Cancer anorexia-cachexia syndrome is characterized by more than one inflammatory pathway.

BACKGROUND: The interdependence of cytokines and appetite-modifying hormones implicated in cancer anorexia-cachexia syndrome (CACS) remains unclear. This study aimed to regroup these cytokines and hormones into distinct inflammatory (or non-inflammatory) pathways and determine whether these pathways can classify patients with CACS phenotypes. METHODS: Clinical characteristics of 133 patients [61.7% male; mean age = 63.4 (SD: 13.1) years] with advanced cancer prior to oncology treatments were documented, including weight loss history. Patients completed the Functional Assessment of Anorexia-Cachexia Therapy (FAACT) questionnaire and Timed Up and Go test and had their sex-standardized skeletal muscle index (z-SMI) and fat mass index (z-FMI) derived using computed tomography scans. Their plasma levels of cytokines and appetite-modifying hormones were also determined. Date of death was recorded. Exploratory factor analysis (EFA) was used to regroup 15 cytokines and hormone into distinct inflammatory pathways (factors). For each patient, regression factor scores (RFS), which tell how strongly the patient associates with each factor, were derived. Two-step cluster analysis on the RFS was used to classify patients into groups. CACS phenotypes were correlated with RFS and compared between groups. Groups' survival was estimated using Kaplan-Meier analysis. RESULTS: Patients had low z-SMI (mean = -3.78 cm2 /m2 ; SD: 8.88) and z-FMI (mean = 0.08 kg2 /m2 ; SD: 56.25), and 62 (46.6%) had cachexia. EFA identified three factors: (F-1) IFN-γ, IL-1ß, Il-4, IL-6, IL-10, IL-12, TGFß1 (positive contribution), and IL-18 (negative); (F-2) IL-8, IL-18, MCP-1, TGFß1, TNF-α (positive), and ghrelin (negative); and (F-3) TRAIL and leptin (positive), and TGFß1 and adiponectin (negative). RFS-1 was associated with cachexia (P = 0.002); RFS-2, with higher CRP (P < 0.0001) and decreased physical function (P = 0.01); and RFS-3 with better appetite (P = 0.04), lower CRP (P = 0.002), higher z-SMI (P = 0.04) and z-FMI (P < 0.0001), and less cachexia characteristics (all P < 0.001). Four patient groups were identified with specific RFS clusters aligning with the CACS continuum from no cachexia to pre-cachexia, cachexia, and terminal cachexia. Compared to the other two groups, groups 1 and 2 had higher plasma levels of IL-18 and TRAIL. Group 1 also had lower inflammatory cytokines, adiponectin, and CRP compared to the other three groups. Group 3 had inflammatory cytokine levels similar to group 2, except for TNF-α and leptin which were lower. Group 4 had very high inflammatory cytokines, adiponectin, and CRP compared to the other 3 groups (all P < 0.0001). Groups 3 and 4 had worse cachexia characteristics (P < 0.05) and shorter survival (log rank: P = 0.0009) than the other two groups. CONCLUSIONS: This exploratory study identified three distinct pathways of inflammation, or lack thereof, characterizing different CACS phenotypes.

Experiences and Lessons Learned from Implementing the RELIEF Digital Symptom Self-Reporting App in a Palliative Home Care Setting.

The majority of Canadians agree they have the right to end-of-life care in their own homes. While a palliative approach to care in the home setting has been demonstrated to be beneficial for patients and the healthcare system, it has rarely been well-integrated through an eHealth approach. Thus, in 2018, we piloted the RELIEF app, a digital symptom self-reporting tool for patients with palliative care needs. This was followed by the initiation of an extension phase of RELIEF in the home care setting. In this commentary, we share the implementation perspectives and experiences of the researchers and healthcare workers involved in this home care phase. It was mainly expressed that there were challenges with nurses feeling involved, supporting the research program, and using the technology, while patients and family caregivers had challenges using the app and cooperating with staff. We describe our lessons learned from these experiences and future changes to be enacted. A detailed report of this trial will be made available in future publications.

