Baseline Quality Of Life Scores Research Articles

Prospective evaluation of quality of life 54 months after high-dose intensity-modulated radiotherapy for localized prostate cancer

ObjectiveTo determine late toxicity and quality of life (QoL) in patients with localized prostate cancer after high-dose intensity-modulated radiotherapy (IMRT).Patient and methodsThis was a prospective study in patients with localized prostate adenocarcinoma who had been treated by IMRT (76 Gy) between February and November 2006. Physicians scored acute and late toxicity using the Common Terminology Criteria for Adverse Events (version 3.0). Patients completed cancer and prostate-specific QoL questionnaires (EORTC QLQ-C30 and QLQ-PR25) before IMRT (baseline) and at 2, 6, 18 and 54 months.ResultData were available for 38 patients (median age, 73 years) (18% low risk; 60% intermediate risk; 32% high risk). The incidence of urinary and gastrointestinal toxicity was respectively: immediately post IMRT: 36.8% and 23.7% (grade 1), 5.3% and 5.3% (grade 2), 2.6% and 0% (grade 3); at 18 months: 23.7% and 10.3% (grade 1), 26.3% and 13.2% (grade 2), 0% and 2.6% (grade 3); at 54 months: 34.2% and 23.7% (grade 1), 5.3% and 15.8% (grade 2), 5.3% and 0% (grade 3). At 54 months, significant worsening was reported by patients for 11/19 QoL items but the worsening was clinically relevant (>10 points) for 7 items only: physical, role as well as social functioning, fatigue, pain, dyspnoea and constipation. There was no significant difference between 54-month and baseline QoL scores for global health, gastrointestinal symptoms, treatment-related symptoms and sexual function. However, there was significant - but clinically non-relevant (<10 points) - worsening of urinary symptom.ConclusionHigh-dose IMRT to the prostate with accurate patient positioning did not induce any clinically relevant worsening in late urinary and gastrointestinal QoL at 54 months. Impaired physical and role functioning may be related to age and comorbidities.

The relationship between clinical outcomes and quality of life in first‐episode mania: a longitudinal analysis

Despite growing attention to the relationship between bipolar disorder (BD) and quality of life (QoL), there remains a lack of information about QoL in the early stages of BD, and about the course of QoL in people with BD over time. Here, we report on QoL and symptomatic outcomes over a 1.5-year period in a Canadian sample of first-episode mania patients. Patients (n = 63) with DSM-IV-TR BD type I recovering from a recent episode of mania were recruited from a university-based hospital setting in Vancouver, BC, Canada and assessed at six monthly intervals for 18 months. In addition to symptomatic and cognitive assessments, two self-report QoL scales [the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) and the Medical Outcomes Study Short Form 36 (SF-36)] were administered. Baseline QoL scores were high, with mean Q-LES-Q scores at 70% of the maximum possible score; QoL continued to show a trend towards improvement over time. Multiple hierarchical regressions were used to explore predictors of QoL over time, finding that: (i) length of illness and severity of depressive symptoms at baseline predicted Q-LES-Q scores at both baseline and six months; (ii) the number of previous depressive episodes and severity of depression at baseline and 12 months all predicted QoL at 12 months; and (iii) only severity of depressive symptoms at 12 months predicted QoL at 18 months. Our observation that QoL in patients who have recently experienced an episode of mania can be relatively preserved offers hope, both for healthcare providers and for those newly diagnosed. Further, that severity of depressive symptoms even in the early stages of the disease was the consistent predictor of QoL suggests that depressive symptoms need to be aggressively treated to improve QoL.

Impact of FOLFIRINOX Compared With Gemcitabine on Quality of Life in Patients With Metastatic Pancreatic Cancer: Results From the PRODIGE 4/ACCORD 11 Randomized Trial

