Impact of recurrence on health-related quality of life in patients at high risk of recurrence after radical surgery for muscle-invasive urothelial carcinoma (MIUC): Results from the phase 3 CheckMate 274 trial.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 4540-4540
Author(s):  
Matt D. Galsky ◽  
Johannes Alfred Witjes ◽  
Jürgen Gschwend ◽  
Julia Braverman ◽  
Edward Broughton ◽  
...  
Keyword(s):  
High Risk ◽  
Local Recurrence ◽  
Radical Surgery ◽  
Distant Recurrence ◽  
Related Quality ◽  
Eortc Qlq C30 ◽  
Health Related ◽  
Hrqol Assessment ◽  
Eortc Qlq

4540 Background: Patients (pts) undergoing radical surgery for MIUC face a high risk of disease recurrence. Recurrence is associated with worse survival, but its effect on health-related quality of life (HRQoL) is unclear. This post hoc analysis assessed the impact of recurrence on HRQoL using data from the phase 3 CheckMate 274 trial. Methods: Pts who had undergone radical surgery for high-risk MIUC (≤ 120 days previously) were randomized 1:1 to nivolumab 240 mg Q2W or placebo for ≤ 1 year. HRQoL was assessed using the EORTC QLQ-C30 and EQ-5D-3L every 4–6 weeks during treatment; 35 and 115 days after the last dose; and every 3 months after that until the end of the study (EQ-5D-3L only). The analysis included pts with a valid HRQoL assessment at baseline and at ≥1 post-baseline visits. Confirmed deterioration in HRQoL was defined as worsening exceeding an a priori points threshold (± 10 for the EORTC QLQ-C30 domains, –7 for the EQ-5D visual analogue scale [VAS]) at ≥ 2 consecutive visits. Recurrence was classified as local only or distant (with or without local recurrence). The effect of recurrence on HRQoL deterioration was assessed by Cox proportional hazards regression with recurrence as a time-dependent covariate. The models controlled for treatment arm and baseline HRQoL score, and were stratified by PD-L1 expression, pathologic nodal status, and use of neoadjuvant cisplatin-based chemotherapy. Results: The analysis included 645 pts for EORTC QLQ-C30, of whom 71 (11%) had local recurrence only and 136 (21%) had distant recurrence during the HRQoL assessment period; and 648 pts for EQ-5D-3L. with recurrence had a significantly higher risk of confirmed deterioration in all HRQoL domains than those without recurrence (see table). However, hazard ratios were consistently greater for distant recurrence than for local recurrence across all HRQoL domains. For local recurrence only, a higher risk of confirmed deterioration in HRQoL compared to no recurrence was observed only for global health status/QoL. Conclusions: Recurrence, particularly distant recurrence, had a significant, negative impact on HRQoL. This suggests that treatment delaying recurrence after radical surgery for high-risk MIUC may prevent or delay HRQoL deterioration in these pts. Clinical trial information: NCT02632409. [Table: see text]

Health-Related Quality of Life Profile and Request of Prognostic Information on Survival At the Time of Diagnosis in Patients with High-Risk Myelodysplastic Syndromes

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 2078-2078
Author(s):  
Fabio Efficace ◽  
Gianluca Gaidano ◽  
Reinhard Stauder ◽  
Giovanni Caocci ◽  
Maria Teresa Voso ◽  
...  
Keyword(s):  
Quality Of Life ◽  
High Risk ◽  
Myelodysplastic Syndromes ◽  
Health Related Quality ◽  
Prognostic Information ◽  
Related Quality ◽  
Eortc Qlq C30 ◽  
Health Related ◽  
Eortc Qlq