Utilization of Point-of-Care Ultrasound in a Specialist Palliative Care Team Across Multiple Care Settings: A Retrospective Chart Review.

Background: Technological advancements have rapidly increased the use of point-of-care ultrasound (POCUS) across various medical disciplines, leading to real-time information for clinicians at the bed side. However, literature reveals scant evidence of POCUS use in palliative care. The objective of this study was to examine the use of POCUS in a specialist palliative care setting. Methods: A retrospective chart review was conducted from January 2018 to June 2019 in Brampton, Canada, to evaluate characteristics of patients for whom POCUS was utilized. Patients were identified through pre-existing logs and descriptive information was collected from electronic health records, including demographic information, life-limiting diagnosis, patient assessment location, diagnosis made with POCUS, and, if applicable, volume of fluid drained. Results: We identified 126 uses of POCUS in 89 unique patients. Sixty-two patients (69.7%) had a cancer diagnosis, with patients most commonly suffering from gastrointestinal, lung, and breast pathologies. Sixty-one POCUS cases (48.4%) were in the outpatient setting. Eighty-one POCUS cases (64.3%) revealed a diagnosis of ascites and 21 POCUS cases (16.7%) revealed a diagnosis of pleural effusion. Other diagnoses made with POCUS included bowel obstruction, pneumonia, and congestive heart failure. During the study period, 52 paracentesis and 7 thoracentesis procedures were performed using POCUS guidance. Conclusion: We identified multiple indications in our specialist palliative care setting where POCUS aided in diagnosis/management of patients in both inpatient and outpatient settings. Further studies can be conducted to identify the potential benefits in symptom burden, patient and caregiver satisfaction, and health care utilization in palliative care patients receiving POCUS.

Examining guidelines and new evidence in oncology nutrition: a position paper on gaps and opportunities in multimodal approaches to improve patient care.

Malnutrition, muscle loss, and cachexia are prevalent in cancer and remain key challenges in oncology today. These conditions are frequently underrecognized and undertreated and have devastating consequences for patients. Early nutrition screening/assessment and intervention are associated with improved patient outcomes. As a multifaceted disease, cancer requires multimodal care that integrates supportive interventions, specifically nutrition and exercise, to improve nutrient intake, muscle mass, physical functioning, quality of life, and treatment outcomes. An integrated team of healthcare providers that incorporates societies' recommendations into clinical practice can help achieve the best possible outcomes. A multidisciplinary panel of experts in oncology, nutrition, exercise, and medicine participated in a 2-day virtual roundtable in October 2020 to discuss gaps and opportunities in oncology nutrition, alone and in combination with exercise, relative to current evidence and international societies' recommendations. The panel recommended five principles to optimize clinical oncology practice: (1) position oncology nutrition at the center of multidisciplinary care; (2) partner with colleagues and administrators to integrate a nutrition care process into the multidisciplinary cancer care approach; (3) screen all patients for malnutrition risk at diagnosis and regularly throughout treatment; (4) combine exercise and nutrition interventions before (e.g., prehabilitation), during, and after treatment as oncology standard of care to optimize nutrition status and muscle mass; and (5) incorporate a patient-centered approach into multidisciplinary care.

RELIEF: A Digital Health Tool for the Remote Self-Reporting of Symptoms in Patients with Cancer to Address Palliative Care Needs and Minimize Emergency Department Visits.

The lack of timely symptom reporting remains a barrier to effective symptom management and comfort for patients with cancer-related palliative care needs. Poor symptom management at home can lead to unwanted outcomes, such as emergency department visits and death in hospital. We developed and evaluated RELIEF, a remote symptom self-reporting app for community patients with palliative care needs. A pilot feasibility study was conducted at a large, community hospital in Ontario, Canada. Patients self-reported their symptoms each morning using validated clinical symptom measures and RELIEF would alert for worsening or severe symptoms. RELIEF alerts were monitored by palliative care nurses who would then contact patients to determine if appropriate clinical intervention could be initiated to avoid unnecessary emergency department visits. A total of 20 patients were recruited to use RELIEF for two months. Patients completed 80% of daily self-report assessments; 133 alerts were trigged, half of which required clinical intervention. No patient visited the emergency department for symptom management during the study. Clinical staff estimated five emergency department visits were avoided because of RELIEF-saving an estimated cost of over CAD 60,000. RELIEF is a feasible and acceptable method for the remote monitoring of patients with palliative care needs through regular symptom self-reporting.

