Functional Assessment Of Chronic Illness Therapy-Fatigue Research Articles

Patient-reported outcomes (PROs) with ibrutinib-rituximab in Waldenström macroglobulinemia (WM): Results from iNNOVATE.

8018 Background: Anemia and fatigue can impair quality of life in patients (pts) with WM. Ibrutinib (ibr) as single agent or in combination with RTX is FDA-approved for WM. In pts with RTX-refractory WM, single-agent ibr induced meaningful improvements in PROs (Trotman, EHA 2017). In iNNOVATE, ibr-RTX (IR) produced higher rates of sustained hemoglobin improvement and meaningful improvements in PROs versus placebo-RTX (R; Dimopoulos NEJM 2018). Here, we report detailed PRO analyses from iNNOVATE. Methods: Pts with symptomatic WM requiring therapy were randomized to daily 420 mg oral ibr or placebo, both with RTX (375 mg/m2/week IV at weeks 1–4 and 17–20). PRO measures included FACIT-Fatigue (FACIT-F), FACT-An total score (TS) and anemia subscale score (AS), and EQ-5D-5L (EuroQol Research Foundation. EQ-5D is a trade mark of the EuroQol Research Foundation) visual analog scale (VAS), and utility score (US). Results: For 150 randomized pts (n=75/arm), most common reasons for initiating therapy were fatigue (61%), constitutional symptoms (32%), and anemia (32%). Baseline PRO scores were comparable in both arms. At a median follow-up of 26.5 mo, numerically more pts showed clinically meaningful improvement in FACIT-F, TS, and AS with IR than R (Table). Median time to PRO improvement was short (1-2 mo) in both arms. At week 25, the Pearson correlation coefficients were 0.28, 0.29, and 0.26 for changes in hemoglobin levels vs changes in FACIT-F, TS and AS, respectively, in the IR arm; no meaningful correlations were observed on R. The correlation coefficients were -0.32, -0.33, -0.35 and -0.26 for changes in IgM levels vs changes in FACIT-F, TS, AS, and EQ-VAS, respectively, for IR and 0.29 and 0.35 vs FACIT-F and TS for R. Conclusions: Clinical response and improvements in anemia with IR are consistent with more pts showing clinically meaningful improvement in PROs versus R. Changes in IgM correlate with improvements in PROs. Clinical trial information: NCT02165397. [Table: see text]

PMS48 A LANDSCAPE ASSESSMENT OF STAND-ALONE PATIENT-REPORTED OUTCOME (PRO) MEASURES USED IN CLINICAL TRIALS FOR RHEUMATOID ARTHRITIS (RA)

PROs can be used to measure symptom severity, patient function, and patient satisfaction. Typically, clinical trials for RA include composite endpoints, such as the American College of Rheumatology Score (i.e. ACR20) which includes a PRO component, as primary endpoints. Other PRO measures in RA are “stand-alone” (i.e. evaluated by themselves) and could provide more information on the condition and its impacts. The objective of this study was to identify stand-alone PRO measures used in adult RA clinical trials. Interventional (pharmaceutical), phase III, ongoing and completed clinical trials in adults with RA in the United States, Canada, France, Germany, Italy, Spain, United Kingdom, and Japan were identified using ClinicalTrials.gov. Trials were limited between December 2013 and December 2018, and were evaluated to identify stand-alone PRO measures. PRO measures were stratified into generic, condition-specific, or RA-specific through a PRO database or PubMed search. Of 2,267 trials, 11 trials met inclusion criteria and 17 unique stand-alone PRO measures were identified. Most of the commonly used PRO measures were not RA-specific, such as the Health Assessment Questionnaire Disability Index (HAQ-DI) (11 trials), Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F) (6 trials), Short Form-36 (SF-36) (3 trials), and EuroQol-5D (EQ-5D) (3 trials). Additionally, the 8 identified RA-specific measures were only used once each among included trials. While 8 of the 17 measures identified were RA-specific, they were not widely used. Most clinical trials conducted within the past 5 years used generic or condition-specific PRO measures focused on physical function and overall health-related quality of life, without being specific to RA. Other measures used infrequently include ones that focused on sleep, mood, and work productivity. Future research should focus on conducting a gap analysis of RA-specific PROs measures to determine which measures are fit-for-purpose for inclusion in future clinical trials.

