Quality-of-Life Questionnaire-Core 30 Scores Research Articles

Influence of initial check, information exchange, final accuracy check, reaction information nursing on the psychology of elderly with lung cancer.

As one of the fatal diseases with high incidence, lung cancer has seriously endangered public health and safety. Elderly patients usually have poor self-care and are more likely to show a series of psychological problems. To investigate the effectiveness of the initial check, information exchange, final accuracy check, reaction (IIFAR) information care model on the mental health status of elderly patients with lung cancer. This study is a single-centre study. We randomly recruited 60 elderly patients with lung cancer who attended our hospital from January 2021 to January 2022. These elderly patients with lung cancer were randomly divided into two groups, with the control group taking the conventional propaganda and education and the observation group taking the IIFAR information care model based on the conventional care protocol. The differences in psychological distress, anxiety and depression, life quality, fatigue, and the locus of control in psychology were compared between these two groups, and the causes of psychological distress were analyzed. After the intervention, Distress Thermometer, Hospital Anxiety and Depression Scale (HADS) for anxiety and the HADS for depression, Revised Piper's Fatigue Scale, and Chance Health Locus of Control scores were lower in the observation group compared to the pre-intervention period in the same group and were significantly lower in the observation group compared to those of the control group (P < 0.05). After the intervention, Quality of Life Questionnaire Core 30 (QLQ-C30), Internal Health Locus of Control, and Powerful Others Health Locus of Control scores were significantly higher in the observation and the control groups compared to the pre-intervention period in their same group, and QLQ-C30 scores were significantly higher in the observation group compared to those of the control group (P < 0.05). The IIFAR information care model can help elderly patients with lung cancer by reducing their anxiety and depression, psychological distress, and fatigue, improving their tendencies on the locus of control in psychology, and enhancing their life qualities.

Effect of Individualized Nutrition Intervention Care Combined with Swallowing Training on Postoperative Nutritional Status in Patients with Laryngeal Cancer

Introduction: Laryngeal carcinoma accounts for 13.9% of head and neck tumors, and squamous cell carcinoma is the main pathological type. At present, the treatment of laryngeal cancer is mainly surgical treatment or postoperative radiotherapy. The surgery is delicate, complex, time-consuming and traumatic. Postoperative patients are prone to dysphagia, leading to an increase in the incidence of malnutrition. Malnutrition can cause a series of negative effects, including weight loss, increased incidence of infection, reduced tolerance of anti-tumor treatment, and extended length of hospital stay. Therefore, how to effectively improve the nutritional status of laryngeal cancer patients through nursing intervention has become an important topic of nursing research. Objective: Investigate the effect of individualized nutrition intervention care combined with swallowing training on postoperative nutritional status in patients with laryngeal cancer. Methods: A total of 120 consecutive patients who underwent laryngeal surgery at our hospital for the first time between May 2018 and May 2021 were selected for the study and equally divided into the control group and the study group by the random number table method, with 60 patients in each group. Patients in the control group were given swallowing function training and health counseling, and the study group adopted individualized nutrition intervention care based on the control group. The nutritional status, swallowing function, and quality of life (QOL) of the patients were assessed using the Patient-generated Subjective Global Assessment (PG-SGA), MD Anderson Dysphagia Inventory (MDADI), and Quality of Life Questionnaire-Core30 (QLQ-C30) before the intervention and three months after the intervention. Results: Before the intervention, the scores of MDADI, PG-SGA, and QLQ-C30 were not significantly different between the two groups (P > 0.05), and three months after the intervention, the scores of MDADI and QLQ-C30 increased and the score of PG-SGA decreased in the study group, with significant differences (P 0.05). At three months after the intervention, patients in the study group had higher scores on MDADI, QLQ-C30 and lower scores on PG-SGA than the control group, with significant differences (P < 0.05); There were significant differences in the scores of MDADI, PG-SGA, and QLQ-C30 between the two groups before and after intervention (P < 0.05). Conclusion: Combining individualized nutrition intervention care with swallowing training improves the postoperative nutritional status, swallowing function, and QOL of patients with laryngeal cancer.

Reminiscence therapy care program as a potential nursing intervention to relieve anxiety, depression, and quality of life in older papillary thyroid carcinoma patients: A randomized, controlled study.

