bluuebunny/crossref_metadata_2025 huggingface dataset:
Complications of intrathecal pump therapy in malignancy-related pain.
Authors: Noreika Danielle M , Del Fabbro Egidio
Published: February 2017

102

Background: Intrathecal pumps (ITP) are used to manage severe malignancy related pain by delivering analgesics directly into the cerebrospinal fluid, in theory allowing for a reduced opioid dose and fewer complications. Although there is literature to support efficacy in patients with cancer, including improved survival, this mode of drug delivery also carries a risk of serious complications. Reports of complications in non-malignant pain suggest the risks and mortality related to ITP may be under-appreciated and that injury and liability occur with both ITP placement and ITP maintenance. Additional burdens to consider in patients with cancer include accurate prognostication to identify appropriate candidates, and the logistics of providing ITP maintenance. Methods: A retrospective chart review of 26 consecutive patients that underwent implantation of a programmable ITP at a National Cancer Institute center between 2008 and 2014 for malignancy related pain. Results: 53% (n = 14) of patients experienced major and minor ITP complications. Major complications occurred in 35% (9) including leg weakness post operatively requiring wheelchair use for months; granuloma formation causing leg weakness and requiring repeat operation; pump infection leading to sepsis and death; intra-abdominal abscess; significant bleeding requiring discontinuation of therapeutic anticoagulation for PE; and neurological complications including delirium and protracted seizures requiring ICU admission. Minor complications occurred in 31% (8) and included wound infections, urinary retention requiring catheterization, foot drop, and spinal headaches related to CSF leaks. 42% (11) died < 90 days after ITP implantation; 19% (5) died < 30 days after ITP implantation. 7 patients (27%) were either lost to follow up, relocated, transitioned to hospice, or had difficulty finding providers to refill the pump. Conclusions: More than a third of patients with cancer receiving an ITP at our institution experienced major complications including death, sepsis, and neurological problems.
A pilot trial of early specialty palliative care for patients with advanced pancreatic cancer: Challenges encountered and lessons learned.
Authors: Schenker Yael , Bahary Nathan , Claxton Rene , Childers Julie , Kavalieratos Dio , King Linda , Lembersky Barry C. , Park Seo Young , Tiver Greer A , Arnold Robert
Published: February 2017

110

Background: Palliative care trials face implementation barriers. We describe challenges encountered in a pilot trial of early specialty palliative care for patients with pancreatic cancer. Methods: We conducted a mixed-methods pilot randomized controlled trial of early specialty physician-led palliative care in advanced pancreatic cancer. Recently diagnosed patients with borderline, locally-advanced, or metastatic pancreatic cancer and their caregivers (total N=60) were recruited from clinic at a comprehensive cancer center and randomized (2:1) to receive monthly specialty palliative care visits for 3 months in addition to standard oncology care vs. standard oncology care alone. Feasibility assessments included enrollment and intervention completion rates. Acceptability and perceived effectiveness were assessed via drop-out rates and semi-structured participant interviews. Results: The enrollment target was reached after 50 weeks, with a randomized: approached rate of 27%. Mean patient age was 63 (SD 11) and 50% were male. Mean caregiver age was 62 (SD 12), 47% were male, and 80% were the spouse or partner of a patient. 70% of participants in the intervention group completed at least one specialty palliative care visit and 15% completed 3 palliative care visits within the 3-month time period. Two patients and 3 caregivers withdrew, and 4 patients died prior to 3 months. Enrollment barriers included patients not planning to continue receiving care from a participating oncologist and feeling too overwhelmed at the time of diagnosis to consider research participation. In semi-structured interviews, patients and caregivers noted that long travel times to the cancer center, difficulty scheduling palliative care visits at a convenient time, and lengthy study assessments posed burdens. Oncologists and palliative care physicians recommended more in-person communication between clinicians and tailoring palliative care visit content and schedules to match patient needs. Conclusions: Future palliative care intervention trials must consider implementation challenges related to recruitment, retention, intervention fidelity, and participant burden. Clinical trial information: NCT01885884.
Palliative Care Always as a massive open online course (MOOC) to build primary palliative care in a global audience.
Authors: Tribett Erika Lauren , Ramchandran Kavitha , Fronk Joshua , Passaglia Judy , Bugos Kelly , Kogon Manuela , Klein Lori , Brown Ellen , Chan Sandy , Hutton Lynn , Lyo Grace , Sickler Kimberly Frost
Published: February 2017

