Integral Quality Of Life Index Research Articles

Reliability of self-assessment of quality of life in patients with hiatal hernia associated with gastroesophageal reflux disease after videolaparoscopic anti-reflux surgery

This article aims to investigate the reliability of self-assessment of the quality of life in patients with hiatal hernia after undergoing videolaparoscopic anti-reflux intervention. To achieve this, the responses to a questionnaire were compared with the results of a study on the failure of the cardia anti-reflux mechanism.Materials and methods. A total of 213 patients who underwent videolaparoscopic oesophagus fundoplication were included in this study. The participants completed three questionnaires: GORD-HRQL, GIQLI, and SF-36. The responses obtained from the questionnaires were then compared with the results of a cardia anti-reflux mechanism study, which involved X-ray endoscopy of the oesophagus and stomach, daily oesophageal pH-metry, and oesophagogastric junction manometry. Based on the responses to the three questionnaires, the quality of life index was calculated for all patients. Additionally, a composite index of cardia anti-reflux mechanism failure was computed to assess the severity of pathological gastro-oesophageal reflux and describe the effectiveness of the cardia anti-reflux mechanism in preventing it.Results. The comparison of the components forming the integral quality of life index with the composite index of cardia anti-reflux mechanism failure before and after the operation revealed an inverse relationship: as the values of the integral quality of life index decreased, the values of the composite index of cardia anti-reflux mechanism failure increased.Conclusion. The self-assessment of the quality of life by patients with GORD-associated hiatal hernia after anti-reflux intervention, as assessed through GORD-HRQL, GIQLI, and SF-36 questionnaires, is accurate and can be effectively utilized for screening and diagnosing disease recurrence.

Integral quality of life index as a criterion for the efficiency of videolaparoscopic antireflux intervention in patients with hiatal hernia combined with gastroesophageal reflux disease

Integral quality of life index as a criterion for the efficiency of videolaparoscopic antireflux intervention in patients with hiatal hernia combined with gastroesophageal reflux disease

Quality of life of patients with total loss of teeth and psychometric properties of the OHIP-20 DG enquireR. Part 2. Monitoring stages of dental orthopedic treatment

BACKGROUND: The most affordable and economical types of prosthetics are modern designs of completely removable plate prostheses. However, in most cases, they do not meet the patients expectation. OHIP-20-DG, which is a specific quality-of-life (QOL) questionnaire, is a valid tool that allows diagnosis of patients response to treatment, assessment of the effectiveness of prosthetics, and better understanding of patients complaints and dissatisfaction.
 AIM: To create a sensitive specific questionnaire of dental QOL indicators for patients with total loss of teeth based on the well-known valid questionnaire Dental health impact profile OHIP-49 and to examine patients quality of life before and after prosthetic application.
 MATERIAL AND METHODS: The QOL of 50 patients with total loss of teeth (17 women and 33 men, aged 4287 years), who received removable dentures with an acrylic polymer base and set teeth, was examined. QOL monitoring was performed using the proposed specific questionnaire OHIP-20 DG.
 RESULTS: The integral QOL index increased to 47.42% after prosthetic application and to 78.43% following adaptation to the prosthesis after 6 months. Age and gender differences in the QOL level of patients were determined. According to the domains physical discomfort, psychological discomfort, and social maladjustment, men and women assessed their satisfaction with their physical, psychological, emotional, and social functioning differently. Gender differences in patients aged 55 years in the psychological discomfort and social maladjustment domains were significant (p=0.065) when compared with those of patients aged 55 years (p=0.115).
 CONCLUSION: Results of monitoring the QOL of patients with total loss of teeth before, during the stages, and after application of prosthetics with fully removable dentures, obtained using the OHIP-20 DG questionnaire, allow us to reliably assess the effectiveness of prosthetics.

Изучение факторов риска развития синдрома профессионального выгорания у врачей-стоматологов, работающих в государственных детских стоматологических поликлиниках

Recently occupational burnout has become more frequent among dentists. Exposure to stress is especially typical for those dentists who work with children. Our research goal was to identify risk factors that caused developing occupational burnout among dentists employed by state children’s dental polyclinics. We performed comprehensive questioning with 120 dentists participating in it. They all were employed by state children’s dental polyclinics in Saint Petersburg. Totally, there were 8 male participants and 112 female ones; their average age was 47.2 ± 11.34 years; average working experience as a dentist, 19.2 ± 13.6 years. The dentists filled in standardized questionnaires including Maslach Burnout Inventory (MBI), RAND SF-36 for assessing quality of life and Work Ability Index. Our study was designed as a “case – control” one. Based on the data of MBI, two groups were created: respondents with occupational burnout by two and three MBI scales (case) and respondents without any occupational burnout (control). To analyze risk factors of occupational burnout, we compared frequency of signs in the groups and calculated odds ratio and their statistical significance. Several significant risk factors of occupational burnout were identified for this group. They included age >40 years; working experience as a dentist >10 years; presence of chronic diseases and diseases of the musculoskeletal system; impaired physical functioning, general health, and emotional role functioning, as well as the integral quality of life index. Dentists aged 40–49 years have the highest risk of occupational burnout. Working experience that is longer than 20 years creates significantly elevated risks of occupational burnout. Chronic diseases and diseases of the musculoskeletal system as well as impaired quality of life multiply risks of occupational burnout. These research results can be used to develop activities aimed at preventing occupational burnout among dentists working with children.