Abstract Abstract 2078 Background: Health-related quality of life profile (HRQOL) of patients diagnosed with high-risk myelodysplastic syndromes (MDS) can be compromised already at the time of diagnosis before receiving any kind of treatment. Clinical decision-making is challenging due to the poor prognosis and no data exist on the possible relationships between patient's HRQOL and the request of prognostic information on survival during consultation. Aim: The main objectives were to assess preferences for prognostic information of patients with high-risk MDS and the relationship between such preferences and patient characteristics including HRQOL. To date no such evidence exists in this population. Patients and Methods: Data were gathered through an ongoing international prospective observational study that recruits newly diagnosed patients with MDS. These patients typically have a limited life expectancy. At the time of diagnosis, and during one of the first clinical consultations in which treatment options were discussed, patients completed the European Organization for Research and treatment of Cancer, Quality of life Questionnaire (EORTC QLQ-C30). The EORTC QLQ-C30 is a psychometrically robust generic HRQOL cancer measure assessing both symptoms and functional aspects. Physicians also completed an extensive survey about their patient's preference for involvement in treatment decisions and whether the patient explicitly requested prognostic information for survival. Associations between request for prognostic information, HRQOL socio-demographic characteristics (i.e., living arrangements, age, gender, education) and clinical data including: performance status, comorbidity and disease severity (i.e. IPSS risk category intermediate 2 vs. high risk) were investigated using Fisher's exact test and Wilcoxon-Mann-Whitney test as appropriate. Results: Overall, 184 patients (36% female and 64% male) were analyzed. Mean age of patients was 70 years (range: 31–88). 65% explicitly requested information about expected survival at the time of diagnosis. The symptom profile of patients requesting prognostic information was better than those who did not in 7 out of the 8 symptoms evaluated. The largest clinically meaningful difference was found for fatigue with a mean score of 39 (SD:26) and 52 (SD:28) respectively for those requesting prognostic information versus those who did not. Request for prognostic information was significantly associated with younger age (P=.01) and fewer comorbidities (P=.04). In addition, better physical functioning (P=.009), better role functioning (P=.002) and a lower level of fatigue (P=.002) were also associated with a request for prognostic information during consultation. Additional supportive analysis revealed that patients with a higher overall mean symptom score did not request information about survival (P=.02). Conclusion: These data suggest that the majority of patients with high-risk MDS request prognostic information on survival from their physicians at the time of diagnosis. There is also an indication that patients who are more likely to request such information are those who are in better health condition reporting higher functional abilities and lower symptoms. Disclosures: No relevant conflicts of interest to declare.

scholarly journals Randomized Trial Assessing the Impact of Routine Assessment of Health-Related Quality of Life in Patients with Head and Neck Cancer

Cancers ◽  
2021 ◽  
Vol 13 (15) ◽  
pp. 3826
Author(s):  
Oumar Billa ◽  
Franck Bonnetain ◽  
Jérôme Chamois ◽  
Angeline Ligey ◽  
Valérie Ganansia ◽  
...  
Keyword(s):  
Head And Neck ◽  
Satisfaction With Care ◽  
Related Quality ◽  
Eortc Qlq C30 ◽  
Health Related ◽  
Eortc Qlq ◽  
The Impact ◽  
Routine Assessment ◽  
Eq Vas

The impact of routine assessment of health-related quality of life (HRQoL) on satisfaction with care and the HRQoL of patients with head and neck cancer (HNC) treated with radiotherapy was assessed. Patients with HNC were randomly assigned to two arms, with stratification on sex, cancer localization, and stage of the disease. In the intervention arm, the patients completed the EORTC QLQ-C30 and EORTC QLQ-H&N35 questionnaires first before randomization, then before each medical appointment during radiotherapy (7 weeks), and then every 3 months until 1 year and at 2 years thereafter. In the control arm, the EORTC QLQ-C30 and EORTC QLQ-H&N35 questionnaires were completed before randomization and at 1 year and 2 years thereafter. The primary endpoint was mean change in HRQoL at score at 2 years from baseline assessed by EQ VAS from the EuroQol questionnaire. The secondary endpoint was mean change in satisfaction with care at 2 years from baseline assessed by QLQ-SAT32. Two hundred patients with head and neck cancers were involved in this study (mean age, 58.83 years (range, 36.56–87.89)), of whom 100 were assigned to the intervention arm and 100 to the control arm. Patients in the intervention arm were reported to have a statistically significant increase in EQ VAS at 2 years (p < 0.0001) and exceeded the minimal clinically important difference (mean change at 2 years from baseline = 10.46). In the two arms, mean differences between arms were not statistically significant, but minimal clinically important differences in favor of the intervention arm were found for EQ VAS (mean change difference (MD) = 5.84), satisfaction with care, in particular waiting times (MD = 10.85) and satisfaction with accessibility (MD = 6.52). Routine assessment of HRQoL improves HRQoL and satisfaction with care for patients with HNC treated with radiotherapy.

scholarly journals Reliability and validity of Amharic version of EORTC QLQ-C30 and QLQ-BR23 modules for assessing health-related quality of life among breast cancer patients in Ethiopia

2019 ◽  
Vol 17 (1) ◽  
Author(s):  
Diriba Alemayehu Gadisa ◽  
Esayas Tadesse Gebremariam ◽  
Getnet Yimer Ali
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Cancer Patients ◽  
Health Related Quality ◽  
Breast Cancer Patients ◽  
Related Quality ◽  
Eortc Qlq C30 ◽  
Health Related ◽  
Eortc Qlq