123

Background: Primary palliative care (PC) is critical to improve access to PC from the point of diagnosis. Still, barriers exist to providing primary PC worldwide, including a lack of awareness, time, and training. Interactive online learning experiences can help overcome these. This project describes a massive open online course (MOOC)--Palliative Care Always--designed to build primary PC skills in a global audience. Methods: A team of PC providers and online instructional experts developed 12 modules that included: patient scenes, brief lectures, empathy exercises, and Google Hangout discussions. Course objectives included awareness of PC, practicing effective communication skills, basic symptom assessment and management. The target audience included oncology clinicians; secondary audience included patients and families. The MOOC launched January-April 2016. Participant engagement, satisfaction and self-reported knowledge were assessed through pre- and post-surveys. Multiple choice assessments captured knowledge gain. Follow-up assessments will be distributed three months post-MOOC. Results: By April 2016, the course reached 1,300 participants from 91 countries. 54% were from the US, followed by India, Brazil, and Canada. 76% were healthcare professionals, the majority being nurses (40%), physicians (19%) and social workers (13%). The remaining 24% included patient, caregivers, and others interested in PC. Top reasons for enrolling were interest in PC, personal growth and job relevance. On average, 27% of enrollees actively engaged week-over-week. Eighty-six percent of respondents were “very satisfied” with the amount learned, and over 50% cited learning “a great deal” in: communicating difficult news, goals of care, psychosocial and hospice care. 93% cited being “very likely” to recommend the course. Conclusions: Interactive MOOC experiences have the potential to build PC awareness, primary skills and global PC networks. Upcoming iterations will incorporate: accommodations for varying levels of PC knowledge; additional opportunities for interaction between participants, including social networks; blended learning; and evaluation of impact on practice and healthcare outcomes.
Disparities in access to palliative care services among cancer patients in south Texas.
Authors: Rauenzahn Sherri L. , Schmidt Susanne , Aduba Ifeoma , Jones Jessica , Tenner Laura LaNiel
Published: February 2017

130

Background: Palliative medicine is dedicated to improving quality of life for patients throughout their disease course. The integration of palliative medicine in oncology practice has increased due to growing evidence of benefits for patient. While the collaboration of palliative and oncology care is beneficial, access to palliative services remains an issue for cancer patients. The aim of this project is to evaluate how insurance status impacts palliative care access for cancer patients in South Texas. Methods: During a 5-month study period, 607 patients from medical oncology clinics were evaluated based on their Edmonton Symptom Assessment System (ESAS) scores collected during their clinic visit to determine symptom burden and palliative care need. If providers saw a need, palliative care referrals were made. 27 unique patients received a total of 32 referrals over the study period. We examine time to initial palliative care appointment after the first referral was made. We compare time to consult based on where patients were able to receive palliative services. Location of care was based on type of insurance coverage. Results: During our study period, 13 patients were eligible to receive care through the University of Texas (UT) Medicine System (Group A) and 14 patients qualified for care at University System, which provides services to under-insured and safety net patients (Group B). Of the 27 referred patients, 85% made efforts to seek palliative care (n = 23), of which 78% had a palliative care visit (n = 18). On average, patients seeking care at the safety net facility (Group B) had 29.8 days longer wait times until their first potential visit (p < 0.01) compared to patients eligible for UT Medicine (Group A). Time to actual visit was on average 39.2 days longer for patients in Group B compared to patients in Group A (p = 0.02), averaging at 55.7 days for patients seeking care at the safety net facility. Conclusions: This investigation revealed a 4-fold increase in time to scheduled visit depending on insurance coverage. While this study is limited by a small sample, data suggests that under-insured oncology patients may have significantly different access to palliative care services which may impact the quality of cancer care.
Strength training to enhance early recovery after hematopoietic stem cell transplantation.
Authors: Hacker Eileen Danaher , Collins Eileen , Park Chang , Peters Tara , Rondelli Damiano
Published: February 2017

