orphans”) symptoms. Examine the clinical importance of “orphan” symptoms. Methods: A 46-symptom checklist was developed from available evidence. This was compared against the content of 6 commonly used, validated, multisymptom instruments. Those with ≤ 2 symptoms, cancer site-specific, and tumor response instruments were excluded. Results: Symptom numbers varied in the 6 instruments; median (range) 19 (3-32). Of the 46 checklist symptoms, only 28 were present in 1 or more of the instruments. “Orphans”: 18 of the 46 were not evaluated in any of the 6 (e.g., confusion, agitation, early satiety, indigestion, tremors). 12 of the 18 had prevalence rates >10%. These symptoms are also often rated moderate/severe and distressful. “Champions”: Only four checklist symptoms (pain, fatigue, dyspnea, anorexia) were present in all 6 instruments. Conclusions: Eighteen “orphan” symptoms (severe/distressing) were not captured by any tool. Only four “champion” symptoms were present in all validated tools. Unreported and misdiagnosed symptoms can bias our view of the cancer symptom experience. Validated cancer symptom assessment tools do not capture accurate, reliable comprehensive data on the cancer symptom experience. These challenge the validity and reliability of current symptom assessment tools in clinical research.
Risk of proteinuria with the new angiogenesis inhibitor axitinib in patients with cancer.
Authors: Kuei Andrew , Zhu Xiaolei , Wu Shenhong 
Published: March 2020

e20602 Background: The use of axitinib, a potent inhibitor of vascular endothelial growth factor receptor (VEGFR), is associated with proteinuria, which may cause morbidity and treatment interruptions in cancer patients. We performed a systematic review and meta-analysis of published clinical trials to assess the overall risk of proteinuria with axitinib. Methods: Potentially relevant studies were identified by searching databases including Pubmed and abstracts presented at the American Society of Clinical Oncology annual meetings until June, 2012. Eligible studies included prospective clinical trials in cancer patients treated with axitinib containing data on proteinuria. Summary incidence, relative risk (RR), and 95% confidence interval (CI) were calculated using the fixed- or random-effects models. Results: A total of 1,671 patients with advanced renal cell carcinoma (RCC) and other solid tumors from 9 studies were included for analysis. The overall incidences of all-grade and high-grade (grade 3 or 4) proteinuria with axitinib were 22.7% (95% CI: 10.4-42.6%) and 3.8% (95% CI: 2.6-5.7%) respectively. The risk did not vary significantly with tumor types (P=0.13). There was no significant difference between RCC and non-RCC patients (P=0.45), although the incidence in RCC patients was higher (30.0%, 95% CI: 8.4-66.7 versus 17.5%, 95% CI: 7.4-36.3%). In comparison with a control (gemcitabine), axitinib significantly increased the incidence of high-grade proteinuria (3.3%, 95% CI: 1.6-6.5% versus 0.1%, 95% CI: 0-2.3%; P=0.031). When compared to another angiogenesis inhibitor sorafenib, axitinib did not have a significantly higher risk of all-grade (RR=1.48, 95% CI: 0.92-2.38, P=0.10) and high-grade proteinuria (RR=1.81, 95% CI: 0.68-4.85, P=0.24). Conclusions: There was a significant risk of proteinuria associated with the use of axitinib in cancer patients.
The effect of oral β-glucan on mucositis and leukopenia in colorectal cancer patients receiving adjuvant FOLFOX-4 combination chemotherapy.
Authors: Karaca Halit , Berk Veli , Inanc Mevlude , Dikilitas Mustafa , Ozkan Metin 
Published: March 2020

e20603 Background: β-glucans have antibacterial, immunomodulator and anti-cancer effects. The present study aimed to determine the effect of oral β-glucan on mucositis and leukopenia in a group of colorectal cancer patients with a high risk for neutropenia and mucositis who received adjuvant FOLFOX-4 (oxaliplatin, 5-flourouracil, and folinic acid) combination chemotherapy. Methods: This retrospective study included 62 patients with colorectal cancer that underwent a FOLFOX-4 treatment regimen between July 2009 and July 2010. Ethics committee of Erciyes University approved the study design. Colorectal cancer patients treated with a FOLFOX-4 regimen were retrospectively evaluated in 2 equal groups: One group received β-glucan (treatment group), and the other did not (control group). In both groups the level of leucocytes, neutrophils, and platelets were evaluated before and 1 week after chemotherapy. The occurrence of oral mucositis and diarrhea was noted. Data were statistically analyzed. Results: There were 21 male and 10 female patients in the treatment group, and the median age was 61 years (range: 43-72 years). The control group included 17 male and 14 female patients, and the median age was 55 years (range: 30-78 years). There weren't any statistically differences in age or gender between the 2 groups. Leucocyte and neutrophil counts after chemotherapy in the treatment group were 7300/mm3 and 3800/mm3, respectively, and the reductions, as compared to baseline, were not significant (p = 0.673 and 0.784). The median platelet count was 264000/mm3 after chemotherapy in the treatment group and the reduction, as compared to baseline, was borderline significant (p = 0.048). In the control group the reduction in leucocyte, neutrophil, and platelet counts was statistically significant (median values were 5600/mm3, 2880/mm3, and 229000/mm3, respectively; p < 0.01). In addition, oral mucositis and diarrhea secondary to chemotherapy were less common in the treatment group (19% v.s 42%). Conclusions: β-glucan effectively suppressed the adverse effects of chemotherapy. We think that nutritional supplementation with β-glucan in cancer patients should be investigated further.
Effects of animal-assisted visits on quality of life during multi-modal radiation therapy: Chemotherapy regimens.
Authors: Fleishman Stewart Barry , Rosenwald Victoria , Homel Peter 
Published: March 2020

