Effects of a Home-Based Exercise Intervention Program on Physical Capacity and Fatigue in Patients with Myelodysplastic Syndrome (MDS) - a Feasibility Study

Abstract Introduction: Cancer-related fatigue (CrF) is a frequent and disabling symptom in hematological malignancies and associated with significant impairment in quality of life (QoL). Patients suffer from tiredness, weakness and limited capability. CrF involves physical, psychological, mental and social aspects, and often leads to inactivity or depressive mood. There is evidence for the benefit of exercise and physical activity on CrF, but clinical trials targeting patients with MDS are missing. Methods: We conducted a prospective, non-randomized trial to assess the feasibility, safety and efficacy of a home-based exercise intervention in patients with IPSS low to intermediate risk MDS. Subjects underwent an introduction and first exercise session at baseline (T0) under supervision of a physiotherapist. Workout sessions were then performed unsupervised in an outpatient setting. Patients were asked to record results in a sports diary. Exercise schedule contained six sessions per week - endurance or strength training in daily turns - over 12 weeks (T1). Follow-up assessment was performed at week 24 (T2). Endurance training included walking, running, cycling or swimming at patient´s preference. Strength training consisted of six exercises with an elastic strap for both upper and lower limb and the spine. Subjects were examined three times (T0, T1, T2). All examinations included 6-minutes walking distance (6-MWD), an ergometer check, isometric strength measurement of lower limb and isokinetic strength measurement of the abdomen and back. Quality of life and fatigue were assessed by the EORTC QLQ-C30 and Multidimensional Fatigue Inventory (MFI). Results: Twenty-one patients (13 male, 8 female) with low to intermediate risk MDS were included. Median age was 66 years (range 29-87). Fifteen patients completed the program at week 12 (T1). Twelve patients voluntarily continued the exercise program until week 24 (T2). The primary endpoint was met, since 11 patients (52%) performed more than 75% of all planned session. Median number of individual workout session was 54 (range 1-72). There were no adverse events reported due to the intervention. Main reasons for missed training sessions were doctor´s appointments or hospitalization, other private appointments, followed by acute infection and general weakness. Six-minute walking distance (6-MWD) improved from 570 meters (m) (T0) to 645 m (T1, +13%) and 660 m (T2, +16%). Among other parameters of physical capacity, strength of lower limbs increased from 2230 Newton (N) (T0) to 2570 (T1, +15%) and 2730 (T2, +22%). Between T0, T1 and T2 most functional measures like global health status (53 vs. 50 vs. 52), role functioning (62 vs. 49 vs. 61) and social functioning (63 vs. 58 vs. 53) were equal or slightly decreased. General fatigue did not significantly change over time (49 vs. 52 vs. 47 using the EORTC QLQ-C30 score [scale 0-100] and 12.2 vs. 12.4 vs. 11.9 on MFI [scale 0-21]. Results of all endurance and resistance parameters and QoL measures including fatigue subscales are displayed in Table 1. Conclusion: These data provide evidence that an unsupervised outpatient exercise program is feasible in MDS patients. The results of this pilot study also demonstrate that patients' acceptance of the program is high and physical capacity can be improved. Fatigue as a predominant symptom did not worsen during observational period. Further studies are therefore warranted. Figure 1. Results of all endurance and resistance parameters and QoL measures including fatigue subscales Figure 1. Results of all endurance and resistance parameters and QoL measures including fatigue subscales Disclosures Schuler: PharmaMar: Research Funding. Ehninger:Cellex GmbH: Equity Ownership. Platzbecker:Novartis: Honoraria, Research Funding; Celgene: Honoraria, Research Funding; Boehringer: Research Funding.

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Feasibility and Effects of a Supervised Exercise Program Suitable for Independent Training at Home on Physical Function and Quality of Life in Head and Neck Cancer Patients: A Pilot Study

Integrative Cancer Therapies ◽

10.1177/1534735420918935 ◽

2020 ◽

Vol 19 ◽

pp. 153473542091893 ◽

Cited By ~ 1

Author(s):

Sabine Felser ◽

Martin Behrens ◽

Jan Liese ◽

Daniel Fabian Strueder ◽

Kirsten Rhode ◽

...

Keyword(s):

Quality Of Life ◽

Head And Neck Cancer ◽

Physical Function ◽

Exercise Program ◽

Moderate Intensity ◽

Attendance Rate ◽

Home Based ◽

Physical Functions ◽

Eortc Qlq

Introduction: Head and neck cancer patients often suffer from physical and cognitive impairments after cancer treatment. During rehabilitation, exercise therapy can improve physical function and quality of life (QoL). Surveys demonstrated patients’ preference for home training with low- to moderate-intensity. This study was conducted in order to develope a suitable home-based training program. Therefore, the feasibility and effects of a low- to moderate-intensity exercise intervention on physical functions and QoL were evaluated. Methods: Training was conducted as supervised group training and consisted of mobilization, coordination, resistance, stretching, and relaxation exercises. The intervention lasted 12 weeks with 2 training sessions per week. Feasibility, attendance rate, physical function (eg, range of motion, 6-minute walk test [6MWT]), and QoL (eg, EORTC QLQ-30) were analyzed. Results: Ten out of 12 participants completed the intervention (83%) with an average attendance rate of 83%. Participants showed significant improvements in selected physical functions. For example, head rotation increased by 11.2° ( P = .042), walking distance in the 6MWT increased by an average of 43.3 m ( P = .010), and the global QoL scale improved by 8.2 points ( P = .059). Additionally, there were positive changes in the physical function scale ( P = .008), cognitive function scale ( P = .015), and social function scale ( P = .031) of the EORTC QLQ-30. Conclusion: Data indicate that the exercise program was feasible and had positive effects on physical function and QoL. Future research will analyze the effects of a home-based exercise program on physical function and QoL in a large-scale study.