Reminiscence therapy (RT) ameliorates psychological problems and quality of life in cancer patients. However, no study reports its effect on older papillary thyroid carcinoma (PTC) patients. This study intended to investigate the effect of the RT-care program (CP) on anxiety, depression, quality of life, and survival in older PTC patients. Eighty-six postoperative older PTC patients were enrolled and randomly assigned to RT-CP group (N = 44) and usual (U)-CP group (N = 42) as a 1:1 ratio for a 6-month intervention. Hospital Anxiety and Depression Scale (HADS) and Quality of Life Questionnaire-Core 30 (QLQ-C30) scores were assessed at baseline, month (M)1, M2, M4, and M6. HADS and QLQ-C30 scores at baseline were not different between two groups. Additionally, HADS-anxiety score at M6 (p = 0.029), and HADS-depression score at M2 (p = 0.030), M4 (p = 0.029), M6 (p = 0.012) were reduced in RT-CP group versus U-CP group. Meanwhile, anxiety and depression rates from M1 to M6 were slightly decreased in RT-CP group versus U-CP group but did not reach statistical significance. Furthermore, depression severity at M6 was reduced in RT-CP group versus U-CP group (p = 0.049). Besides, QLQ-C30 global health status was increased at M2 (p = 0.023) and M6 (p = 0.033), QLQ-C30 function score was elevated at M2 (p = 0.040) and M4 (p = 0.035), while QLQ-C30 symptom score was decreased at M2 (p = 0.046) in RT-CP group versus U-CP group. Moreover, disease-free survival and overall survival were not different between two groups. RT-CP may be a potential intervention for ameliorating anxiety, depression, and quality of life in older PTC patients.

Influence of the Clinical Nursing Pathway on Nursing Outcomes and Complications of Cervical Carcinoma Patients Undergoing Chemotherapy via PICC.

Background Cervical Carcinoma (CC) is the second most common cause of death in women, with most patients being diagnosed at an advanced stage. The conventional treatment for CC, with a long chemotherapy treatment cycle, is less than satisfactory and will cause serious damage to the patient's blood vessels. Objective To analyze the impact of the clinical nursing pathway (CNP) on the incidence of complications and adverse prognosis in patients undergoing chemotherapy for CC via peripherally inserted central catheters (PICC). Materials and Methods This study enrolled 157 CC patients who underwent PICC chemotherapy in the Shaanxi Provincial Cancer Hospital between March 2017 and April 2020 and assigned them between the two groups according to different nursing interventions. Ninety-three patients treated with CNP intervention were included in the research group (RG), and sixty-four cases treated with the routine nursing intervention were included in the control group (CG). The self-care ability and intervention satisfaction of patients were assessed using the self-care ability scale and the intervention satisfaction questionnaire, respectively, both developed by our hospital. The complication rate was observed in both cohorts, and the adverse prognosis of patients was statistically analyzed. Finally, an assessment was made on the patients' quality of life (QOL) using the quality of life questionnaire core 30 (QLQ-C30). Results Higher scores of self-management information, catheter nursing ability, self-care compliance, and abnormal situation management were determined in RG after the nursing intervention. RG also outperformed CG in the overall incidence rates of complications and poor prognosis. Moreover, RG presented statistically higher nursing satisfaction and QLQ-C30 scores than CG after the nursing intervention. Conclusion CNP has a significant nursing effect on patients with CC treated with PICC chemotherapy, which can not only reduce the incidence of postchemotherapy complications but also improve patient prognosis, satisfaction, and life quality, with the value for clinical promotion.

Quality of life, functioning, and symptoms in patients with previously treated locally advanced or metastatic urothelial carcinoma from EV-301: A randomized phase 3 trial of enfortumab vedotin versus chemotherapy.