To compare the quality of life (QoL) of patients receiving oxaliplatin, irinotecan, fluorouracil, and leucovorin (FOLFIRINOX) or gemcitabine as first-line chemotherapy and to assess whether pretreatment QoL predicts survival in patients with metastatic pancreatic cancer. Three hundred forty-two patients with performance status 0 or 1 were randomly assigned to receive FOLFIRINOX (oxaliplatin, 85 mg/m(2); irinotecan, 180 mg/m(2); leucovorin, 400 mg/m(2); and fluorouracil, 400 mg/m(2) bolus followed by 2,400 mg/m(2) 46-hour continuous infusion, once every 2 weeks) or gemcitabine 1,000 mg/m(2) weekly for 7 of 8 weeks and then weekly for 3 of 4 weeks. QoL was assessed using European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire C30 every 2 weeks. Improvement in global health status (GHS; P < .001) was observed in the FOLFIRINOX arm and improvement in emotional functioning (P < .001) was observed in both arms, along with a decrease in pain, insomnia, anorexia, and constipation in both arms. A significant increase in diarrhea was observed in the FOLFIRINOX arm during the first 2 months of chemotherapy. Time until definitive deterioration ≥ 20 points was significantly longer for FOLFIRINOX compared with gemcitabine for GHS, physical, role, cognitive, and social functioning, and six symptom domains (fatigue, nausea/vomiting, pain, dyspnea, anorexia, and constipation). Physical functioning, constipation, and dyspnea were independent significant prognostic factors for survival with treatment arm, age older than 65 years, and low serum albumin. FOLFIRINOX significantly reduces QoL impairment compared with gemcitabine in patients with metastatic pancreatic cancer. Furthermore, baseline QoL scores improved estimation of survival probability when added to baseline clinical and demographic variables.

561P - Quality of Life Analysis in Patients with Kras Wild-Type Metastatic Colorectal Cancer Treated with First-Line Folfiri Plus Cetuximab

ABSTRACT Background In the CRYSTAL study adding cetuximab to first-line FOLFIRI significantly improved clinical outcome in patients (pts) with KRAS wild-type metastatic colorectal cancer (mCRC). Quality of life (QoL) was assessed and associations with tumor response and survival were studied. Material and methods The European Organization for Research and Treatment of Cancer QoL questionnaire core-30 was used. The primary analysis was a pattern-mixture analysis for the global health score (GHS)/QoL and social functioning scales. Exploratory analyses included the change from baseline QoL scores by severity of skin reactions, the change in reported symptoms from baseline according to tumor response and treatment, and the effect of symptomatic status at baseline on response and survival. Results QoL was evaluable in 627/666 pts (94%) with KRAS wild-type tumors, 52% received FOLFIRI, and 48% FOLFIRI plus cetuximab. No significant differences for GHS/QoL (p = 0.12) and social functioning scores (p = 0.43) were found between the treatment arms. In pts receiving cetuximab, the mean change from baseline in GHS/QoL was 3.00 in pts without skin reactions compared with -1.09 and -0.51 in those with grade I and grade II-IV early skin reactions, respectively. Social functioning score worsened in pts with no skin reactions (mean -6.41) compared with a slight improvement in those with grade I (mean 1.64) and grade II-IV (mean 1.48) early skin reactions, respectively. Tumor response was higher (58% vs 40%, p = 0.0002) and survival longer (hazard ratio 1.68, p Conclusions Adding cetuximab to FOLFIRI improved clinical outcome without negatively impacting on QoL, improving response despite baseline symptoms and leading to earlier symptom relief in pts whose tumors had responded. Symptom status at baseline was demonstrated to be a useful prognostic factor in mCRC. Disclosure C. Kohne: The author reports honoraria from Pfizer and Merck KGaA. G. Folprecht: The author reports consultant/advisory roles for Merck KGaA, Roche and BMS, honoraria from Merck KGaA, Pfizer, Roche and Novartis and research funding from Merck KGaA. P. Rougier: The author reports, in relation to the topic concerned, honoraria for three years from Merck KGaA for participation at scientific boards and symposia. D. Curran: The author acted as a consultant (on statistical and QoL analysis) for Merck KGaA. U. Sartorius: The author is an employee of Merck KGaA. I. Griebsch: At the time of this research, the author was an employee of Merck KGaA. E. Van Cutsem: The author has received research funding from Merck KGaA. All other authors have declared no conflicts of interest.

Prospective evaluation of quality of life effects in patients undergoing palliative radiotherapy for brain metastases