Evaluation of fatigue in inflammatory bowel disease - a useful tool in daily practice

Background: Fatigue is a common symptom reported in inflammatory bowel disease (IBD) patients. It can be severe and modify the self-perception of disease.Objective: To evaluate the contribution of clinical and demographic factors to the level of fatigue in IBD patients.Methods: Patients consecutively observed in an outpatient IBD clinic during a 9-month period were studied. Demographic and clinical data were collected. Fatigue was assessed using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F). A FACIT-F score <30 was considered as severe fatigue.Results: One hundred and five patients were evaluated. Of them, 57.1% had Crohn´s Disease (CD) and 42.9% had Ulcerative Colitis. Also 85.0% and 77.8% were in clinical remission, respectively. The mean FACIT-F score was 39.63 ± 9.67. Severe fatigue was observed in 17.1% of patients. Female gender and active CD were significantly associated with a severe level of fatigue (p = .05 and p = .04). There was no significant correlation between the level of fatigue (severe vs. non-severe) and type of IBD, hemoglobin, C-reactive protein, ferritin levels or previous surgeries. Patients under biological therapy had a significantly higher level of fatigue and a higher rate of previous hospitalizations (p = .02).Conclusions: Fatigue level is a simple and useful tool to evaluate the disease’s impact in patients’ life, and it should, therefore, be included in clinical practice. Biological therapy was associated to higher levels of fatigue. Future studies should evaluate the impact of therapy on the level of fatigue.

Subjective, but not objective, cognitive complaints impact long-term quality of life in cancer patients

Objectives: Cognitive complaints, of objective or subjective nature, may negatively impact cancer patients’ quality of life (QoL). Further, the early detection of cognitive alterations may lead to an improved QoL. However, the content of such screening is yet unclear. This paper presents long-term QoL data of cancer patients treated with curative intent and its relation with objective and subjective cognitive complaints, and patient-reported outcome measures (PROMs).Methods: QoL data, measured by the EORTC QLQ C-30, were obtained at baseline, 6 (T1), 12 (T2), and 24 months (T3) after treatment start, and compared between patients with and without objective and subjective cognitive complaints. The predictive value of PROMs was also examined.Results: QoL data at baseline was collected in 125 patients. Response rates at T1, T2, and T3 were 84.7%, 81.5%, and 83.1%, respectively. Eighty-nine patients returned their QoL questionnaires at all times. Baseline subjective cognitive complaints had a stronger association with worse scores on patients’ overall QoL and QoL subscale scores than objective cognitive complaints. An exploratory analysis into the value of PROMs in predicting long-term QoL at T3 revealed a significant effect for the Hospital Anxiety and Depression Scale-Depression and FACIT Fatigue scale.Conclusions: Self-perceived cognitive alterations are negatively associated with patients’ overall QoL. As these troubles may already be present at baseline, oncology nurses should screen for the early signs of subjective cognitive complaints by use of PROMs, in order to refer the patient to proper intervention programs which may lead to an improved long-term QoL and faster reintegration into society.

Treatment outcomes in patients with seropositive versus seronegative rheumatoid arthritis in Phase III randomised clinical trials of tofacitinib

ObjectivesTofacitinib is an oral JAK inhibitor for the treatment of rheumatoid arthritis (RA). We examined response to tofacitinib 5 or 10 mg two times a day in patients with seropositive...

Improved patient-reported outcomes in patients with psoriatic arthritis treated with abatacept: results from a phase 3 trial

BackgroundTo explore the effect of abatacept treatment on patient-reported outcomes (PROs) in psoriatic arthritis (PsA).MethodsPatients with PsA were randomised (1:1) to subcutaneous abatacept 125 mg weekly/placebo for 24 weeks with early escape (EE) to open-label abatacept (week 16). Adjusted mean changes from baseline to weeks 16 (all patients) and 24 (non-EE responders) in Health Assessment Questionnaire-Disability Index (HAQ-DI), Short Form-36 (SF-36; physical and mental component summary and domains), Dermatology Life Quality Index and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) were evaluated. Subpopulations were analysed by baseline C-reactive protein (CRP) level (> vs ≤ upper limit of normal [ULN]) and prior tumour necrosis factor inhibitor (TNFi) exposure. Proportions of patients reporting improvements ≥ minimal clinically important differences (MCIDs) and ≥ normative values (NVs) in HAQ-DI, SF-36 and FACIT-F (week 16 before EE) were analysed.ResultsIn total population, numerically higher improvements in most PROs were reported with abatacept (n = 213) versus placebo (n = 211) at both time points (P > 0.05). Higher proportions of abatacept versus placebo patients reported PRO improvements ≥ MCID and ≥ NV at week 16. At week 16, all PRO improvements were numerically greater (P > 0.05) in patients with baseline CRP > ULN versus CRP ≤ ULN (all significant [95% confidence interval] for abatacept vs placebo); improvements in SF-36 component summaries and FACIT-F were greater in TNFi-naïve versus TNFi-exposed patients (abatacept > placebo). Week 24 subgroup data were difficult to interpret due to low patient numbers.ConclusionsAbatacept treatment improved PROs in patients with PsA versus placebo, with better results in elevated baseline CRP and TNFi-naïve subpopulations.Trial registrationClinicalTrials.gov number, NCT01860976 (funded by Bristol-Myers Squibb); date of registration: 23 May 2013.

