bluuebunny/crossref_metadata_2025_split huggingface dataset:
Efficacy of anamorelin in cachectic patients with non-small cell lung cancer (NSCLC) and low BMI (< 20 kg/m2): Post-hoc analysis of two phase III studies.
Authors: Currow David Christopher , Temel Jennifer S. , Abernethy Amy Pickar , Giorgino Ruben , Friend John , Fearon Kenneth 
Published: February 2017

203 Background: Patients with advanced cancer frequently experience anorexia/cachexia, which can be characterized by weight loss or low BMI, and is associated with reduced function and quality of life. The randomized, phase III, double-blind ROMANA 1 [NCT01387269; N = 484] and ROMANA 2 [NCT01387282; N = 495]) trials in cachectic NSCLC patients demonstrated that the ghrelin receptor agonist anamorelin improved LBM, body weight, fat mass (FM), and symptom burden compared with placebo, and was well tolerated. The aim of this analysis was to assess the response to anamorelin specifically in patients with BMI below 20 kg/m2. Methods: Stage III/IV NSCLC patients with cachexia ( ≥ 5% weight loss during prior 6 months or BMI < 20 kg/m2) were randomly assigned (2:1) to daily oral 100 mg anamorelin or placebo for 12 weeks. A post-hoc pooled analysis of efficacy data from both trials was conducted in patients with BMI < 20 kg/m2 (N = 182) and with BMI ≥ 20 kg/m2(N = 647). Endpoints included changes in lean body mass (LBM), fat mass (FM), and changes in self-reported anorexia/cachexia symptoms/concerns and fatigue. Results: Compared with placebo, anamorelin significantly increased LBM both in patients with low BMI (treatment difference: 1.71 kg [95% CI 0.88 – 2.54]) and in those with normal/high BMI (1.47 kg [1.00 - 1.94]) (p < 0.001). Greater increases in FM were observed in the BMI < 20 kg/m2 (1.66 kg [0.86 – 2.46], p < 0.001) than in the BMI ≥ 20 kg/m2 subgroup (0.79 kg [0.30 - 1.28], p = 0.002). Significant improvements in anorexia/cachexia symptoms/concerns were observed in the BMI < 20 kg/m2 subgroup (5.27 [2.11 - 8.43], p = 0.001), while in the BMI ≥ 20 kg/m2 subgroup these were not significant (0.91 [(-0.56) - 2.37], p = 0.224). In patients with low BMI, anamorelin also improved fatigue (3.94 [0.56 – 7-32], p = 0.023), while this was not significant in patients with BMI ≥ 20 kg/m2 (-0.42) [(-2.07) – 1.23], p = 0.616). Conclusions: In patients with BMI < 20 kg/m2 anamorelin increased lean and fat mass as well as improved anorexia/cachexia symptoms/concerns. Additionally, improvements in fatigue were also noted in patients with BMI < 20 kg/m2. Clinical trial information: NCT01387282; NCT01387269.
A randomized controlled trial (RCT) of 2 dose ratios for conversion from parenteral to oral methadone in patients with cancer pain.
Authors: Gonzalez-Barboteo Jesus , Porta-Sales Josep , Nabal-Vicuña Maria , Diez-Porres Leyre , Canal Jaume , Alonso-Babarro Alberto , Vilches Yolanda , Llorens Silvia , Sanllorente Mireia , Perez-Pujol Silvia , Bruera Eduardo 
Published: February 2017