BackgroundRecently published results of quality of life (QoL) studies indicated different outcomes of palliative radiotherapy for brain metastases. This prospective multi-center QoL study of patients with brain metastases was designed to investigate which QoL domains improve or worsen after palliative radiotherapy and which might provide prognostic information.MethodsFrom 01/2007-01/2009, n=151 patients with previously untreated brain metastases were recruited at 14 centers in Germany and Austria. Most patients (82 %) received whole-brain radiotherapy. QoL was measured with the EORTC-QLQ-C15-PAL and brain module BN20 before the start of radiotherapy and after 3 months.ResultsAt 3 months, 88/142 (62 %) survived. Nine patients were not able to be followed up. 62 patients (70.5 % of 3-month survivors) completed the second set of questionnaires. Three months after the start of radiotherapy QoL deteriorated significantly in the areas of global QoL, physical function, fatigue, nausea, pain, appetite loss, hair loss, drowsiness, motor dysfunction, communication deficit and weakness of legs. Although the use of corticosteroid at 3 months could be reduced compared to pre-treatment (63 % vs. 37 %), the score for headaches remained stable. Initial QoL at the start of treatment was better in those alive than in those deceased at 3 months, significantly for physical function, motor dysfunction and the symptom scales fatigue, pain, appetite loss and weakness of legs. In a multivariate model, lower Karnofsky performance score, higher age and higher pain ratings before radiotherapy were prognostic of 3-month survival.ConclusionsModerate deterioration in several QoL domains was predominantly observed three months after start of palliative radiotherapy for brain metastases. Future studies will need to address the individual subjective benefit or burden from such treatment. Baseline QoL scores before palliative radiotherapy for brain metastases may contain prognostic information.

Depression, Anxiety, and Quality of Life After Catheter Ablation in Patients With Paroxysmal Atrial Fibrillation

Patients with paroxysmal atrial fibrillation (AF) experience impaired quality of life (QoL) and psychological distress. Catheter ablation of AF can markedly improve QoL. However, the effect of catheter ablation of AF on psychological status is unknown. Depression, anxiety, and QoL improve after catheter ablation in patients with paroxysmal AF. A total of 166 consecutive patients with symptomatic paroxysmal AF were examined. Eighty-two patients (55 men, mean age 55.9 ± 6.1 y) underwent catheter ablation and 84 patients (58 men, mean age 57.2 ± 5.4 years) received antiarrhythmic drug (AAD) therapy. The Self-Rating Depression Scale, Self-Rating Anxiety Scale, and Medical Outcomes Survey 36-item Short-Form questionnaires were completed by these patients at baseline, and at 3, 6, 9, and 12 months of follow-up. Results in the ablation group were compared with those of the AAD group. In the ablation group, 42.7% of patients showed symptoms of depression and 37.8% showed symptoms of anxiety, which were similar to those in the AAD group. Both groups similarly displayed reduced physical and mental QoL. Catheter ablation was effective in reducing symptoms of depression and anxiety and improving QoL, and it was superior to AAD therapy (all P < 0.001). Multiple regression analysis demonstrated that catheter ablation, no AF recurrence, avoidance of warfarin use, higher baseline depression and anxiety scores, and lower baseline QoL scores contributed to improvement of depression, anxiety, and QoL, respectively. Catheter ablation is more effective for improving depression, anxiety, and QoL in patients with paroxysmal AF compared with AAD therapy.

Quality of Life After Palliative Radiation Therapy for Patients With Painful Bone Metastases: Results of an International Study Validating the EORTC QLQ-BM22

Radiation therapy (RT) is an effective method of palliating painful bone metastases and can improve function and reduce analgesic requirements. In advanced cancer patients, quality of life (QOL) is the primary outcome of interest over traditional endpoints such as survival. The purpose of our study was to compare bone metastasis-specific QOL scores among patients who responded differently to palliative RT. Patients receiving RT for bone metastases across 6 countries were prospectively enrolled from March 2010-January 2011 in a trial validating the QLQ-BM22 and completed the QLQ-BM22 and the core measure (QLQ-C30) at baseline and after 1 month. Pain scores and analgesic intake were recorded, and response to RT was determined according to the latest published guidelines. The Kruskal-Wallis nonparametric and Wilcoxon rank sum tests compared changes in QOL among response groups. A Bonferroni-adjusted P<.003 indicated statistical significance. Of 79 patients who received palliative RT, 59 were assessable. Partial response, pain progression, and indeterminate response were observed in 22, 8, and 29 patients, respectively; there were no patients with a complete response. Patients across all groups had similar baseline QOL scores apart from physical functioning (patients who progressed had better initial functioning). One month after RT, patients who responded had significant improvements in 3 of 4 QLQ-BM22 domains (painful site, P<.0001; painful characteristic, P<.0001; and functional interference, P<.0001) and 3 QLQ-C30 domains (physical functioning, P=.0006; role functioning, P=.0026; and pain, P<.0001). Patients with progression in pain had significantly worse functional interference (P=.0007) and pain (P=.0019). Patients who report pain relief after palliative RT also have better QOL with respect to bone metastasis-specific issues. The QLQ-BM22 and QLQ-C30 are able to discriminate among patients with varying responses and are recommended for use in future bone metastasis clinical trials.

