Objective QOL Research Articles

A prospective study of the relation of patient-reported outcome measures with lumbar disc surgery for herniated lumbar disc

Introduction: The aim of this 6-month prospective study was to seek out the factors affecting surgical outcome, predictors of treatment response and their correlates in open discectomy for herniated lumbar disc. Methods and Materials: Eighty patients who fulfilled the required criteria were chosen. Socio-demographic, clinical data proforma, Visual Analogue Scale for pain (VAS), Japanese Orthopedic Association (JOA) Scale for subjective and objective pain related QoL, General Health Questionnaire-12 (GHQ-12) for screening mental health, Short Form-36 (SF-36) Health Survey for assessing Health-related Quality of Life (HRQOL) and Montgomery Asberg Depression Rating Scale (MADRS) for measurement of clinical depression were used at the preoperative stage and reassessed again at 1 month, 3 months and 6 months post-discectomy. Results: Postoperatively, VAS and JOA Scale scores continued to show improvement at each follow up (p<0.001). Majority of the SF-36 subscales showed significant improvement at 3-months and 6-months of the postoperative period. A significant correlation was seen between the duration of pain symptoms and depression scores at 6 months (rho 0.301 p<0.01). Baseline VAS score had a significant negative correlation with baseline Physical Functioning and General Health scores at 6 months. The duration and severity of pain symptoms before surgery predicted the depression scores at 6 months (adjusted R square 0.056 p<0.001) postoperatively. Conclusion: The discectomy procedure resulted in significant improvement in baseline subjective pain symptoms and overall HRQOL. Greater the duration and intensity of pain symptoms at baseline, greater was the depression scores and lesser was the SF-36 physical functioning and general health at 6-month postoperative period.

Investigating Subjective and Objective Quality of Life in Rural Areas: the Case of Tehran Province in Iran

Given the importance of measuring QOL and the need for sound and efficient planning to improve and enhance the well-being of citizens, the objective of this study was to investigate QOL in rural areas of Tehran province, Iran. To this end, the relevant literature and secondary sources were used to develop a questionnaire whose validity was determined by a panel of experts. To the best knowledge of the authors, no similar study has assessed QOL in rural areas of Tehran province and none of them has compared objective and subjective QOL in rural areas. The findings showed that in terms of objective QOL, which indicates the minimum living standards, the villagers in Tehran province were in a moderate to high status, but in the subjective QOL, about 20% of the villagers were rated as poor. According to the findings, there was a significant difference between the residents of different rural areas of Tehran in terms of objective and subjective QOL at the 99% level, but the differences were not the same. This calls for policymakers’ attention. In this regard, policies should be put on the planning agenda to reduce rural migration by adopting a coordinated approach to rural and urban development and improving the physical and environmental conditions of rural communities to provide welfare services and reduce the disparity between urban and rural areas.

RTID-06. ENHANCING TUMOR TREATING FIELDS THERAPY FOR RECURRENT GLIOBLASTOMA WITH TARGETED AND INDIVIDUALIZED SKULL REMODELING SURGERY. A MULTI-CENTER RANDOMIZED PHASE 2 TRIAL

Abstract BACKGROUND We present an upcoming(Sep. 2020) randomized, comparative, multi-center, investigator-initiated, interventional, phase 2 trial testing the efficacy of a novel therapeutic concept for recurrent glioblastoma(GBM). The intervention combines personalized targeted skull remodeling surgery(SR-surgery) with Tumor Treating Fields(TTFields) and best practice medical oncological therapy. SR-surgery involves strategically placed burr holes to strengthen the electric field in the tumor region. Preclinical studies indicate that SR-surgery provides a marked and focal enhancement(~100%) of TTFields. We recently concluded a phase 1 safety/feasibility study indicating promising clinical efficacy and no clinically significant toxicity related to the intervention. This subsequent randomized, comparative phase 2 trial aims to validate superior efficacy of the treatment. METHOD We will utilize a comparative, 1:1 randomized, minimax two-stage phase 2 design with an expected sample size of 70 patients, interim futility analysis at 1-yr follow-up of the first 52 patients and a maximum sample size of 84 patients. Patients will receive either 1)TTFields and best practice medical oncological treatment(control arm) or 2) SR-surgery plus TTFields and best practice medical oncological treatment (interventional arm). Major eligibility criteria include age ≥ 18 years, supratentorial GBM, Karnofsky performance score(KPS) ≥ 70, focal tumor, and lack of uncontrollable epilepsy or significant co-morbidity. The study is designed to detect a 20% increase in the overall survival rate 12 months(OS12) assuming OS12=40% in the control group and OS12= 60% in the intervention group. Secondary endpoints include hazard ratio of overall survival and progression-free survival, objective response rate, QoL, KPS, steroid dose, and toxicity. Patients will be followed for the whole trial period(36 months). The average expected follow-up is 18 months and includes regular assessment of toxicity, response and QoL. Endpoint data will be collected at the end of the trial, occurrence of suspected unexpected serious adverse reactions(SUSARs) or unacceptable serious adverse events(SAEs), withdrawal of consent, or loss-to-follow-up.