Changes in health-related quality of life with long-term eltrombopag treatment in adults with persistent/chronic immune thrombocytopenia: Findings from the EXTEND study.

Patients with persistent/chronic immune thrombocytopenia (cITP) have low platelet counts, increased risk of bleeding and bruising, and often suffer from reduced health‐related quality of life (HRQoL). cITP treatments may either improve HRQoL by increasing platelet counts or decrease it because of side effects. The open‐label EXTEND study (June 2006 to July 2015) evaluated long‐term safety, tolerability, and efficacy of eltrombopag (an oral thrombopoietin‐receptor‐agonist) in adults with cITP who completed a previous eltrombopag ITP trial. The final results of EXTEND were published and used to assess changes in patient‐reported HRQoL over time and association between HRQoL and platelet response. Four validated HRQoL instruments were administered: SF‐36v2 including physical component summary (PCS) and Mental Component Summary; Motivation and Energy Inventory Short Form (MEI‐SF); Fatigue Subscale of FACIT (FACIT‐Fatigue); and FACT‐Thrombocytopenia Subscale Six‐Item Extract (FACT‐Th6). For the 302 patients enrolled, median duration of eltrombopag treatment was 2.37 years. All 4 HRQoL instruments demonstrated positive mean changes from baseline over time adjusted for patient baseline characteristics and rescue therapy use, and had positive association with platelet response (platelet count ≥30 × 109/L; ≥50 × 109/L; and ≥50 × 109/L and >2 times baseline). Improvements from baseline started within 3 months and persisted through 5 years of treatment for FACIT‐Fatigue and FACT‐Th6 (P <.05 for nearly all time points); through 2.5 years for SF‐36v2 PCS and less consistently for the MEI‐SF. In conclusion, in addition to eltrombopag increasing platelet counts and reducing bleeding/bruising, it also alleviated fatigue, concerns about bleeding and bruising, and improved physical function in many patients, especially responders.

Inhibition of C3 with APL-2 Results in Normalisation of Markers of Intravascular and Extravascular Hemolysis in Patients with Autoimmune Hemolytic Anemia (AIHA)