Baseline quality of life as a prognostic survival tool in patients receiving sunitinib for metastatic renal cell carcinoma

Background:In a randomized phase III trial of sunitinib vs interferon-alfa (IFN-α) in metastatic renal cell carcinoma (mRCC), better baseline quality of life (QoL) was predictive of longer survival. Using this dataset, we have developed a novel prognostic tool that establishes a relationship between baseline QoL scores and median survival time.Methods:Baseline QoL was assessed using the FACT-Kidney Symptom Index-15 item (FKSI-15), its disease-related symptoms (FKSI-DRS) subscale, and the Functional Assessment of Cancer Therapy–General (FACT-G) scale. Weibull models estimated median progression-free survival (mPFS) and overall survival (mOS) as a function of baseline QoL.Results:Longer PFS and OS were associated with higher baseline FKSI-15, FKSI-DRS, and FACT-G scores (P<0.05), and baseline FKSI-15 score was the best predictor of survival. For example, for a baseline FKSI-15 score of 60, the predicted mPFS was 67.9 weeks, and predicted mOS was 240.6 weeks. The magnitude of benefit was greater with sunitinib vs IFN-α for a given baseline QoL score.Conclusion:This novel tool indicates that baseline FKSI-15 scores were linked to mPFS and mOS in a clear and interpretable way. The results support evaluation of patient-reported QoL symptoms at baseline as a prognostic indicator of survival in clinical research and practice.

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,

Abstract 3842▪▪This icon denotes a clinically relevant abstract 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*Parameter MeasuredRuxolitinib (mean)Placebo (mean)Maximum Score PossibleMFSAF - TSS18.016.560 (worst possible)PROMIS Fatigue43.443.2100 (worst possible)EORTC QLQ C-30 SubscalesEORTC Global Health52.654.5100 (best possible)Physical Functioning69.567.6100 (best possible)Role Functioning64.665.1100 (best possible)Emotional Functioning73.776.3100 (best possible)Cognitive Functioning81.179.3100 (best possible)Social Functioning68.065.9100 (best possible)*Baseline measures for patients with both baseline and wk 24 data.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. [Display omitted] 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.

Altered health status and quality of life in South Asians with coronary artery disease

People of South Asian (SA) ancestry are susceptible to coronary artery disease (CAD). Although studies suggest that SA with CAD has a worse prognosis compared with Europeans, it is unknown whether corresponding differences in functional status and quality-of-life (QOL) measures exist. Accordingly, we compared symptoms, function, and QOL in SA and European Canadians with CAD using the Seattle Angina Questionnaire (SAQ). Using the Alberta Provincial Project for Outcomes Assessment in Coronary Heart Disease, an outcomes registry that captures patients undergoing cardiac catheterization in Alberta, Canada, we identified 635 SA and 18,934 European patients with angiographic CAD from January 1995 to December 2006 who reported health status outcomes using the SAQ at 1 year after the index catheterization. To obtain comparable clinical variables among SA and Europeans, we used a propensity score-matching technique. One-year adjusted mean (SD) scores were significantly lower in SA compared with European Canadians for most SAQ domains: exertional capacity (75 [23] vs 80 [23], P = .011), anginal stability (77 [28] vs 77 [27], P = .627), anginal frequency (86 [23] vs 88 [20], P < .001), treatment satisfaction (86 [19] vs 89 [16], P < .001), and SAQ QOL (71 [24] vs 76 [21], P < .001). These results could not be accounted for by differences in baseline QOL scores or changes in health status from baseline to 1 year. South Asian Canadians with established CAD have significantly worse health status outcomes at 1 year after angiography compared with European Canadians. Further studies are warranted to improve functional outcomes in SA with CAD.

Influence of body mass index on quality of life in atrial fibrillation patients undergoing catheter ablation