Abstract Background Breast cancer is the most common cancer among women and it affects quality of life of those women. So far, the two most frequently used tools for assessing health related quality of life in breast cancer patients, EORTC QLQ-C30 and EORTC QLQ-BR23 modules, were not validated in Ethiopia. Hence, the present study aimed to assess the psychometric properties of the tools among Ethiopian breast cancer patients. Methods Institutional based longitudinal study was conducted from January 1 to May 1, 2017 GC at only nationwide oncology center, Tikur Anbessa Specialized Hospital (TASH), Addis Ababa, Ethiopia. A total of 146 patients who visited the facility during that period, with no missing quality of life data, were selected for analysis. The psychometric properties of the EORTC QLQ-C30 and EORTC QLQ-BR23 were evaluated in terms of reliability, convergent, divergent, construct and clinical validity using SPSS version 22. Results Satisfactory internal consistency reliability (Cronbach’s α coefficients > 0.7) was confirmed, except for cognitive function (α = 0.516) of EORTC QLQ-C30 and body image (α = 0.510) of EORTC QLQ-BR23. Multiple-trait scaling analysis demonstrated a good convergent and divergent validity. No scaling errors were observed. Most items in EORTC QLQ-BR23 possessed a weak or no correlation with its own dimension in EORTC QLQ-C30 (r < 0.4) except with some of symptom scales. A statistically significant chemotherapy induced quality of life scores changes (P ≤ 0.05) were observed in all dimensions of both instruments between baseline and the end of first cycle chemotherapy, except for body image (P = 0.985) and sexual enjoyment (P = 0.817) of EORTC QLQ-BR23, indicating clinical validity. Conclusion Amharic version of the EORTC QLQ-C30 and EORTC QLQ-BR23 modules are valid and adequately reliable tool and can be used for clinical and epidemiological cancer researches to study the health related quality of life (HRQoL) of women with breast cancer in Ethiopia.

Health-Related Quality of Life As a Survival Predictor for Patients With Localized Head and Neck Cancer Treated With Radiation Therapy

2009 ◽  
Vol 27 (18) ◽  
pp. 2970-2976 ◽  
Author(s):  
François Meyer ◽  
André Fortin ◽  
Michel Gélinas ◽  
Abdenour Nabid ◽  
François Brochet ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Radiation Therapy ◽  
Head And Neck ◽  
Prognostic Value ◽  
Health Related Quality ◽  
Related Quality ◽  
Eortc Qlq C30 ◽  
Health Related ◽  
Eortc Qlq

Purpose To assess the added prognostic value for overall survival (OS) of baseline health-related quality of life (HRQOL) and of early changes in HRQOL among patients with localized head and neck cancer (HNC) treated with radiation therapy. Patients and Methods All 540 patients with HNC who participated in a randomized trial completed two HRQOL instruments before radiation therapy: the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) and the Head and Neck Radiotherapy Questionnaire. Six months after the end of radiation therapy, 497 trial participants again completed the two HRQOL instruments. During the follow-up, 179 deaths were observed. Multivariate Cox proportional hazards models were used to test whether HRQOL variables, baseline and change, provided additional prognostic value beyond recognized prognostic factors. Results The baseline EORTC QLQ-C30 physical functioning (PF) score was an independent predictor of OS. The hazard ratio (HR) associated with a 10-point increment in baseline PF was 0.87 (95% CI, 0.81 to 0.94). In multivariate models, the change in HRQOL was significantly associated with OS for most HRQOL dimensions. Among these, PF change was the strongest predictor. The magnitude of the association between PF change and survival decreased over time. At 1 year, the HR associated with a positive PF change of 10 points was 0.75 (95% CI, 0.68 to 0.83). After PF is taken into account, no other HRQOL variable was associated with survival. Conclusion Our findings indicate that both baseline PF and PF change provide added prognostic value for OS beyond established predictors in patients with HNC. Assessing HRQOL could help better predict survival of cancer patients.

scholarly journals Health-related quality of life assessed by the EORTC QLQ-C30 questionnaire in the general slovenian population

2017 ◽  
Vol 51 (3) ◽  
pp. 342-350 ◽  
Author(s):  
Vaneja Velenik ◽  
Ajra Secerov-Ermenc ◽  
Jasna But-Hadzic ◽  
Vesna Zadnik
Keyword(s):  
Quality Of Life ◽  
Health Related Quality ◽  
Linear Regression Models ◽  
Slovenian Population ◽  
Related Quality ◽  
Eortc Qlq C30 ◽  
Health Related ◽  
Eortc Qlq ◽  
The Impact