Risk factors of occupational burnout in dentists employed by state children’s dental poly-clinics

Recently occupational burnout has become more frequent among dentists. Exposure to stress is especially typical for those dentists who work with children. Our research goal was to identify risk factors that caused developing occupational burnout among dentists employed by state children’s dental polyclinics. We performed comprehensive questioning with 120 dentists participating in it. They all were employed by state children’s dental polyclinics in Saint Petersburg. Totally, there were 8 male participants and 112 female ones; their average age was 47.2 ± 11.34 years; average working experience as a dentist, 19.2 ± 13.6 years. The dentists filled in standardized questionnaires including Maslach Burnout Inventory (MBI), RAND SF-36 for assessing quality of life and Work Ability Index. Our study was designed as a “case – control” one. Based on the data of MBI, two groups were created: respondents with occupational burnout by two and three MBI scales (case) and respondents without any occupational burnout (control). To analyze risk factors of occupational burnout, we compared frequency of signs in the groups and calculated odds ratio and their statistical significance. Several significant risk factors of occupational burnout were identified for this group. They included age >40 years; working experience as a dentist >10 years; presence of chronic diseases and diseases of the musculoskeletal system; impaired physical functioning, general health, and emotional role functioning, as well as the integral quality of life index. Dentists aged 40–49 years have the highest risk of occupational burnout. Working experience that is longer than 20 years creates significantly elevated risks of occupational burnout. Chronic diseases and diseases of the musculoskeletal system as well as impaired quality of life multiply risks of occupational burnout. These research results can be used to develop activities aimed at preventing occupational burnout among dentists working with children.

ՀՀ ԼՈՌՈՒ ՄԱՐԶԻ ՀԻՄՆԱԽՆԴԻՐՆԵՐԻ ԱԽՏՈՐՈՇՈՒՄԸ ԸՍՏ ԿՅԱՆՔԻ ՈՐԱԿԻ ԻՆՏԵԳՐԱԼԱՅԻՆ ՑՈՒՑԻՉԻ / DIAGNOSIS OF RA LORI REGION ISSUES ACCORDING TO INTEGRAL QUALITY OF LIFE INDICATOR

This article aims to identify the issues and priorities of strategic management of Lori marz of the Republic of Armenia. For this purpose, the concept of the Integral Quality of Life Index was used, through which the problems of the region were considered in three parts: the level of welfare of the population, quality of life and quality of the social sphere. As a result of the research, it was revealed that the priorities for Lori region are the reduction of extreme poverty and the reduction of unemployment rate, the reduction of migration rate, the reduction of crime rate, and the creation of conditions for increasing housing security of citizens.

ИНТЕГРАЛЬНЫЙ ПОКАЗАТЕЛЬ КАЧЕСТВА ЖИЗНИ: МЕТОДОЛОГИЧЕСКИЕ АСПЕКТЫ

The issues of using the integral quality of life index, taking into account the quality of
 the environment and the quality of health. It can be obtained on the evaluation of subjective opinions
 of the respondents in the population-based health and social studies.

The Impact of Comorbidity on Quality of Life in Chronic Myeloid Leukemia Patients with Deep Molecular Response Who Stopped Therapy By Tyrosine Kinase Inhibitors: Results of the RU-SKI Trial

Background The data on quality of life (QoL) in chronic myeloid leukemia (CML) patients (pts) with deep molecular response (DMR) in the treatment-free remission (TFR) studies are limited. The influence of comorbidities on QoL in CML pts before and after tyrosine kinase inhibitors (TKIs) discontinuation has not been studied. Aim We aimed to study the impact of comorbidities on QoL in CML pts before and after the stop therapy by TKIs. Patients and methods The chronic phase (CP) CML pts who had received therapy by any TKI ≥3 years (yrs) with sustained DMR (BCR-ABL ≤0.01% IS) during ≥2 yrs were enrolled into the prospective TFR study RU-SKI. A regular qPCR with BCR-ABL IS evaluation was performed after TKI cessation. TKI were resumed in pts with major molecular response loss (MMR loss, BCR-ABL>0,1%). The QoL was evaluated by RAND SF-36 questionnaire at baseline before TKI stop and at 1, 3, 6, 12 mo during TFR. Eight functional scales were assessed: physical functioning, role limitations physical, bodily pain, general health perceptions, energy/vitality, social functioning, role limitations emotional, mental health. The Integral QoL Index (IQoLI) was calculated based on the scales. Mann-Whitney test, paired Wilcoxon test χ2 were used for the statistical analysis. Molecular relapse free survival (MRFS) was evaluated by Kaplan-Meier method, log-rank test was used for comparison. Results The analysis was performed in the group of 97 CML pts. Median (Me) age was 47±14.5 (yrs), 48.5% were males. The TKI before treatment cessation were as follows: imatinib and second-generation (2G) TKIs in 67 (70%) and 30 (30%) pts accordingly; 9 (30%) pts received 2G TKIs in 1st line and 21 (70%) pts in 2nd line. Me time of observation was 25 mo (range 12-42). Comorbidities were present in 81 pts (82%) at baseline. The most frequent comorbidities were cardiovascular (38.4%), gastroenterological (29.3%) and musculoskeletal disorders (27.3%). First we compared baseline QoL in 2 pts groups: group 1 - pts with acute comorbidity status at baseline (n=42), group 2 - pts with stable comorbidity status (n=29) and with no comorbidity (n=16). QoL in group 1 was significantly worse by all functional scales, except mental health (p<0.05). The IQoLI at baseline was significantly lower in group 1 vs group 2: 0.477 vs 0.589 (p<0.001). Then we evaluated QoL at 3 mo after TKI stop in 72 available pts, as acute status comorbidity remained in 30 pts. The majority of pts exhibited QoL improvement or stabilization by all SF-36 scales. The most pronounced positive changes were observed by SF-36 scales in pts with acute comorbidity status (group 1).The proportion of pts with QoL improvement at 3 mo after TKI stop was higher in group 1 as compared to group 2 by physical functioning (57% vs 29%), role physical functioning (30% vs 5%) and social functioning (40% vs 24%), p<0.05. Increasing of social functioning was statistically significant: ∆20.2 in group 1 vs ∆12.6 in group 2 (p=0.005). The proportion of pts with QoL worsening at 3 mo after TKI stop was similar in both groups. MRFS at 24 mo was 62% (CI 46-77%) and 45% (CI 32-58%) in groups 1 and 2 respectively, with no significant differences between the groups (p=0.107). Conclusion CML pts with DMR and acute comorbidity status had a worse QoL before TKI therapy cessation compared to pts without comorbidity or with comorbidity in remission. The majority of pts exhibited QoL improvement or stabilization in early terms after TKI stop. Pts with acute comorbidity status had more pronounced positive QoL changes after treatment cessation than other pts. Possible explanation is that TKI therapy could increase the clinical symptoms manifestation by overlapping with the treatment toxicity effects. The molecular relapse rate was similar in pts with and without acute comorbidity status. Thus, comorbidity is not a factor which may have negative impact on the outcomes of stop TKI therapy in CML pts. Disclosures Ionova: Takeda, BMS: Other: Principal Investigator of IISR, Research Funding. Chelysheva:Novartis: Consultancy, Honoraria; Fusion Pharma: Consultancy. Shukhov:Novartis: Consultancy; Pfizer: Consultancy. Turkina:Novartis: Consultancy, Speakers Bureau; Pfizer: Consultancy; Bristol Myers Squibb: Consultancy; fusion pharma: Consultancy; Novartis: Consultancy, Speakers Bureau.