Impaired meaning-based cognitive skills are specifically associated with poorer subjective quality of life in schizophrenia

Cognitive impairment is characteristic of schizophrenia but the nature and severity often differ between patients and the relationship with subjective quality of life (sQOL) is inconsistent. This study sought to better characterise the cognition-sQOL relationship in schizophrenia by 1) examining associations between factor analysis-derived cognitive domains and sQOL, 2) investigating if these domains independently predicted sQOL, and 3) exploring if clinical, demographic and functional variables moderated any significant relationships. 47 schizophrenia/schizoaffective disorder patients and 48 healthy controls were assessed. QOL was measured using the Lehman’s QOL Interview. Composite scores were created to represent objective QOL and sQOL, and factor analysis was used to determine cognitive domains from 14 cognitive tasks. Three cognitive domains were derived: visuospatial planning, verbal linguistic and inhibition switching. Tasks comprising the verbal linguistic cognitive domain were significantly associated with and predicted sQOL. Moderation analyses revealed that the direction of this relationship differed between patients and healthy controls, and may be moderated by positive symptom severity in patients. In conclusion, meaning-based (e.g. verbal-linguistic) cognitive abilities may be most closely related to sQOL in schizophrenia. Symptomatology may also impact this relationship, with worsening sQOL among those with more intact verbal-linguistic processing and persistent positive symptoms. These patients may therefore be at greater risk for poor sQOL, but may be more motivated and capable of engaging in and benefiting from offered psychosocial interventions.

S237. MODERATORS AND RELATIONSHIPS OF COGNITION AND SUBJECTIVE QUALITY OF LIFE IN SCHIZOPHRENIA

BackgroundThe relationship between cognitive impairments and subjective quality of life (sQOL) in schizophrenia remains indeterminate, relative to studies of objective QOL (oQOL), despite much previous work. This study sought to better characterise the cognition-sQOL relationship in schizophrenia by 1) examining associations between factor analysis-derived cognitive domains and sQOL, 2) investigating if these domains predicted sQOL over other demographic and clinical variables, and 3) exploring if clinical, demographic and functional variables moderated the significant relationships.Methods47 schizophrenia/schizoaffective disorder patients (age: M=43.72, SD=11.35) and 48 healthy controls (age: M=39.82, SD=13.89) were assessed. QOL was measured using the Lehman’s QOL Interview. Composite scores were created to represent oQOL and sQOL, and factor analysis (principal axis factoring with varimax rotation) assessed for latent domains within 14 cognitive tasks. Symptomatology was assessed using the PANSS and MADRS. Pearson’s correlations and a stepwise linear regression were conducted to examine the associations between cognition and sQOL before the moderation analyses.ResultsThree cognitive domains were derived: visuospatial planning, verbal linguistic and inhibition switching. Only tasks comprising the verbal linguistic cognitive domain were significantly associated with, and predicted, sQOL (p<.05). Moderation analyses revealed that the direction of this relationship differed between patients and healthy controls (p<.05), and was moderated in patients only by positive symptom severity (p<.05).DiscussionThe relationship between cognition and sQOL in schizophrenia is determined by, and more associated with, meaning-based cognitions. It is affected by symptomatology, notably positive symptoms, which lead to worsening sQOL among those with more intact verbal linguistic processing.

Relationship between subjective and objective QOL in dementia.

Relationship between subjective and objective QOL in dementia.

Correlation between the Quality of Life after Brain Injury in Japanese version (QOLIBRI-J) and Community Integration Questionnaire (CIQ)

The Quality of Life after Brain Injury (QOLIBRI; 37 items) is a disease specific subjective questionnaire of health-related quality of life (HRQoL) in persons after traumatic brain injury. We developed Japanese version of QOLIBRI; QOLIBRI-J and reported that it's test-retest reliability (ICC; 0.92, Cronbach α = 0.86) and validity (Correlations of SF-36) were excellent. The Questionnaires of QOLIBRI-J are based on subjective satisfaction, although those of another popular QOL instrument, Community Integration Questionnaire; CIQ is based on objective situations. We investigated between the relationship of QOLIBRI-J and CIQ of the persons with higher brain dysfunctions after TBI to show the differences of subjective and objective QOL. Subjects: 73 recruited community-dwelling Japanese with higher brain dysfunction after traumatic brain injury [61 male, 12 female: age 41.6 ± 14.3, Glasgow Outcome Scale-Extended; GOSE (3 to 8: median 5)]. The Correlations between QOLIBRI-J and CIQ were investigated in 73 subjects at the same time. They were also asked to fill the GOSE. The questionnaires were administered in one of three modes: by self-report (mail), self-report (participant presents at the clinic), and face-to-face interview. Distribution of GOS-E score were as follows, 3: lower severe disability (12.3%), 4: upper severe disability (27.4%), 5: lower moderate disability (27.4%), 6: upper moderate disability (16.4%), 7: lower good recovery (11.0%), 8: upper good recovery (5.5%). There was a low correlation between QOLIBRI-J total score and the CIQ total score (ρ=0.326 Spearman correlation coefficient). By the subscale analysis, the strongest correlation was found between QOLIBRI-J (Daily life/autonomy) and CIQ (social life). In contrast there was the weakest correlation between QOLIBRI (emotions) and CIQ (productive life). There was no correlation between the QOLIBRI and GOSE (ρ=0.21). QOLIBRI-J had a mild correlation with CIQ. There were some differences between QOLIBI and CIQ. One of the reasons of this difference was thought to be the subjective emotional factor about taking a productive work.