Abstract Background The aim of our study was to obtain reference data of the EORTC QLQ-C30 quality of life dimensions for the general Slovenian population. We intend to provide the researchers and clinicians in our country with the expected mean health-related quality of life (HRQL) scores for distinctive socio-demographic population groups. Methods The EORTC QLQ-C30 questionnaire supplemented by a socio-demographic inquiry was mailed or distributed to 1,685 randomly selected individuals in the Slovenian population aged 18 – 90. Answers from 1,231 subjects representing socio-demographic diversity of the Slovenian population were collected and transformed into EORTC dimensions and symptoms. The impact of socio-demographic features on HRQL scores was assessed by multiple linear regression models. Results Gender, age and self-rated social class are the important confounders in the quality of life scores in our population. Men reported better quality of life on the majority of the specific scales and, at the same time, reported fewer symptoms. There was no gender-specific difference in cognitive functioning. The mean scores were consistently lower with age in both sexes. Conclusions This is the first study to report the normative EORTC QLQ-C30 scores for one of the south-eastern European populations. The reported expected mean scores allow Slovenian oncologists to estimate what the quality of life in cancer patients would be, had they not been ill. As they are derived by common methodology, our results can easily be included in any further international comparisons or in the calculation of European summarized HRQL scores.

scholarly journals The Relationship between Minimal Residual Disease and Patient Reported Outcomes in Relapsed/Refractory Multiple Myeloma

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 3273-3273
Author(s):  
Hervé Avet-Loiseau ◽  
Jianming He ◽  
Katharine S. Gries ◽  
Huiling Pei ◽  
Sourish Saha ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Board Of Directors ◽  
Health Related Quality ◽  
Advisory Committees ◽  
Related Quality ◽  
Eortc Qlq C30 ◽  
Health Related ◽  
Index Value ◽  
Eortc Qlq

Abstract Objective With the introduction of novel treatments for multiple myeloma, patients are now achieving deeper and sustainable clinical responses. Recent studies have demonstrated that achieving Minimal Residual Disease (MRD) negativity leads to better progression-free survival and overall survival outcomes (Lahuerta JJ, et al. J Clin Oncol 2017. 35[25]:2900-10; Munshi NC, et al. JAMA Oncol 2016. 3[1]:28-35; Landgren O, et al. Bone Marrow Transplant 2016. 51[12]:1565-1568). However, the relationship between MRD status and patient reported outcomes (PRO) has not been reported. The objective of this analysis is to evaluate whether PRO endpoints change by MRD status using data from two randomized clinical trials of daratumumab containing treatment regimens, POLLUX (Dimopoulos MA, et al. N Engl J Med 2016. 375[14]:1319-1331) and CASTOR (Palumbo A, et al. N Engl J Med 2016. 375[8]:754-766), for patients with relapsed or refractory multiple myeloma. Methods MRD status was assessed in POLLUX at the time of suspected CR, and at 3 and 6 months post-suspected CR for responders. Similarly, in CASTOR, MRD status was assessed for patients at the time of suspected CR and at 6 months and 12 months after first dose. MRD was assessed via next generation sequencing using the clonoSEQ® assay V2.0 (Adaptive Biotechnologies, Seattle, WA) at sensitivities of 0.001%. The PRO instruments (EORTC-QLQ-C30 and EQ-5D-5L) were collected in both POLLUX and CASTOR study prior to treatment, during the treatment phase, and post-progression. EQ-5D-5L assessed general health status and included an index value and visual analog scale (VAS) score. EORTC QLQ C30 assessed health related quality of life and included five functional scales (physical, role, emotional, social and cognitive), three symptom scales (fatigue, nausea & vomiting and pain) and a global health status (GHS) scale as well as six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Summary statistics (mean, standard deviation, median, min and max) by MRD status (baseline, prior to MRD negativity, MRD negativity prior to progression) were reported and for subjects who did not achieve MRD negativity (baseline, post baseline prior to progression) on a pooled sample of subjects from the two clinical trials. To interpret a meaningful change, a 5-point threshold was defined based on the EORTC guidelines for assessing quality of life in clinical trials. Results Overall 137 subjects in both CASTOR and POLLUX achieved MRD negativity and had PRO data available for analysis. At baseline, GHS, EQ-5D-5L VAS and index value were 62.1, 66.7, and 0.72 respectively (GHS and VAS scores closer to 100, and index value closer to 1.0 represent better health state). Mean values increased to 67.2, 70.9, and 0.75 after achieving MRD negativity. Pain scale (symptom scores closer to 0 represent less symptoms) reduced from 30.4 to 23.5 and fatigue was similar (33.8 at baseline to 31.2) when patients achieved MRD negativity. However, when we compared the five functional scales prior to and post MRD negativity, no evident differences were identified. The mean change from baseline to post-MRD-negativity in the EORTC QLQ-C30 GHS and Pain scores exceeded a 5-point threshold, reflecting a meaningful change in subject's health-related quality of life. A total of 893 subjects in the pooled data set did not achieve MRD negativity and had PRO data available for analysis (EQ-5D-5L data were not available for 3 subjects). Baseline values for these MRD positive subjects were 60.0, 65.3, and 0.71 and the mean post-baseline (pre-progression) values remained similar at 61.1, 66.0, and 0.71 for GHS, VAS, and the index value, respectively. Pain reduced from mean 33.3 to 29.4 and fatigue was similar, changing from 36.2 to 37.6. Conclusion To our knowledge, this is the first analysis exploring the relationship between MRD status and PRO endpoints. Results from this analysis demonstrate that patients who achieve MRD negativity status show a trend in better health-related quality of life, with meaningful improvement in EORTC QLQ-C30 GHS and pain scores. These preliminary findings indicate that overall health-related quality of life and symptom domains of EORTC-QLQ-C30 and EQ-5D-5L might be sensitive to changes in MRD status, with changes in GHS and Pain exceeding meaningful threshold for subjects. Disclosures Avet-Loiseau: Amgen: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Sanofi: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Takeda: Membership on an entity's Board of Directors or advisory committees, Research Funding; Celgene: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Janssen: Consultancy, Membership on an entity's Board of Directors or advisory committees; Abbvie: Membership on an entity's Board of Directors or advisory committees. He:Janssen global services: Employment. Gries:Janssen Research & Development, LLC: Employment. Pei:Janssen Research & Development, LLC: Employment. Saha:Janssen Research & Development, LLC: Employment. Chiu:Janssen Research & Development, LLC: Employment. Cote:Janssen Research & Development, LLC: Employment. Lam:Janssen Global Services, LLC: Employment.