Diagnostic criteria for cancer cachexia: reduced food intake and inflammation predict weight loss and survival in an international, multi-cohort analysis.

BACKGROUND: Cancer-associated weight loss (WL) associates with increased mortality. International consensus suggests that WL is driven by a variable combination of reduced food intake and/or altered metabolism, the latter often represented by the inflammatory biomarker C-reactive protein (CRP). We aggregated data from Canadian and European research studies to evaluate the associations of reduced food intake and CRP with cancer-associated WL (primary endpoint) and overall survival (OS, secondary endpoint). METHODS: The data set included a total of 12,253 patients at risk for cancer-associated WL. Patient-reported WL history (% in 6 months) and food intake (normal, moderately, or severely reduced) were measured in all patients; CRP (mg/L) and OS were measured in N = 4960 and N = 9952 patients, respectively. All measures were from a baseline assessment. Clinical variables potentially associated with WL and overall survival (OS) including age, sex, cancer diagnosis, disease stage, and performance status were evaluated using multinomial logistic regression MLR and Cox proportional hazards models, respectively. RESULTS: Patients had a mean weight change of -7.3% (±7.1), which was categorized as: ±2.4% (stable weight; 30.4%), 2.5-5.9% (19.7%), 6.0-10.0% (23.2%), 11.0-14.9% (12.0%), ≥15.0% (14.6%). Normal food intake, moderately, and severely reduced food intake occurred in 37.9%, 42.8%, and 19.4%, respectively. In MLR, severe WL (≥15%) (vs. stable weight) was more likely (P < 0.0001) if food intake was moderately [OR 6.28, 95% confidence interval (CI 5.28-7.47)] or severely reduced [OR 18.98 (95% CI 15.30-23.56)]. In subset analysis, adjusted for food intake, CRP was independently associated (P < 0.0001) with ≥15% WL [CRP 10-100 mg/L: OR 2.00, (95% CI 1.58-2.53)] and [CRP > 100 mg/L: OR 2.30 (95% CI 1.62-3.26)]. Diagnosis, stage, and performance status, but not age or sex, were significantly associated with WL. Median OS was 9.9 months (95% CI 9.5-10.3), with median follow-up of 39.7 months (95% CI 38.8-40.6). Moderately and severely reduced food intake and CRP independently predicted OS (P < 0.0001). CONCLUSIONS: Modelling WL as the dependent variable is an approach that can help to identify clinical features and biomarkers associated with WL. Here, we identify criterion values for food intake impairment and CRP that may improve the diagnosis and classification of cancer-associated cachexia.

Systematic rapid living review of the impact of the COVID-19 pandemic on cancer survivors: update to August 27, 2020.

BACKGROUND: The COVID-19 pandemic has resulted in drastic changes in the global healthcare delivery landscape and has had practical repercussions for cancer survivors. This systematic rapid living review has been undertaken to synthesise the available knowledge regarding the impact of the COVID-19 pandemic in a timely manner. This initial rapid review will present the findings of literature published up to August 27, 2020. DESIGN: A systematic search of PubMed, Scopus and Google Scholar databases was conducted to identify all articles, available in English language, regarding the impact of the COVID-19 pandemic on cancer survivors published between December 2019 and August 27, 2020. The search strategy employed the following search strings: "covid-19 OR coronavirus OR sars-cov-2" with "cancer survivors OR cancer survivorship". RESULTS: The database search yielded 1639 articles, of which 19 were included. Of the 19 selected articles, there were 12 expert opinion articles, two literature reviews, two prospective cohort studies, one retrospective cohort study, one descriptive study and one pooled meta-analysis that comment on the impact of the COVID-19 pandemic on the physical wellbeing (16 articles), psychosocial wellbeing (15 articles) and financial wellbeing of cancer survivors (3 articles). CONCLUSIONS: Limited definitive evidence exists regarding the impact of the COVID-19 pandemic on cancer survivors. Currently available literature provides preliminary indications of wide-ranging impacts of the pandemic on cancer survivors with respect to the requirement to adapt to new means of healthcare delivery as well as their physical, psychosocial and economic wellbeing. The pandemic has left survivors dealing with the consequences of rigorous cancer treatment in the context of new challenges related to social isolation, financial hardship and uncertainty with respect to their ongoing care. Additional rigorously designed research initiatives are required to elucidate the impact of the pandemic on cancer survivors.