Response to Brentuximab Vedotin and Quality of Life in Patients with Relapsed/Refractory Hodgkin Lymphoma (RR HL) in the Real World Setting

There is a continued unmet medical need in pts with relapsed/refractory Hodgkin's lymphoma (RR HL). Curing HL pts who have refractory disease after salvage chemotherapy, who relapse after ASCT, or those who are not candidates for ASCT, remains a clinical challenge due to limited effective treatments. There are data available indicating that brentuximab vedotin (BV) brings considerable promise for the treatment of pts with RR HL. Information about BV treatment effectiveness and tolerability both from physician's and patient's perspective is worthwhile in this difficult patient population. We aimed to evaluate clinical and patient-reported outcomes in RR HL patients receiving BV as >2nd treatment line. Here we report the outcomes with respect to clinical response, tolerability, quality of life (QoL) and symptoms after 3 mos of BV treatment. The total number of pts to be included in the multicenter observational real-world study is 70 pts with RR HL who received BV 1.8 mg/kg q3w till disease progression, intolerance toxicity of BV or refusal. Treatment response was assessed using RECIST criteria v. 1.0. Adverse events (AEs) were assessed in accordance with NCI CTCAE v. 4.03. For QoL assessment pts filled out RAND SF-36, for symptom assessment - ESAS questionnaire; also pts filled out PGIC scale for self-assessment of changes in their health. For QoL analysis paired t-test, Mann-Whitney test, Wilcoxon test and χ2 were used. The analysis was performed in the group of 55 pts RR HL (median age - 28 years, range 18-67, 54.5% males) who were involved in the study: 63.6% pts had advanced stage (III-IV) at diagnosis; ≥50% pts had B-symptoms (58.2%); 82% pts - ECOG 0-1. All the pts received a median of 3 previous treatment lines; among them 14 pts (25.5%) failed to ASCT in the past; half of pts were primary chemotherapy resistant (49%). Before BV treatment start QoL was dramatically worsened for all SF-36 scales (p<0.05). All the pts experienced symptoms, 83.3% pts had moderate-to-severe symptoms. The most frequent (>70% pts) symptoms were drowsiness, tiredness, anxiety, and worse wellbeing. More than half pts had moderate-to-severe drowsiness,tiredness, depression, lack of appetite and worsened wellbeing before BV treatment start. After 3 mos of BV treatment objective response was registered in 55% pts with 27.5% complete response. Adverse events of grade I-II were reported in 8 pts (20%) and were consistent with known toxicities. Most common adverse events (≥10%) were increasing ALT and AST (each 4/8), peripheral neuropathy, fatigue, skin itch (each 3/8). Severe adverse event (III grade) not related with BV occurred in one patient (2.5%) - sepsis, respiratory insufficiency due to agranulocytosis (BV was temporary stopped). During BV treatment meaningful QoL improvement was revealed for all SF-36 scales (p<0.05), excluding mental health. IQoLI significantly increased at 3 mos after treatment start as compared to baseline: 0.260 at baseline vs 0.390 at 3 mos (p<0.001). Proportion of pts with significant Integral QoL Index (IQoLI) impairment dramatically decreased during treatment as compared to baseline: 60% before treatment vs 35% at 3 mos (χ2, p=0.05). The most pronounced meaningful improvement was revealed for role functioning scales (∆>20.0). The severity of the vast majority of symptoms excluding depression significantly decreased during 3 mos of treatment (p<0.05). Total Symptom Score by ESAS significantly decreased at 3 mos after BV treatment start (35.8 vs 25.4, p=0.001). Also according to PGIC, 90% pts noted the improvement of their health. The first results obtained in this multicenter observational real world study demonstrate notable activity of BV as a treatment modality for RR HL. BV showed a safety profile consistent with known toxicities. BV treatment was accompanied with dramatic QoL improvement and significant decrease of symptom burden already after 3 mos of treatment. Evaluation of BV treatment outcomes both from physician's and patient's perspective may provide unique information which will be helpful in decision making for patients with RR HL. Disclosures Ionova: Takeda, BMS: Other: Principal Investigator of IISR, Research Funding. Baryakh:Takeda: Consultancy, Honoraria, Speakers Bureau.