Background:Autoimmune hemolytic anemia (AIHA) is a rare autoimmune disease characterized by hemolysis mediated by autoantibodies directed against red blood cells (RBC). AIHA is classified as either warm (60-70%), or cold agglutinin disease (CAD, 20-25%), depending upon the temperature at which the autoantibodies show maximum binding. Warm AIHA is mediated by warm reactive autoantibodies, which are usually of the immunoglobulin G class (IgG). Almost 90% of CAD is medicated by monoclonal antibodies of IgM class. The diagnosis of wAIHA or CAD is based on the presence of hemolytic anemia, signs of hemolysis, and a positive direct antiglobulin test (DAT) for IgG or IgM, and/or complement C3.Complement plays an important role in warm antibody AIHA. When erythrocytes are heavily coated with immunoglobulin, the amount of antigen-antibody complex can be sufficient for binding complement protein complex C1, thereby activating the classical complement pathway. CAD is almost entirely a complement-dependent disorder. Cold antibodies (IgM) temporarily bind to the RBC membrane, activate complement, and deposit complement factor C3 on the cell surface. These C3-coated RBCs are cleared slowly by the macrophages of the liver through extravascular hemolysis. Less frequently, the complete complement cascade is activated on the cell surface, resulting in the insertion of membrane attack complex C5b to C9 and intravascular hemolysis. Therefore, treatment with inhibitors of complement cascade may halt or at least attenuate acute complement mediated hemolysis in AIHA patients and improve recovery of RBC destruction.Aims: This Phase 2, open-label study is being conducted in the US and Italy to assess the safety, tolerability, efficacy, and PK of multiple subcutaneous (SC) doses of APL-2 administered daily in subjects with wAIHA or CAD.Methods: Patients with primary AIHA are eligible. Patients are required to have hemoglobin (Hb) levels <11 g/L, signs and symptoms of hemolysis, and a positive direct antiglobulin test (DAT) for IgG or IgM, and/or complement C3. The study will recruit 12 subjects with wAIHA and 12 subjects with CAD. APL-2 270 mg/d or 360 mg/d will be administered for 48 weeks. Efficacy is assessed by change from baseline in Hb, transfusion requirements, reticulocytes, lactate dehydrogenase (LDH), haptoglobin, bilirubin, and FACIT fatigue score. Endpoints will be assessed at Weeks 8, 12, 44, and 48.Results: 2 subjects with CAD (Subject 1: 270 mg/d; Subject 2: 360 mg/d) have been treated for at least 8 weeks and up to 12 weeks; 2 subjects with wAIHA (Subject 3: 270 mg/d; Subject 4: 360 mg/d) have been treated for at least 4 weeks. Subject 1 screened with Hb (NR 13.5 g/dL-17.5g/dL) of 10.0 g/dL and reported an increase to 13.0 g/dL at Week 12, with reticulocyte (NR 30-100 10^9/L) reduction from 99.6 10^9/L at Week 2 to 56.34 10^9/L at Week 8 (screening/baseline values not available). Subject 2 had baseline Hb of 7.9 g/dL and reported an increase to 13.6 g/dL at Week 8, with reticulocyte reduction from 154.34 10^9/L at baseline to 67 10^9/L at Week 8. Subject 3 had baseline Hb of 8.0 g/dL and reported an increase to 11.2 g/dL at Week 4, with reticulocyte reduction from 223.44 10^9/L at baseline to 27.12 10^9/L at Week 4. Subject 4 did not show signs of haematological improvement by Week 4, and the principal investigator decided to discontinue the subject at Day 42. Subject 1 had LDH levels within the normal range (100-200 I/U) at screening and remained normal through the study. Subjects 2 reported a baseline LDH of 339 I/U with a reduction to within NR to 107 I/U at Week 8. Subject 3 reported a baseline LDH of 235 I/U, which was also reduced to within NR at Week 4 to 123 I/U. Subject 1 had consistent indirect bilirubin (NR 0.2-0.7 mg/dL) through the study with a baseline value of 1.5 mg/dL and a Week 12 value of 1.4 mg/dL. Subject 2 had a reduction in indirect bilirubin with a baseline value of 1.3 mg/dL and a Week 8 value of 0.5 mg/dL.To date, APL-2 has generally been well-tolerated. No significant infections have been observed.Summary/Conclusions: Interim results demonstrate that systemic inhibition of C3 with APL-2 has demonstrated positive trends in haematological parameters in patients with wAIHA and CAD as early as Week 4. To date, APL-2 has been safe and well tolerated. The study is ongoing and will enroll up to 12 subjects with wAIHA and 12 subjects with CAD. DisclosuresGrossi:Apellis Pharmaceuticals: Employment, Equity Ownership. Gertz:spectrum: Consultancy, Honoraria; Medscape: Consultancy; Amgen: Consultancy; Physicians Education Resource: Consultancy; Apellis: Consultancy; Teva: Consultancy; Alnylam: Honoraria; Prothena: Honoraria; janssen: Consultancy; Ionis: Honoraria; Research to Practice: Consultancy; celgene: Consultancy; Abbvie: Consultancy; annexon: Consultancy. Deschatelets:Apellis Pharmaceuticals: Employment, Equity Ownership. Hamdani:Apellis Pharmaceuticals: Employment, Equity Ownership. Stout:Apellis Pharmaceuticals: Employment, Equity Ownership. Francois:Apellis Pharmaceuticals: Employment, Equity Ownership, Membership on an entity's Board of Directors or advisory committees.

The SMART Anti-hC5 Antibody (SKY59/RO7112689) Shows Good Safety and Efficacy in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH)

The SMART Anti-hC5 Antibody (SKY59/RO7112689) Shows Good Safety and Efficacy in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH)

Inhibition of C3 with APL-2 Results in Normalisation of Markers of Intravascular and Extravascular Hemolysis in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH)

Inhibition of C3 with APL-2 Results in Normalisation of Markers of Intravascular and Extravascular Hemolysis in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH)

Prevalence and Correlation of Depressive Symptoms with Functional Scores, Therapy and Disease Activity among Croatian Patients with Rheumatoid Arthritis: A Preliminary Study.