206 Background: Methadone (M) is frequently used for severe cancer pain using the parenteral and oral route. The most commonly used dose ratio (DR) parenteral: oral is 1:2. However, methadone is highly bioavailable and a lower ratio might result in similar analgesia with less toxicity. The main objective of this RCT is to compare success and side effects with 2 ratios of parenteral to oral M: 1:2 vs 1:1.2 in hospitalized patients with cancer pain. Methods: Inpatients with cancer pain well controlled with parenteral M requiring rotation to the oral route. Double blind RCT. Outcomes included pain intensity (BPI), opioid toxicity (CTCAE), and M dose. Success was defined as good pain control with no toxicity at 72hs. Results: 39/44 randomized patients were evaluable (89%): 21 in DR 1:2 and 18 in DR 1:1.2. 71% male, median age 65. No significant difference between DR1:2 and DR1:1.2 in frequency of neuropathic pain (64 Vs 68%), Papscore A/B (100 Vs 91%), CAGE + (23 Vs 18%). Median M dose pre/post was 24.5mg±13.5 y 49 mg±27.3 for DR 1:2, Vs 23.3mg±9.4 (p: NS) y 28mg±11.3 (p < 0.01) for DR 1:1.2. The DR1:2 group developed more cumulative toxicity at dasy 1, 2 and 3 (p < 0.015, p < 0.006 y p < 0.001 respectively). Pain intensity pre/ post was: 1.58±1.3 and 0.87±1.0, ns for DR 1:2, Vs 1.13±0.7 (p:NS) and 1.07±0.9 (p:NS) for DR 1:1.2. Success was observed in 12 pts in DR1:2 Vs 18 in DR 1:1.2, p < 0.001. Side effects related to M were observed in 33/46 pts in DR 1:2 (mainly neurotoxicity symptoms) Vs 1/6 in DR 1:1.2. Conclusions: DR 1:1.2 when changing from parenteral to oral M resulted in lower toxicity and no difference in analgesia. More conservative dose adjustment during M route change should be considered. Granted by Spanish Ministry of Health EC10-133. EUDRACT Number: 2010-024092-39. Clinical trial information: 2010-024092-39.
Differences in self-care behaviors by varying levels of caregiving intensity, performance, and well-being among family caregivers of patients with high-mortality cancer.
Authors: Dionne-Odom J Nicholas , Demark-Wahnefried Wendy , Taylor Richard A. , Rocque Gabrielle Betty , Azuero Andres , Acemgil Aras , Martin Michelle Y , Astin Meka , Ejem Deborah , Kvale Elizabeth Ann , Heaton Karen , Pisu Maria , Partridge Edward E. , Bakitas Marie 
Published: February 2017

239 Background: Family caregivers of high-mortality cancer patients perform vital tasks that deter from their own self-care. We aimed to determine differences in self-care behaviors by varying levels of caregiving intensity, well-being, and performance. Methods: Cross-sectional survey conducted in community settings of 8 cancer centers in AL, FL, and TN. Two-hundred and ninety-four family caregivers of Medicare beneficiaries diagnosed with pancreatic, lung, brain, ovarian, head & neck, hematologic, or stage IV cancer completed measures of self-care behaviors, including health responsibility, physical activity, nutrition, spiritual growth, interpersonal relations, stress management, and sleep; anxiety and depression; health-related quality of life (HRQoL); caregiver competence and preparedness; and decision-making self-efficacy. Results: Caregivers averaged 66 years and were mostly female (72.8%), white (91.2%), Protestant (76.2%), retired (54.4%) and patients’ spouse/partner (60.2%). Approximately half were rural-dwellers (46.9%) and had incomes <$50,000 (53.8%). The majority provided support 6-7 days per week (71%) for > 1 year (68%). Lower self-care behavior scores were associated with longer durations, higher hours, and more days/week of caregiving and with fair or poor patient health. Worse caregiver anxiety, depression, and mental HRQoL scores were significantly associated with lower scores in every self-care subdomain (all ps < .05). Nearly a quarter of respondents reported high depression scores (23%) and 34% reported borderline or high anxiety scores. Caregivers with lower competence, preparedness, and decision-making efficacy had lower spiritual growth, interpersonal relation, and stress management scores. Conclusions: Higher caregiving intensity is associated with worse caregiver self-care. Poorer self-care in all domains is associated with worse caregiver well-being. Interventions to optimize caregiver wellbeing should target all self-care behaviors and to optimize caregiver performance should target spiritual growth, interpersonal relation, and stress management self-care behaviors.
Spirituality, religiosity, spiritual pain, and quality of life among caregivers of Latin American patients with advanced cancer: A multicenter study.
Authors: Delgado-Guay Marvin Omar , Palma Alejandra , Duarte Eva Rossina , Grez Monica , Tupper Laura , Liu Diane D , Ferguson Andrea Octavia , Cantu Hilda , Ochoa Jewel , Williams Janet L. , Bruera Eduardo 
Published: February 2017