PB1934 QUALITY OF LIFE IN CHRONIC MYELOID LEUKEMIA PATIENTS WITH DEEP MOLECULAR RESPONSE AFTER STOPPING TREATMENT BY TYROSINE KINASE INHIBITORS AT LONG‐TERM FOLLOW‐UP

Background:It is reasonable to incorporate the quality of life (QoL) assessment into the comprehensive evaluation of treatment outcomes in chronic phase chronic myeloid leukemia (CML CP) patients (pts) with deep molecular response (DMR) who enter the treatment‐free remission (TFR) phase and stop therapy by tyrosine kinase inhibitors (TKIs).Aims:We aimed to study QoL in CML CP pts who had stable DMR at long‐term follow‐up.Methods:The CML CP pts who had received therapy by any TKI ≥ 3 years (yrs) and had maintained DMR (MR4 or deeper with BCR‐ABL ≤0.01% IS) were enrolled into the prospective multicenter study RU‐SKI which has been conducted within the clinical approbation supported by Ministry of Health of RF. TKI were resumed in a case of major molecular response (MMR, BCR‐ABL>0.1% IS) loss. The QoL questionnaires RAND SF‐36 and EORTC QLQ C30 were filled out by the pts before stopping TKI treatment (base‐line) and at different time points after TKI treatment discontinuation. QoL analysis was performed in patients who were in TFR lasting >12 months. The paired Wilcoxon test was used for the statistical analysis.Results:In total, 98 CML CP pts with DMR were enrolled in the trial. Mean age was 46 yrs; 48% were males; 13% had high Sokal risk score; 80.6% pts were with comorbidity. The TKIs before treatment cessation were the following: imatinib in 67 (78%) pts, second‐generation (2G) TKIs were used as 1st line and as 2nd line in 11 (11.2%) and in 20 (20,4%) pts respectively. Toxicity to TKI was revealed in 62/98 pts (63.2%). During TFR phase TKI withdrawal syndrome was observed in 41/98 pts (41.8%). Me TFR duration was 24 mos (range 14–42). MMR loss and TKI resuming was in 46 (47%) pts. In QoL analysis at long term follow‐up 51/98 pts were included. In the vast majority of pts (46/51) during TFR phase QoL scores improved (11.8%) or were stable (78.4%) as compared with base‐line. Physical functioning (80.7 vs 87.2) and general health (63.3 vs 69.7) significantly improved (p≤0.01); Integral QoL Index (IQoLI) increased from 0.575 to 0.633 (p < 0.05). Also significant decrease of fatigue, nausea/vomiting, shortness of breath and sleep disturbance during long‐term TFR was revealed (p < 0.05). To note, five pts who exhibited QoL worsening at long‐term follow‐up after stopping treatment (57% decrease of mean IQoLI as compared with base‐line) had toxicity to TKI, TKI withdrawal syndrome and comorbidities.Summary/Conclusion:In general, the positive QoL changes and decrease of symptom burden was revealed in the majority of CML CP pts who maintained stable MMR and were off‐treatment for more than 12 months. Toxicity to TKI, TKI withdrawal syndrome and comorbidities may be accompanied with unfavorable QoL changes in CML CP pts at long‐term follow‐up after TKI stop therapy. The results of QoL assessment may contribute to optimization of the treatment strategies of CML patients with DMR.

PS1239 NIVOLUMAB FOR TREATMENT OF PATIENTS WITH RELAPSED/REFRACTORY CLASSICAL HODGKIN'S LYMPHOMA (CHL): CLINICAL AND PATIENT‐REPORTED OUTCOMES

Background:Treatment of pts with relapsed/refractory cHL is focused on achievement of survival benefits and improvement of patients’ quality of life (QoL).Aims:We aimed to evaluate clinical and patient‐reported outcomes of nivolumab (Nivo) as ≥3nd treatment line in pts with relapsed/refractory cHL.Methods:Pts with relapsed/refractory cHL who received Nivo 3 mg/kg q2w till disease progression, intolerance/toxicity of Nivo or refusal were included in the study. Treatment response was assessed using CT/PET‐CT in accordance with LYRIC criteria for response assessment of malignant lymphomas to immunotherapy. Safety was assessed in accordance with NCI CTCAE v. 4.03. For QoL assessment pts filled out RAND SF‐36 and EQ‐5D questionnaires, for symptom assessment – CSP‐Lym 41–1w questionnaire at baseline and at 3, 6, 9 and 12 mos after Nivo treatment start. Overall survival (OS) and progression‐free survival (PFS) were evaluated by the Kaplan‐Meyer method. For longitudinal QoL analysis paired t‐test, Wilcoxon test, Fridman ANOVA and χ2 test were used.Results:In total, 101 pts cHL (median age – 31 y.o., range 19–62, 52% males) who received 2–10 previous treatment lines were involved in the study. 90 out of 101 pts received Nivo as part of an named patient program. At the time of diagnosis 63.4% pts had advanced stage (III–IV), 61.4% ‐ primary chemotherapy resistance. Median follow‐up – 25 mos (3–31). Treatment response was registered in 64% pts: 32 (31.7%) pts achieved complete response, 33 (32.7%) – partial response. Stabilization and progression as the best response were registered in 5 (5.0%) and 10 (9.9%) pts, respectively. Indeterminate response was observed in 21 (20.8%) pts. The 2‐year OS was 96%; the median of OS was not achieved. The 2‐year PFS – 40.6%, the median of PFS was 17.9 mos. Adverse events were reported in 87.1% pts. Severe adverse events (III–IV grade) occurred in 18.8% pts. Analysis of QoL changes during treatment was performed in 87 pts. Before Nivo treatment start QoL was dramatically worsened for all SF‐36 scales. Significant QoL impairment was observed in 66% pts. All the pts experienced symptoms, 84% pts had moderate‐to‐severe symptoms. The most frequent (>80% pts) symptoms were quick tiredness, fatigue and decreased work energy. During Nivo treatment meaningful QoL improvement was revealed for all SF‐36 scales. Integral QoL Index significantly increased at 3, 6, 9 and 12 mos of treatment as compared to baseline: 0.298 at baseline vs 0.504 at 3 mos, 0.538 at 6 mos, 0.545 at 9 mos, 0.597 at 12 mos (p < 0.001). Proportion of pts with significant QoL impairment significantly decreased during treatment as compared to baseline: 66% before treatment, 32% at 3 mos, 34% at 6 mos (Cochran's Q test, p < 0.001). During treatment proportion of pts with no problems by EQ‐5D significantly increased by all 5 dimensions as compared to those pts with problems (Cochran's Q test, p < 0.01). EQ VAS significantly improved during treatment: 59.4 before treatment vs 80.6 at 12 mos (p = 0.006). The severity of the vast majority of symptoms (38/41) significantly decreased during 6 mos of treatment (p < 0.05). At 9 and 12 mos of treatment significant decrease of symptom severity was registered for more than 50% symptoms of CSP‐Lym 41–1w (p < 0.05).Summary/Conclusion:The results obtained in this observational study demonstrate high efficacy of Nivo as a monotherapy for relapsed/refractory cHL and its good tolerability. Nivo treatment leads to dramatic QoL improvement and significant decrease of symptom burden in this patient population.