Rheumatoid arthritis (RA) is a chronic, autoimmune and disabling disease that significantly affects the quality of life. Additionally, significant number of patients with RA suffer from depressive disorders, which are commonly underrecognised and undertreated. We aimed to estimate the prevalence of depressive symptoms in Croatian RA patients and to assess the relationship between them and clinical correlates. Fifty-four RA patients treated at the Clinic for Rheumatic Diseases and Rehabilitation at the University Hospital Centre Zagreb were prospectively enrolled in the study and evaluated for functional status using the Disease Activity Score 28 (DAS-28), Health Assessment Questionnaire (HAQ), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) and Visual Analogue Scale (VAS) for pain and health related quality of life (HRQL) measurement. The depressive symptoms were assessed using the Beck Depression Inventory-II (BDI-II) questionnaire. Thirty RA patients (55.6%) had some sort of mood disorder, with 10 (18.5%) patients accounting as depressed. Positive correlation was found between depressive symptoms, higher disease activity and disablity during daily activities (τb=0.385, p=0.001 and τb=0.282, p=0.024 respectively). We found no significant association between depression and disease activity in the whole sample of RA patients, but for postmenopausal patients, the disease activity correlated with postmenopausal patients accounting as depressed (BDI-II score moderate or severe; τb=0.363, p=0.021). The use of biologic therapy correlated negatively with the disease acitivity, pain intensity and worse health related quality of life score (τb=-0.360, p=0.06; τb=-0.310, p=0.07; τb=-0.380, p=0.01 respectively). Considering the high prevalence of depressive sympoms in RA patients and the effect on functional disability and quality of life, we wanted to emphasize the importance of recognizing and optimizing depression treatment through multidisciplinary approach in RA patients.

A Two-Arm Randomized Pilot Study to Evaluate the Impact of a Mobile Health App on Quality of Life in Patients on Oral Anti-Cancer Medications

Background: CORA is a personalized smartphone-based self-management app designed to help cancer patients on oral anti-cancer medications manage medication, medication side-effects, and symptoms with the overall goal of improving their quality of life. Objective: To evaluate the effect of CORA on quality of life in patients on oral anti-cancer medications. Methods: Eighty-four patients were randomized to either an intervention group that received CORA plus usual care or a control group that received usual care. Quality of life was measured using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale administered at enrollment, 6 and 12 weeks. Engagement with the app was assessed by determining the unique days using the app. We evaluated the effect of engagement on FACIT-F both as a continuous variable (days using the app) and as a categorical outcome (low, medium, and high). Group differences for all outcomes over the study period were assessed using repeated measures mixed model analysis. Results: Relative to the control group, the intervention group improved FACIT-F by 0.36 (95% CI 0.10-0.61) P=.006 per week over the study period. As a continuous variable, each additional day using the app was significantly associated with an improved FACIT-F score per week in the study [0.0060 (95% CI -0.000034-0.012), P=.05]. Within the intervention group that used the app, those who were most engaged with the app were significantly more likely to improve their quality of life over the study relative to the least engaged group [0.37 per week (95% CI 0.19-1.94), P=.05]. Conclusions: CORA may have significantly improved quality of life (FACIT-F) in cancer patients over 12 weeks. Smartphone applications may positively impact health and behavioral outcomes in cancer patients on oral anti-cancer medications.

Shenmai injection for the treatment of cancer-related fatigue in advanced non-small cell lung cancer patients undergoing chemotherapy: study protocol for a randomized controlled trial

BackgroundCancer-related fatigue (CRF) is the most common symptom in patients with advanced non-small cell lung cancer (NSCLC) undergoing treatment with chemotherapy. However, evidence upon which to base management strategies is scarce. Traditional Chinese Medicine (TCM) has been shown to be beneficial to patients with CRF. Chinese herbal injections should be administered under an evidence-based approach. This trial aims to assess the efficacy and safety of the addition of the Shenmai injection (SMI) to conventional therapy for CRF in NSCLC patients undergoing chemotherapy.Methods/designThe study is a two-group, prospective, randomized controlled trial (RCT) designed to evaluate the efficacy and safety of SMI for CRF NSCLC patients undergoing chemotherapy. Eligible participants will be randomized to either a treatment group receiving a 5-day Shenmai injection regimen plus conventional therapy or a control group receiving only conventional therapy. The primary outcome is fatigue, assessed using severity scores from the Functional Assessment for Chronic Illness Therapy-Fatigue (FACIT-F) measurement system. Secondary outcomes include symptom distress scores, depression, sleep disorders, quality of life, and levels of immunologic indicators. Assessments will be carried out at baseline and on day 5 (the end of the intervention).DiscussionThis study can provide evidence to support clinical decision-making in the management of CRF in NSCLC patients undergoing chemotherapy in a way that can be scaled up and used throughout China.Trial registrationChinese Clinical Trial Registry (chictr.org.cn), ChiCTR-INR-17013737. Registered on 6 December 2017.