Perceptions of palliative care in a South Asian community: findings from an observational study.

BACKGROUND: Patients often view "palliative care" (PC) as an approach that is synonymous with end-of-life and death, leading to shock and fear. Differing cultural and social norms and religious affiliations greatly determine perception of PC among diverse populations. METHODS: This prospective observational study aimed to explore perceptions of PC among South Asian community members at one Canadian site. Patients who identified themselves as being of South Asian origin were consented and enrolled at a PC Clinic at a community hospital in Brampton, Ontario serving a large South Asian population. Participants filled out an 18-question survey created for the study and responded to a semi-structured interview consisting of 8 questions that further probed their perceptions of PC. Survey responses and semi-structured interviews content were analyzed by four authors who reached consensus on key exploratory findings. RESULTS: Thirty-four participants of South Asian origin were recruited (61.8% males), and they were distributed by their age group as follows: [(30-49) - 18%; (50-64) - 21%; (65-79) - 41%; (≥ 80) - 21%]. Five main exploratory findings emerged: (i) differing attitudes towards talking about death; (ii) the key role of family in providing care; (iii) a significant lack of prior knowledge of PC; (iv) a common emphasis on the importance of alleviating suffering and pain to maintain comfort; and (v) that cultural values, faith, or spiritual belief do not pose a necessary challenge to acceptance of PC services. CONCLUSIONS: Observations from this study provide a source of reference to understand the key findings and variability in perceptions of palliative care in South Asian communities. Culturally competent interventions based on trends observed in this study could assist Palliative Physicians in delivering personalized care to South Asian populations.

Effects of a Cancer Survivorship Clinic-preliminary results.

PURPOSE: Initial investigation of the impact of a Cancer Survivorship Clinic following its introduction in February 2017. METHODS: A systematic chart review of 176 patients enrolled in the Cancer Survivorship Clinic (CSC) who completed a minimum of one follow-up visit after the initial baseline visit. This was assessed using three screening tools: distress thermometer (DT), Canadian Problem Checklist (CPC), and Edmonton Symptom Assessment Scale (ESAS). Descriptive statistics and t tests were utilized to assess the impact of the CSC. RESULTS: Distress thermometer: Statistically significant decline in scores from the baseline visit to the follow-up visit among the study population (p < 0.05). There was a significant decline in score among high-risk patients with an initial DT≥4 (p < 0.0001). Canadian Problem Checklist: Based on the initial baseline visit, the top five reported causes of distress among the study population include pain, anxiety, fatigue, tingling in hands and feet, sleep. Edmonton Symptom Assessment Scale: Statistically significant decline in reported pain, tiredness, nausea, depression, anxiety, drowsiness, and shortness of breath scores (p < 0.05). CONCLUSIONS: Overall, patients had a significant reduction in distress from the baseline visit to the follow-up visit. High-risk patients experienced a more significant reduction in distress. Reduction in patient distress was independent of the number of visits to the clinic. Reported symptom severity for pain, tiredness, depression, anxiety, drowsiness, and shortness of breath also declined significantly following clinic intervention. Further qualitative studies required to establish the clinical significance of study findings. IMPLICATIONS FOR CANCER SURVIVORS: Continued active clinical support and education for cancer survivors should be considered a potentially essential element in the cancer treatment trajectory to address patient well-being and distress.

The effect of ginger (Zingiber officinale Roscoe) in patients with advanced cancer.