Obesity increases the risk of atrial fibrillation (AF), and AF seriously impairs the quality of life (QoL). However, it is not known whether body mass index (BMI) has any direct influence on QoL in AF. To study the association between baseline BMI and QoL improvement in patients with AF following catheter ablation. Six hundred sixty patients with AF (62 ± 10 years, male 69%, paroxysmal AF 27%, persistent AF 31%, long-standing persistent AF 42%) made up the study population. On the basis of the baseline BMI, patients were categorized into 2 groups: normal (BMI < 25) and overweight/obese (BMI ≥ 25). The QoL survey was done at baseline and at 12-month postablation by using the Medical Outcomes Study Short Form-36 (SF-36), Beck Depression Inventory (BDI), Hospital Anxiety and Depression (HAD) scale, and State-Trait Anxiety Inventory (STAI). At baseline, dyslipidemia, hypertension, diabetes, coronary artery disease, and large left atrium had higher prevalence in the overweight/obese population. In addition, the preprocedure QoL scores on the SF-36, HAD scale, and STAI were significantly lower in this group than in the normal-BMI group. At the 12-month postablation assessment, no significant improvement in QoL score was noted in the normal-BMI group. However, in the overweight/obese group, QoL scores improved significantly in all scales, except the physical functioning and bodily pain categories of SF-36. Long-term ablation success was not different across the groups (69% normal BMI, 63% high BMI, log-rank P = .109). Patients with successful ablation showed significant improvement in QoL scores compared with those who failed. The multivariable analysis revealed the baseline QoL score and BMI ≥ 25 to be independent predictors of QoL improvement. Obese patients with AF tend to have a better postablation QoL outcome than do their nonobese counterparts.

Quality-of-life trajectory of clients and carers referred to a community palliative care service

Palliative care clients often have a reduced quality of life (QOL). The purpose of this study was to explore the QOL trajectory of clients and carers newly referred to a community palliative care service. A total of 49 clients and 43 carers respectively completed the McGill QOL scale (MQOL) and the caregiver QOL cancer scale (CQOLC) questionnaires. Baseline data relating to demographics, health status, and QOL are presented for the 49 participants and their 43 carers, and these are compared with follow-up data from 22 clients and 13 carers (matched pairs). On average, there were no significant differences between baseline and follow-up QOL scores in any respects for either clients or carers, including measures of burden, disruptiveness, positive adaptation, and financial concerns. Whether this indicates that the care administered succeeded in cancelling out the worsening of the clients' conditions or whether it indicates a shortcoming of the care was not assessed.

Quality of life in patients with no-option critical limb ischemia underlines the need for new effective treatment

To provide a solid baseline reference for quality of life (QoL) in patients with no-option critical limb ischemia (CLI). CLI is associated with surgery, endovascular interventions, hospitalization, and a poor prognosis. An increasing number of clinical trials are, therefore, investigating new treatment strategies (eg, therapeutic neovascularization) in patients with CLI. QoL serves as an important secondary endpoint in many of these trials, but solid reference QoL data for patients with no-option CLI are lacking. The Medical Outcomes Study Short Form 36 (SF-36) and the EuroQol-5D (EQ-5D) questionnaires were used to obtain baseline QoL scores from 47 patients with no-option CLI participating in a therapeutic neovascularization trial. To allow for easy comparability, a norm-based scoring (NBS) method was used to report the results of the SF-36. Scores of patients with CLI were furthermore compared with scores of patients with milder forms of peripheral arterial disease (PAD) and with patients with cardiovascular risk factors only. Determinants of QoL in patients with PAD were identified using multiple linear regression methods. Patients with no-option CLI reported QoL scores below the general population mean on every health dimension of the SF-36. Physical functioning, role physical functioning, and bodily pain were affected most intensively. These poor physical QoL scores were further underlined when compared with other patients with milder forms of PAD or patients with cardiovascular risk factors only. Patients with CLI scored poorly on the pain/discomfort and the usual activities domain of the EQ-5D. Diabetes, female gender, body mass index, and the ankle-brachial index at rest were significant determinants of the QoL in PAD on multivariate analysis. The QoL data of patients with no-option CLI using NBS methods for the SF-36 provide a baseline reference for ongoing clinical trials on new treatment strategies. Our data stress the need for new revascularization therapies in patients with no-option CLI.

Quality of Life in Hormone Receptor–Positive HER-2+ Metastatic Breast Cancer Patients During Treatment with Letrozole Alone or in Combination with Lapatinib