OS09.8 Randomized placebo-controlled trial of autologous formalin-fixed tumor vaccine for newly diagnosed glioblastoma

Abstract Introduction: There is a growing interest in development of novel therapeutic modalities based on tumor-specific immune reactions for management of glioblastoma multiforme (GBM). Autologous formalin-fixed tumor vaccine (AFTV) was designed by our group for in vivo induction of killer lymphocytes and activation of T-lymphocyte (Nat Med 1995, 1996). In first trial for recurrent GBM, 3 responding patients survived more than 20 months after AFTV administration (Cancer Sci, 2007). Efficacy of AFTV concomitant with fractionated radiotherapy (FRT) without chemotherapy with temozolomide (TMZ) in patients with newly-diagnosed GBM was evaluated in prospective phase I/IIa trial (2), which showed median overall survival (OS) of 19.8 months (J Neurosurg, 2011). Another prospective multicenter phase I/IIa trial (UMIN01426) for evaluation of the combined use of AFTV and standard chemoradiotherapy with TMZ (AFTV+RT/TMZ: (Stupp regimen) for newly-diagnosed GBM, showing median progression-free survival (PFS) and OS of 8.2 and 22.2 months, respectively (J Neurosurg, 2013). Currently, prospective multicenter placebo-controlled double-blind phase IIb/III trial (UMIN10602) directing on evaluation of AFTV+RT/TMZ for newly-diagnosed GBM is ongoing and recruiting of patients for its phase IIb part has been finished in January 2016. We here report preliminary results before a key opening. METHODS: The phase IIb/III study investigated the AFTV plus chemoradiotherapy with temozolomide (AFTV + RT/TMZ; Stupp protocol) versus placebo plus chemoradio- therapy (Pla + RT/TMZ) for newly diagnosed glioblastoma. After resection surgery, patients with glioblastoma were randomly assigned 1:1 to receive AFTV (2 courses; 3 times, once a week) + RT/TMZ or Pla + RT/TMZ until disease progression. The primary end point was overall survival (OS), and secondary end points were progression-free survival (PFS), objective response rate, QOL, and safety. RESULTS: Adult 63 patients with supratentrial glioblastoma were enrolled, although 3 patients withdraw the consents. Among 60 patients for full analysis set, baseline characteristics were balanced. The median age was 61 years old, men vs. women were 33 vs. 27, and the median resection rate was 95%. Mean follow-up period was 15.8 months. The median PFS was 14.2 months and 6-month PFS was 75% both for AFTV+RT/TMZ and Pla+RT/TMZ. The median PFS was 21.4 months and 1-year survival was 86% both for AFTV+RT/TMZ and Pla+RT/TMZ. No severe adverse events caused by AFTV or placebo were observed. CONCLUSION: The phase IIb part of the trial has been done safely and trial would be promising because the median PFS for both groups was more than a year. If AFTV+RT/TMZ would show longer survival time compared to Pla+RT/TMZ by the key open, a phase III would be warranted.

Quality of Life Research: Material Living Conditions in the Visegrad Group Countries