BACKGROUND: Anorexia-cachexia syndrome (ACS) is a complex condition in advanced cancer patients, defined by disproportionate loss of skeletal muscle mass, and a lack or loss of appetite. This condition greatly lowers the quality of life and limits the treatment options. ACS is commonly associated with gastrointestinal symptoms such as nausea and vomiting. Ginger has been successful in treating these symptoms but has not yet been tested on patients with advanced cancer. Electrogastrography is a technology that allows the direct recording of the gastric myoelectrical activity (GMA). PURPOSE: The aim of this study is to (1) determine the effects of ginger on the GMA in these patients, (2) evaluate the subjective symptoms using 3 validated scales, and (3) correlate the level of inflammatory factors and ghrelin in this patient population. METHODS: Patients with ACS and advanced cancer were recruited from the Palliative Rehabilitation outpatient program at Elisabeth Bruyère Hospital. Patients were instructed to take a daily capsule of 1650 mg of ginger for 14 days and outcome measures were recorded at pre- and post-intervention, which included a blood test for analysis of CRP, albumin and ghrelin levels, 3 self-administered surveys (DSSI, PG-SGA, ESAS), patient-reported symptoms, and an EGG diagnosis. RESULTS: Fifteen patients with a median age of 58 and varying cancer diagnoses were enrolled. EGG diagnosis showed that 9 of the 15 patients had a direct improvement in their GMA, and all patients showed improvement in reported symptoms, most notably nausea, dysmotility- and reflux-like symptoms. There was no correlation found for ginger administration and inflammatory factors. CONCLUSION: These findings suggest that ginger may improve GMA as measured by EGG and may have a notable effect on symptom improvement.

Recent developments in the clinical pharmacology of rolapitant: subanalyses in specific populations.

Knowledge of the involvement of the neurokinin substance P in emesis has led to the development of the neurokinin-1 receptor antagonists (NK-1 RAs) for control of chemotherapy-induced nausea and vomiting (CINV), in combination with serotonin type 3 receptor antagonists and corticosteroids. The NK-1 RA rolapitant, recently approved in oral formulation, has nanomolar affinity for the NK-1 receptor, as do the other commercially available NK-1 RAs, aprepitant and netupitant. Rolapitant is rapidly absorbed and has a long half-life in comparison to aprepitant and netupitant. All three NK-1 RAs undergo metabolism by cytochrome P450 (CYP) 3A4, necessitating caution with the concomitant use of CYP3A4 inhibitors, but in contrast to aprepitant and netupitant, rolapitant does not inhibit or induce CYP3A4. However, rolapitant is a moderate inhibitor of CYP2D6, and concomitant use with CYP2D6 substrates with narrow therapeutic indices should be avoided. Aprepitant, netupitant, and rolapitant have all demonstrated efficacy in the control of delayed CINV in patients receiving moderately and highly emetogenic chemotherapy in randomized controlled trials, including over multiple cycles of chemotherapy. We reviewed recent post hoc analyses of clinical trial data demonstrating that rolapitant is efficacious in the control of CINV in patient populations with specific tumor types, namely, breast cancers, gastrointestinal/colorectal cancers, and lung cancers. In addition, we show that rolapitant has efficacy in the control of CINV in specific age groups of patients receiving chemotherapy (<65 and ≥65 years of age). Overall, the safety profile of rolapitant in these specific patient populations was consistent with that observed in primary analyses of phase 3 trials.

Reported distress in patients living with advanced cancer: changes pre-post interdisciplinary palliative rehabilitation.