Multicenter observational prospective study of nivolumab (Nivo) as 2+ line treatment in advanced refractory NSCLC pts: Clinical and quality of life outcomes.

e20567 Background: We aimed to evaluate clinical and quality of life (QoL) outcomes of Nivo as 2+ line treatment in NSCLC pts within expanded access program and real world practice. Methods: Adult pts with advanced refractory NSCLC were enrolled in 11 centers in RF. All the pts received Nivo 3 mg/kg q2w. Tumor response was assessed using RECIST v. 1.1, adverse events (AEs) – NCI CTCAE v3.0. Patients filled out RAND SF-36 and ESAS-R at baseline, 1, 3, 6 and 12 mos after treatment start. Overall survival (OS) and progression-free survival (PFS) curves were evaluated by the Kaplan-Meyer method and compared by the log-rank test. GEE method was used for QoL analysis; χ2 test – for disease control rate (DCR) comparison. Results: The preliminary analysis was performed in the group of 200 pts with median follow-up 7.4 mos (65% – males; median age – 62 y.o.; ECOG 0-1 – 81%; former/current smokers – 70.5%; non squamous NSCLC – 64%; ≥2 lines of previous treatment – 53%, bone mts – 22%). DCR was revealed in 60.3% pts (108/179 pts, median first evaluation – 2.1 mos); 13 pts died before first response evaluation; 8 pts were not evaluated for response at cut-off. DCR was higher in squamous NSCLC (66%, squamous vs 51%, non squamous; χ2 = 4.0, p = .045). Median OS – 11.5 mos (95%CI 8.3–14.7), median PFS – 4.2 mos (95%CI 3.5–4.9). Patients with poor ECOG (ECOG 2-3 vs 0-1: median OS – 5.6 mos vs 12.4 mos, median PFS – 2.7 vs 4.2 mos) and those with bone mts (with mts vs without mts: median OS – 5.0 vs 12.5 mos, median PFS – 2.8 vs 4.1 mos) had worse survival; log-rank p < 0.05. QoL improved during 6 mos of treatment in more than 50% pts; average increase by 60% of mean Integral QoL Index (IQoLI) at different time-points was observed. Upon GEE, IQoLI improvement during 12 mos was revealed (p < .0001). The severity of fatigue and dyspnea, which had the highest burden at base-line, decreased during 6 mos of treatment in more than 50% and 30% pts, consequently. AEs were registered in 32.7% pts (median of Nivo treatment – 2 mos); among them 17 pts had grades 3-4 AEs; 5 pts – SAEs. Conclusions: Preliminary results of this study support the acceptable efficacy and safety of Nivo in NSCLC pts. Nivo treatment leads to meaningful QoL improvement and decrease of symptom burden in this patient population.

Quality of Life in Chronic Myeloid Leukemia Patients with Deep Molecular Response Who Stopped Therapy By Tyrosine Kinase Inhibitors: Interim Results of Russian Prospective Multicenter Trial RU-SKI

BackgroundIt is reasonable to incorporate quality of life (QoL) assessment into the comprehensive evaluation of treatment outcomes in chronic myeloid leukemia (CML) patients (pts) with deep molecular response (DMR) who enter the treatment-free remission (TFR) phase and stop therapy by tyrosine kinase inhibitors (TKIs). QoL assessment was included into the design of Russian prospective multicenter trial RU-SKI along with the clinical outcomes evaluation.AimTo study QoL in chronic phase (CP) CML pts with DMR before stopping TKI treatment and during TFR observation.Materials and methodsThe study has been conducted within the clinical approbation supported by the Ministry of Health of RF. The CML CP pts with therapy by any TKI ≥ 3 years (yrs) and stable DMR (BCR-ABL ≤0.01% IS) during ≥2 yrs were enrolled. Pts who met these criteria and had previous resistance to any TKI were also eligible. TKIs were resumed in case of major molecular response loss (MMR, BCR-ABL>0,1%). The QoL questionnaires RAND SF-36 and EORTC QLQ C30 were filled out by the pts before stopping TKI treatment and at 1, 3, 6 and 12 months (mo) after treatment discontinuation. The comparison group consisted of healthy persons matched by age and gender to CML CP pts (n=97). The Mann-Whitney test, paired Wilcoxon test and Generalized Estimation Equations (GEE) with adjustment to age, gender, the risk group according to Sokal score and duration of TKI treatment were used for the statistical analysis.ResultsQoL assessment was performed in all 99 CML CP pts who were enrolled into the trial during a period from Aug 2015 till Dec 2017. The TKIs before treatment cessation were as follows: imatinib and second-generation (2G) TKIs were used in 69(70%) and 30(30%) pts accordingly. 2G TKIs were used in 9(30%) and in 21(70%) pts as 1st and 2nd line accordingly. Mean age was 47±14.5 yrs, 48.5% were males, 12.1% had high Sokal risk score. The physical functioning of CML pts before stopping TKI treatment compared to the healthy controls was significantly worse (p<0.05). Other QoL scales before stopping TKI treatment were slightly worse with no statistically significant difference compared to healthy controls (figure 1). MMR was lost in 45 pts, and was maintained in 54 pts, Me follow-up time after TKI stop was 14,9 mo (range 2,5-32). The significant improvement of role physical functioning and role emotional functioning was found (p<0.05) in pts who maintained stable MMR during 12 mo after TKI discontinuation. The Integral QoL Index increased from 0,58 to 0,72 (p<0,001) in these pts. The decreasing of nausea/vomiting, diarrhea, shortness of breath at different time points (p<0.05) during TFR was revealed (figure 2). The QoL and symptoms before TKI interruption and after reinitiating of TKIs in 45 pts who resumed treatment were similar. The Integral QoL Index before and after stopping TKI treatment was 0.62 vs 0.64 (p>0.05).ConclusionThe QoL in CML CP pts with DMR on TKI treatment is slightly worse and physical functioning is significantly lower as compared to healthy controls. The positive changes of the role functioning along with TKI treatment-related symptoms decrease were revealed in pts who maintained stable MMR during 12 mo of TFR. No changes in QoL and no new symptoms were found in pts who reinitiated treatment before and after TKIs interruption. The results of QoL assessment may contribute to optimization of the treatment strategies of CML patients with DMR. [Display omitted] DisclosuresChelysheva:Fusion Pharma: Other: provided consultations ; Bristol Myers Squibb: Other: provided consultations and performed lectures; Novartis: Other: provided consultations and performed lectures. Shukhov:Bristol Myers Squibb: Other: provided consultations and performed lectures ; Novartis: Other: provided consultations and performed lectures . Turkina:Novartis: Other: provided consultations; Bristol Myers Squibb: Other: provided consultations; Phizer: Other: provided consultations; Fusion Pharma: Other: provided consultations. Ionova:Takeda: Research Funding; BMS: Research Funding.