4539 Background: In EV-301, a randomized, open-label phase 3 study (NCT03474107), enfortumab vedotin (EV), a Nectin-4–directed therapy, significantly prolonged median overall survival by ̃3.9 months and reduced the risk of death by 30% compared with standard chemotherapy (SC; docetaxel, paclitaxel, or vinflunine) in patients with previously treated locally advanced/metastatic urothelial carcinoma. Understanding patient perspectives and experiences is important to further contextualize the benefits/risks of EV. Here, we report key prespecified quality-of-life (QoL) endpoints, a secondary objective of EV-301. Methods: Patients completed the validated European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire Core 30 (QLQ-C30) at baseline, on Day 1 of each week for the first 12 weeks, and then every 12 weeks until discontinuation. The QLQ-C30 assessed functional domains, symptom scales/items, financial impact, and overall health/QoL. Descriptive statistics were used to summarize instrument compliance rates and scores; mixed model repeated measures were used to evaluate changes from baseline over time. Logistic regressions were conducted to assess confirmed improvement rates, defined as clinically meaningful improvement (predefined per domain) over two subsequent visits. Results: Of the 608 randomized patients (EV, n = 301; SC, n = 307), 77.3% were male, median age was 68 (range: 30-88), and 30.9% had liver metastasis. Questionnaire compliance rates at baseline were ̃90% in both groups; during the study, average rates were 70.2% (EV) and 66.9% (SC). Baseline QLQ-C30 scores were similar between groups. At Week 12, scores on the global health status (GHS) scale were similar between groups (EV: -2.8, SC: -5.0; P=.2429), but SC was associated with numerically greater deterioration and more variability in QoL over the first 12 weeks. Patients receiving EV had significant reduction in pain symptoms (EV: -5.62, SC: +0.11; adjusted difference: -5.73, P&lt;.05), but significant worsening of appetite loss (EV: +8.55, SC: +1.26; adjusted difference: 7.29, P&lt;.05) compared with SC. Other symptom scores were not significantly different between groups. Higher proportions of patients on EV vs SC had significant confirmed improvements across all functioning domains (role, physical, emotional, social, cognitive), GHS, and several symptom scales (pain, fatigue, dyspnea, constipation). The greatest difference in improvement was reported for pain (EV: 51.6%, SC: 28.8%; OR = 2.76[1.81, 4.22]). Conclusions: Compared with SC, patients receiving EV had numerically less deterioration and variability in QoL during the first 12 weeks of treatment. More patients in the EV group had improvements over SC in 10 of 15 QLQ-C30 domains; improvement in pain showed the largest benefit. Clinical trial information: NCT03474107.

FP14.12 Quality of Life and Subgroup Analysis in a Phase 3 Randomized Study of Ensartinib vs Crizotinib in ALK–Positive NSCLC Patients: eXalt3.

Ensartinib (X-396) is a novel second-generation ALK tyrosine kinase inhibitor (TKI). In a phase 3 study interim analysis, ensartinib showed statistically significant improvement of median PFS over crizotinib in patients with ALK+ NSCLC who were ALK TKI naive or received up to one prior chemotherapy line, including higher efficacy against brain metastases. Ensartinib was well tolerated, with low grade rash, pruritus, edema, and transaminitis as the most frequent treatment-related AEs. Here we plan to present subgroups analyses and the quality of life outputs of the phase 3 eXalt3 study (NCT02767804). Patients with locally tested ALK+ NSCLC (ITT population) were randomized 1:1 to ensartinib (225 mg QD orally) or crizotinib (250 mg BID orally). No crossover was allowed. Patients were stratified by prior chemotherapy, ECOG PS, brain metastases, and geographic region. The modified ITT (mITT) population was prespecified to include all centrally ALK+ patients by Abbott FISH test. The primary endpoint was blinded independent review committee (BIRC)–assessed progression-free survival (PFS; RECIST v.1.1). Secondary endpoints included overall survival (OS), overall response rate (ORR), and time to treatment failure (TTF) in the brain and patients reported outcomes (PRO). PRO data collection included the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (QLQ-C30). A linear mixed model for repeated measures was used to analyze change from baseline in the Global Health Status/Quality of Life subscale (GHS/QOL), with a change of greater than or equal to ten points deemed meaningful. Time to symptom deterioration will be presented. In total, 290 patients were randomized (ensartinib [n=143]; crizotinib [n=147]).Median age was 54.1 y, 26% of patients had prior chemotherapy, and 36% of patients had baseline CNS metastases (5% had prior brain radiotherapy). The mITT population included 247 patients (ensartinib [n=121]; crizotinib [n=126]). At the July 1, 2020, data cutoff, 139 BIRC-assessed PFS events (73%) occurred in the ITT population and 119 (63%) in the mITT population. Median PFS was 25.8 months with ensartinib vs 12.7 months with crizotinib (HR, 0.52; P=.0003 by log-rank test) with a median follow-up of 23.8 and 20.2 months in the ITT population. Median PFS was not reached with ensartinib vs 12.7 months with crizotinib in the mITT population (HR, 0.48; P=.0002 by log-rank test). New subgroup analyses in mITT for ensartinib showed a trend for higher efficacy by prior chemotherapy vs no chemotherapy (mPFS NR vs 25.8). Both global health status (GHS) as well as 5 functional and 9 symptom domains within EORTC QLQ-C30 had clinical meaningful improvement over time for ensartinib. Ensartinib delays the time to worsening of GHS with HR =0.83 (95% CI [0.57, 1.20]) vs crizotinib. Complete subgroup analyses (forest plot and multivariate analyisis) will be presented at the conference as well as OS updates. Comprehenive EORTC QLQ-C30 and Lung Cancer Symptom Scale scores will also be reported at the conference. In ALK+ NSCLC patients ensartinib represents a new option in first-line setting. QOLs data support its favorable safety profile. Relevant subgroups analyses to evaluate its clinical impact will be presented at the meeting.