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Effect of Physical Activity (PA) Interventions On Health-Related Quality of Life (HRQoL) Post Hematopoietic Stem Cell Transplantation (HSCT): A Systematic Review and Meta-Analysis

Blood ◽

10.1182/blood.v120.21.1968.1968 ◽

2012 ◽

Vol 120 (21) ◽

pp. 1968-1968

Author(s):

Alina S. Gerrie ◽

Siobhan White ◽

Katherine L. Harvey ◽

Ritu Gill ◽

Cynthia L. Toze

Keyword(s):

Exercise Intervention ◽

Rank Correlation ◽

Fixed Time ◽

Effect Estimate ◽

Exercise Interventions ◽

Exercise Participation ◽

Eortc Qlq C30 ◽

American Society ◽

Eortc Qlq

Abstract Abstract 1968 Background: Recent advances in HSCT have resulted in improved overall and relapse-free survival and decreased incidence of serious complications. Improved survival has prompted an increased focus on enhancing HRQoL. There is an accumulating body of evidence emphasizing that physical activity (PA) may be one modifiable lifestyle factor associated with decreased negative side effects related to HSCT and improved HRQoL. We sought to summarize the available evidence related to the effects of PA participation and HRQoL in HSCT recipients. Methods: We searched electronic databases including Pubmed/MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials and conference proceedings from American Society of Hematology and American Society of Clinical Oncology to April 1, 2012. No language or publication date limits were used. Studies were eligible for inclusion if they were randomized controlled trials (RCTs) or quasi-experimental trials with a control group comparing exercise interventions with placebo-control or standard of care in adult HSCT recipients. Exercise was defined as any form of PA that was performed on a repeated basis for a fixed time frame over a fixed time interval. Included studies were required to have a HRQoL measure as a primary (1o) or secondary (2o) outcome. Change in global HRQoL from pre to post-intervention for intervention and control groups were compared using a DerSimonian and Laird random effects model. Heterogeneity was assessed by calculating the Q- and I2 statistics. Meta-regression was performed for the following study characteristics: total number (no.) of study participants; mean age; % female; average body mass index (BMI); mean exercise duration in minutes per session; intervention length in weeks; % adherence; type of transplant (allo- or combination of allo- and auto-transplants); and whether HRQoL was a 1o or 2o outcome. Sensitivity analysis assessed the cumulative effect of studies by publication year and no. of participants. Influential analysis was conducted to determine change in pooled effect estimate by removing one study at a time. Publication bias was assessed the Begg's rank correlation and Egger's regression test and plot. Results: Of the 1606 studies originally identified, 7 studies involving 420 patients who underwent HSCT (of which 208 were assigned to exercise or PA intervention) met all inclusion criteria. One study was excluded from the final analysis as it was identified as an extreme outlier. All 6 remaining studies used the European Organization of Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) measurement tool thus weighted mean differences (WMD) were calculated for ease of interpretation. Participation in an exercise intervention resulted in an increase in global HRQoL with a WMD of 4.72 points (95% CI: −0.04, 9.47; P = 0.05). The proportion of variability in WMD attributed to intra-study heterogeneity was 65% (95% CI: 15%, 85%; P = 0.02) and was due primarily to variation in exercise intervention protocols and study quality. Meta-regression identified that whether HRQoL was a 1o or 2o outcome significantly affected the pooled effect estimate (P=0.02). Sensitivity analysis did not reveal any important trends. Influential analysis demonstrated that the study with the most influence when removed was Baumann A, where WMD decreased to 2.86 points (95% CI: −1.25, 8.57). There was no statistical evidence of publication bias by assessment with the Egger's regression test (coefficient for bias 2.35, 95% CI −1.90 to, 6.59, P = 0.20) and Begg's rank correlation test (Z-score 0.75 with continuity correction, P = 0.45). Conclusions: This analysis summarizes the best available evidence regarding effect of exercise participation on overall self-reported HRQoL in adult HSCT recipients. The pooled estimate, after excluding outliers, showed that exercise participation resulted in a 4.72 point increase in the global HRQoL score on the EORTC QLQ-C30 measure, which was borderline statistically significant (P =0.05). This effect estimate is similar in magnitude to pivotal meta-analyses of exercise interventions in breast cancer survivors. Substantial heterogeneity existed among included trials. Larger RCTs with a strong focus on study quality and long-term effects of exercise participation should be conducted. Disclosures: No relevant conflicts of interest to declare.

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Age and Gender-Related Pretreatment Quality of Life Profiles in Patients with Higher-Risk Myelodysplastic Syndromes. Establishing Benchmark Data from an International Study

Blood ◽

10.1182/blood.v126.23.2099.2099 ◽

2015 ◽

Vol 126 (23) ◽

pp. 2099-2099

Author(s):

Fabio Efficace ◽

Gianluca Gaidano ◽

Massimo Breccia ◽

Pasquale Niscola ◽

Francesco Cottone ◽

...

Keyword(s):

Quality Of Life ◽

Research Funding ◽

Control Groups ◽

Age And Gender ◽

Respective Control ◽

Eortc Qlq C30 ◽

And Gender ◽

Mean Differences ◽

Eortc Qlq

Abstract Background: Patients myelodysplastic syndromes (MDS) diagnosed with higher-risk disease have poor prognosis thus making improvements in health-related quality of life (HRQOL) a major goal of therapy. Understanding HRQOL profile of untreated patients is important to help clinicians to better target subpopulations in need of special attention from the very beginning of therapy. Aims: The primary objective of this study is to investigate whether HRQOL differences exist by age and gender in untreated patients with higher-risk MDS. A secondary objective is to provide age and gender pretreatment HRQOL profiles to be used as reference baseline data for comparing HRQOL of MDS patients under treatments. Methods: This analysis is based on 280 adult patients diagnosed with IPSS risk score of intermediate-2 (74%) and high-risk (26%), enrolled in an international prospective observational study. Median age of patients was 71 years (range 32-89), 176 were men (63%) and 104 (37%) women. HRQOL was assessed at study entry and before treatment for higher-risk disease (except for transfusions), with the EORTC QLQ-C30, the most widely used HRQOL outcome measure in MDS research. Thus, our data are likely to further ease interpretation of outcomes in many studies using this questionnaire. One hundred seventy-five patients had received at least one red blood cell transfusion at the time of baseline HRQOL assessment. HRQoL data of MDS patients were age-gender matched with those general population norms. Wilcoxon-Mann-Whitney and Wilcoxon signed ranks tests were used for unmatched and matched comparisons, respectively (α=0.05). Effect sizes were also computed. Results: No statistically significant differences existed in any of the HRQOL domain by IPSS category (intermediate-2 versus high-risk). However, HRQOL profiles differed by age and gender and results are reported in Table 1. Women generally reported lower HRQOL scores than men, with statistically significant impairments in the global quality of life (P=0.008), role (P=0.014), emotional (P=0.024) and social functioning (P=0.028). When compared to their peers in the general population, HRQOL was found to be impaired in all age group categories (Figure 1, A and B). However, the magnitude of impairments across HRQOL domains was markedly larger in younger patients (aged 30-59 years) compared to older age groups (≥60 years). The top three largest impairments in this younger group were found for: fatigue (ES=2.47, P<0.001), dyspnea (ES=2.14, P<0.001) and role functioning RP (ES=1.96, P<0.001). This latter aspect indicates the ability to perform daily activities. Conclusion: Pretreatment HROQL of higher-risk MDS patients vary by age and gender and current reference data will help making more accurate comparisons with HRQOL of patients under treatment. Clinicians should also pay special attention to younger patients, as these are those most in need of HRQOL improvements. Figure 1. Adjusted mean differences between MDS patients and their respective control groups by age categories (30-59 years, 60-69 years, 70-79 years and over 80) in functional aspects and global quality of life. A score below 0 line means worse outcomes for MDS patients. *= Statistically significant (P<0.05) **= Statistically significant (P<0.001) Figure 1. Adjusted mean differences between MDS patients and their respective control groups by age categories (30-59 years, 60-69 years, 70-79 years and over 80) in functional aspects and global quality of life. A score below 0 line means worse outcomes for MDS patients. / *= Statistically significant (P<0.05) **= Statistically significant (P<0.001) Figure 2. Adjusted mean differences between MDS patients and their respective control groups by age categories (30-59 years, 60-69 years, 70-79 years and over 80) in symptom scales. A score above 0 line means worse outcomes for MDS patients. *=Statistically significant (P<0.05) **=Statistically significant (P<0.001) Figure 2. Adjusted mean differences between MDS patients and their respective control groups by age categories (30-59 years, 60-69 years, 70-79 years and over 80) in symptom scales. A score above 0 line means worse outcomes for MDS patients. / *=Statistically significant (P<0.05) **=Statistically significant (P<0.001) Figure 3. Quality of life profile by the EORTC QLQ-C30 in higher risk-MDS patients by gender and age groups. Means scores of the EORTC QLQ-C30 are reported. Figure 3. Quality of life profile by the EORTC QLQ-C30 in higher risk-MDS patients by gender and age groups. Means scores of the EORTC QLQ-C30 are reported. Disclosures Gaidano: MorphoSys; Roche; Novartis; GlaxoSmithKline; Amgen; Janssen; Karyopharm: Honoraria, Other: Advisory boards; Celgene: Research Funding. Santini:celgene, Janssen, Novartis, Onconova: Honoraria, Research Funding. Platzbecker:Celgene: Honoraria; GlaxoSmithKline: Honoraria, Research Funding; Novartis: Honoraria; Amgen, Inc.: Honoraria. Di Renzo:Celgene: Research Funding.