A phase III trial compared lapatinib plus letrozole (L + Let) with letrozole plus placebo (Let) as first-line therapy for hormone receptor (HR)(+) metastatic breast cancer (MBC) patients. The primary endpoint of progression-free survival (PFS) in patients whose tumors were human epidermal growth factor receptor (HER)-2(+) was significantly longer for L + Let than for Let (8.2 months versus 3 months; p = .019). This analysis focuses on quality of life (QOL) in the HER-2(+) population. QOL was assessed at screening, every 12 weeks, and at withdrawal using the Functional Assessment of Cancer Therapy-Breast (FACT-B). Changes from baseline were analyzed and the proportions of patients achieving minimally important differences in QOL scores were compared. Additional exploratory analyses evaluated how QOL changes reflected tumor progression status. Among the 1,286 patients randomized, 219 had HER-2(+) tumors. Baseline QOL scores were comparable in the two arms. Mean changes in QOL scores were generally stable over time for patients who stayed on study. The average change from baseline on the FACT-B total score in both arms was positive at all scheduled visits through week 48. There was no significant difference between the two treatment arms in the percentage of QOL responders. The addition of lapatinib to letrozole led to a significantly longer PFS interval while maintaining QOL during treatment, when compared with letrozole alone, thus confirming the clinical benefit of the combination therapy in the HR(+) HER-2(+) MBC patient population. This all oral regimen provides an effective option in this patient population, delaying the need for chemotherapy and its accompanying side effects.

Evaluation of Health-Related Quality of Life in Patients with Prostate Cancer after Treatment with Radical Retropubic Prostatectomy and Permanent Prostate Brachytherapy

Aim: The aims of this study were to evaluate the health-related quality of life (HRQOL) and make the treatment decision less difficult. Methods: Between 2007 and 2009 radical retropubic prostatectomy (RRP) was performed in 96 patients and permanent prostate brachytherapy (PPB) in 88 patients at our hospital. The general and disease-specific HRQOL was measured using two instruments, the Medical Outcome Study 8-Item Short-Form Health Survey (SF-8) and the expanded prostate index composite (EPIC). Results: Comparing RRP and PPB, there were significant differences in all scores except for general health in the 1st month after treatment which had the same score in both groups. The baseline quality of life scores in physical function (p < 0.05), physical role (p < 0.01), social functioning (p < 0.01), emotional role (p < 0.01) and mental health (p < 0.01) showed significant differences between the group and were better in the PPB group than in the RRP group. The physical component summary score in the PPB group was better than in the RRP group in the 1st month (p < 0.01) but recovered up to 3 months in the RRP group. The urinary bother and irritative/obstructive scores in the 1st month were worse from baseline in both groups (p < 0.05) and remained significantly worse up to 6 months in the PPB group than in the RRP group where these scores recovered within3 months. The urinary incontinence score in the RRP group was still worse than in the PPB group up to 12 months (p < 0.01). Bowel function and bother were significantly better in the RRP group at 3 (p < 0.05) and 6 months (p < 0.01) than in the PPB group where bowel function at 12 months was worse than at baseline and in the RRP group. Sexual function (p < 0.01) and sexual bother were better in the PPB group and did not change until 12 months. Conclusion: The difference in disease-specific quality of life has become clearer using EPIC. As with other published studies, our results provide important information that will therefore be useful for selecting the optimal treatments for localized prostate cancer.

地域在住高齢者のQuality of Life（QOL）と慢性疾患およびその発症との関連性―4年間の縦断調査の結果から―

Chronic illnesses are common among elderly people, and may considerably affect to their quality of life (QOL). We investigated the impact of chronic conditions on QOL among community-dwelling elderly people, and the stability of QOL over time. A total of 2,762 community-dwelling elderly persons (men: 47.0%, age 76.7±5.8 [mean±SD]) completed postal QOL questionnaires twice over 4 years. Chronic illnesses were selected from the following 9 conditions: cerebrovascular disease, hypertension, heart disease, cancer, diabetes mellitus, bone fracture, chronic digestive disease, chronic respiratory disease, and the diseases of joints or muscles. The QOL questionnaire was developed based on the QOL components proposed by Lawton, and consisted of 6 subscales: daily activity, health satisfaction, human support satisfaction, economic state satisfaction, symptoms of depression, and positive mental attitude. The subjects were divided into 3 groups regardless of the presence of chronic illnesses. QOL subscale scores were compared among the 3 groups, and fluctuations over 4 years were also evaluated. The baseline QOL scores showed significant differences among the 3 groups, especially regarding health satisfaction, but not in satisfaction with human support. There were significant differences among the 3 groups in fluctuations over 4 years in health satisfaction, daily activity, and positive mental attitude. Chronic illnesses have a negative impact on the QOL of elderly people, and also influence fluctuations in QOL over time. Degrees of impacts differed according to each QOL subscale. Therefore, evaluation of QOL in community-dwelling elderly needs multi-dimensional assessment.

International Observational Study On Bortezomib (VELCADE) in Relapsed Multiple Myeloma: Preliminary Efficacy and Quality of Life (QoL) Results From the Belgian Population.