Fatigue predicts impaired social adjustment in survivors of allogeneic hematopoietic cell transplantation (HCT).

The aim of this study is to examine social adjustment to illness and to identify factors related to social adjustment in allogeneic hematopoietic cell transplantation (HCT) survivors. Cross-sectional data were drawn from a longitudinal study of patients ≥ 3years after their first HCT. The five subscales of the Psychosocial Adjustment to Illness Scale (PAIS) that reflect social adjustment, specifically vocational environment (VE); domestic environment (DE); sexual relationships (SEX); extended family relationships (ER); and social environment (SE) were examined in this analysis. Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) measured cancer-related fatigue. Subjects (N = 171) were a median of 5.19years from HCT (range 3-16). The most impaired dimension of social adjustment was ER with 38% of participants reaching clinically relevant (score ≥ 62) levels of social maladjustment. Unmarried and unemployed participants had lower levels of social adjustment in VE (p < .001 and p < .001, respectively) and DE (p = .004 and p = .006, respectively). Survivors with some college had poorer SEX adjustment than those with less or more education (p < .005). Hispanics reported lower adjustment with respect to ER adjustment (p = .002). Participants with higher fatigue had poorer adjustment in all five dimensions (p < .001). Although the majority of survivors are well adjusted, subgroups may experience significant poor social adjustment. Specifically, survivors with fatigue are at risk to experience lower levels of social adjustment. Development of effective rehabilitation strategies to improve affected areas of social health is warranted, and all HCT survivors should be screened periodically for social maladjustment and provided with resources and referrals.

Improvement in Parameters of Hematologic and Immunologic Function and Patient Well-being in the Phase III RESONATE Study of Ibrutinib Versus Ofatumumab in Patients With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

BackgroundIbrutinib compared with ofatumumab significantly improves progression-free and overall survival in patients with previously treated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). Patients and MethodsMeasures of well-being were assessed in RESONATE, where previously treated patients with CLL/SLL were randomized to receive ibrutinib 420 mg/day (n = 195) or ofatumumab (n = 196) for up to 24 weeks. Endpoints included hematologic function, Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-F), disease-related symptoms, European Organization for Research and Treatment of Cancer Quality of Life Questionnaires Core 30 (EORTC QLQ-C30), and medical resource utilization. ResultsWith up to 24 months’ follow-up (median, 16.4 months), 79% of cytopenic patients showed sustained hematologic improvement (82% with improved platelet count, 69% with improved hemoglobin) on ibrutinib versus 43% on ofatumumab (P < .0001). Higher rates of clinically meaningful improvement were demonstrated with ibrutinib versus ofatumumab for FACIT-F and EORTC global health. Greater improvement was observed in disease-related weight loss, fatigue, night sweats, and abdominal discomfort with ibrutinib versus ofatumumab. Hospitalizations in the first 30 days occurred less frequently with ibrutinib than ofatumumab (0.087 vs. 0.184 events/patient; P = .0198). New-onset diarrhea was infrequent with ibrutinib after the first 6 months (47% at ≤6 months vs. 5% at 12-18 months). With ibrutinib, grade ≥ 3 hypertension occurred in 6%, grade ≥ 3 atrial fibrillation in 4%, major hemorrhage in 2%, and tumor lysis syndrome in 1% of patients. ConclusionIbrutinib led to significant improvements in hematologic function and disease symptomatology versus ofatumumab, and can restore quality of life while prolonging survival in relapsed/refractory CLL/SLL.