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Health-Related Quality of Life and Symptoms in Myelofibrosis Patients Treated with Ruxolitinib Versus Best Available Therapy

Blood ◽

10.1182/blood.v118.21.795.795 ◽

2011 ◽

Vol 118 (21) ◽

pp. 795-795

Author(s):

Claire N. Harrison ◽

Jean-Jacques Kiladjian ◽

Haifa Kathrin Al-Ali ◽

Heinz Gisslinger ◽

Laurent Knoops ◽

...

Keyword(s):

Research Funding ◽

Treatment Phase ◽

Well Being ◽

Employment Equity ◽

Advisory Committees ◽

Eortc Qlq C30 ◽

Health Related ◽

Equity Ownership ◽

Eortc Qlq

Abstract Abstract 795FN2 Background: Ruxolitinib (INC424), a potent and selective oral JAK1 and JAK2 inhibitor, demonstrated rapid and durable reductions in splenomegaly and improved disease-related symptoms, role functioning, and quality of life (QoL) in 2 phase 3 studies in patients with myelofibrosis (MF) (the COMFORT studies). Per-protocol, patient-reported, health-related QoL (HRQoL) and symptoms analyses in the COMFORT-II study are limited. Here we report on additional post hoc analyses of these outcomes. The COMFORT-II study includes 219 patients (ruxolitinib, n=146; best available therapy [BAT], n=73). At entry, all patients were classified into intermediate 2-risk or high-risk prognostic groups (Cervantes F, et al. Blood, 2009;113(13):2895-2901) and had palpable splenomegaly ≥5 cm below the costal margin. Patients could have received prior therapy for MF. On BAT, doses and schedules or no therapy were selected by the investigator; therapy adjustments were permitted during the randomized treatment phase at the investigator's discretion. Patients in both arms continued in the randomized treatment phase as long as there was no protocol-defined disease progression. Methods: The European Organisation for the Research and Treatment of Cancer (EORTC) QoL Questionnaire–Core 30 (QLQ-C30) and Functional Assessment of Cancer Therapy–Lymphoma (FACT-Lym) questionnaires were assessed at baseline and weeks 8, 16, 24, and 48. EORTC QLQ-C30 consists of 30 items combined into 15 subscales (Global Health Status/QoL, 5 functioning subscales, and 9 symptom subscales; scores range from 0 to 100, and higher scores indicate better HRQoL and functioning but a worsening of symptoms). FACT-Lym consists of 42 items combined into 8 subscales (4 well-being subscales; 1 symptom subscale [LymS]; and 3 total scale scores: FACT-General [G], FACT-Lym trial outcome index [TOI], and FACT-Lym total; scores for the different subscales vary from 0–28 to 0–168, and higher scores indicate better outcomes). This analysis includes evaluable patients in the randomized treatment phase and assesses changes from baseline in HRQoL and MF symptom scores, including the EORTC subscales, LymS, and FACT total scores, which incorporate well-being and/or symptom subscales. Mixed-model analyses, adjusted for age, sex, baseline score, and prognostic risk category, are used to evaluate treatment differences at each time point and overall across time. Results: HRQoL and MF symptoms, on average, improved compared with baseline for patients receiving ruxolitinib, but remained the same or worsened for patients receiving BAT. Based on the EORTC QLQ-C30, the treatment differences in physical functioning, role functioning, fatigue, and appetite loss significantly favored ruxolitinib starting at week 8 (P <.05) and remained significant at week 48 (P <.05). The overall between-treatment differences (on average across time) in adjusted mean change from baseline for MF symptom scores (95% confidence interval) were: Fatigue, –10.2 (–15.9, –4.5; P <.001); Dyspnea, –11.6 (–17.6, –5.6; P <.001); Appetite loss, –16.3 (–21.5, –11.1; P <.0001); Insomnia, –9.8 (–16.7, –3.0; P <.01); and Pain, –9.0 (–14.9, –3.0), P <.01); negative values favor ruxolitinib. Global Health Status/QoL (Figure) was significantly improved in the ruxolitinib arm compared with the BAT arm at weeks 8, 16, and 48. Scores on the LymS, which includes symptoms of pain, swelling, fever, night sweats, itching, trouble sleeping, fatigue, weight loss, loss of appetite, trouble concentrating, and other patient concerns, also improved significantly during treatment (Figure). Additionally, FACT-G, FACT-Lym TOI, and FACT-Lym total scores were all significantly (P <.05) improved for patients receiving ruxolitinib treatment compared with BAT. Most EORTC QLQ-C30 and FACT-Lym scores improved significantly on ruxolitinib compared with BAT. The treatment effect between the high-risk and intermediate 2-risk prognostic groups was not significantly different based on an analysis of the risk group–by–treatment interaction. Conclusions: These additional analyses from the COMFORT-II study further support that ruxolitinib significantly improves overall HRQoL and MF symptoms compared with BAT. Disclosures: Harrison: Novartis: Honoraria; Incyte: Honoraria; S*Bio: Honoraria; Celgene: Honoraria; Sanofi Aventis: Honoraria. Kiladjian:Novartis: Honoraria; Celgene: Honoraria. Gisslinger:Novartis: Speakers Bureau; Celgene Austria: Research Funding, Speakers Bureau; Aop-Orphan: Speakers Bureau. Knoops:Novartis: Consultancy. Waltzman:Novartis: Employment. Mendelson:Novartis: Employment, Equity Ownership. Zhou:RTI-HS: Employment; Novartis: Research Funding. Copley-Merriman:RTI-HS: Employment; Novartis: Research Funding. Hunter:Incyte Corporation: Employment, Equity Ownership. Levy:Incyte Corporation: Employment, Equity Ownership. Cervantes:Bristol-Myers-Squibb: Speakers Bureau; Novartis: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Passamonti:Novartis: Consultancy, Membership on an entity's Board of Directors or advisory committees. Vannucchi:Novartis: Honoraria. Barosi:Novartis: Consultancy.