Abstract 4523 IntroductionBortezomib (VELCADE) is a proteasome inhibitor for treatment of MM. The eVOBS (electronic VELCADE Observational Study) evaluates treatment and clinical outcome with bortezomib in daily practice in the relapsed setting. Enrollment in the study started in Oct 06 and is still continuing, with 3 y follow-up for every enrolled patient. This report concerns preliminary efficacy and Quality of Life (QoL) results of 136 Belgian patients included in the latest interim analysis from June 2009. Patients and MethodsAdults were eligible for study if they were scheduled to initiate bortezomib within the approved indication. All bortezomib dosages and concomitant treatments were permitted, except investigational therapies. Due to the non-interventional nature of the study, no predefined response criteria were mandated; response criteria included M-protein, EBMT, SWOG, or others as defined by the investigator. QoL assessment was conducted in Belgium only, using the EORTC Quality of Life Core Questionnaire (QLQ-C30). The EORTC QLQ-C30 comprises a global health status (GHS) scale, five functional scales and six symptom scales. The questionnaire was administered at baseline and at the start of each treatment cycle. Evolution of mean scores was determined in correlation with baseline characteristics and response. Results were also analyzed for all patients and responders (partial response (PR) or better) vs. non-responders. For this, a mixed model was used comparable to that described by Lee et al. [BJH (2008) 143, 511-519], with missing data due to death being assigned the lowest possible score (model A) vs. being treated as missing (model B). Predictive value of baseline QoL scores for Overall Survival (OS) and Progression Free Survival (PFS) was assessed. ResultsOne hundred thirty six patients (57% male) are included in this analysis, with median age of 65y, and mean time since MM diagnosis of 2.9 years. Prior number of therapies received was 1 in 56%, 2 in 27%, and 3 or more in 11%. Five % received bortezomib in first line and for 1% data were missing. 97% of patients started bortezomib at 1.3 mg/m2 on the standard schedule. Median treatment duration was 5 cycles. Of the 97 patients that were evaluated for response so far, overall response rate was 69%, with 57% PR and 12% CR/nCR. 14% and 9% of patients reached MR and SD, respectively. 78% of all enrolled patients experienced AEs of any grade, which led to discontinuation of treatment in 30%, comparable with the 37% in the APEX trial (Richardson, NEJM 2005). For QOL assessment 103 patients completed the EORTC QLQ C-30 at baseline, with this number decreasing substantially in subsequent cycles (n=42 by cycle 4). Using model A (death = worst possible outcome), a small but significant decline in QoL was seen for physical, role, emotional, cognitive and social functioning, and for symptom scales of nausea and vomiting and financial impact. Of these, only the decline in cognitive functioning remained significant when applying model B (death = missing). In the APEX trial as well there was a decline in GHS as well as in 8 of the EORTC scale scores (Lee et al BJH 2008). No significant differences were seen according to baseline data (gender, age, line of therapy, lab values). Using model A, the evolution of QoL scores was significantly worse for non-responders vs. responders on the scales of physical, cognitive and emotional functioning, nausea and vomiting, sleep disturbance, diarrhea and financial impact. When using model B, no significant differences in QOL between responder and non-responder groups were detected. Worse baseline scores for nausea and vomiting and dyspnoea were predictive for worse PFS, but only dyspnoea was predictive for worse OS. ConclusionOverall in this study a slight decline was seen for some QoL parameters over the course of treatment, consistent with findings from the APEX trial (Lee et al. BJH 2008), which included patients similar to those in the eVOBS trial (Zervas IMW 2009). Using the model that assigns “worst possible outcomes” to data missing because of death, better QoL was seen in responders vs. non-responders, suggesting better QoL is at least partly linked to response. Interpretation should be done with caution due to the number of patients and the decreasing number of returned questionnaires over time. Disclosures:Delforge:Janssen-Cilag: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees. Van Droogenbroeck:Celgene: Consultancy; BMS: Consultancy; Novartis: Consultancy; Janssen-Cilag: Consultancy. Kuijten-Celzo:Johnson & Johnson: Employment. Diels:Johnson & Johnson: Employment. Ganguly:Johnson & Johnson: Employment, Equity Ownership. Dhawan:Johnson and Johnson Research Pharmaceuticals: Employment.