Observational study of the efficacy of nivolumab (Nivo) as 2+ line treatment and quality of life (QoL) in advanced refractory non-small cell lung cancer (NSCLC) patients: Interim analysis.

e14593 Background: Therapy with immune checkpoint inhibitors (ICI) changed the paradigm of treatment in many solid tumors including NSCLC. Recently several ICI were approved for NSCLC second and first line. By now data on Nivo benefits/risks in NSCLC is quite limited. The aim of this study was to evaluate clinical and patient-reported outcomes on Nivo in second plus line within the expanded access program in NSCLC. We report interim analysis on response rates, safety and QoL. Methods: Adult pts with advanced refractory NSCLC received Nivo 3 mg/kg q2w. Tumor response was assessed using RECIST v. 1.1., adverse events (AEs) with NCI CTCAE v3.0. and QoL by RAND SF-36. Group comparisons were made using Wilcoxon test. Results: From July of 2015 to January of 2017, 157 pts were enrolled in 7 centers in RF. Median follow-up time was 14 weeks. Clinical characteristics: 66% – males; median age – 62 (29−80); ECOG PS 0-1/2-3 – 81%/19%; former/current smokers – 73%; non squamous NSCLC – 64%; ≥2 lines of previous systemic treatment – 51%. We observed 1.5 increase of Integral QoL index in 53% of pts at 4 weeks; significant improvement was observed for emotional functioning (33.3 vs 50.0; p &lt; 0.05). Efficacy was evaluated in 56 pts: PR – 6/56, SD – 35/56, PD – 15/56. Clinical improvement was noticed in 36 pts. Early deaths from cancer occurred in 9 pts; early deaths not related to cancer – 2 pts. 18 pts discontinued Nivo prematurely ( &lt; 8 weeks) because of rapid clinical worsening. 72 pts were not evaluated for response on cut-off. More pts with quick worsening as compared with responders were with non squamous NSCLC (75% vs 50%) and had brain mets (20% vs 0%). Among responders 33% were with PS &gt; 1 and were &gt; 65 y.o; pts in this group had no brain mets. AEs were registered in 40 pts (median of Nivo treatment – 6 weeks); among them 11 with grade 3-4 AEs. Conclusions: Early data from this study supports thata large number of pts benefits fromNivo treatment. Nivo is well tolerated by this population, with 7% of grade 3 or 4 toxicities. Nivo treatment is accompanied with significant QoL improvement in 53% pts.

Dasatinib in Firstand Second-Line Therapy of Chronic Myeloid Leukemia: Efficacy, Safety and Quality of Life

Background &amp; Aims. The article presents results of two observational, prospective, multicenter studies “Quality of Life, Symptom Profile, and Adherence to Treatment in Adult Patients with Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia Receiving Dasatinib” (20122015) and “Quality of Life and Symptom Profile in Imatinib-Resistant or Intolerant Patients with Chronic Myeloid Leukemia” (2011-2014). Methods. Data of 107 patients with chronic myeloid leukemia in chronic phase were involved in the real-world analysis - 32 newly diagnosed patients on first-line treatment with dasatinib or after yearly switch to dasatinib after ima-tinib treatment failure and 75 imatinib-resistant or intolerant patients on second-line treatment with dasatinib. Treatment effectiveness and safety of dasatinib were assessed during first- and second-line dasatinib treatment using clinical outcomes as well as quality of life and symptom profile assessment. Results. The real-world data obtained during observational study in limited population of CML patients conform the results of clinical trials devoted to evaluation of treatment efficacy and safety of dasatinib treatment in first- and second-line treatment and demonstrate the importance of patient-reported outcomes. Patient's quality of life improved within 12 months of the first-line dasatinib therapy according to the following scales: role physical functioning, pain, vitality, social functioning and role emotional functioning. The most pronounced and clinically significant improvement was observed for the role emotional functioning (51.1 vs. 68.9). During the second-line dasatinib treatment, stabilization of quality of life parameters was registered for the following scales: vitality, social functioning, mental health, and pain. Significant improvement of the Integral Quality of Life Index was observed (p &lt; 0.05). Positive dynamics of relevant symptoms was registered. The symptom severity decreased during both the first- and second-line therapy. Conclusion. Quality of life and symptom assessment in CML patients contribute to a better disease control in accordance with the principles of risk-adaptive therapy.