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Associations Between Improvements in Myelofibrosis (MF) Symptoms and Quality of Life Measures with Splenomegaly Reduction in COMFORT-I: A Randomized, Double-Blind, Phase III Trial of the JAK1 and JAK2 Inhibitor Ruxolitinib Versus Placebo in Patients with MF,

Blood ◽

10.1182/blood.v118.21.3842.3842 ◽

2011 ◽

Vol 118 (21) ◽

pp. 3842-3842 ◽

Cited By ~ 1

Author(s):

Ruben A. Mesa ◽

Jason Gotlib ◽

Vikas Gupta ◽

John F. DiPersio ◽

John Catalano ◽

...

Keyword(s):

Quality Of Life ◽

Placebo Group ◽

Board Of Directors ◽

Research Funding ◽

Phase Iii ◽

Advisory Committees ◽

Jak2 Inhibitor ◽

Eortc Qlq C30 ◽

Eortc Qlq

Abstract Abstract 3842 Background: Dysregulated JAK-STAT signaling is a key feature in MF, which is characterized by splenomegaly, debilitating symptoms, poor quality of life (QoL), cytopenias, and shortened survival. Ruxolitinib is a selective JAK1 and JAK2 inhibitor with clinical activity in MF. COMFORT-I is a Phase III, double-blinded, placebo-controlled study of ruxolitinib in patients with MF. At wk 24, 41.9% of patients receiving ruxolitinib reached the protocol-defined threshold of a ≥35% reduction in spleen volume (SV) compared to 0.7% in the placebo group (p<0.0001). The objective of this analysis was to evaluate the relationship between SV reduction achieved with ruxolitinib treatment and changes in symptoms and QoL. Methods: 309 patients were randomized to receive ruxolitinib (n=155) or placebo (n=154). Initial dosing was based on baseline platelet counts: 15 mg BID for counts of 100–200 x109/L and 20 mg BID for >200 x109/L. SV was measured by blinded imaging (MRI or CT scan) every 12 wks. Via electronic diary, patients reported MF symptoms daily using the modified Myelofibrosis Symptom Assessment Form (MFSAF) v2.0. The Total Symptom Score (TSS) from the MFSAF represents a combined score for the individual symptoms of abdominal discomfort, pain under ribs on left side, early satiety, itching, night sweats, and bone/muscle pain. The European Organization for Research and Treatment of Cancer Quality-of-Life 30 (EORTC QLQ-C30) and Patient-Reported Outcomes Measurement System (PROMISE) Fatigue questionnaires were administered at each visit; Patient Global Impression of Change (PGIC) was administered at every visit beginning at wk 4. The PGIC rates a patient's overall sense of whether a treatment has been beneficial or not on a 7-point scale, ranging from 1 = very much improved to 7 = very much worse, with 4 = no change. Results: Baseline QoL scores reflected debilitating disease, and were similar to scores for similar-aged patients with other cancers (Scott NW, Fayers PM, Aaronson NK, et al. EORTC QLQ-C30 Reference Values Manual, July 2008). The impact on patients was particularly evident on the PROMIS Fatigue scale and QLC-C30 Global Health, Physical Functioning, Role Functioning, and Social Functioning subscales. Baseline Symptom and QoL Measures* Associations between changes in symptoms and QoL with the objectively measured changes in SV were evaluated. Patients receiving ruxolitinib were grouped according to SV reduction at 24 wks of treatment: ≥35% reduction in SV (n=65), 10-<35% (n=51), and <10% (n=23). Symptom and QoL responses were evaluated among the various subgroups (of the SV reduction percentage strata) and comparisons were made across these and the total placebo group (n=106). Shown in the Figure are mean changes at wk 24 relative to baseline for TSS, QoL indicators, and PGIC scores. Conclusions: Changes in SV as low as 10% in ruxolitinib-treated patients were associated with improvements on EORTC QLQ-C30 Global Health subscale, PROMISE Fatigue scale, and the MFSAF v2.0 diary TSS. Moreover, commensurate improvements in these outcomes were observed as the SV reduction increased. Importantly, the simple PGIC questionnaire allowed patients to characterize a meaningful change in their condition that was consistent with more comprehensive measures of MF symptoms and quality of life, reflecting a doctor-patient assessment easily applied to clinical practice. Disclosures: Mesa: Incyte: Research Funding; Lilly: Research Funding; SBio: Research Funding; Astra Zeneca: Research Funding; NS Pharma: Research Funding; Celgene: Research Funding. Gotlib:Incyte: Consultancy, Research Funding. Gupta:Incyte: Honoraria, Membership on an entity's Board of Directors or advisory committees; Novartis: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees. Catalano:Incyte: Honoraria; Novartis: Honoraria. Deininger:BMS: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Ariad: Consultancy, Membership on an entity's Board of Directors or advisory committees; Novartis: Consultancy, Membership on an entity's Board of Directors or advisory committees; Celgene: Research Funding; Genzyme: Research Funding. Shields:Incyte: Consultancy. Miller:Incyte: Research Funding; Novartis: Honoraria, Research Funding, Speakers Bureau. Winton:Incyte: Consultancy. Hare:Incyte: Employment. Erickson-Viitanen:Incyte: Employment. Sun:Incyte: Employment. Sandor:Incyte: Employment. Levy:Incyte: Employment, Equity Ownership. Kantarjian:Incyte: Research Funding; Novartis: Consultancy, Research Funding. Verstovsek:Incyte: Research Funding.