e20607 Background: Animal-assisted visits (AAV) are known to affect blood pressure, mood and anxiety, yet their effects in cancer remained unexamined. Methods: 42 subjects signed IRB-approved informed consent to have AAVs daily during multi-modal chemotherapy and radiation therapy for head & neck cancer. 37 subjects completed at least baseline assessment visits for an intent to treat analysis. Assessments included FACT-Head and Neck scale; Satisfaction with AAV Intervention (SAAVI) assessing bi-weekly motivation to attend appointments, tolerance of waits, ability to withstand treatment, lingering effect of AAV after treatment and perception of social support. Subject characteristics: 25 (68%) male, mean age 57 years (57.22 ±8.44); (57%) white, 8 (22%) Hispanic, 6 (16%) black and 2 (5%) Asian. Cancer sites: oropharynx 23 (62%), hypopharynx 4 (11%), esophagus 3 (8%), laryngopharynx 2 (5%) and nasal cavity 2 (5%). Stage: stage II: 1 (3%), III: 6 (16%), IV: 30 (81%). All subjects received concomitant external beam radiation therapy with periodic cis-platin (23 pts, 57%), weekly carboplatin (7 pts; 16%) or cetuximab (5; 11%). Results: Comparing baseline, week 3 and week 7 assessments, FACT Physical Well-being (PWB; p<0.001) and Functional Well-Being (FWB; (p=0.003) showed significant declines; in contrast, Social Well-Being (SWB; p = 0.03) showed significant gains. Controlling for declines in PWB, increases in EWB were also significant (p = 0.004). Satisfaction was measured after the first and last AAV. Mean scores for satisfaction related to psychological symptoms, generally liking animals/pets, and positive attitudes towards pets at both times were significantly better than “Neutral” or “Unsure” (all p < 0.001), and did not change from first to last AAV. Mean scores for physical symptoms were not significantly different from “Neutral.” Conclusions: FACT analysis showed significant increase in EWB in the face of clinically evident and expected declines in PWB and FWB in spite of high symptom burden. The SAAVI assessment further supports the utility of the AAV intervention. Though self-selected for an affinity to pets and animals, subjects endorsed a high level of satisfaction with the intervention.
Assessment of the current implementation and barriers to uptake of the guidelines for the psychosocial care of adults with cancer according to cancer nurses in Australia.
Authors: Lawsin Catalina , McMillan Kirsty , Butow Phyllis , Turner Jane , Yates Patsy , Stephens Moira , Lambert Sylvie D. , White Kathryn 
Published: March 2020

e20615 Background: The Clinical Practice Guidelines for the Psychosocial Care of Adults with Cancer (the Guidelines) were launched in 2003 to guide cancer care providers in the assessment of psychosocial issues and provision of evidence-based interventions. Despite multi-faceted Australia-wide dissemination efforts, the current study aimed to be the first to assess current implementation of the Guidelines across and barriers to uptake. Methods: A cross-sectional web-based survey was developed to assess clinical use of recommendations in the Guidelines in relation to the provision of psychosocial support, and assessment of distress and pain. Data was collected about perceived barriers to the provision of psychosocial support at participants’ place of employment, as well as roles and training needs. Cancer nurses were recruited through the Cancer Nurses Society of Australia, the Royal College of Nursing Australia, and the Haematology Society of Australia & New Zealand. Descriptive and correlational analyses were conducted. Results: Of 354 respondents, 266 completed the assessment. Relaxation training was the most prevalent form of psychosocial support (24%) and web-based support (20%) was the most common modality. While 26% of institutions had no systematic means of assessing distress amongst patients, those that did relied primarily on clinical interviews (37%). Once a patient was identified as distressed, most often the care coordinator was responsible for providing ensuing interventions. An organizational culture in which psychosocial issues are seen as less important than medical treatment (23%) and role ambiguity proved to be barriers to provision of psychosocial support, particularly when nurses did not perceive psychosocial support was beneficial and supervision was inadequate (R2= .313, F(1, 265) = 6.58, p < .001). Conclusions: Results confirmed that dissemination does not necessarily equal implementation. Clear pathways for assessment and treatment need to be established to reduce individual barriers and promote organizational cultures that appreciate the need to integrate psychosocial care in standard medical treatment.
End-of-life care planning in patients with recurrent gynecologic cancers.
Authors: Jones Nathan L , Galvin Shelley L , Vanderkwaak Timothy J , Hetzel David J. , Harkness Cameron Blair , Case Ashley S 
Published: March 2020