Evaluating Hand Grip Strength Prior to Hematopoietic Stem Cell Transplantation as a Predictor of Patient Outcomes

Background and Purpose: The primary purpose of this study was to determine the predictive capacity of hand grip strength on overall survival among patients undergoing hematopoietic stem cell transplantation (HCT). Design: Retrospective chart review. Setting: Hand grip strength was measured at the time of HCT in an inpatient setting in 2009. Patients: Forty-nine patients with various hematologic malignancies. Intervention: Hand grip strength was performed using the dominant hand. The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) was administered during the same visit. Chart abstraction was performed 5 years postassessment to obtain mortality data, Karnofsky Performance Status (KPS) at HCT, graft type, gender, comorbidity index, and age at HCT. Main Outcome Measure: Survival Results: Median follow-up time was 5.62 years. In multivariable analyses, higher hand grip strength was associated with shorter length of stay, higher FACIT-F total score, and higher FACIT-F subscale score in female patients only. Higher hand grip strength was associated with an improved overall survival in all patients with and without adjustment for gender, graft type, and comorbidity index (unadjusted hazard ratio [HR]: 0.86; 95% confidence interval [CI]: 0.74-0.99; P = .034; adjusted HR: 0.82; 95% CI: 0.69-0.98; P = .033). Limitations: Retrospective design did not allow for assessment of posttransplant complications. Conclusion: Higher hand grip strength was associated with a shorter length of stay, higher quality of life, and lower fatigue for female patients, and better overall survival among men and women. Larger prospective studies are needed to confirm this finding.

Anxiety and Extraversion in Lupus-Related Atherosclerosis.

Objectives: Patients with systemic lupus erythematosus (SLE) are characterized by increased cardiovascular disease (CVD) risk as well as heightened rates of psychological distress. Since a link between psychological issues and CV morbidity has been previously suggested, the influence of psychological burden on subclinical atherosclerosis in SLE patients was investigated.Methods: 71 SLE patients were assessed for the presence of subclinical atherosclerosis—defined either as carotid and/or femoral plaque formation or arterial wall thickening [Intima Media Thickness (IMT) levels > 0.90 mm by Doppler ultrasound]; personality traits, anxiety and depression, sleeping habits and fatigue levels were also evaluated by specific questionnaires including Eysenck Personality Questionnaire Scale, State-Trait Anxiety Inventory (STAI), Zung Depression Scale, Athens Insomnia Scale and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F). Disease related clinical and laboratory features and traditional risk factors for atherosclerosis were documented. Univariate and multivariate analysis were performed.Results: SLE patients with arterial wall thickening displayed higher STAI anxiety scores (either as a current state or as a personality trait) compared to those without (49.8 ± 5.6 vs. 46.9 ± 5.4, p-value: 0.03 and 49.2 ± 4.4 vs. 45.7 ± 6.8, p-value: 0.009, respectively). In a multivariate model, trait anxiety and extraversion personality scores were found to be independently associated with arterial wall thickening and plaque formation, respectively [OR95%(CI):1.2(1.0–1.5) and 0.7(0.6–1.0), respectively], following adjustment for potential confounders. No other associations were detected.Conclusions: Anxiety and extraversion personality traits have been independently associated with subclinical atherosclerosis in lupus patients, implying psychoneuroimmunological interactions as contributors in SLE related atherosclerosis.

Quality of life, symptoms and care needs in patients with persistent or recurrent platinum-resistant ovarian cancer: An NRG Oncology/Gynecologic Oncology Group study

ObjectivesThe goals of treating recurrent platinum-resistant ovarian cancer are palliative, aimed at reducing symptoms and improving progression free survival. A prospective trial was conducted to determine the prevalence and severity of symptoms, and associated care needs. MethodsEligible women included those with persistent or recurrent platinum-resistant ovarian cancer with an estimated life expectancy of at least 6 months. The Needs at the End-of-Life Screening Tool (NEST), FACIT-Fatigue (FACIT-F), NCCN-FACT Ovarian Symptom Index [NFOSI-18]; Disease Related Symptoms (DRS), Treatment Side Effects (TSE), and Function/Well Being (F/WB) were collected at study entry, 3 and 6 months. ResultsWe enrolled 102 evaluable patients. Initiation of Do Not Resuscitate (DNR) discussions increased over time from 28% at study entry to 37% at 6 months. At study entry, the most common disease-related symptoms were fatigue (92%), worry (89%), and trouble sleeping (76%); 73% reported being “bothered by treatment side effects”, which included nausea (41%) and hair loss (51%) neither of which changed over time. The most common NEST unmet needs were in the symptom dimension. The social dimension was associated with F/WB (p = 0.002) and FACIT-F (p = 0.006); symptoms were associated with DRS (p = 0.04), TSE (p = 0.03), and FACIT-F (p = 0.04); existential was not associated with any of the patient-reported symptoms; therapeutic was associated with F/WB (p = 0.02). ConclusionsIn patients nearing the end of life, there are significant associations between disease and treatment related symptoms and unmet patient needs, which do not change substantially over time. Careful exploration of specific end-of-life care needs can improve patient-centered care and QOL.