245 Background: Caregivers of cancer patients often face physical, and psychosocial hardship. The association between spirituality (S), religiosity (R), spiritual pain (SP), coping, and quality of life (QOL) have not been well characterized. The main purpose of this multicenter study was to determine these associations among LACs. Methods: We interviewed 319 LACs at palliative care clinics in Chile, Guatemala, and the US. LACs completed FICA (S/R assessment), ESAS–FS, PSWQ (worry), B-COPE/B-R-COPE (coping), and FACIT-Sp (spiritual well-being). Results: Median age 47 y, IQR=36, 59; 231 (73%) female, 207 (66%) married, 194 (61%) Catholic, 90 (28%) Non-Catholic Christian, 10 (3%) non-religious affiliation. Relationship: 111 (35%) spouses, 102 (32.5%) children, 31 (10%) siblings, 21 (7%) parents, and 59 (19%) others. 103 (32%) worked full-time, 38 (12%) worked-part-time, 96 (30%) homemaker, and 29 (9%) retired. 278 (92%) considered themselves moderately/highly spiritual and 75% moderately/highly religious, median: 8 (IQR: 6, 9) and 6 (4, 8) respectively. Median importance of S/R in their life was 10 (IQR: 7-10). The frequency and associations among the importance of S/R and different items were as follows: S/R is a source of strength and comfort (98%, r = 0.71; p < 0.0001), helps them to cope with patients’ illness (98%, r = 0.65; p < 0.0001). 44% of LACs reported that their spiritual/religious needs had not been supported by the medical team. 243/301 (81%) of LACs reported spiritual pain (median 6; IQR: 2-9). Spiritual pain significantly correlated with worse pain (r = 0.42, p < 0.0001), fatigue (r = 0.34, p < 0.0001), depression (r = 0.46, p < 0.0001), anxiety (r = 0.48, p < 0.0001), financial distress (r = 0.36, p < 0.0001), well-being (r = 0.3, p < 0.0001), worry (r = 0.42, p < 0.001), denial (r = 0.3, p < 0.0001), behavioral disengagement (r = 0.3, p < 0.0001), FACIT-sp (r = -0.18, p = 0.002), negative religious coping (r = 0.35, p < 0.0001). Conclusions: LACs report high level and importance of S/R in dealing with the patient’s illness and low level of S/R support from clinicians. 81% of LACs expressed spiritual pain that impacts their own symptoms, coping, and QOL. More research is needed.
Integrating contemplative and spiritual care in outpatient palliative care: A pilot study.
Authors: Blinderman Craig D , Schapiro Alex Beth 
Published: February 2017

247 Background: Spiritual support is associated with better outcomes in cancer care and at the end of life (1, 2). Consensus guidelines advocate for incorporating spiritual care in the provision of specialist level palliative care (3). Contemplative care practices and chaplaincy interventions have the potential for mitigating existential distress, cultivating prognostic awareness, and fostering spiritual approaches to grieving and coping with advanced cancer. We present the results of a pilot program demonstrating the feasibility and impact of integrating a contemplative care chaplain in an outpatient palliative care program in a culturally diverse patient population in a large, academic cancer center. Methods: Case series and descriptive analysis. A description of 10 cases seen by a contemplative care chaplain in our outpatient palliative care clinic in the Herbert Irving Comprehensive Cancer Center (HICCC) at Columbia University will be presented. A descriptive analysis using a chaplaincy-centered model of assessment will highlight the domains of suffering and subjective integration of psychosocial and spiritual concepts. Results: Patients were generally in favor of meeting with and sharing their feelings openly with the chaplain. Patients’ describe important domains pertinent to their well being: meaning, family integration, spiritual practices, existential concerns, prognostic awareness. Subjective transformation and integration of the following constructs: “healing,” “gratitude,” “anger,” “hope,” “fear” were possible with only a few patient encounters. None of the patients were opposed to an initial visit and assessment. In only one case, the family requested not having further visits due to strong emotional reactions that came up. Conclusions: Preliminary results from a novel, pilot program integrating contemplative and spiritual care in an outpatient palliative care program suggest that it is a feasible intervention and should be considered in other cancer centers. Further studies will need to qualify and quantify the additional value and impact of spiritual care integrated in ambulatory palliative care services.
What does 'palliative care' mean? Diverse definitions from cancer care providers.
Authors: Kent Erin E. , Ferrer Rebecca A. , Mollica Michelle , Huang Grace , Falisi Angela , Chou Wen-ying Sylvia 
Published: February 2017