190

Background: Intensive cancer treatment followed by hematopoietic stem cell transplantation (HCT) results in moderate to severe fatigue and physical inactivity leading to diminished functional ability. Methods: This study compared strength training to enhance early recovery (STEER) (n = 33) to attentional control with health education (n = 34) in adult HCT patients on primary outcomes (physical activity and fatigue) and secondary outcome (functional ability) in a single-blind randomized clinical trial. Subjects were randomly stratified by type of transplant (allogeneic or autologous) and age (≤ 60 years of age or > 60 years of age). STEER consisted of a comprehensive program of progressive resistance introduced during hospitalization and continued for six weeks following hospital discharge. Attention control with health education subjects received structured weekly health education post hospitalization. Variables were assessed prior to HCT hospital admission and six weeks following hospital discharge. Using the two-sided alpha level of 0.05, a final sample size of 66 (n = 33 per arm) was planned with 80% statistical power. Data were analyzed using split-plot ANOVAs. Results: Interactions effects were noted for fatigue, p = .04, ηp 2 = .06. The STEER group reported more fatigue at baseline and less fatigue following strength training compared to the health education group. Time, p < .001, ηp 2 = .16, and group effects, p = .05, ηp 2 = .05, were observed for physical activity. Physical activity decreased from baseline to six weeks post hospitalization. The STEER group was more physically active. Group effects were observed for two functional tests (15-foot timed walk, p = .04, ηp 2 = .06; and, timed up and go test, p = .03, ηp 2 = .07). The STEER group completed both tests faster. The timed stair climb, p = .03. ηp 2 = .07, and timed up and go tests, p = .05, ηp 2 = .06, interaction effects. The STEER group completed both tests faster following completion of strength training. Conclusions: Strength training enhances early recovery following HCT with moderate effect sizes. Strength training significantly reduced fatigue while improving physical activity and functional ability six weeks following hospital discharge.
A cluster randomized trial of a patient-centered communication intervention in advanced cancer: The Values and Options In Cancer Care (VOICE) study.
Authors: Fenton Joshua J , Kravitz Richard L , Duberstein Paul , Tancredi Daniel J , Xing Guibo , Epstein Ronald M.
Published: February 2017

2

Background: Observational studies demonstrate links between patient-centered communication, prognosis discordance, quality of life (QoL) and aggressive treatments near the end of life, yet there are few randomized evaluations of communication interventions in advanced cancer. Methods: We completed a cluster randomized controlled trial in cancer clinics in Western NY and Northern CA with medical oncologists (n = 38 randomized to intervention or control) and their community-dwelling adult patients with advanced non-hematologic cancer (n = 265; 194 with enrolled caregivers). Interventions foroncologists (individualized communication training using Standardized Patient Instructors) and patients/caregivers (individualized coaching using question prompt lists) were directed towards enhancing patient engagement in consultations, oncologists’ response to emotions, and provision of balanced information about prognosis and treatment choices. Oncologists and patients randomized to control received no interventions. Primary outcome was a composite of 4 communication measures coded from audio-recorded oncologist visits shortly after patient coaching (intervention) or enrollment (control). Secondary outcomes included the patient-physician relationship, shared understanding of prognosis, QoL, and utilization of aggressive treatments and hospice in the last 30 days of life. Results: In fully-adjusted models, the intervention significantly improved mean composite communication scores [0.34, 95% CI (0.06, 0.62), p = 0.017]. Effects on secondary outcomes were not significant. Conclusions: Oncologist communication training combined with coaching for patients with advanced cancer and available caregivers promoted patient-centered communication. Nevertheless, we did not observe changes in QoL and utilization, suggesting that more intensive, psychologically-oriented or longitudinal interventions may be needed, along with support and incentives for clinicians to participate. Clinical trial information: NCT01485627.
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.
Degarelix/bicalutamide combination versus degarelix alone as initial androgen-deprivation therapy
Authors: Nozawa Masahiro , Sugimoto Koichi , Nagai Yasuharu , Sugiyama Takahide , Hatanaka Yuji , Oki Takashi , Tahara Hideo , Matsuda Hisao , Yamamoto Yutaka , Uemura Hirotsugu
Published: February 2017