Quality of Life (QoL) and Clinical Outcomes of Dasatinib Treatment in TKI-Naive and Early Switched from Imatinib Patients with Chronic Myeloid Leukemia in Chronic Phase (CP CML) in a Real World Setting

Dasatinib as a front-line is a promising treatment option for CP-CML pts. Assessment of benefits and risks of this treatment regimen both from physician's and patient's perspective sounds worthy. We aimed to study QoL and clinical outcomes of dasatinib as a front-line treatment in CP CML pts in a real world setting.The total of 30 pts with CP CML (16 pts - TKI-naive, 14 pts - early switched to dasatinib after failure of imatinib treatment, median duration of imatinib treatment - 6 mths; switched pts) were involved in the multicenter observational prospective study. Median age - 47.6 y.o. (20-74), female - 33.3%; median disease duration - 5 mths; distribution of pts according to the Sokal score - 27.6% pts at low risk, 41.4% - at intermediate risk, 31% - at high risk. 27% pts had comorbidities: median Charlson Comorbidity Index was 3.0. All the pts filled out the QoL questionnaire SF-36 before dasatinib treatment, 3 and 12 mths after treatment start. Hematological, cytogenetic and molecular response rates (HR, CyR, MR) were registered after 3 and 12 mths of dasatinib treatment. Healthy controls (n=30) from QoL population normative database adjusted by age and gender to pts group were used for QoL comparison at baseline. Group comparisons were made using Mann-Whitney test, ANOVA and Wilcoxon matched pair test.QoL in CP CML pts at baseline was lower than in healthy controls: Integral QoL Index - 0.358 in pts vs 0.497 in healthy controls (p<0.05). Physical functioning in CP CML pts was significantly lower than in healthy controls: 78.8 vs 90.8 (p<0.05). No QoL differences were found between TKI-naive and switched pts before dasatinib treatment (p>0.05). During 12 months of dasatinib treatment positive changes in QoL were observed: Integral Quality of Life Index increased from 0.358 at baseline to 0.493 after 12 mths (p=0.05) and became comparable to healthy controls (p>0.05). Significant QoL improvement was registered in 12 mths of dasatinib treatment for role emotional (48.1 vs 81.5), role physical (44.4 vs 56.5) and social functioning(62.5 vs 80.6); p<0.05. Clinical outcomes were similar to the data of randomized clinical trials. After 3 mths of dasatinib treatment the majority of pts (92%) achieved complete HR, others had partial HR. After 12 mths of treatment 81.6% pts maintained or achieved complete HR; 69.2% pts exhibited complete CyR; 53.8% pts - major/complete MR. Four pts were dropped out of the study due to resistance to dasatinib (n=2) or due to severe AE (n=2). No cases of death were observed during the study. AE were similar to the ones registered within the clinical trials: in the most cases they were non-severe/moderate; severe AE (lung edema, bleeding from stomach ulcer) were observed in 2 pts; no cases of pleural effusion were revealed.In conclusion, patient-reported and clinical outcomes of dasatinib treatment in TKI-naïve pts and in pts early switched to dasatinib after failure of imatinib were obtained in a real world study. Significant QoL improvement in terms of role physical, role emotional and social functioning was observed. Clinical outcomes support the data obtained in clinical trials. Benefits and risks of front-line treatment with dasatinib in CML-CP both from physician’s and patient’s perspective were demonstrated in a real world setting. DisclosuresIonova:BMS: Research Funding; MSD: Speakers Bureau. Bulieva:BMS: Research Funding. Vinogradova:BMS: Research Funding. Kurbatova:BMS: Research Funding. Nikitina:BMS: Research Funding. Novitskaya:BMS: Research Funding. Rodionova:BMS: Research Funding. Usacheva:BMS: Research Funding. Chukavina:BMS: Research Funding. Shumkova:BMS: Research Funding.

Patient-Reported Outcomes in Myelofibrosis Patients Help to Identify Patients' Needs

Myelofibrosis (MF) is the most symptomatic of the myeloproliferative neoplasms and is associated with the greatest symptom burden and poorest prognosis. Patient-reported outcomes is an effective way to identify patients' needs and risks/benefits of MF treatment. We aimed to study quality of life (QoL) and symptom burden in MF patients in a real-world setting.44 MF patients - 27 primary MF, 8 post-essential thrombocytopenia, 9 post-polycythemia vera - were enrolled in the multicenter real-world QoL study. Mean age - 60.8±13.3; male/female - 14/30. All the patients received the best available treatment (BAT, n=28) or novel treatment modality ruxolitinib (n=16) for at least 6 months (range 6-160 mths). A high proportion of patients (80%) had intermediate to high prognostic risk scores according to International Prognostic Scoring System. All the patients completed the QoL questionnaire SF-36, symptom assessment questionnaire CSP-MF and Patient Global Impression of Change (PGIC) tool. Integral QoL Index (IQoLI) in MF patients was calculated on the basis of SF-36 and QoL impairment grade was assessed in comparing with QoL population norms (PN). Comparison t-test for independent samples or Mann-Whitney test was applied.The heterogeneity of MF patients population in terms of QoL impairment was shown: 55% of patients had mild QoL impairment (IQoLI≤25% from PN), 7% - moderate (IQoLI≤25-50% from PN), 38% - severe or critical QoL impairment (IQoLI≤50% from PN). Patients receiving BAT exhibited more pronounced QoL impairment as compared to patients receiving ruxolitinib (p<0.05); they had worse physical functioning, general health, vitality, social functioning, and mental health (p<0.05). All the patients experienced multiple symptoms; the most severe symptoms were fatigue, inactivity and pain in bones/muscles. The symptoms were more expressed in patients on BAT as compared to patients on ruxolitinib (p<0.005). Patient's impression of health changes was better in patients treated with ruxolitinib: the mean PGIC score was higher in patients on BAT on ruxolitinib - 4.4 vs 2.3 (p=0.001).Quality of life and perceived change in health condition are better and symptom severity is less in MF patients on ruxolitinib therapy than those on BAT. Results of this real-world study demonstrate benefits of ruxolitinib therapy from patient perspective. Patient-reported outcomes are of help to better identify the needs of MF patients. DisclosuresNo relevant conflicts of interest to declare.

