Summary Background Patients with advanced cancer frequently experience anorexia and cachexia, which are associated with reduced food intake, altered body composition, and decreased functionality. We ...assessed anamorelin, a novel ghrelin-receptor agonist, on cachexia in patients with advanced non-small-cell lung cancer and cachexia. Methods ROMANA 1 and ROMANA 2 were randomised, double-blind, placebo-controlled phase 3 trials done at 93 sites in 19 countries. Patients with inoperable stage III or IV non-small-cell lung cancer and cachexia (defined as ≥5% weight loss within 6 months or body-mass index <20 kg/m2 ) were randomly assigned 2:1 to anamorelin 100 mg orally once daily or placebo, with a computer-generated randomisation algorithm stratified by geographical region, cancer treatment status, and weight loss over the previous 6 months. Co-primary efficacy endpoints were the median change in lean body mass and handgrip strength over 12 weeks and were measured in all study participants (intention-to-treat population). Both trials are now completed and are registered with ClinicalTrials.gov , numbers NCT01387269 and NCT01387282. Findings From July 8, 2011, to Jan 28, 2014, 484 patients were enrolled in ROMANA 1 (323 to anamorelin, 161 to placebo), and from July 14, 2011, to Oct 31, 2013, 495 patients were enrolled in ROMANA 2 (330 to anamorelin, 165 to placebo). Over 12 weeks, lean body mass increased in patients assigned to anamorelin compared with those assigned to placebo in ROMANA 1 (median increase 0·99 kg 95% CI 0·61 to 1·36 vs −0·47 kg –1·00 to 0·21, p<0·0001) and ROMANA 2 (0·65 kg 0·38 to 0·91 vs −0·98 kg –1·49 to −0·41, p<0·0001). We noted no difference in handgrip strength in ROMANA 1 (−1·10 kg –1·69 to −0·40 vs −1·58 kg –2·99 to −1·14, p=0·15) or ROMANA 2 (−1·49 kg –2·06 to −0·58 vs −0·95 kg –1·56 to 0·04, p=0·65). There were no differences in grade 3–4 treatment-related adverse events between study groups; the most common grade 3–4 adverse event was hyperglycaemia, occurring in one (<1%) of 320 patients given anamorelin in ROMANA 1 and in four (1%) of 330 patients given anamorelin in ROMANA 2. Interpretation Anamorelin significantly increased lean body mass, but not handgrip, strength in patients with advanced non-small-cell lung cancer. Considering the unmet medical need for safe and effective treatments for cachexia, anamorelin might be a treatment option for patients with cancer anorexia and cachexia. Funding Helsinn Therapeutics.
Background.
Oral antineoplastic therapies not only improve survival but also reduce the burden of care for patients. Yet patients and clinicians face new challenges in managing adherence to these ...oral therapies. We conducted a systematic literature review to assess rates and correlates of adherence to oral antineoplastic therapies and interventions aimed at improving adherence.
Methods.
Following Preferred Reporting Items for Systematic Reviews and Meta‐Analyses guidelines, we conducted a comprehensive literature search of the Ovid MEDLINE database from January 1, 2003 to June 30, 2015, using relevant terminology for oral antineoplastic agents. We included observational, database, and intervention studies. At least two researchers evaluated each paper to ensure accuracy of results and determine risk of bias.
Results.
We identified 927 records from the search and screened 214 s. After conducting a full‐text review of 167 papers, we included in the final sample 51 papers on rates/correlates of adherence to oral antineoplastic therapy and 12 papers on intervention studies to improve adherence. Rates of adherence varied widely, from 46% to 100%, depending on patient sample, medication type, follow‐up period, assessment measure, and calculation of adherence. Of the intervention studies, only 1 of the randomized trials and 2 of the cohort studies showed benefit regarding adherence, with the majority suffering high risk of bias.
Conclusions.
Although no reliable estimate of adherence to oral antineoplastic therapies can be gleaned from the literature, a substantial proportion of patients struggle to adhere to these medications as prescribed. The few intervention studies for adherence have notable methodological concerns, thereby limiting the evidence to guide practice in promoting medication adherence among patients with cancer.
Implications for Practice:
Given the tremendous growth and development of oral antineoplastic therapies in the last decade, significant gaps have emerged in oncology practice with respect to standardized procedures for safe administration, monitoring, and management of these medications. Although rates of adherence to oral antineoplastic therapies vary widely depending on population, cancer type, and method of measurement, a substantial proportion of patients struggle to take their oral antineoplastic medications as prescribed. On the basis of current evidence and national recommendations, oncology practices should develop standard procedures for educating patients, reviewing and documenting treatment plans, and routinely monitoring patient adherence to oral antineoplastic therapies.
Although no reliable estimate of adherence to oral antineoplastic therapies can be gleaned from the literature, a substantial proportion of patients struggle to adhere to these medications as prescribed. The few intervention studies for adherence have notable methodological concerns, thereby limiting the evidence to guide practice in promoting medication adherence among patients with cancer.