40 Background: Existing literature on the epistemology of palliative care has mostly centered on patient/family perspectives. Understanding how multi-disciplinary healthcare providers themselves define palliative care is a critical step towards addressing barriers and harnessing facilitators that affect optimal delivery. Methods: Semi-structured key informant interviews (N = 19) were conducted with members of healthcare provider teams as part of a qualitative study on goals of care for cancer patients enrolled in clinical trials. Purposive sampling included diverse roles: attending physicians/principal investigators, oncology fellows, physician assistants, research and clinical nurses, patient care coordinators, palliative care physicians, social workers, chaplains, and pharmacists. One probe asked participants, “What does palliative care mean to you in your work?” Responses were transcribed and independently coded by two raters using interview-derived deductive and emergent inductive codes. Themes were then identified and analyzed using NVivo. Results: Informants included different elements in their definitions: attributes of palliative care (“Palliative care is helpful”); structure (“We have a pain and palliative team”); patient outcomes “(comfort”), and relation to other services (“adjunct to necessary medical care”). Additional themes also included (1) the charge of palliative care to alleviate suffering; (2) the recognition that palliative care should be holistic; (3) the centrality of symptom management, in particular pain; (4) the conflation of end-of-life, hospice, and palliative care; (5) tensions between palliative and curative care. Provider role and specific team membership appear to influence perspectives on definitions of palliative care. Conclusions: Providers share a wide range of perspectives on the operationalization of palliative care in their work. In addition to soliciting input from patients and family members, the viewpoints of a diverse set of providers should be ascertained often to inform models of care, alleviate tensions between palliative and curative care provider teams, and increase optimal usage of palliative care.
A study of discrepancy between laboratory-calculated and weight-based glomerular filtration rate (GFR) as a marker of renal function in a palliative care population.
Authors: Power Jenny , Colleran Miriam 
Published: February 2017

58 Background: Renal function is important in a palliative care population and can impact on frequently-used medications including chemotherapeutic agents, opioids, non-steroidal anti-inflammatory drugs and neuropathic agents. In local practice, estimated glomerular filtration rate (eGFR), calculated on a presumed weight of 70kg, is displayed in laboratory results. However, the weight of palliative patients varies considerably, for example, due to cancer cachexia or malabsorption and a considerable population weigh less than 70kg. Our aim was to assess whether there is a discrepancy between glomerular filtration rate when laboratory-estimated versus weight-based and to explore the potential clinical relevance. Methods: Data was retrospectively collated for 50 patients admitted consecutively to a specialist palliative care unit over a 6 month period. Laboratory-derived eGFR was compared to GFR using the Cockroft-Gault equation (CreatClear = Sex*(140-Age)/(SerumCreat))*(Weight/72). Results: 25 (50%) patients were admitted for end of life care, 19 (38%) for symptom control, 6 (12%) for respite. 36 patients (72%) had weight documented. 45 (90%) patients had bloods taken. 41 patients had an eGFR documented, 7 of whom had an eGFR of less than 60ml/min. 25 patients had a weight-based GFR calculated of whom 10 (40%) had a GFR less than 60ml/min A significant discrepancy was seen between estimated and calculated GFR in 7 of these (accounting for 28%). This was most notable at less than 65kg. 2 patients with a weight of 55kg had a greater than 40ml/min difference in creatinine clearance. 50% of patients with a GFR of less than 60ml/min were on at least one nephrotoxic drug, most frequently pregabalin or ibuprofen. The most frequently-used opioid was oxycodone. No patient had opioids or medications discontinued on the basis of renal function. Conclusions: Results show a significant discrepancy between estimated and calculated GFR in a palliative care population which is most pronounced at lower weights. We would recommend, where appropriate, calculating a weight-based GFR on patients, with a review of opioid and nephrotoxic medications when reduced.
Patterns of palliative care utilization and end-of-life care in adult patients with cancer who died as inpatients at Mayo Clinic.
Authors: Zimmerman Collin Thomas , Shinde Shivani S. , Kasi Pashtoon Murtaza , Litzow Mark Robert , Huddleston Jeanne M. 
Published: February 2017