scholarly journals Health-Related Quality of Life Among Rural Chinese Patients With Upper Gastrointestinal Diseases at Different Pathological Stages: A Cross-Sectional Study

2020 ◽  
Author(s):  
Tingting Qin ◽  
Yuchen Shao ◽  
Nan Zhang ◽  
Jialin Wang ◽  
Nengliang Yao ◽  
...  
Keyword(s):  
Chinese Patients ◽  
Pathological Stage ◽  
Cross Sectional ◽  
Upper Gi ◽  
Significant Difference ◽  
Related Quality ◽  
Eortc Qlq C30 ◽  
Health Related ◽  
Eortc Qlq

Abstract Objective: The aim of this study was to compare the health-related quality of life (HR-QoL) among rural Chinese patients with upper gastrointestinal (GI) diseases at different pathological stages and to determine the factors influencing HR-QoL in this population.Methods: A cross-sectional survey was conducted in two counties in Shandong province in China from July to September 2018. Demographic and clinical characteristics were collected, and HR-QoL of patients was assessed using a set of questionnaires, including the EORTC QLQ-C30 (V3.0), the QLQ-OES18 and the QLQ-STO22. Multivariate analysis of variance (MANOVA) and Kruskal–Wallis test were used to compare the HR-QoL of patients of different pathological stage subgroups, and multivariate regression analyses were used to determine influencing factors.Results: A total of 406 patients were included in this study. The mean scores for patients with upper GI diseases were 74.88 (SD=19.15), 8.04 (SD=16.17) and 8.64 (SD=16.96) for the global QoL scale of EORTC QLQ-C30, QLQ-OES18 and QLQ-STO22, respectively. There was no significant difference in most of the scales between the precancerous and early stage groups, but a significant difference in HR-QoL between the precancerous and advanced groups as well as between early and advanced groups. Residence area, age, education level and pathological stage were the significant factors influencing HR-QoL scores, controlling for other variables.Conclusions: The overall HR-QoL of patients with advanced upper GI cancer needs to be managed as a component of cancer care. Measures should be taken to routinely identify patient symptoms so that follow-up care can alleviate patient symptom burden. Tailored treatment and care for patients with upper GI diseases of different age, educational level and pathological stage may be needed to help improve HR-QoL.

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