PURPOSE: Patients are living extended life with advanced cancer making it chronic rather than imminently terminal. Literature on the experience of living with advanced cancer is emerging, indicating ongoing polysymptomatic burden, lack of information, burnout (patients and caregivers), and emotional concerns, all of which contribute to emotional distress. The interdisciplinary Ottawa Palliative Rehabilitation Program (PRP) offers a scarce clinical resource for this population. The current research aimed to explore changes in self-reported distress for patients who completed the PRP, from baseline to program completion. METHODS: A secondary analysis of self-report and clinical measures was performed for 180 patients who completed the PRP. Measures included the Distress Thermometer and the Problem checklists. Descriptive statistics described the sample, paired-sample t tests examined changes in Distress Thermometer scores from baseline to PRP completion, and McNemar's tests revealed whether the most commonly endorsed checklist items changed by PRP completion. RESULTS: Participants (n = 180) had advanced heterogeneous cancers (mean age = 62.18, 49.4% male). From baseline to completion, significant reported changes included decreases in endorsement of clinical distress (from 55.6 to 38.9%; p < 0.001) and decreases in 7/10 of the most commonly endorsed checklist problems (p values ranging from 0.016 to <0.001). CONCLUSIONS: A number of endorsed checklist problems significantly decreased, as did overall self-reported distress. Compared to the existing literature that does not show improvements, our finding begins to support that palliative rehabilitation may benefit patient levels of distress by improving function and quality of life. Psychotherapy, anesthesia, and additional intervention for cognitive difficulties may further benefit patients.

The longitudinal course of depression symptomatology following a palliative rehabilitation program.

PURPOSE: Patients with advanced cancer have increased life expectancy but suffer from ongoing burden. Depressive symptomatology is their most common mental health concern. The Ottawa Palliative Rehabilitation Program (PRP) offers rehabilitation for this population. It offers 8 weeks of individualized interdisciplinary rehabilitation, post cancer treatment. Interventions include medical (physician and nurse), physiotherapy, occupational therapy, dietary, and social work using a general self-efficacy framework. Pilot data suggest benefits in a range of domains, including ratings of feeling "depressed." We examined whether reduced symptomatology was maintained 3 months after PRP completion. METHODS: Participants with advanced heterogeneous cancers who completed the PRP were mailed the Hospital Anxiety and Depression Scale (among others) 3-month post-PRP (n = 44). Demographic and medical information were obtained from patient files. RESULTS: There was a significant linear trend (mean T1: 6.79 ± 2.29; T2: 5.23 ± 3.06; T3: 4.59 ± 3.34; p = 0.007) with statistically and clinically significant decreases in reported depressive symptomatology between T1 and T2 (p = 0.042) and T1 and T3 (p = 0.007). There was a significant decreases in number of cases reporting symptomatology scores in the clinical range from T1 to T3 (p = 0.038). CONCLUSION: Patients who undergo a palliative rehabilitation program may experience relief of mild depressive symptomatology, maintainable 3-month post-PRP. The sample was exhibiting mild symptomatology and these results may not be generalizable to those with higher scores; a lack of specialized psychosocial clinician may have affected the acquired sample. Experimental designs are needed to more thoroughly compare these findings to independent rehabilitation interventions.

Effect of Standard Radiotherapy With Cisplatin vs Accelerated Radiotherapy With Panitumumab in Locoregionally Advanced Squamous Cell Head and Neck Carcinoma: A Randomized Clinical Trial.