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Evaluation of a Post-Operative Rehabilitation Program in Patients Undergoing Laparoscopic Colorectal Cancer Surgery: A Pilot Study

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18115632 ◽

2021 ◽

Vol 18 (11) ◽

pp. 5632

Author(s):

Sveva Maria Nusca ◽

Attilio Parisi ◽

Paolo Mercantini ◽

Marcello Gasparrini ◽

Francesco Antonio Pitasi ◽

...

Keyword(s):

Quality Of Life ◽

Colorectal Cancer ◽

Pilot Study ◽

Exercise Program ◽

Cancer Surgery ◽

Colorectal Cancer Surgery ◽

End Of Treatment ◽

Eortc Qlq C30 ◽

Eortc Qlq

This pilot study explores the effects of a post-operative physical exercise program on the quality of life (QoL) and functional and nutritional parameters of patients that underwent laparoscopic colorectal cancer surgery, compared to usual care alone. The intervention group (IG) attended a 2-month-long supervised and combined exercise–training program during the post-operative period. Both IG and control group (CG) participated in the QoL, functional, and nutritional assessments before exercise training (T0), 2 months after the beginning of the exercise (end of treatment) (T1), and 2 (T2) and 4 (T3) months from the end of treatment. Eleven patients with colorectal cancer that underwent laparoscopic surgery were enrolled (six intervention; five control). The IG showed significant improvements compared to the CG in “Physical functioning” (PF2) (p = 0.030), “Cognitive functioning” (CF) (p = 0.018), and “Fatigue” (FA) (p = 0.017) of the European Organization for Research and Treatment of Cancer Quality of Life-C30 Questionnaire (EORTC QLQ-C30) at T1; in SMWT (p = 0.022) at T1; in PF2 (p = 0.018) and FA (p = 0.045) of EORTC QLQ-C30 at T2, in phase angle (PhA) of bioelectrical impedance analysis (p = 0.022) at T3. This pilot study shows that a post-operative, combined, and supervised physical exercise program may have positive effects in improving the QoL, functional capacity, and nutritional status in patients that undergo laparoscopic colorectal cancer surgery.

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Improved Quality of Life (QOL) with Lisocabtagene Maraleucel (liso-cel), a CD19-Directed Chimeric Antigen Receptor (CAR) T Cell Therapy, Compared with Standard of Care (SOC) As Second-Line (2L) Treatment in Patients (Pts) with Relapsed or Refractory (R/R) Large B-Cell Lymphoma (LBCL): Results from the Phase 3 Transform Study

Blood ◽

10.1182/blood-2021-151611 ◽

2021 ◽

Vol 138 (Supplement 1) ◽

pp. 3845-3845

Author(s):

Jeremy S. Abramson ◽

Scott R. Solomon ◽

Jon E. Arnason ◽

Patrick B. Johnston ◽

Bertram Glass ◽

...

Keyword(s):

Cognitive Functioning ◽

Research Funding ◽

Publicly Traded ◽

Meaningful Improvement ◽

Car T ◽

Evaluable Population ◽

Eortc Qlq C30 ◽

Eortc Qlq ◽

To Receive

Abstract Background: Pts with previously treated R/R aggressive LBCL have compromised health-related QOL (HRQOL). Liso-cel is an autologous, CD19-directed, defined composition, 4-1BB CAR T cell product administered at equal target doses of CD8 + and CD4 + CAR + T cells. In a prespecified interim analysis of TRANSFORM (NCT03575351), a randomized, open-label, pivotal trial, liso-cel demonstrated statistically significant and clinically meaningful improvement in the primary endpoint of event-free survival and key secondary endpoints (complete response rate and progression-free survival) in adults with R/R LBCL after failure of first-line (1L) immunochemotherapy compared with SOC, with no new safety signals. Here we present results of the pt-reported outcomes (PRO) analysis from TRANSFORM. Methods: Adults (age ≤ 75 yrs) with R/R LBCL (≤ 12 mo after 1L therapy), who were eligible for autologous stem cell transplantation (ASCT), were randomized to receive either SOC (3 cycles of salvage chemotherapy [CT] and BEAM + ASCT for responding pts) or liso-cel after lymphodepletion. Crossover to receive liso-cel was allowed in the SOC arm for pts who failed treatment. The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - 30 items (EORTC QLQ-C30) and the Functional Assessment of Cancer Therapy - Lymphoma Subscale (FACT-LymS) were administered at randomization (baseline) and on Days 29 (infusion of liso-cel or 2 cycles of salvage CT), 64 (1 mo post liso-cel or completion of CT), 126 (3 mos post liso-cel or 2 mos post ASCT), and Mo 6 and other prespecified timepoints up to Mo 36 or end of study. No PRO data were collected after crossover. The analysis was based on the PRO-evaluable population (pts with a baseline and ≥ 1 post-baseline assessment). Predefined thresholds determined clinically meaningful changes. Global health/QOL (GH/QOL), physical functioning, cognitive functioning, fatigue, pain, and FACT-LymS were the primary domains of interest based on their relevance to the study population and treatment. A linear mixed model for repeated measures (MMRM) analysis was performed to assess the between-treatment difference in overall least squares (LS) mean change from baseline for each primary domain, using data collected up to Day 126 for visits with a sample size per arm ≥ 10. Proportions of pts with meaningful change from baseline were assessed for each primary domain up to Mo 6. All analyses were descriptive only. Results: Of 184 randomized pts, 90 (49%) and 85 (46%), respectively, were included in the PRO-evaluable population for the EORTC QLQ-C30 (SOC vs liso-cel n=43 vs 47) and FACT-LymS (n=40 vs 45, respectively). The PRO assessment completion rate from baseline up to Mo 6 was ≥ 45%, which was lower than expected primarily due to operational challenges during the COVID-19 pandemic but was comparable for both arms. In the MMRM analysis, the liso-cel arm had more favorable overall LS mean changes from baseline to Day 126 than the SOC arm in most of the EORTC QLQ-C30 domains and FACT-LymS. In particular, the between-treatment differences for cognitive functioning (−2.09 vs 2.21) and fatigue (3.75 vs −1.95) for SOC versus liso-cel, respectively, exceeded the prespecified minimal important difference threshold (Table); in those domains, the SOC arm deteriorated while the liso-cel arm improved. In individual-level analyses, the proportion of pts with meaningful improvement for fatigue and GH/QOL was higher, while deterioration was lower, in the liso-cel arm versus SOC arm from baseline up to Mo 6 (Figure). At Mo 6, a higher proportion of pts experienced worsened fatigue (71% vs 18%) and a lower proportion experienced improved fatigue (29% vs 47%) in the SOC arm compared with the liso-cel arm; for GH/QOL, a higher proportion of pts worsened (57% vs 18%) and lower proportion improved (14% vs 53%), respectively. For the other primary domains, the proportions of pts with improvement or deterioration favored liso-cel or were similar between arms. Conclusions: Compared with SOC, liso-cel showed favorable improvement in most primary PRO domains, particularly EORTC QLQ-C30 cognitive functioning and fatigue and more pts showed PRO improvements and fewer showed deterioration by Mo 6 with liso-cel. The results were achieved despite only responders remaining in the SOC arm after salvage CT. HRQOL was either improved or maintained after liso-cel treatment in pts with R/R LBCL after failure of 1L therapy. Figure 1 Figure 1. Disclosures Abramson: Bristol-Myers Squibb Company: Consultancy, Research Funding; Morphosys: Consultancy; C4 Therapeutics: Consultancy; Kite Pharma: Consultancy; Kymera: Consultancy; Incyte Corporation: Consultancy; Bluebird Bio: Consultancy; Astra-Zeneca: Consultancy; Allogene Therapeutics: Consultancy; Novartis: Consultancy; EMD Serono: Consultancy; Genmab: Consultancy; Seagen Inc.: Research Funding; AbbVie: Consultancy; Karyopharm: Consultancy; Genentech: Consultancy; BeiGene: Consultancy. Arnason: Juno/BMS: Honoraria. Glass: BMS: Consultancy; Roche: Consultancy, Research Funding, Speakers Bureau; Riemser: Research Funding; Kite: Consultancy; Novartis: Consultancy; Helios Klinik Berlin-Buch: Current Employment. Crotta: Bristol Myers Squibb: Current Employment, Current equity holder in publicly-traded company. Montheard: Bristol Myers Squibb: Current Employment, Current equity holder in publicly-traded company. Previtali: Bristol Myers Squibb: Current Employment, Current equity holder in publicly-traded company. Liu: Bristol Myers Squibb: Current Employment, Current equity holder in publicly-traded company. Braverman: BMS: Current Employment, Current equity holder in publicly-traded company. Guo: Daiichi Sankyo: Consultancy; UCB: Consultancy; Janssen: Consultancy; Gilead: Consultancy; Bristol Myers Squibb: Consultancy; EMD Serono: Consultancy; Evidera: Current Employment. Shi: Bristol Myers Squibb: Consultancy. Kamdar: ADC Therapeutics: Consultancy; Adaptive Biotechnologies: Consultancy; TG Therapeutics: Research Funding; Genentech: Research Funding; AbbVie: Consultancy; KaryoPharm: Consultancy; Kite: Consultancy; AstraZeneca: Consultancy; SeaGen: Speakers Bureau; Celgene: Other; Genetech: Other; Celgene (BMS): Consultancy.