(ProQuest: ... denotes formulae omitted.)IntroductionThere is a large amount of literature on quality of life (hereinafter QOL) measuring relationship between overall life satisfaction and the objective life conditions. There is no unified definition of QOL, neither a unified methodology for its assessment. According to Stiglitz et al. (2009), QOL represents a broader concept than economic production and living conditions. Many different factors have influence on the evaluation of life above its material aspect (Soltes & Gavurova, 2015). Multidimensional character of QOL is implied by various research studies which explored QOL from different aspects (e.g. Eurostat, 2015a; Khaef & Zebardast, 2015; Eby et al., 2012). However, there is no standard method for selection of indicators (Diener, 1995). Eurostat (2015a) recommends multidimensional measurement of QOL which focuses on the different aspects of QOL complementing the traditionally used indicators of economic and social development, e.g. GDP. Therefore, assessment framework for the QOL dimension of material living conditions is considered further in the paper in more detail.The V4 countries belong to the former Socialist Bloc countries and have undergone the process of transformation from centrally planned to modern free market democracy, recording changes in value system of their citizens (Bartak & Gavurova, 2014). According to their GDP per capita, they are on similar level of economic development, but in comparison with the average values of GDP per capita in the EU-27 (25.800 in PPS units), values in the V4 countries are considerably lower (from 17.200 to 20.600 in PPS units). Assessment of material living conditions in countries can provide more detailed picture of progress in the transformation process and social development than a development analysis of traditional indicators of economic growth itself. Indicators of material living conditions offer useful information about important issues of QOL, e.g. distribution of income in households, income inequality, risk of poverty, subjective perception of poverty and social exclusion in households, material deprivation or problems with housing.The main goal of this paper is to assess material living conditions in the V4 countries in comparison to the EU-27 by the means of a development analysis of the most important indicators recommended by Eurostat and by the means of the calculated integrated indices. The paper consists of four parts. The first one contains brief overview of QOL research with emphasis on material living conditions. In the second part, there is a description of data used and methodology. The next part is dedicated to a development analysis of material and living conditions and the calculated indices during the period of 2005-2013. Finally, we conclude and evaluate research findings.1. Literature Review1.1. Defining the Quality of LifeAccording to Havasi (2013), well-being and its synonym - QOL do not equal welfare. QOL represents the concept with broader meaning and consists of many different aspect of human being which indicates its multidimensional character. For QOL, there is no universally accepted definition (e.g. Ira & Andrasko, 2007; Das, 2008; Royuela et al., 2009). In general, there is distinction between two different sides of QOL: objective and subjective. The objective (descriptive) QOL consists of life conditions of people, whereas the subjective (evaluative) QOL is based on the judgement and evaluation of life conditions and feelings towards them (Havasi, 2013; Dzuka, 2004; Stiglitz et al., 2009). According to Fayers and Machin (2000), QOL represents differences between the hopes and expectations of the individual and of the present experience of the individual. Veenhoven (2000) distinguishes between four qualities of life, namely: liveability of the environment, life-ability of the person, utility of life for the environment and appreciation of life by the person. …

Genital psoriasis awareness program: physical and psychological care for patients with genital psoriasis.

Genital psoriasis is a neglected manifestation of psoriasis, although it affects numerous patients and has major effects on sexual quality of life (SQoL). We aimed to assess the value of specialised care for patients with genital psoriasis. Patients were treated for at least one year at a specialised research outpatient clinic with extensive attention for genital lesions and SQoL. The genital lesions were treated according to a stepwise algorithm. First follow-up was planned after 6 weeks; subsequent follow-up visits were scheduled every 3 months. At every visit, psoriasis severity and SQoL were measured with validated tools. Differences in scores between visits were analysed by a mixed model for repeated measures. Forty-two patients were included (M:F = 25:17). All objective and subjective genital psoriasis severity and QoL parameters improved significantly within the first follow-up period of approximately 6 weeks. In female patients, SQoL also significantly improved. In conclusion, genital psoriasis can relatively easy be treated within limited time exposure, resulting in significant improvement of QoL. Prompt and simple adjustments in the provided care are enough to accomplish this.

353O - Efficacy and Safety in Tania, a Randomised Phase III Trial of Continued or Reintroduced Bevacizumab (Bev) After 1St-Line Bev for Her2-Negative Locally Recurrent/Metastatic Breast Cancer (Lr/Mbc)

ABSTRACT Aim: Combining BEV with 1st- or 2nd-line chemotherapy (CT) improves progression-free survival (PFS) in HER2-negative LR/mBC. The open-label randomised phase III TANIA trial evaluated further BEV in BEV-pretreated LR/mBC. Methods: Patients (pts) whose HER2-negative LR/mBC had progressed during/after ≥12 weeks of 1st-line BEV + CT were randomised 1:1 to 2nd-line single-agent CT either alone or with BEV (15 mg/kg q3w or 10 mg/kg q2w). Stratification factors were: hormone receptor status; time to 1st-line progression (PD; 1.5 × upper normal limit). 2nd-line therapy was continued until PD, unacceptable toxicity or consent withdrawal. At PD, pts in the CT arm received 3rd-line CT without BEV (no crossover); pts initially randomised to CT + BEV received 3rd-line CT + BEV. The primary endpoint was PFS from randomisation to 2nd PD/death. Additional endpoints included 2nd-line PFS in prespecified subgroups, 2nd- and 3rd-line PFS (randomisation to 3rd PD/death), 2nd-line objective response rate, overall survival (OS), safety, QoL and biomarkers. Sample size was calculated based on a log-rank test assuming median PFS of 7 → 9.3 mo and a HR of 0.75. PFS events were required in 384 of 488 pts for 80% power at 2-sided a = 0.05. Results: From Jan 2011 to Apr 2013, 494 pts were enrolled (247 CT; 247 CT + BEV). Baseline characteristics, CT vs CT + BEV: median age 54 vs 56 y; triple negative 23% vs 20%; disease-free interval ≤12 mo 10% vs 7%. The most frequently chosen 2nd-line CT was capecitabine (59% vs 61%). CT (N = 247) CT + BEV (N = 247) Median follow-up, mo 15.9 16.1 2nd-line PFS (primary endpoint) Events, n (%) 203 (82) 204 (83) Median 2nd-line PFS, mo 4.2 6.3 Stratified HR (95% CI) 0.75 (0.61–0.93) p = 0.0068a Best objective response rate, % (95% CI) 16.8 (11.7–22.9) 20.9 (15.2–27.5) Difference (95% CI) 4.1 (–4.2 to 12.4) p = 0.3457b 2nd-line grade ≥3 adverse events of special interest, %c (N = 238) (N = 245) Hypertension 7.1 13.5 Proteinuria 0.4 6.9 Venous thromboembolic event 2.1 3.3 Febrile neutropenia 1.7 3.3 Congestive heart failure 0.4 2.0 Bleeding 1.7 0.4 Arterial thromboembolic event 1.3 0 Wound-healing complication 0 0.8 Gastrointestinal perforation 0 0.4 Fistula/abscess 0 0 a2-sided stratified log-rank test. b2-sided chi-squared test with Schouten correction. cBEV basket terms, MedDRA v16.1. Data cut-off: 20 Dec 2013. Conclusions: The primary objective was met, showing statistically significantly improved PFS with BEV after PD on 1st-line BEV-containing therapy. 2nd-line safety results were as expected from previous BEV trials in LR/mBC. Final OS, 2nd and 3rd-line PFS and 3rd-line safety results are due in 2015. Disclosure: G. von Minckwitz: is a paid member on Roche's advisory boards, and has received speaker honoraria and conducted Roche-sponsored research; F. Puglisi: has received honoraria from Roche; J. Cortes: has received honoraria from Roche, Celgene, Novartis and Eisai and has acted as a consultant for Roche and Celgene; E. Vrdoljak: is a member of Roche advisory boards and has received corporate sponsored research; N. Marschner:is a member of Roche advisory boards and has received corporate sponsored research; C. Zielinski: has received speaker honoraria Roche, Eli Lilly and Pfizer; G. Romieu: is a member of a Roche Advisory Board; M. De Laurentiis: has received honoraria for talks, seminars and Advisory Board participation from Roche; C. Veyret: is an expert member of Roche Boards; S. De Ducla: is an employee of, and holds stock in Roche; U. Freudensprung: is an employee of F. Hoffmann-La Roche Ltd S. Srock: SS is an employee of, and holds stock in Roche; J. Gligorov: has acted as a Consultant/Advisor for, and has received honoraria and research funding from Roche. All other authors have declared no conflicts of interest.