IMPORTANCE: The Canadian Cancer Trials Group study HN.6 is the largest randomized clinical trial to date comparing the concurrent administration of anti-epidermal growth factor receptor (EGFR) monoclonal antibodies with radiotherapy (RT) to standard chemoradiotherapy in locoregionally advanced squamous cell carcinoma of the head and neck (LA-SCCHN). OBJECTIVE: To compare progression-free survival (PFS) in patients with LA-SCCHN treated with standard-fractionation RT plus high-dose cisplatin vs accelerated-fractionation RT plus the anti-EGFR antibody panitumumab. DESIGN, SETTING, AND PARTICIPANTS: A randomized phase 3 clinical trial in 17 Canadian centers. A total of 320 patients were randomized between December 2008 and November 2011. INTERVENTIONS: Patients with TanyN+M0 or T3-4N0M0 LA-SCCHN were randomized 1:1 to receive standard-fractionation RT (70 Gy/35 over 7 weeks) plus cisplatin at 100 mg/m2 intravenous for 3 doses (arm A) vs accelerated-fractionation RT (70 Gy/35 over 6 weeks) plus panitumumab at 9 mg/kg intravenous for 3 doses (arm B). MAIN OUTCOMES AND MEASURES: Primary end point was PFS. Due to an observed declining event rate, the protocol was amended to a time-based analysis. Secondary end points included overall survival, local and regional PFS, distant metastasis-free survival, quality of life, adverse events, and safety. RESULTS: Of 320 patients randomized (268 [84%] male; median age, 56 years), 156 received arm A and 159 arm B. A total of 93 PFS events occurred. By intention-to-treat, 2-year PFS was 73% (95% CI, 65%-79%) in arm A and 76% (95% CI, 68%-82%) in arm B (hazard ratio [HR], 0.95; 95% CI, 0.60-1.50; P = .83). The upper bound of the HR 95% CI exceeded the prespecified noninferiority margin. Two-year overall survival was 85% (95% CI, 78%-90%) in arm A and 88% (95% CI, 82%-92%) in arm B (HR, 0.89; 95% CI, 0.54-1.48; P = .66). Incidence of any grade 3 to 5 nonhematologic adverse event was 88% in arm A and 92% in arm B (P = .25). CONCLUSIONS AND RELEVANCE: With a median follow-up of 46 months, the PFS of panitumumab plus accelerated-fractionation RT was not superior to cisplatin plus standard-fractionation RT in LA-SCCHN and noninferiority was not proven. Despite having negative results, HN.6 has contributed important data regarding disease control and toxic effects of these treatment strategies. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00820248.

Oncology Nurses' Attitudes Toward the Edmonton Symptom Assessment System: Results From a Large Cancer Care Ontario Study.

PURPOSE/OBJECTIVES: To examine oncology nurses' attitudes toward and reported use of the Edmonton Symptom Assessment System (ESAS) and to determine whether the length of work experience and presence of oncology certification are associated with their attitudes and reported usage.
. DESIGN: Exploratory, mixed-methods study employing a questionnaire approach.
. SETTING: 14 regional cancer centers (RCCs) in Ontario, Canada.
. SAMPLE: Oncology nurses who took part in a larger province-wide study that surveyed 960 interdisciplinary providers in oncology care settings at all of Ontario's 14 RCCs.
. METHODS: Oncology nurses' attitudes and use of ESAS were measured using a 21-item investigator-developed questionnaire. Descriptive statistics and Kendall's tau-b or tau-c test were used for data analyses. Qualitative responses were analyzed using content analysis.
. MAIN RESEARCH VARIABLES: Attitudes toward and self-reported use of standardized symptom screening and ESAS.
. FINDINGS: More than half of the participants agreed that ESAS improves symptom screening, most said they would encourage their patients to complete ESAS, and most felt that managing symptoms is within their scope of practice and clinical responsibilities. Qualitative comments provided additional information elucidating the quantitative responses. Statistical analyses revealed that oncology nurses who have 10 years or less of work experience were more likely to agree that the use of standardized, valid instruments to screen for and assess symptoms should be considered best practice, ESAS improves symptom screening, and ESAS enables them to better manage patients' symptoms. No statistically significant difference was found between oncology-certified RNs and noncertified RNs on attitudes or reported use of ESAS.
. CONCLUSIONS: Implementing a population-based symptom screening approach is a major undertaking. The current study found that oncology nurses recognize the value of standardized screening, as demonstrated by their attitudes toward ESAS.
. IMPLICATIONS FOR NURSING: Oncology nurses are integral to providing high-quality person-centered care. Using standardized approaches that enable patients to self-report symptoms and understanding barriers and enablers to optimal use of patient-reported outcome tools can improve the quality of patient care.

Rolapitant improves quality of life of patients receiving highly or moderately emetogenic chemotherapy.