Reliability and Validity of the Korean Language Version of the U.S. National Cancer Institute's Patient-Reported Outcomes Common Terminology Criteria for Adverse Events

ContextTo improve precision and accuracy in the capture of symptomatic adverse events (AEs) by self-report, the U.S. National Cancer Institute has developed a library of 124 patient-reported outcome (PRO) items reflecting 78 symptomatic AEs drawn from the Common Terminology Criteria for Adverse Events (CTCAE). The PRO-CTCAE™ item library has been translated and linguistically validated in the Korean language. ObjectivesThe aim of this study was to examine the psychometric properties of PRO-CTCAE-Korean. MethodsPRO-CTCAE-Korean and the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire Core 30 (QLQ-C30) were administered to 1358 Korean-speaking individuals receiving treatment for cancer at two medical centers in Korea (mean age 55.1 years; SD ±11.9; 60% females; and 61% high school education or less). A subset of 82 study participants completed the same two measures on a second occasion approximately three days later. ResultsCorrelations between PRO-CTCAE-Korean and conceptually relevant QLQ-C30 items were all greater than r = 0.30 except for headache severity. Most PRO-CTCAE-Korean items correlated at least moderately with QLQ-C30 summary scores. Monotonically decreasing total QLQ-C30 scores were observed across worsening levels of symptom frequency, severity, and interference (all P < 0.01), indicating that PRO-CTCAE-Korean response choices are well comprehended, and that PRO-CTCAE-Korean discriminates respondents with different levels of symptom burden. PRO-CTCAE-Korean also demonstrated generally acceptable to good reliability (88% of items intraclass correlation coefficient >0.50). ConclusionPRO-CTCAE-Korean is a reliable and valid instrument to capture symptomatic AEs by self-report in patients on cancer clinical trials.

The EORTC QLQ-C30 Summary Score as Prognostic Factor for Survival of Patients with Cancer in the "Real-World": Results from the Population-Based PROFILES Registry.

BackgroundHealth‐related quality of life (HRQoL) has been shown to be a prognostic factor for cancer survival in randomized clinical trials and observational “real‐world” cohort studies; however, it remains unclear which HRQoL domains are the best prognosticators. The primary aims of this population‐based, observational study were to (a) investigate the association between the novel European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire‐Core30 (QLQ‐C30) summary score and all‐cause mortality, adjusting for the more traditional sociodemographic and clinical prognostic factors; and (b) compare the prognostic value of the QLQ‐C30 summary score with the global quality of life (QoL) and physical functioning scales of the QLQ‐C30.Materials and MethodsBetween 2008 and 2015, patients with cancer (12 tumor types) were invited to participate in PROFILES disease‐specific registry studies (response rate, 69%). In this secondary analysis of 6,895 patients, multivariate Cox proportional hazard regression models were used to investigate the association between the QLQ‐C30 scores and all‐cause mortality.ResultsIn the overall Cox regression model including sociodemographic and clinical variables, the QLQ‐C30 summary score was associated significantly with all‐cause mortality (hazard ratio [HR], 0.77; 99% confidence interval [CI], 0.71–0.82). In stratified analyses, significant associations between the summary score and all‐cause mortality were observed for colon, rectal, and prostate cancer, non‐Hodgkin lymphoma, chronic lymphocytic leukemia, and multiple myeloma. The QLQ‐C30 summary score had a stronger association with all‐cause mortality than the global QoL scale (HR, 0.82; 99% CI, 0.77–0.86) or the physical functioning scale (HR, 0.81; 95% CI, 0.77–0.85).ConclusionIn a real‐world setting, the QLQ‐C30 summary score has a strong prognostic value for overall survival for a number of populations of patients with cancer above and beyond that provided by clinical and sociodemographic variables. The QLQ‐C30 summary score appears to have more prognostic value than the global QoL, physical functioning, or any other scale within the QLQ‐C30.Implications for PracticeThe finding that health‐related quality of life provides distinct prognostic information beyond known sociodemographic and clinical measures, not only around cancer diagnosis (baseline) but also at follow‐up, has implications for clinical practice. Implementation of cancer survivorship monitoring systems for ongoing surveillance may improve post‐treatment rehabilitation that leads to better outcomes.