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Correlation between MPN-SAF TSS and EORTC QLQ-C30 Scores in Patients with PV: Data from the Reveal Study

Blood ◽

10.1182/blood-2018-99-112937 ◽

2018 ◽

Vol 132 (Supplement 1) ◽

pp. 2259-2259 ◽

Cited By ~ 1

Author(s):

Ivy Altomare ◽

Aaron T. Gerds ◽

David Lessen ◽

Philomena Colucci ◽

Shreekant Parasuraman ◽

...

Keyword(s):

Health Status ◽

Global Health ◽

Research Funding ◽

Symptom Burden ◽

Global Health Status ◽

Employment Equity ◽

Eortc Qlq C30 ◽

Equity Ownership ◽

Eortc Qlq

Abstract Introduction Polycythemia vera (PV) is characterized by clonal proliferation of myeloid cells and erythrocytosis. Patients with PV often present with symptoms or develop symptoms that may negatively impact quality of life (QOL). In clinical trials, the Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) and European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) have both been used to assess symptom burden in patients with PV. This analysis was conducted in patients with PV enrolled in REVEAL, a multicenter, prospective, observational trial, in an attempt to corroborate previous work by Emanuel et al (J Clin Oncol 2012;30:4098), which demonstrated associations between the MPN-SAF TSS and EORTC QLQ-C30. Methods Patients ≥ 18 years of age with PV were enrolled and followed during usual care visits for ≤ 36 months. Patient-reported outcomes, including the MPN-SAF TSS and EORTC QLQ-C30, were collected at enrollment and at approximate 3-month intervals; only the forms completed at the time of enrollment were included in this analysis. MPN-SAF TSS items are scored on a linear analog scale ranging from 0 (absent) to 10 (worst imaginable), and individual symptom scores were added together to calculate a TSS; higher scores represent worse symptom burden. In the EORTC QLQ-C30, 28 questions are scored using a 4-point scale indicating frequency: 1 (not at all), 2 (a little bit), 3 (quite a bit), and 4 (very much); this includes 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Two questions on overall health and QOL are rated on a 1 (very poor) to 7 (excellent) scale. Five multi-item functional scales (physical, role, cognitive, emotional, and social), 3 multi-item symptom scales (fatigue, nausea/vomiting, and pain), and a multi-item global health status/QOL scale are derived from the 30 questions. Linear transformation to 0-100 was applied to raw scores to obtain scores for each scale or single item. Higher scores for functional scales and global health status represent higher functioning and better health status/QOL, respectively. Higher scores for symptom scales/items represent higher symptom burden. Pearson correlation coefficient was used to assess correlations between MPN-SAF TSS and EORTC QLQ-C30 scales. Results As of data cutoff (April 30, 2018), 2,298 of 2,510 enrolled patients (91.6%) had completed both MPN-SAF TSS and EORTC QLQ-C30 forms at enrollment. Median age was 67 years (range, 22-97 years), 54.0% were male, and 89.7% were Caucasian. Median disease duration at the time of enrollment was 4.1 years. The majority (52.5%) of patients were treated with hydroxyurea (28.7%) or hydroxyurea with phlebotomy (23.8%). The mean MPN-SAF TSS was 18.7 (out of 100) compared to 21.8 reported by Emanuel et al 2012. The 4 symptoms with the highest mean scores were fatigue (3.5), early satiety (2.6), inactivity (2.5), and itching (2.3). The QLQ-C30 mean scores for overall QOL and health were 5.5 and 5.3, respectively. EORTC QLQ-C30 symptom scales were highest for fatigue (29.9), insomnia (28.7), and pain (20.0). Correlation between MPN-SAF TSS and EORTC QLQ-C30 results showed stronger associations between multiple items (Table). Calculated TSS had the strongest association with fatigue (r = 0.72), pain (r = 0.59), cognitive functioning (r = -0.58), and emotional functioning (r = -0.58). Problems with concentration in the MPN-SAF TSS was moderately correlated with cognitive functioning (r = -0.70) in the EORTC QLC-C30. Fatigue assessments were also moderately correlated (r = 0.65) between the MPN-SAF TSS and EORTC QLQ-C30. Conclusions In this analysis of prospectively gathered real-world data, the MPN-SAF TSS results confirm that patients with PV experience a recognizable constellation of symptoms, including fatigue, early satiety, inactivity, and itching. Not surprisingly, PV-related symptoms have a negative impact on QOL. There were moderate correlations (r = 0.5-0.75) between the MPN-SAF TSS and the EORTC QLC-C30 with respect to global health status/QOL, the 5 functional scales, and fatigue, pain, and dyspnea. Consistent with the previous analysis, this analysis provides further evidence that the MPN-SAF TSS represents an accurate, yet simple tool to assess PV-related symptoms and their potential impact on QOL. Disclosures Altomare: Novartis: Consultancy; Incyte: Consultancy; Amgen: Consultancy; Bayer: Consultancy; Genentech: Consultancy; Celgene: Other: Advisory Board Member; Ipsen: Other: Advisory Board Member. Gerds:Celgene: Consultancy; Apexx Oncology: Consultancy; Incyte: Consultancy; CTI Biopharma: Consultancy. Lessen:Abbvie: Honoraria; Teva: Honoraria, Speakers Bureau; Incyte: Honoraria, Research Funding, Speakers Bureau; Astellas: Research Funding; Bayer: Honoraria, Speakers Bureau; Amgen: Honoraria, Speakers Bureau; Portola: Honoraria, Speakers Bureau; Janssen: Research Funding. Colucci:Incyte: Employment, Equity Ownership. Parasuraman:Incyte: Employment, Equity Ownership. Paranagama:Incyte: Employment, Equity Ownership. Mesa:Pfizer: Research Funding; Incyte Corporation: Research Funding; Gilead: Research Funding; Promedior: Research Funding; NS Pharma: Research Funding; Celgene: Research Funding; Novartis: Consultancy; UT Health San Antonio - Mays Cancer Center: Employment; CTI Biopharma: Research Funding; Genentech: Research Funding.