PURPOSE: Addition of rolapitant to standard antiemetic therapy improved protection against chemotherapy-induced nausea and vomiting (CINV) in phase 3 trials of patients receiving highly emetogenic chemotherapy (HEC) or moderately emetogenic chemotherapy (MEC). Here, we assessed the impact of CINV on the daily lives of patients receiving HEC or MEC using the Functional Living Index-Emesis (FLIE). METHODS: In three double-blind phase 3 studies, patients receiving HEC or MEC were randomized 1:1 to receive oral rolapitant 180 mg or placebo prior to chemotherapy plus 5-hydroxytryptamine type 3 receptor antagonist and dexamethasone therapy. Patients completed the FLIE questionnaire on day 6 of cycle 1. Endpoints included FLIE total score, nausea and vomiting domain scores, and the proportion of patients with no impact on daily life (total score >108 [range 18-126]). We performed a prespecified analysis of the MEC/anthracycline-cyclophosphamide (AC) study and a post hoc analysis of two pooled cisplatin-based HEC studies. RESULTS: In the pooled HEC studies, rolapitant significantly improved the FLIE total score (114.5 vs 109.3, p < 0.001), nausea score (55.3 vs 53.5, p < 0.05), and vomiting score (59.2 vs 55.8, p < 0.001) versus control; similar results were observed in the MEC/AC study for FLIE total score (112.7 vs 108.6, p < 0.001), nausea score (54.1 vs 52.3, p < 0.05), and vomiting score (58.6 vs 56.3, p < 0.001). A higher proportion of patients reported no impact on daily life with rolapitant than with control in the MEC/AC study (73.2 vs 67.4, p = 0.027). CONCLUSIONS: Compared with control, rolapitant improved quality of life in patients receiving HEC or MEC.

Rolapitant for the treatment of chemotherapy-induced nausea and vomiting: a review of the clinical evidence.

Chemotherapy-induced nausea and vomiting (CINV), both acute and delayed, has a dramatic effect on the well-being and quality of life of patients with cancer. Improved understanding of the mechanisms involved in CINV has led to the development of agents targeting the 5-HT3 receptor as well as the NK-1 receptor. Antiemetic prophylaxis given to patients receiving highly emetogenic chemotherapy combines agents blocking the 5-HT3 and NK-1 receptors along with corticosteroids given regularly and repeatedly. Rolapitant is a long-acting NK-1 receptor antagonist with proven efficacy in controlling CINV as part of the prophylaxis regimen. This review will detail the clinical efficacy and safety of rolapitant in the treatment of patients with cancer receiving highly or moderately emetogenic chemotherapy.

Efficacy and safety of rolapitant for prevention of chemotherapy-induced nausea and vomiting over multiple cycles of moderately or highly emetogenic chemotherapy.

OBJECTIVE: Rolapitant, a novel neurokinin-1 receptor antagonist (RA), was shown to protect against delayed chemotherapy-induced nausea and vomiting (CINV) during the first cycle of moderately emetogenic chemotherapy (MEC) or highly emetogenic chemotherapy (HEC) in randomized, double-blind trials. This analysis explored the efficacy and safety of rolapitant in preventing CINV over multiple cycles of MEC or HEC. PATIENTS AND METHODS: Patients in one phase III MEC, one phase II HEC, and two phase III HEC clinical trials were randomized to receive oral rolapitant (180 mg) or placebo in combination with a 5-hydroxytryptamine type 3 RA and dexamethasone. Regardless of response in cycle 1, patients could continue the same antiemetic treatment for up to six cycles. On days 6-8 of each subsequent chemotherapy cycle, patients reported the incidence of emesis and/or nausea interfering with normal daily life. Post hoc analyses of pooled safety and efficacy data from the four trials were performed for cycles 2-6. RESULTS: Significantly more patients receiving rolapitant than control reported no emesis or interfering nausea (combined measure) in cycles 2 (p = 0.006), 3 (p < 0.001), 4 (p = 0.001), and 5 (p = 0.021). Over cycles 1-6, time-to-first emesis was significantly longer with rolapitant than with control (p < 0.001). The incidence of treatment-related adverse events during cycles 2-6 was similar in rolapitant (5.5%) and control (6.8%) arms. No cumulative toxicity was observed. CONCLUSIONS: Over multiple cycles of MEC or HEC, rolapitant provided superior CINV protection and reduced emesis and nausea interfering with daily life compared with control and remained well tolerated.