Adaptation and Dissonance in Quality of Life: A Case Study in Mekelle, Ethiopia

The aim of this paper is to present an approach to identify the main reasons behind the mismatch between objective and subjective quality of life (QoL) conditions that result in adaptation and dissonance. A mixed method approach was developed and applied in the sub-city of Mekelle, Ethiopia to measure objective and subjective QoL and to understand the divergence between the two. Focused group discussions, household surveys and walking interviews were the methods used for data collection and descriptive analysis, spatial analysis and content analysis were the methods of data analysis employed in this study. The results show that indicators such as ‘access to health facilities’ score a high level of objective QoL but low level of subjective QoL. Some citizens do not necessarily perceive their QoL condition in the same way as objective indicators do. By combining the subjective and objective QoL four states are identified: wellbeing, deprivation, adaptation and dissonance. Household’s strategies and priorities explain adaptation to inadequate objective QOL conditions. Some of the main reasons for adaptation and dissonance are related to issues of access to basic infrastructure, housing ownership, housing affordability, quality of services, and having additional means of income and survival strategies. Understanding the reasons identified for adaptation and dissonance can be used to provide better evidence for the formulation and implementation of public policies.

Evaluating Quality of Life in Urban Areas (Case Study: Noorabad City, Iran)

Quality of urban life (QOUL) has become an important field within urban studies. The increased level of attention to this topic is due to the increasing importance of QoL studies in monitoring public policies and in the role they can play as effective tools in urban management and planning. The main objective of this study is to measure the QOUL in the town of Noorabad in Iran, using subjective and objective indicators. In addition to secondary datasets, this study relies on a perception survey of households in the selected city. Based on an 11-point Likert scale, the mean of the overall life satisfaction of the respondents was found to be 6.06. At the same time, it has been found that satisfaction from employment opportunities is lowest among all other indicators. The comparison between the subjective and objective QoL in Noorabad indicated that 25 % of the households are in a state of well-being, 30.1 % are in a state of deprivation, while 24.4 % are in dissonance and 20.4 % are in a state of adaptation. Although correlation between objective and subjective dimensions of the QoL has not been found to be high, in general, the findings of this study reveal the importance of simultaneous studying of both objective and subjective dimensions of QoL. Results and findings of this study will be useful in designing and implementing future policies in the town of Noorabad.

Comparison of the Subjective QOL and the Objective QOL in Elderly Nursing Home Resident with Dementia

Comparison of the Subjective QOL and the Objective QOL in Elderly Nursing Home Resident with Dementia

Phase I study of lapatinib (L) in combination with whole-brain radiation therapy (WBRT) in patients (pts) with brain metastases from HER2-positive breast cancer.