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Patient Subgroup Analysis of Quality-of-Life Outcomes in Checkmate 205, a Phase 2 Study of Nivolumab in Patients with Classical Hodgkin Lymphoma

Blood ◽

10.1182/blood.v128.22.1831.1831 ◽

2016 ◽

Vol 128 (22) ◽

pp. 1831-1831 ◽

Cited By ~ 4

Author(s):

Andreas Engert ◽

Fiona Taylor ◽

Bryan Bennett ◽

Ishan Hirji ◽

Kim Cocks ◽

...

Keyword(s):

Quality Of Life ◽

Global Health ◽

Research Funding ◽

Brentuximab Vedotin ◽

Classical Hodgkin Lymphoma ◽

Eortc Qlq C30 ◽

Eortc Qlq ◽

Ecog Ps ◽

Patient Subgroups

Abstract Introduction: Nivolumab is a fully human IgG4 immune checkpoint inhibitor targeting programmed death receptor-1 (PD-1). It has recently been approved by the FDA in the US for patients with classical Hodgkin lymphoma (cHL) who have failed autologous hematopoietic stem cell transplantation (auto-HSCT) and post-transplant brentuximab vedotin (cohort B of CheckMate 205). The objective response rates in cohort B of CheckMate 205 (NCT02181738) per independent radiologic review committee (IRRC) assessment was 66%, with median time to response of 2.1 months. Furthermore, mean EuroQol Five Dimensions (EQ-5D) visual analog scale (VAS) score increased over time during treatment with nivolumab, and European Organisation for Research and Treatment of Cancer Core Quality-of-Life questionnaire (EORTC QLQ-C30) data suggested an improvement from baseline (BL) across functional, symptom, and global health scores [Younes et al. Lancet Oncol 2016; Jul 20 (Epub ahead of print)]. The aim of the current analysis is to understand if quality-of-life (QoL) changes observed in the cohort of patients with cHL vary across patient subgroups. Methods: CheckMate 205 is a multi-cohort study evaluating the efficacy and safety of nivolumab 3 mg/kg by IV infusion every 2 wks in 3 cohorts of patients with cHL post-auto-HSCT. Patient-reportedgeneral health status was assessed using the 3-level version of the EQ-5D questionnaire, and cancer-specific QoL using the EORTC QLQ-C30. Questionnaires were administered to patients every 4 cycles (every 8 wks). All treated patients with BL and at least 1 post-BL assessment in cohort B were included in this analysis population. Scores were examined across prespecified patient subgroups, including age, sex, Eastern Cooperative Oncology Group (ECOG) performance status (PS) at BL, smoking status, B symptoms at BL, region (USA/Canada or Europe), and best overall response (BOR) per investigator assessment or IRRC at wks 9, 17, 25, and 33. Least squares (LS) means were used to describe post-BL score changes over time for the overall analysis population and subgroups. Minimally important differences were prespecified. Results: 72 patients (90%) from CheckMate 205, cohort B, completed BL and at least 1 post-BL EORTC QLQ-C30 or EQ-5D assessment. By wk 33, 58% of patients were included. The mean (SD) age was 38.9 (13.3) years. 34.7% of patients were female, 45.8% had BL ECOG PS 1, and 68.1% had stage IV disease at study entry. LS mean (standard error) score change from BL at wk 33 was 19.1 (3.1) for EQ-5D VAS and 7.6 (2.3) for the EORTC QLQ-C30 global health/QoL status scale. For the global health status subscale, all subgroup estimates were consistent with the overall changes from BL, except patients with absence of B symptoms who experienced significantly smaller changes at wk 17 only. For other EORTC subscales where statistically significant improvements in LS mean from BL were observed at each time point (fatigue, dyspnea, appetite loss, physical functioning, role functioning), although all subgroup estimates were in line with the overall change, there were some trends for non-smokers (vs smokers), ECOG PS 0 (vs 1), USA/Canada (vs Europe), and B symptoms at BL (vs none) toward better symptom improvement. Changes from BL across responders and non-responders were consistent with overall changes from BL. Conclusions: In this small cohort of patients with cHLwho had failed auto-HSCT and subsequent brentuximab vedotin, the improvement in QoL observed while on-treatment with nivolumab was mostly consistent across the subgroups investigated. Funding: Bristol-Myers Squibb (BMS). Medical writing: S Addison, Caudex, funded by BMS. Disclosures Engert: Takeda, BMS: Consultancy, Honoraria, Research Funding. Taylor:Bristol-Myers Squibb: Consultancy. Bennett:Bristol-Myers Squibb: Consultancy. Hirji:Bristol-Myers Squibb: Employment. Cocks:Bristol-Myers Squibb: Consultancy. McDonald:Bristol-Myers Squibb: Consultancy. Mann:Bristol-Myers Squibb: Consultancy. Kato:Bristol-Myers Squibb: Employment. Cella:Alexion, Inc., Astellas, Biogen Idec, Celgene, Clovis Oncology, Inc., Daiichi Sankyo, Eli Lilly, Evidera, Inc., Exelixis, Fiborgen, Genetech, Helsinn Therapeutics, Inc., Immunogen, Ipsen Pharma, Janssen, Lexicon Pharmaceuticals, Inc., Merck, Novartis, Onc: Consultancy, Research Funding; Bristol-Meyers Squibb: Consultancy, Research Funding; Abbvie, Inc.: Consultancy, Research Funding; GlaxoSmithKline: Consultancy, Research Funding; Bayer Pharmaceuticals, Inc.: Consultancy, Research Funding; Facit.org: Other: President.