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Background: Antiandrogens have been used to prevent symptoms due to testosterone surge in the early phase of treatment with gonadotropin-releasing hormone (GnRH) agonist as well as to add antitumor efficacy. Degarelix, an antagonist of GnRH does not introduce testosterone surge, however, the combination of degarelix and antiandrogen can exert a stronger antitumor effect than degarelix alone. We conducted a phase II study to investigate the early-phase efficacy and safety of combination of degarelix and bicalutamide compared with degarelix alone in patients with prostate cancer (PCa). Methods: Patients with histologically proven adenocarcinoma in the prostate indicated for androgen-deprivation therapy (ADT) were randomly assigned to a treatment group with either combination of degarelix and bicalutamide or degarelix alone. Degarelix was administered subcutaneously with an initial dose of 240 mg followed by 80 mg thereafter every four weeks. Bicalutamide was taken 80 mg every day. The primary endpoint was the percentage of patients whose serum prostate-specific antigen (PSA) declined with greater than 90% of the baseline at Day 28. Secondary endpoints were the transition of serum PSA and testosterone during treatment of 12 weeks, safety, and quality of life. Results: A total of 93 patients were evaluable in this final analysis. Median age was 75 years. Median baseline serum PSA was 10.2ng/ml. Baseline patient characteristics were well-balanced in both arms. The percentage of patients with serum PSA declines greater than 90% from baseline was 34% and 27% in the combination group and the degarelix monotherapy group, respectively (P= 0.503). The transition of serum PSA and testosterone levels were similar in both groups. No grade 3 or greater adverse event was observed in both groups. Conclusions: Adding bicalutamide on degarelix as initial ADT does not produce a greater impact on serum PSA decline in the early-treatment phase compared to degarelix alone. Clinical trial information: UMIN000011506.
The impact of statin use on abiraterone acetate (AA) treatment duration in patients with castration-resistant prostate cancer (CRPC).
Authors: Harshman Lauren Christine , Werner Lillian , Nakabayashi Mari , Tripathi Abhishek , McKay Rana R. , Wang Xiaodong , Pomerantz Mark , Mucci Lorelei A. , Taplin Mary-Ellen , Sweeney Christopher , Lee Gwo-Shu Mary , Kantoff Philip W.
Published: February 2017

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Background: Statins compete with DHEAS for influx through the transporter SLCO2B1 and may prolong time to progression (TTP) on androgen deprivation therapy (ADT). The androgen biosynthesis inhibitor, AA, may also undergo SLCO-mediated transport. We hypothesized that statins may compete with AA for influx by SLCO2B1, which could negatively impact drug efficacy. Methods: We queried our institutional clinical database for patients treated with AA for CRPC. Data on statin use including on-therapy dates were retrospectively collected from the medical record. Time on AA was used as a surrogate for TTP. Duration of AA was defined as the time from AA initiation to time to when AA was discontinued or censored on the last known alive date. The association between statin use and AA duration was estimated using the Kaplan-Meier method. Multivariable Cox regression adjusted for known prognostic factors (e.g, prior docetaxel (D) or enzalutamide (E) use, and sites of metastases (mets) specifically bone or lymph node versus liver or other viscera. Results: Of the 224 patients eligible for analysis, the majority (96%) had metastatic disease at time of AA initiation. 26% had prior D and 7% E. Nearly half were statin users (41%). The median duration on AA was 10.7 months (mo) with a trend to longer duration in statin users: 14.2 vs. 9.2 mo (HR 0.79, 95% CI: 0.57-1.09, p = 0.14). Prior D and E was significantly associated with shorter AA duration while site of mets and age were not. Adjusting for prior use of D, E, and site of mets did not alter the relationship between statin use and AA duration (p = 0.18, HR 0.81, 0.58-1.11). Conclusions: Contrary to our initial hypothesis, there was a trend to longer AA duration in statin users. Given our prior work demonstrating a 10 mo prolonged TTP on ADT in men concurrently taking statins (adjusted HR 0.83), and in vitro findings of inhibition of DHEAS uptake by statins, we postulate that there could be an additive effect of statins and AA by blocking DHEAS uptake. Alternatively, statins may inhibit hepatic AA uptake prolonging drug exposure and increasing effectiveness. Ongoing analyses are evaluating the impact of SLCO SNPs on AA efficacy.
Pharmacokinetic food-effect study of abiraterone acetate (AA) in patients with metastatic castration resistant prostate cancer (mCRPC): The ABIFOOD trial (EudraCt number: 2012-003226-25).
Authors: Espinosa M. , Falcon A , Gutierrez-Valencia A , Cervera A , Rosso-Fernandez CM , Martinez-Lozano E , Perez-Valderrama B , Martinez-Atienza J , Jimenez Gonzalez-Serna L , Sanchez-Simon I , Cruz M , Rodriguez A , Virizuela JA , Maiquez P , Hindi N , Gallego Jimenez I , Lopez-Cortes FL , Paz-Ares Luis G. , Duran Ignacio
Published: February 2017