1154 Background: In preclinical models, lapatinib sensitizes breast cancer cell lines to radiation. This study was designed to determine the maximum tolerated dose (MTD) and feasibility of L + WBRT in pts with brain metastases from HER2+ breast cancer. Methods: Eligible pts had HER2+ breast cancer and at least one brain metastasis. Measurable disease (dz) was not required. Pts received L 750 mg BID on day 1, followed by 1,000 mg, 1,250 mg, or 1,500 mg QD, beginning 1-8 days(d) prior to WBRT (37.5 Gy in 15 fractions) and continuing through RT. Following WBRT, pts received trastuzumab 2 mg/kg weekly and L 1,000 mg QD. The primary endpoint was determination of the MTD, defined as the dose at which DLTs occurred in 7 d during WBRT. Planned accrual at the MTD was 27 pts to fully assess feasibility. The regimen would be considered feasible if ≤ 3/27 patients experienced a DLT. Secondary endpoints included objective response, QOL, and survival. Results: 35/35 planned pts have enrolled. 0/3 pts receiving L 1,000 mg and 0/5 pts receiving L 1,250 mg experienced a DLT. At L 1,500 mg, DLTs were observed in 2 pts: G3 diarrhea and G3 rash, each associated with L dose hold of 16 d during cycle 1. An additional 22 pts were enrolled at the MTD (1,250 mg); DLT have been observed in 5/24 pts with >/=8 wks data (21%, 95% CI 7-42%): 2 cases of pulmonary embolus (PE), 1 pt with G3 herpes simplex rash, 1 pt with G3 hypoxia, 1 pt with G3 hyponatremia/hypokalemia. No G3/4 neurological toxicity has been reported. Of 24 pts with measurable dz and who have at least 8 wks follow-up, 20 (83%, 95% CI 63-95%) achieved an objective CNS response by 1 month after completion of WBRT. Conclusions: The study did not meet the predefined criteria for feasibility. However, the relationship between study treatment and some of the DLTs (e.g. PE) seems uncertain. L + WBRT using this dose or a lower dose of L could still be considered in future trials, though careful safety monitoring would be required. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration GlaxoSmithKline BrainLAB Genentech, GlaxoSmithKline

A Comparison of Alternative Models of Individual Quality of Life for Social Service Recipients

There is considerable debate in the area of individual quality of life research regarding the factor structure of the QOL construct that is focused on the number and composition of QOL factors and domains, and its hierarchical nature. The main goal of this study involve testing by means of confirmatory factor analyses five models that have been pointed out by recent scientific literature: firstly, an unidimensional model; secondly, a QOL model that consisted of eight inter-correlated domains proposed by Schalock and Verdugo (2002); thirdly, a model composed of these eight 1st-order factors and one 2nd- order factor; the forth and five are model with the eight 1st-order factors and three 2nd-order factor that has been denominated in other studies ‘Salamanca model’ and ‘Schalock model’. Data were collected from 3.029 social service recipients from Catalonia (Spain) who completed the GENCAT Scale, an objective QOL questionnaire. The best fit of the eight inter-correlated and 1st order domains was empirically demonstrated. Implications for future research are also discussed.

RFA for Small Breast Cancer — What Tumor Can Be Treated Safely?

Abstract Breast conserving surgery for small breast cancer has been acceptable as one of standard treatments. However, there are some patients who do not be satisfied with the cosmesis. The aim of this study is to verify the clinical safety and usefulness of the RadioFrequency Ablation (RFA) for small breast cancer without resection. Between January 2006 and Octobar 2007, 20 breast cancer patients were performed RFA with cool-tip RF system after sentinel LN biopsy under general anesthesia. All patients has consented as a clinical research, beforehand. MR mammography was performed after 3 and 6 months of follow-up. All patients were performed postoperative histological examination by 8G-needle mammotome biopsy after 6 months MRI evaluation.Tumor viability after RFA was assessed by hematoxylin -eosin and ssDNA staining. QOL after RFA was assessed both subjectively(QOL-ACD score) and objectively(JBCS cosmesis criterion). Preoperative mammotome revealed 4 patients had DCIS and 16 patients had IDC. The patients median age was 53 years old. The mean greatest dimension of tumors was 1.0 cm (range, 0.5-1.5 cm). MRI showed the dimention of coagulation necrotic area by RFA treatment was 3.5cm (range, 2.5-5.4 cm).All patients have been performed postoperative histlogical examination by 8G mammtome biopsy 6 month after RFA treatment. Coagulation necrosis of the tumor was complete in 20of 20 patients (100%).No patient was troubled skin burn. Neither local and distant recurrence has occurred in all patients (median follow up was 30 month). To treat RFA for breast cancer more safely, we analyzed factors which influenced the size of necrosis. Patient age, body mass index (BMI), background concentration measured by MMG, Fat involvement measured by CT did not influence with the size of nectosis (P=0.21,0.17,0.64,0.40). The state of posterior echo detected by ultrasonography was associated with the size of necrosis (p=0.045). Hence, RFA for the tumor with rich fiber such as scirrhous type tend to make necrosis wider than one with poor fiber such as solid tubular type.Most of patients were satisfied with the cosmesis of the RFA treated breast. Objective QOL score (JBCS cosmesis criterion) showed splendid cosmetic outcome. RFA is one of the effective local treatment for small breast cancer (&amp;lt; 1.5 cm in diameter), and bring breast cancer patients cosmetic satisfaction. Citation Information: Cancer Res 2009;69(24 Suppl):Abstract nr 4119.