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Myeloproliferative Neoplasm Quality of Life (MPN-QOL) Study Group: MPN Experimental Assessment of Symptoms By Utilizing Repetitive Evaluation (MEASURE) Trial

Blood ◽

10.1182/blood-2018-99-111559 ◽

2018 ◽

Vol 132 (Supplement 1) ◽

pp. 1762-1762

Author(s):

Allison Gathany ◽

Robyn M. Scherber ◽

Marlene Girardo ◽

Heidi E. Kosiorek ◽

Amylou C. Dueck ◽

...

Keyword(s):

Quality Of Life ◽

Research Funding ◽

Myeloproliferative Neoplasms ◽

Myeloproliferative Neoplasm ◽

Study Group ◽

Experimental Assessment ◽

Eortc Qlq C30 ◽

Evaluation Measure ◽

Eortc Qlq

Abstract Background: Myeloproliferative neoplasms (MPN) including polycythemia vera (PV), essential thrombocythemia (ET), and myelofibrosis (MF) are clonal hemopathies characterized by burdensome symptom profiles and impaired quality of life. Treatments include pharmacologic approaches, phlebotomy, and bone marrow transplant. Outcome studies have historically focused on hematologic improvement and survival benefit. Few prospective studies have evaluated patient-reported symptoms and quality of life outcomes after standard therapy. The Myeloproliferative Neoplasm Quality of Life (MPN-QOL) Study Group aims to objectively quantify symptomatic response to standard treatments. Here we provide updated results for the prospective MPN Experimental Assessment of Symptoms by Utilizing Repetitive Evaluation (MEASURE) trial. Methods: The MEASURE trial is a prospective international cohort study evaluating responsiveness of the Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS or MPN-10) in an anticipated 480 ET, PV, and MF patients receiving non-experimental medical therapy and/or phlebotomy. Patients complete the MPN-SAF TSS (JCO 2012) for seven consecutive days at enrollment then again for seven days between 90 days and six months later. Patients also complete the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) and M.D. Anderson Symptom Inventory (MDASI) instruments at enrollment and on the first day of the second assessment. Physicians report demographic, laboratory, and clinical data. Results: Demographics To date, 340 patients have enrolled and 270 have completed both study visits. Participants include ET (60%), PV (29%), and MF (12%; including 68% primary MF, 12% post-ET, 20% post-PV) patients. Enrolled patients are 51% male. The most common therapies received prior to enrollment were aspirin (34%), phlebotomy (15%), hydroxyurea (14%), and warfarin/clopidogrel/anticoagulation (6%). The most common current MPN therapies were hydroxyurea (67%), aspirin (24%), phlebotomy (9%), and ruxolitinib (8%). Information on mutational analysis was also collected; 77% of patients have a known JAK2 V617F mutation, 3% have an MPL W515 mutation. Symptom Measures On the MPN-SAF TSS, the majority of individual symptoms assessed did not change significantly between the two assessment time points while on standard therapy. Notable exceptions were a significant decrease in weight loss (mean 2.0 vs. 1.7 on a 0=absent to 10=worst imaginable scale, p=0.005) and a significant worsening in quality of life (mean 3.6 vs. 3.8 on a 0=as good as it can be to 10=as bad as it can be scale, p=0.04). No changes were seen in other symptoms including early satiety, abdominal discomfort, night sweats, fatigue, inactivity, poor concentration, bone pain, itching, or fever. Similarly, the cumulative MPN-SAF TSS score remained stable at a mean of 24.4 over the treatment period. These findings were congruent with those observed using the EORTC QLQ-C30 instrument, with no significant changes seen in emotional, physical, role, cognitive, or social functioning. Finally, the MDASI also revealed a lack of change in either symptom severity (mean 2.7) or symptom distress (mean 3.0) scores, which remained stable over the study period. Discussion: Myeloproliferative neoplasms are associated with burdensome symptoms that significantly compromise quality of life. To date, no studies have quantified symptomatic response to standard-of-care treatments. Overall, results from the MEASURE study suggest that standard treatments have limited systematic impact on patient symptomatology over time, with no improvements in overall quality of life. However, we note the relatively low proportion of patients in this cohort treated with ruxolitinib, which has been shown previously to improve symptom burden, and this may have impacted the symptom responses seen in the group as whole; detailed responses by treatment and MPN subtype will be presented. Figure. Figure. Disclosures Dueck: Pfizer: Honoraria; Bayer: Employment; Phytogine: Employment. Ross:BMS: Honoraria; Novartis: Consultancy, Honoraria, Research Funding, Speakers Bureau; Celgene: Research Funding. Tam:Janssen: Honoraria, Research Funding; Gilead: Honoraria; AbbVie: Honoraria, Research Funding; Pharmacyclics: Honoraria, Travel funding; AbbVie: Honoraria, Research Funding; Roche: Honoraria; Beigene: Honoraria, Other: Travel funding; Pharmacyclics: Honoraria; Gilead: Honoraria; Roche: Honoraria; Beigene: Honoraria, Other: Travel funding. Radia:Novartis: Speakers Bureau; Blueprint: Consultancy. Mesa:UT Health San Antonio - Mays Cancer Center: Employment; Celgene: Research Funding; NS Pharma: Research Funding; Pfizer: Research Funding; Gilead: Research Funding; Genentech: Research Funding; Promedior: Research Funding; CTI Biopharma: Research Funding; Incyte Corporation: Research Funding; Novartis: Consultancy.

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