Relationship of Quality of Life Scores With Baseline Characteristics and Outcomes in the African-American Heart Failure Trial

Background To characterize the quality of life (QOL) in the African-American Heart Failure Trial (A-HeFT) for factors associated with baseline score, relation of score to prognosis, and response to therapy with a fixed-dose combination of isosorbide dinitrate/hydralazine (FDC I/H). Limited data exist on QOL scores in African-American heart failure patients or on the prognostic value of theses scores in any population. Finally, the effect of FDC I/H on QOL scores, particularly in A-HeFT, is not known. Methods and Results A-HeFT randomized 1050 African-American patients with New York Heart Association (NYHA) Class III-IV heart failure and systolic dysfunction. QOL measurements using Minnesota Living with Heart Failure Questionnaire (MLHFQ) were done at baseline and 3-month intervals. At baseline, worse MLHFQ scores were associated with younger age, female sex, greater body mass index, nonischemic etiology, high heart rate and NYHA Class, low systolic blood pressure, and chronic obstructive pulmonary disease. Both baseline and change in MLHFQ score were associated with a higher risk for combined all-cause mortality or heart failure hospitalization (baseline P < .0001, change at 3 months P = .001, and at 6 months P = .0008), but not mortality. Treatment with FDC I/H significantly improved MLHFQ score compared with placebo. Conclusions In A-HeFT, baseline QOL (MLHFQ) scores and change in score were predictive of combined HF morbidity and mortality outcomes. FDC I/H consistently improved QOL scores in A-HeFT compared with placebo.

Self-reported pad use per day reflects patient quality of life after pubovaginal sling surgery

We hypothesized that self-reported pad use per day (PPD) after pubovaginal sling (PVS) correlated with postoperative quality of life (QOL) scores. Two hundred fifteen women completed the incontinence impact questionnaire 7 (IIQ-7) and urogenital distress inventory 6 (UDI-6) before PVS and during follow-up. Starting 3 days before a visit, women recorded the number of protective urinary pad changes per day. Analysis of variance and Pearson correlation tests were used to determine if women reporting zero, one, or greater than or equal to two urinary pads per day after PVS had significantly different changes in baseline QOL scores. Over a mean 8.5 months follow-up after PVS, 131, 56, and 28 women reported zero, one, and greater than or equal to two pad changes/day. Each pad group showed progressively less improvement from baseline IIQ-7 and UDI-6 scores after PVS. Change in IIQ-7 and UDI-6 scores negatively correlated with PPD (p < 0.0001). Self-reported PPD after PVS reflects patient perception of urinary-specific QOL.

Prospective assessment of quality of life in adult patients with primary brain tumors in routine neurooncology practice

The aim of this article is to evaluate and assess the impact of various factors on quality of life (QOL) in adult patients with primary brain tumors seen consecutively in routine neurooncology practice. Two hundred and fifty-seven adult patients, after undergoing surgical intervention and histologically proven primary brain neoplasms were registered in the NeuroOncology Clinic at our centre during 1 full calendar year. The study included detailed neurological assessment, evaluation of QOL using EORTC questionnaire (QLQ-30) and specific Brain Cancer module (BN 20). In the present analysis, QOL scores before starting adjuvant treatment were measured and impact of patient and tumor related factors were analyzed. Baseline global QOL data of all patients (available in 243) was relatively low including in all histological tumor types. Physical function, role function, emotion function, cognitive and social function scores were 80, 78, 65.7, 70 and 70.5 (higher values better), respectively. Domains of future uncertainty, visual disorder, motor deficit, communication deficit, headache, seizures and drowsiness scores were 19.6, 18.2, 28.5, 30.7, 21, 31.8 and 16 (lower values better), respectively. Elderly patients had poorer global score (21 points difference; p = 0.161). Patients with lower performance status (KPS < 70) had a lower global QOL (KPS >or= 80 vs. <or= 70; 37 vs. 67; p = 0.001) including in all histological types of high-grade gliomas (HGG) (p = 0.005), low-grade gliomas (LGG) (p = 0.04) and benign tumors (p = <0.001). Illiterate patients had lower QOL score (p = 0.005). Tumor type is an important patient related factor that influences baseline global scores (LGG vs. HGG 62 and 52; p = 0.015). Economic status significantly influence QOL scores in HGG (p = 0.052). Type of surgery (biopsy/complete excision) (p = 0.284) and site of tumor (p = 0.309) did not show any impact on QOL score. Patients with primary brain tumours before starting adjuvant therapy have relatively low baseline quality of life scores, especially in lower economic and literacy strata. Patients with malignant tumors and poor performance status had significantly lower QOL scores even before starting adjuvant treatment.