Evaluation of clinically selected patients (pts) with advanced non-small cell lung cancer (NSCLC) recruited in China in a phase III, randomized, open-label, first-line study in Asia of gefitinib (G) versus carboplatin/paclitaxel (C/P) (IPASS)

8041^ Background: The IRESSA Pan Asia Study (IPASS) demonstrated superiority of G vs C/P for progression-free survival (PFS) in 1,217 chemonaïve, never/light ex-smokers with WHO PS 0–2, adenocarcinoma histology and stage IIIB/IV NSCLC. PFS favored C/P initially then G, likely driven by different outcomes according to EGFR mutation (M) status. Planned analyses of pts recruited in China are reported. Methods: 372 pts in China (31% of overall population) were randomized to G 250 mg/day (n=184) or C (AUC 5 or 6)/P (200 mg/m2) (n=188). Primary objective was to assess PFS in ITT population; a treatment by country interaction test (China vs other) was performed. Secondary endpoints were overall survival (OS), objective response rate (ORR, RECIST), QoL (FACT-L, TOI), symptom improvement (LCS) and tolerability. Results: PFS results for pts in China did not significantly differ from other pts (interaction test p=0.4265). G demonstrated numerically longer PFS vs C/P; effect was not constant over time, favoring C/P initially then G. Preliminary OS (28% maturity; follow-up ongoing) was similar for G and C/P. ORR was significantly higher with G (45%) than C/P (30%). QoL improvement rates were higher with G than C/P (FACT-L 44 vs 34%; TOI 45 vs 25%); symptom improvement rates were similar (LCS 48 vs 42%). G had a more favorable tolerability profile than C/P. Conclusions: For pts in China, efficacy and tolerability data were generally consistent with the overall population. G demonstrated improved efficacy (PFS and ORR), similar OS, higher QoL and similar symptom improvement rates and more favorable tolerability profile compared with C/P in chemonaïve, never/light ex-smokers with advanced NSCLC and adenocarcinoma histology. In IPASS, EGFR mutation status appeared to be a strong predictive biomarker for G efficacy compared with C/P. [Table: see text] [Table: see text] ASCO Conflict of Interest Policy and Exceptions In compliance with the guidelines established by the ASCO Conflict of Interest Policy (J Clin Oncol. 2006 Jan 20;24[3]:519–521) and the Accreditation Council for Continuing Medical Education (ACCME), ASCO strives to promote balance, independence, objectivity, and scientific rigor through disclosure of financial and other interests, and identification and management of potential conflicts. According to the ASCO Conflict of Interest Policy, the following financial and other relationships must be disclosed: employment or leadership position, consultant or advisory role, stock ownership, honoraria, research funding, expert testimony, and other remuneration (J Clin Oncol. 2006 Jan 20;24[3]:520). The ASCO Conflict of Interest Policy disclosure requirements apply to all authors who submit abstracts to the Annual Meeting. For clinical trials that began accrual on or after April 29, 2004, ASCO's Policy places some restrictions on the financial relationships of principal investigators (J Clin Oncol. 2006 Jan 20;24[3]:521). If a principal investigator holds any restricted relationships, his or her abstract will be ineligible for placement in the 2009 Annual Meeting unless the ASCO Ethics Committee grants an exception. Among the circumstances that might justify an exception are that the principal investigator (1) is a widely acknowledged expert in a particular therapeutic area; (2) is the inventor of a unique technology or treatment being evaluated in the clinical trial; or (3) is involved in international clinical oncology research and has acted consistently with recognized international standards of ethics in the conduct of clinical research. NIH-sponsored trials are exempt from the Policy restrictions. Abstracts for which authors requested and have been granted an exception in accordance with ASCO's Policy are designated with a caret symbol (^) in the Annual Meeting Proceedings. For more information about the ASCO Conflict of Interest Policy and the exceptions process, please visit www.asco.org/conflictofinterest .

Phase III, randomized, open-label, first-line study of gefitinib (G) versus carboplatin/paclitaxel (C/P) in selected patients (pts) with advanced non-small cell lung cancer (NSCLC) (IPASS): Evaluation of recruits in Japan