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Background: A.A has been approved for the treatment of mCRPC before and after docetaxel. The standard regime consists on daily A.A. 1.000 mg in a fasting state along with prednisone 10mg q.d. However, data from pharmacokinetic (PK) studies in patients (pts) and healthy volunteers has revealed a significant food-effect with up to 7-10 folder increase in area under plasma concentration-time curve (AUC) when A.A is given with food, specially with fat content, [Chi KN, J Clin Pharmacol 2015]. Methods: ABIFOOD is a phase I, randomized trial to evaluate the short and long-term effect of diet on the PKs of A.A. in pts with mCRPC who have progressed to docetaxel. Eligible pts include men ≥ 18 years old with mCRPC, ECOG performance status (PS) < 2 and an adequate organ function. Pts are randomly assigned to receive 4-weekly cycles of 250 mg A.A with standard meal (Arm A), 250 mg A.A with high-fat meal (Arm B) or 1000 mg A.A in fasting conditions (Arm C). PK analyses are conducted at week 1 (W1) and cycle 5. Results: Fifteen pts (5, 3 and 7 in arms A, B and C respectively) have been included and 6 are still on treatment. Median age is 72, 97% have ECOG-PS 1. Gleason Score is > 8 in 6 (40%) pts.Geometric mean abiraterone [AUC (ng.h/ml) (IQR)] at W1 did not significantly differ between treatment arms [arm A: 404.68 (368.4 - 488.2), arm B: 372 (334.6 - 440.5) arm C: 656.51 (387.8 – 1144.5) p 0.15]. PK data did not influence activity or toxicity. Progression free survival was 8.50, 6.33 and 4.86 months in Arms A, B and C respectively (p 0.53). One patient in arm A is still on treatment after 17 cycles. Conclusions: The administration of lower doses of A.A with food [regardless the fat content], might achieve comparable plasma levels to standard dosing with no detriment in efficacy or toxicity parameters. The study is actively recruiting and data on additional pts and long term PK parameters will be presented. Clinical trial information: EudraCt number: 2012-003226-25.
Analysis of the temporal relationship between patient-reported outcomes (PROs) and overall survival (OS) and radiographic progression-free survival (rPFS) in metastatic castration-resistant prostate cancer (mCRPC) patients (pts).
Authors: Traina Shana , Li Tracy , Johnson Kristen , Ho Kai Fai , Molina Arturo , Cella David
Published: February 2017

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Background: PROs are used to measure therapeutic impact. The relationship between PROs and clinical outcomes is not well described. Methods: COU-AA-301 (301) and COU-AA-302 (302) were phase 3 trials of abiraterone acetate + prednisone (P) vs P in post-docetaxel and chemotherapy-naïve mCRPC pts, respectively. Using Cox regression models, we explored the association between self-reported fatigue, pain, physical well-being (PWB), functional well-being (FWB), and PC-specific (PCS) signs and symptoms, and OS and rPFS over the first 181 days, regardless of treatment, using data from 301 (N = 1195) and, separately, from 302 (N = 1088). Pts in 301 had more advanced disease and were more symptomatic at entry; pts in 302 were asymptomatic/mildly symptomatic. PRO improvements were assessed for 301 and worsening was assessed for 302. Results: In 301, pts with PRO improvements had reduced risk of death and radiographic progression (p < 0.0001) vs pts with worsening or stable PROs (Table). When all PROs were included in a multivariate (MV) model, all except pain intensity were significantly associated with OS; pain intensity, PWB, and FWB improvements were significantly associated with reduced radiographic progression. Pts in 302 with worsening PROs had greater risk of radiographic progression (p ≤ 0.02) vs pts with improved or stable PROs (Table). When all PRO end points were included in an MV model, worsening PWB remained significantly associated with worse rPFS. There were too few events at cutoff to explore the relationship between PROs and OS in 302. Conclusions: These results reinforce the clinical meaningfulness of self-reported symptoms and suggest that PROs can be used in combination with clinical measures in practice. Clinical trial information: NCT00887198; NCT00638690. [Table: see text]