Purpose To provide evidence-based recommendations to oncology clinicians, patients, family and friend caregivers, and palliative care specialists to update the 2012 American Society of Clinical ...Oncology (ASCO) provisional clinical opinion (PCO) on the integration of palliative care into standard oncology care for all patients diagnosed with cancer. Methods ASCO convened an Expert Panel of members of the ASCO Ad Hoc Palliative Care Expert Panel to develop an update. The 2012 PCO was based on a review of a randomized controlled trial (RCT) by the National Cancer Institute Physicians Data Query and additional trials. The panel conducted an updated systematic review seeking randomized clinical trials, systematic reviews, and meta-analyses, as well as secondary analyses of RCTs in the 2012 PCO, published from March 2010 to January 2016. Results The guideline update reflects changes in evidence since the previous guideline. Nine RCTs, one quasiexperimental trial, and five secondary analyses from RCTs in the 2012 PCO on providing palliative care services to patients with cancer and/or their caregivers, including family caregivers, were found to inform the update. Recommendations Inpatients and outpatients with advanced cancer should receive dedicated palliative care services, early in the disease course, concurrent with active treatment. Referral of patients to interdisciplinary palliative care teams is optimal, and services may complement existing programs. Providers may refer family and friend caregivers of patients with early or advanced cancer to palliative care services.
The evidence base demonstrating the benefits of an early focus on palliative care for patients with serious cancers, including advanced lung cancer, is substantial. Early involvement of ...specialty-trained palliative care clinicians in the care of patients with advanced lung cancer improves patient-reported outcomes, such as quality of life, and health care delivery, including hospice utilization. Since the time that many of these palliative care trials were conducted, the paradigm of cancer care for many cancers, including lung cancer, has changed dramatically. The majority of patients with advanced lung cancer are now treated with immune checkpoint inhibitors or targeted therapies, both of which have had a significant impact on patient's experience and outcomes. With this changing landscape of lung cancer therapeutics, patients are facing new and different challenges, including dealing with novel side effect profiles and coping with greater uncertainty regarding their prognosis. Patients who are living longer with their advanced cancer also struggle with how to address survivorship issues, such as sexual health and exercise, and decision making about end-of-life care. Although palliative care clinicians remain well-suited to address these care needs, they may need to learn new skills to support patients treated with novel therapies. Additionally, as the experience of patients with advanced lung cancer is becoming more varied and individualized, palliative care research interventions and clinical programs should also be delivered in a patient-centered manner to best meet patient's needs and improve their outcomes. Tailored and technology-based palliative care interventions are promising strategies for delivering patient-centered palliative care.
It is critical for patients with hematologic malignancies to have an accurate understanding of their illness and prognosis to make informed treatment decisions. Illness and prognostic understanding ...have primarily been studied in patients with solid tumors, however, data in patients with hematologic malignancies are rapidly growing. Patients with hematologic malignancies often face a unique and unpredictable illness trajectory with the possibility of cure persisting even in relapsed and refractory settings. These patients often require intensive therapies such as high-dose chemotherapy, hematopoietic stem cell transplantation (HCT), or CAR T-cell therapy, which carry with them significant risk of morbidity, mortality, and prognostic uncertainty. In this review article, we first described the current literature on illness and prognostic understanding in patients with hematologic malignancies including 1) patients' varying desire for prognostic information; (2) patients' prognostic misperceptions, (3) the association between patients' prognostic understanding and their psychological outcomes; and (4) barriers to prognostic understanding. Next, we examined insights gained from the literature about illness and prognostic understanding in patients with solid tumors to guide our understanding of the research gaps in hematologic malignancies. Future studies are needed to better delineate the longitudinal relationship between prognostic understanding, psychological distress, and coping in patients with hematologic malignancies. Strategies such as communicating effectively about prognosis, cultivating adaptive coping in the face of a terminal prognosis, and integrating specialty palliative care for patients with hematologic malignancies have the potential to improve patients' prognostic understanding and their quality of life and care.
For most patients with serious illness, palliative care is provided only near the end of life. The authors review studies showing that earlier palliative care can improve quality of life and reduce ...health care costs and argue that such care should be standard in serious illness.
Palliative care suffers from an identity problem. Seventy percent of Americans describe themselves as “not at all knowledgeable” about palliative care, and most health care professionals believe it is synonymous with end-of-life care.
1
This perception is not far from current medical practice, because specialty palliative care — administered by clinicians with expertise in palliative medicine — is predominantly offered through hospice care or inpatient consultation only after life-prolonging treatment has failed. Limiting specialty palliative care to those enrolled in hospice or admitted to the hospital ignores the majority of patients facing a serious illness, such as advanced cancer, who have . . .
Introduction
Survival prediction for patients with incurable malignancies is invaluable information during end-of-life discussions, as it helps the healthcare team to appropriately recommend ...treatment options and consider hospice enrolment. Assessment of performance status may differ between different healthcare professionals (HCPs), which could have implications in predicting prognosis. The aim of this systematic review and meta-analysis is to update a prior systematic review with recent articles, as well as conduct a meta-analysis to quantitatively compare performance status scores.