Converting EORTC QLQ-C30 scores to utility scores in the brigatinib ALTA study

Aims: Health utilities summarize a patient’s overall health status. This study estimated utilities based on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (QLQ-C30), a widely used measure of health-related quality-of-life (HRQoL) in oncology, using published mapping algorithms.Materials and methods: Data were from the Anaplastic Lymphoma Kinase (ALK) in Lung Cancer Trial of brigatinib (ALTA; NCT02094573), an open-label, international, phase 2 study. ALTA evaluated the efficacy and safety of two randomized dosing regimens of brigatinib in patients with locally advanced or metastatic ALK + non-small cell lung cancer (NSCLC) that had progressed on prior therapy with crizotinib. QLQ-C30 scores were mapped to European Quality-of-Life-5 Dimensions (EQ-5D) utility scores using two published algorithms (Khan et al. for EQ-5D-5L; Longworth et al. for EQ-5D-3L). The impact of brigatinib treatment on health utilities over time was assessed.Results: The analysis included 208 subjects. Mean baseline utility scores for both algorithms ranged between 0.60 − 0.71 and increased to 0.78 by cycle 5. Utility improvements were sustained during most of the treatment, before disease progression. Minor variations were observed between utility scores; Khan et al. estimates were approximately 0.01 or 0.02 points lower than Longworth et al. estimates.Limitations: Algorithms considered were limited to those available in the published literature at the time of the study. This utility analysis was exploratory, and the ALTA trial did not include an internal control group (i.e. standard of care) and was not powered to detect differences in QoL/utility outcomes between treatment arms.Conclusions: Converting QLQ-C30 scores into utilities in trials using established mapping algorithms can improve evaluation of medicines from the patient perspective. Both algorithms suggested that brigatinib improved health utility in crizotinib-refractory ALK + NSCLC patients, and improvements were maintained during most of the treatment.Clinicaltrials.gov identifier: NCT02094573

Replication and validation of higher order models demonstrated that a summary score for the EORTC QLQ-C30 is robust

ObjectiveTo further evaluate the higher order measurement structure of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30), with the aim of generating a summary score. Study Design and SettingUsing pretreatment QLQ-C30 data (N = 3,282), we conducted confirmatory factor analyses to test seven previously evaluated higher order models. We compared the summary score(s) derived from the best performing higher order model with the original QLQ-C30 scale scores, using tumor stage, performance status, and change over time (N = 244) as grouping variables. ResultsAlthough all models showed acceptable fit, we continued in the interest of parsimony with known-groups validity and responsiveness analyses using a summary score derived from the single higher order factor model. The validity and responsiveness of this QLQ-C30 summary score was equal to, and in many cases superior to the original, underlying QLQ-C30 scale scores. ConclusionOur results provide empirical support for a measurement model for the QLQ-C30 yielding a single summary score. The availability of this summary score can avoid problems with potential type I errors that arise because of multiple testing when making comparisons based on the 15 outcomes generated by this questionnaire and may reduce sample size requirements for health-related quality of life studies using the QLQ-C30 questionnaire when an overall summary score is a relevant primary outcome.

Quality of life of 1276 elderly patients with prostate cancer, starting treatment with a gonadotropin-releasing hormone agonist: results of a French observational study

This French observational, longitudinal, prospective study described the health-related quality of life (HRQoL) of elderly men (≥75 years old) with prostate cancer after initiating gonadotropin-releasing hormone (GnRH) agonist therapy. At baseline and 3–6 months after baseline, European Organisation for Research and Treatment of Cancer quality of life questionnaire-core 30 (QLQ-C30) and prostate-specific (QLQ-PR25) questionnaires were completed by patients. Data from 1276 patients were analyzed. At baseline, mean (±SD) age was 80 (±4.1) years, 29.1% of patients had Gleason scores ≥8 and 24.9% had metastases. At baseline, increasing age, presence of metastasis and presence of comorbidity had a negative impact on QLQ-C30 and QLQ-PR25 scores. At follow-up, improvement in emotional-functioning (2.8; p < 0.001), social-functioning (1.7; p = 0.011), global HRQoL (1.6; p = 0.029), sleep-disturbance (−2.1; p = 0.011), appetite-loss (−4.0; p < 0.001) and pain (−4.1; p < 0.001) QLQ-C30 scores were observed. In addition, there was a worsening in treatment-related symptom (8.6; p < 0.001), sexual-activity (−5.5; p < 0.001) and sexual-functioning (−22.6; p < 0.001) QLQ-PR25 scores, and an improvement in urinary symptoms (−3.7; p < 0.001) and incontinence aid (−2.9; p = 0.023) QLQ-PR25 scores. This study shows that, apart from the expected impact on sexual functioning domains, HRQoL is not adversely affected by 3–6 months of GnRH agonist therapy in older men with prostate cancer.

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

Abstract 795▪FN2▪This icon denotes a clinically relevant abstract 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. [Display omitted] 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.