A Meta-analysis Of Tai Chi/qigong On Fatigue And Quality Of Life In Cancer Patients

Due to the advances in cancer treatment, 64% of the person diagnosed with cancer can expected to be alive in 5 years. Long-term cancer-related health problems for these cancer survivors becoming a public health concern. Growing evidence suggests Tai chi or Qigong as a mind-body exercise become an option for cancer patients to improve QoL and reduce the cancer related fatigue symptom (CRF). PURPOSE: To investigate the effects of Tai Chi /Qigong versus non-Tai Chi/Qigong treatment on cancer patients’ health related QoL and CRF. METHODS: Studies on randomized controlled trials (RCT) of Tai Chi /Qigong as an intervention were retrieved from Medline, CINAHL, SPORTDiscus, Cochrane Library, and PubMed. Meta-analyses were performed on changes in QoL and CRF. QoL was measured by SF-36 questionnaire and cancer-specific QoL was assessed by functional assessment of cancer treatment-general (FACT-G). CRF was assessed by brief fatigue inventory (BFI) or functional assessment of chronic illness therapy-fatigue (FACIT-F). Random effects model was used to calculate the pooled mean difference (MD) with 95% confidence interval (CI). RESULTS: A total of 14 RCTs (1,001 subjects)were included in this review. Nine RCTs (567 subjects) provided sufficient data to estimates the effect size for QoL and CRF. For QoL assessed by SF-36 questionnaire, significant differences were found in two subscales, mental health and vitality. The MD of mental health and vitality were 2.33 (95% CI: 1.71, 2.96; Z score = 7.31; p <0.01), 1.50 (95% CI: 0.56, 2.44; Z score = 3.14; p =0.002). QoL assessed by five subscales (PWB, SWB, FWB, total) FACT-G change scores were in support of Tai Chi/Qigong interventions and indicated a statistically significant effect. Their MD were 2.36 (95% CI: 1.32, 3.40), 2.91 (95% CI: 1.49, 4.32), 1.24 (95% CI: 0.03, 2.44), 2.70 (95% CI: 1.73, 3.68), and 7.74 (95% CI: 4.58, 10.91), respectively. For CRF, the standardized mean difference (SMD) was−0.51 (95% CI: −0.98, -0.04; Z score = 2.14, p = 0.03) indicating that Tai Chi /Qigong had significant positive effects on cancer patients’ CRF. CONCLUSIONS: This study concluded that Tai Chi/Qigong had positive effects on QoL and cancer related fatigue symptoms on cancer patients. The findings need to be interpreted with caution due to limited studies and relatively small sample size.

Treatment with Sofosbuvir and Daclatasvir (with or without Ribavirin) Improves Patient Reported Outcomes in Hepatitis C.

ObjectivesTo evaluate the impact of 3 treatment regimens upon health-related quality of life and work productivity using patient-reported outcomes (PROs) in chronic hepatitis C infected patients: sofosbuvir (SOF) + daclatasvir (DCV); SOF + DCV + ribavirin (RBV); SOF + simeprevir (SMV).Methods4 questionnaires were used to evaluate PROs before, during and after treatment: Short Form-36 (SF-36), Chronic Liver Disease Questionnaire (CLDQ) - hepatitis C virus (HCV), Work Productivity and Activity Index, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F).ResultsOf the global sample of 55 patients included in this study; SOF + DCV (n = 10); SOF + DCV + RBV (n = 29); SOF + SMV (n = 16) all had a statistically significant improvement in SF-36, CLDQ and FACIT-F scores during and post-treatment. No statistically significant differences in the PRO questionnaire values were observed between the distinct treatment regimens. The SOF and SMV patient groups presented higher mean PRO variations during and post-treatment, compared to the other groups: SF-36 functional capacity (16.1); SF-36 mental health (21.4); CLDQ activity (1.8); CLDQ emotional function (1.2); FACIT-F physical well-being (8.0); Total FACIT-F (21.6).ConclusionTreatment with SOF + DCV, with or without RBV, results in an improved PRO similar to treatment with SOF + SMV in chronic hepatitis C patients.