Methods
A literature search was carried out in Ovid MEDLINE, Embase, and Cochrane Central Register of Controlled Trials, from the earliest date until the first week of August 2019. Studies were included if they reported on (1) Karnofsky Performance Status (KPS), Eastern Cooperative Oncology Group (ECOG) Performance Status, and/or Palliative Performance Scale (PPS) and (2) assessment of performance status by multiple HCPs for the same patient sets. The concordance statistics (Kappa, Krippendorff’s alpha, Kendall correlation, Spearman rank correlation, Pearson correlation) were extracted into a summary table for narrative review, and Pearson correlation coefficients were calculated for each study and meta-analyzed with a random effects analysis model. Analyses were conducted using Comprehensive Meta-Analysis (Version 3) by Biostat.
Results
Fourteen articles were included, with a cumulative sample size of 2808 patients. The Pearson correlation coefficient was 0.787 (95% CI: 0.661, 0.870) for KPS, 0.749 (95% CI: 0.716, 0.779) for PPS, and 0.705 (95% CI: 0.536, 0.819) for ECOG. Four studies compared different tools head-to-head; KPS was favored in three studies. The quality of evidence was moderate, as determined by the GRADE tool.
Conclusions
The meta-analysis’s Pearson correlation coefficient ranged from 0.705 to 0.787; there is notable correlation of performance status scores, with no one tool statistically superior to others. KPS is, however, descriptively better and favored in head-to-head trials. Future studies could now examine the accuracy of KPS assessment in prognostication and focus on model-building around KPS.
Purpose Inpatient palliative care integrated with transplant care improves patients' quality of life (QOL) and symptom burden during hematopoietic stem-cell transplant (HCT). We assessed patients' ...mood, post-traumatic stress disorder (PTSD) symptoms, and QOL 6 months post-transplant. Methods We randomly assigned 160 patients with hematologic malignancies who underwent autologous or allogeneic HCT to inpatient palliative care integrated with transplant care (n = 81) or transplant care alone (n = 79). At baseline and 6 months post-transplant, we assessed mood, PTSD symptoms, and QOL with the Hospital Anxiety and Depression Scale and Patient Health Questionnaire, PTSD checklist, and Functional Assessment of Cancer Therapy-Bone Marrow Transplant. To assess symptom burden during HCT, we used the Edmonton Symptom Assessment Scale. We used analysis of covariance while controlling for baseline values to examine intervention effects and conducted causal mediation analyses to examine whether symptom burden or mood during HCT mediated the effect of the intervention on 6-month outcomes. Results We enrolled 160 (86%) of 186 potentially eligible patients between August 2014 and January 2016. At 6 months post-transplant, intervention participants reported lower depression symptoms on the Hospital Anxiety and Depression Scale and Patient Health Questionnaire (adjusted mean difference, -1.21 95% CI, -2.26 to -0.16; P = .024 and -1.63 95% CI, -3.08 to -0.19; P = .027, respectively) and lower PTSD symptoms (adjusted mean difference, -4.02; 95% CI, -7.18 to -0.86; P = .013), but no difference in QOL or anxiety. Symptom burden and anxiety during HCT hospitalization partially mediated the effect of the intervention on depression and PTSD at 6 months post-transplant. Conclusion Inpatient palliative care integrated with transplant care leads to improvements in depression and PTSD symptoms at 6 months post-transplant. Reduction in symptom burden and anxiety during HCT partially accounts for the effect of the intervention on these outcomes.
Prior research shows that introducing palliative care soon after diagnosis for patients with metastatic non-small-cell lung cancer (NSCLC) is associated with improvements in quality of life, mood, ...and survival. We sought to investigate whether early palliative care also affects the frequency and timing of chemotherapy use and hospice care for these patients.
This secondary analysis is based on a randomized controlled trial of 151 patients with newly diagnosed metastatic NSCLC presenting to an outpatient clinic at a tertiary cancer center from June 2006 to July 2009. Participants received either early palliative care integrated with standard oncology care or standard oncology care alone. By 18-month follow-up, 133 participants (88.1%) had died. Outcome measures included: first, number and types of chemotherapy regimens, and second, frequency and timing of chemotherapy administration and hospice referral.
The overall number of chemotherapy regimens did not differ significantly by study group. However, compared with those in the standard care group, participants receiving early palliative care had half the odds of receiving chemotherapy within 60 days of death (odds ratio, 0.47; 95% CI, 0.23 to 0.99; P = .05), a longer interval between the last dose of intravenous chemotherapy and death (median, 64.00 days range, 3 to 406 days v 40.50 days range, 6 to 287 days; P = .02), and higher enrollment in hospice care for longer than 1 week (60.0% 36 of 60 patients v 33.3% 21 of 63 patients; P = .004).
Although patients with metastatic NSCLC received similar numbers of chemotherapy regimens in the sample, early palliative care optimized the timing of final chemotherapy administration and transition to hospice services, key measures of quality end-of-life care.
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