60 Background: A significant number of patients with advanced cancer die in the hospital. Examination of patterns of care and palliative care (PC) involvement may identify opportunities for process of care improvements for this vulnerable population. Methods: Patients were identified using the institutional mortality review system registry (Mayo Clinic hospitals from July, 2013-June, 2014). Within this group, patients with a diagnosis of terminal malignancy were identified by chart review and ICD-9 codes. Patient demographics, clinical characteristics, and use of PC resources were characterized in the last 60 days of life. Results: There were 159 of 924 decedents identified whose primary cause of death was advanced malignancy (Table). Ninety-two patients (57%) had PC consultation during the index admission preceding death, while 31 (19%) patients had seen PC as an outpatient or inpatient prior to index admission. Lack of inpatient PC consultation at index admission was associated with hematologic malignancy (p < 0.001), full code status at death (p 0.009), shorter median time between change of code status to DNR and death (13 vs 67 hrs, p < 0.001), death in the ICU (58% vs 31%, p < 0.001), and presence of code blue (22% vs 5%, p-value = 0.003). Patients who received a PC consultation were less likely to have chemotherapy within 14 days of death (15% vs 37%, p-value = 0.001), and had a median composite aggressive end of life score (6 factor composite score based on utilization in last 30 days of life, higher score indicating more aggressive care) of 3 vs 4 (p 0.002). Conclusions: Inpatient PC consultation for cancer patients who die in the hospital is associated with less aggressive cancer care at end of life. The single-institution patient population and small sample size are the limitations of our study. [Table: see text]
Impact of pre-treatment neutrophil-lymphocyte ratio on outcomes in men receiving radical external beam radiotherapy for localised prostate cancer.
Authors: Lyons Ciara , Kanabar Sagar , Mitchell Darren M. , Harney Jacqueline A. , McAleese Jonathan , Shum Lin , Stewart David P. , O'Sullivan Joe M. , Jain Suneil 
Published: February 2017

151 Background: There is a shortage of novel biomarkers in clinical use for the diagnosis and management of prostate cancer. The neutrophil-lymphocyte ratio (NLR) is a potentially useful biomarker derived from a standard full blood count from peripheral blood sampling, which is readily available and relatively inexpensive. An elevated NLR has been shown to be a poor prognostic biomarker in many advanced solid cancers, including prostate cancer (PC); however, data on NLR in non-metastatic PC have been inconsistent. The objective of this study was to evaluate baseline NLR as an independent predictor of outcome following radical radiotherapy for non-metastatic PC. Methods: Data from 477 consecutive PC patients treated with radical EBRT between 2005 and 2009 in Northern Ireland were reviewed. Outcomes included biochemical progression-free survival (bPFS; Phoenix definiton), prostate cancer-specific survival (PCSS) and overall survival (OS). A two-tailed Mann-Whitney test (significance level 5%) was used to compare NLR in each group. Results: Complete data for 409 patients were available. At a median follow-up of 75 months (range 12 – 138), 74 men (16%) had biochemical failure (BF), 12 men (3%) had died of PC, and 65 men (14%) had died of all causes. Actuarial 5-year bPFS was 91%, PCSS was 97% and OS was 89%. Median NLR was 2.42 in both the BF and non-BF groups (p = 0.78), 2.21 and 2.42 in men who died from PC and those who did not (p = 0.39) and 2.40 and 2.42 in those men who died from all causes and those men who remained alive (p = 0.83). See Table for additional data. Conclusions: In this cohort with medium- to long-term follow-up, NLR was not predictive for bPFS, PCSS or OS. Multivariate analysis of this cohort is planned. Additional prognostic biomarkers are required in PC. [Table: see text]
Open-label phase II study evaluating the efficacy of concurrent administration of radium Ra 223 dichloride (Ra-223) and abiraterone acetate (AA) in men with castration-resistant prostate cancer (CRPC) patients with symptomatic bone metastases.
Authors: Shore Neal D. 
Published: February 2017

177 Background: Abiraterone Acetate (AA), a CYP17 inhibitor, further decreases serum testosterone for castrate resistant prostate cancer patients. Radium Ra 223 dichloride (Ra-223), an alpha-emitting radioisotope is a calcium mimetic, forming complexes with hydroxyapatite at sites of bone metastasis (mets). This study evaluates the combinatorial use of concurrent AA + Ra-223 in CRPC patients with symptomatic bone mets. Methods: In this open-label, phase II study (NCT02097303), 30 patients with symptomatic bone mCRPC with no visceral mets were enrolled. All evaluable patients are treated with Rad-223 every 4 weeks x 6 doses, and concomitant AA 1000 mg + prednisone 5 mg BID. The primary endpoint is efficacy. Secondary endpoints include safety, time to measurable disease progression and SRE's, PSA and ALP progression, progression to further antineoplastic therapy and performance status changes. Patients are assessed at screening, weeks 1, 5, 9, 13, 17, 21 and 25. Data will be presented according to all metrics detailed, and by subject and visit. Time to event variables will be summarized using the Kaplan-Meier method to estimate the median, 25th and 75th percentiles, minimum and maximum and the 95% confidence interval for the median time to event. Kaplan-Meier plots will also be generated. This trial is ongoing and closed to enrollment. Clinical trial information: NCT02097303. Results: Pending. Last patient last visit scheduled to occur in December, 2015. Conclusions: Pending. Clinical trial information: NCT02097303.