e20648 Background: Gynecologic oncologists and associates must provide appropriate, acceptable, and patient-centered end-of-life care. Most women with terminal gynecologic cancers do not have do-not-resuscitate (DNR) orders upon hospital admission and many do not receive effective palliative care. Our objective was to assess quality care indicators involving end-of-life care among gynecologic oncology patients treated at our institution. Methods: An IRB-approved retrospective chart review was performed on all patients with recurrent gynecologic cancers and terminal diagnoses who died from January 2009 through October 2012. Data included intervals to death from: diagnoses, DNR status, Hospice/Palliative Care Medicine (HPCM) involvement, and other factors related to end-of-life care. Chi-squared and discriminate analyses were utilized. Results: Complete data were available for 130 of 345 (37.7%) patients. Disease sites included cervix 28 (21.5%), uterine 37 (28.5%), ovarian 51(39.2%), and vaginal/vulvar 14 (10.8%). Median age at diagnosis and death was 63 and 65 years. Relative to death, diagnoses occurred at a median of 1.65 (0.05-32) years prior. 83 (63.8%) patients were DNR at their last hospitalization, 84(64.6%) had HPCM involvement, and 18(13.8%) had an advance care plan. When HPCM was involved, 83.3% were DNR as compared to 28.3% without involvement (p=0.0001). Patients were also significantly more likely to have DNR status with diagnosis of ovarian cancer and as the duration of time between diagnosis and death increased (p=0.0001). The provider obtaining DNR was most often faculty over residents or HPCM (60.2%, 27.7%, 12%). DNR status was declared by 57 (68.7%) patients and 26 (31.3%) power of attorneys. Median duration from DNR to death was 14 days (0-308) and median duration from HPCM involvement to death was 22 days (0-391). Conclusions: DNR status is associated with ovarian cancer, HPCM involvement, and increasing time from diagnosis to death. Earlier intervention from providers or HPCM could allow for greater patient autonomy and fewer interventions at end-of-life.
A new molecular diagnostic tool for pneumocystis jirovecii-pneumonia (PjP) detection: Results from European multicenter clinical study CS-2011.
Authors: Karrasch Matthias , Schulte Berit , Autenrieth Ingo , Denis Olivier , Torres Antoni , Knabbe Cornelius , Luedke Gerd , Straube Eberhard , Keller Peter M. , Weile Jan 
Published: March 2020

e20652 Background: Pneumocystis pneumonia (PCP) is a frequent and serious infectious complication in tumor patients. PCP is caused by Pneumocystis jirovecii, a fungal pathogen which is uncultivable in vitro. Highly-sensitive and time-efficient diagnostic tools are needed for early PCP treatment, especially in patients with impaired immune status. Methods: We evaluated a prototype of a new non-invasive molecular diagnostic tool (Unyvero System) using polymerase chain reaction (PCR) for P. jirovecii detection in respiratory samples (bronchoalveolar lavage fluid, tracheal aspirates, sputum) of hospitalized patients suffering from pneumonia. Results were obtained in an open-label, multicentric, non-randomized clinical study (CS-2011) conducted in 5 European hospitals. Unyvero system test results were compared to study site specific PCR results for P. jirovecii detection. Discrepant results were analysed for clinical relevance of molecular diagnostic tool results. Results: P. jirovecii was detected in 11 patients (1.49 %) out of 739 evaluable study patients: Of these, 8 cases (1.08 %) were detected only with the Unyvero System, 2 cases only with site-established techniques and 1 case with both methods. An independent academic cross-check of these 8 Unyvero System -positive cases showed that 5 cases were false positives due to signal reading failure. The remaining 3 cases could be confirmed as true positives by control PCP-PCR, indicating Unyvero P. jiroveciidetection results of 2 false negatives, 4 true positives and 5 false positives. Conclusions: The overall detection rate for P. jirovecii was low (11 out of 739) in this study population. Although more positive cases were found using the Unyvero System, it remains unclear if this was of clinical significance, especially as two clinically confirmed PCP cases could not be detected. The Unyvero System prototypes had a rate of 0.7% false positive results (5 out of 739 samples) which might have led to an overtreatment under real conditions. However, the correct detection of 4 positive cases within 3 hours might render the Unyvero System a valuable diagnostic future tool.