Quality of life after Whipple pancreatoduodenectomy and pylorus-preserving pancreatoduodenectomy: a comparative study

The authors performed a comparative analysis of the Quality of life (QOL) in 97 patients after pancreatoduodenectomy, 55 of whom underwent pylorus-preserving surgery (PPDE), and 42 underwent classic Whipple procedure (GPDE). QOL was evaluated using questionnaire EORTC-QLQ-C30, version 3.0, and both analyzed groups were divided into 3 subgroups according to the time period after the surgery (less than 6 mo, 6-12 mo, and more than 12 mo). All the patients were operated on for pancreatic or periampullary cancer. During the first period after surgery (less than 6 mo), the integral QOL index is lower than in patients who were examined after the first 6 mo. After PPDE, parameters of physical, role, emotional, cognitive, and social functioning were higher than after GPDE; however, these differences were not statistically significant (p &gt; 0,05). Indicators of QOL have changed with time, but intergroup (PPDE vs GPDE) differences were not statistically significant in every analyzed time period after surgery. Financial constrains were registered in patients of both groups and at different times after surgical treatment.

Long-Term Outcomes of Dasatinib Therapy in Patients with Imatinib-Resistant or -Intolerant Chronic Myeloid Leukemia from Physician’s and Patient’s Perspective

Information about the efficacy and safety of the second-line therapy with dasatinib in patients in chronic phase chronic myeloid leukemia (CML-CP) at long-term follow-up is limited. Evaluation of benefits and risks of the treatment in a “real-world” study both from physician’s and patient’s perspective is worthwhile to better define treatment outcomes in this patients’ population. We aimed to study clinical and patient-reported outcomes as well as safety of the second-line therapy by dasatinib in CML-CP patients with imatinib resistance or intolerance treatment at long-term follow-up.75 CML-CP patients resistant or -intolerant to imatinib were enrolled in the prospective, multicenter, non-interventional study (mean age 51.3 years old, SD 15.4; range 22–83 years; male/female – 37/38). All the patients received dasatinib as the second-line therapy (100 mg daily). Clinical and patient-reported outcomes were evaluated at base-line, 12, 18 and 24 months after treatment start. Twenty six patients were analyzed through all study time-points. For quality of life (QoL) and symptom assessment all the patients filled out the SF-36 and Comprehensive Symptom Profile in Chronic Myeloid Leukemia Patients (CSP Leuk-CML), respectively. Overall and progression-free survival rates as well as cumulative probability of achieving a complete cytogenetic response (CCgR) were calculated using Kaplan-Meier methods. To compare frequencies of CCgR χ2 criterion was applied. Comparison of QoL and symptom scores was conducted using t-test. QoL scores were analyzed using t-test, adjusting for sociodemographic and disease status.At 24 months of dasatinib treatment 94% patients achieved or maintained complete hematologic response and 69% – CCgR. The twenty four-month progression free survival rate was 79% (95% CI; 63.3–88%), overall survival rate – 93% (95% CI; 84–97%). One patient was resistant to dasatinib after 16 months of treatment. During the second year of dasatinib therapy one сase of pleural effusion (grade 3) was registered (at 18 months of treatment); other severe adverse effects (grade 4) were as follows: one patient – neutropenia (at 18 months), one patient – arthralgia/myalgia (at 18 months), one patient – memory loss (at 24 months), one patient – headache and hyperglycemia at 18 months and palpitations, alopecia, hyperglycemia at 24 months of treatment. At 24 months of dasatinib treatment improvement of QoL as compared with base-line was registered: Integral QoL index was significantly higher than at base-line (p<0.02). At 24 months follow-up the proportion of patients with no QoL impairment was 56%; 18.7% patients exhibited severe/critical QoL impairment. It was shown that 56.4% patients with no/mild QoL impairment before dasatinib treatment (favorable group) achieved CCgR as compared with 28% patients with severe/critical QoL impairment (unfavorable group). Progression-free survival rate was 87% in the favorable group vs 60% in the unfavorable group. Cumulative probability of CCgR achievement was higher in the favorable group vs the unfavorable group – 75% vs 50% (log-rank test, p<0.05).Thus, long-term outcomes of second-line therapy in CML-CP patients in a “real world” setting confirm that dasatinib treatment is effective both in terms of clinical outcomes and patient-reported outcomes, as well as exhibits good tolerability. At 24 months of treatment definite QoL improvement was registered. Patients with high QoL before second-line treatment have had better treatment outcomes at long-term follow-up. Comprehensive evaluation of the outcomes of the second-line treatment of CML-CP at long-term follow-up allows to assess the benefits and risks of therapy both from physician’s and patient’s perspective. DisclosuresIonova:BMS: Research Funding. Nikitina:BMS: Research Funding. Fedorenko:BMS: Research Funding. Gritsenko:BMS: Research Funding. Ivanova:BMS: Research Funding. Kuchma:BMS: Research Funding. Shnaider:BMS: Research Funding. Sannikova:BMS: Research Funding. Usacheva:BMS: Research Funding. Kurbatova:BMS: Research Funding.

Theoretical Model of Estimating the Quality of Life Index

The goals of this paper are: to determine the stages of calculation of the quality of life index, to identify the quality of life index estimation branches, to distinguish the main indicators depicting the quality of each working area, to introduce the corresponding mathematical models of each area, and present the method of calculation of the integral quality of life index. Plenty of models are used to measure the quality of population’s life index, but as a rule they estimate influence of economical variables. The author of this paper tries to include many more indicators covering all the important dimensions. The originality of the paper includes determination of major dimensions, which define the quality of life index, two proposed mathematical models of calculation of the integral quality of the life index and the specific indicators suitable for every situation, the estimation of ways to measure weigh constituent coefficients, choosing the unit of measurement for any indicator and the discussion of different ways to obtain the necessary information. The models referred above are modern ones and have not been used before. This research is a theoretical one. The author is going to take practical steps to employ this methodology in the research under the project “Creation of system of measurement indicators and evolution model of the quality of life of Lithuanian population”.