8044^ Background: The IRESSA Pan Asia Study (IPASS) demonstrated superiority of G vs C/P in 1,217 clinically selected chemonaïve pts in Asia with advanced NSCLC. PFS favored C/P initially then G, likely driven by different outcomes according to EGFR mutation (M) status. We report the planned analyses of 233 recruits in Japan (19% of overall population). Methods: From Mar 06 to Oct 07, chemonaïve, never/light ex-smokers with stage IIIB/IV NSCLC and adenocarcinoma histology were randomized to G 250 mg/day (n=114) or C (AUC 5 or 6)/P (200 mg/m2) (n=119). Primary objective was PFS in ITT population; a treatment by country interaction test (Japan vs other) was performed. Secondary endpoints were overall survival (OS), objective response rate (ORR, RECIST), QoL (FACT-L, TOI), symptom improvement (LCS subscale of FACT-L), and tolerability. Results: PFS results in pts in Japan did not significantly differ from other pts (interaction test p=0.4736). G demonstrated superior PFS compared with C/P (HR 0.69; 95% CI 0.51–0.94; p=0.0191); effect was not constant over time, favoring C/P initially then G. Preliminary OS (25% maturity; follow-up ongoing) was similar for G and C/P (HR 0.89; 95% CI 0.53–1.48). ORR for G was 41% vs 35% for C/P;odds ratio [OR] 1.34; 95% CI 0.78–2.30; p=0.2967. QoL improvement rate (TOI) was 43% for G and 28% for C/P (OR 1.92; 95% CI 1.11–3.34; p=0.0200); QoL (FACT-L 41 vs 43%; OR 0.94; 95% CI 0.56–1.60; p=0.8263) and symptom (LCS 42 vs 46%; OR 0.85; 95% CI 0.50–1.43; p=0.5340) improvement rates were similar for G and C/P. Tolerability profile was more favorable with G than C/P. There were no deaths due to ILD-type events (frequency 1.8% [G] vs 0% [C/P]). Conclusions: Efficacy and safety data for pts in Japan were generally consistent with overall population. G demonstrated improved PFS and ORR, similar OS, higher QoL (TOI) and similar symptom improvement rates, and a more favorable tolerability profile compared with C/P in chemonaïve, never/light ex-smokers with advanced NSCLC and adenocarcinoma histology. In IPASS, EGFR M status appeared to be a strong predictive biomarker for G efficacy compared with C/P. [Table: see text] ASCO Conflict of Interest Policy and Exceptions In compliance with the guidelines established by the ASCO Conflict of Interest Policy (J Clin Oncol. 2006 Jan 20;24[3]:519–521) and the Accreditation Council for Continuing Medical Education (ACCME), ASCO strives to promote balance, independence, objectivity, and scientific rigor through disclosure of financial and other interests, and identification and management of potential conflicts. According to the ASCO Conflict of Interest Policy, the following financial and other relationships must be disclosed: employment or leadership position, consultant or advisory role, stock ownership, honoraria, research funding, expert testimony, and other remuneration (J Clin Oncol. 2006 Jan 20;24[3]:520). The ASCO Conflict of Interest Policy disclosure requirements apply to all authors who submit abstracts to the Annual Meeting. For clinical trials that began accrual on or after April 29, 2004, ASCO's Policy places some restrictions on the financial relationships of principal investigators (J Clin Oncol. 2006 Jan 20;24[3]:521). If a principal investigator holds any restricted relationships, his or her abstract will be ineligible for placement in the 2009 Annual Meeting unless the ASCO Ethics Committee grants an exception. Among the circumstances that might justify an exception are that the principal investigator (1) is a widely acknowledged expert in a particular therapeutic area; (2) is the inventor of a unique technology or treatment being evaluated in the clinical trial; or (3) is involved in international clinical oncology research and has acted consistently with recognized international standards of ethics in the conduct of clinical research. NIH-sponsored trials are exempt from the Policy restrictions. Abstracts for which authors requested and have been granted an exception in accordance with ASCO's Policy are designated with a caret symbol (^) in the Annual Meeting Proceedings. For more information about the ASCO Conflict of Interest Policy and the exceptions process, please visit www.asco.org/conflictofinterest .

How do Chinese patients with dementia rate their own quality of life?

This study examines the psychometric properties and clinical experience in using the Mandarin translation of the Quality of Life-Alzheimer's Disease (QoL-AD) instrument in Chinese patients with dementia in Singapore. A Mandarin version of QoL-AD was established following standard guidelines for transcultural adaptation of QoL measures. The instrument was administered to 70 patient-carer dyads; patients with severe dementia (MMSE < 10) were excluded. Reliability by internal consistency and test-retest, and construct validity by correlating the known domains of QoL-AD with validity measures for the respective domains, was performed. Guidelines for Rating Awareness Deficits (GRAD) measured patients' insight into their deficits. Three patients were not able to complete the QoL-AD. Internal consistency (Cronbach's alpha) was high for both patient (0.9) and carer (0.8) QoL-AD ratings, as was test-retest reliability, intraclass correlation coefficient (ICC) 0.7 and 0.8 respectively. Correlation of QoL-AD with domain measures was moderate for carer ratings (0.21 < r < 0.51) and poor for patient (-0.17 < r < 0.13). Patient self-rated QoL correlated poorly with, and was significantly higher than, carer-rated QoL. Correlation between patient and carer QoL-AD was stronger in patients with better insight (GRAD 3-4). The results suggest that while the Mandarin version of QoL-AD can be used reliably in our population, patients' self perceived QoL can be different from carer ratings and from objective QoL measures. The disparity can be attributed to patients' poor insight, denial, fear of "losing face," normalization and accommodation of standards with aging. The patients' lack of education and seclusion from Western cultural exposure are also contributory.