scholarly journals Health-related quality of life in patients with newly diagnosed multiple myeloma ineligible for stem cell transplantation: results from the randomized phase III ALCYONE trial

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Stefan Knop ◽  
Maria-Victoria Mateos ◽  
Meletios A. Dimopoulos ◽  
Kenshi Suzuki ◽  
Andrzej Jakubowiak ◽  
...  

Abstract Background In the phase III ALCYONE trial, daratumumab plus bortezomib/melphalan/prednisone (D-VMP) significantly improved overall response rate and progression-free status compared with VMP alone in transplant-ineligible patients with newly diagnosed multiple myeloma (NDMM). Here, we present patient-reported outcomes (PROs) from ALCYONE. Methods The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) and EuroQol 5-dimensional descriptive system (EQ-5D-5L) questionnaire were administered at baseline, every 3 months (year 1) and every 6 months (until progression). Treatment effects were assessed using a repeated-measures, mixed-effects model. Results Compliance with PRO assessments was comparable at baseline (> 90%) and throughout study (> 76%) for both treatment groups. Improvements from baseline were observed in both groups for EORTC QLQ-C30 Global Health Status (GHS), most functional scales, symptom scales and EQ-5D-5L visual analog scale (VAS). Between-group differences were significant for GHS (p = 0.0240) and VAS (p = 0.0160) at month 3. Improvements in pain were clinically meaningful in both groups at all assessment time points. Cognitive function declined in both groups, but the magnitude of the decline was not clinically meaningful. Conclusions Patients with transplant-ineligible NDMM demonstrated early and continuous improvements in health-related quality of life, including improvements in functioning and symptoms, following treatment with D-VMP or VMP. Trial registration ClinicalTrials.gov identifier NCT02195479, registered September 21, 2014

2019 ◽  
Vol 53 (3) ◽  
pp. 337-347 ◽  
Author(s):  
Sanja Ledinski Ficko ◽  
Vlatko Pejsa ◽  
Vesna Zadnik

Abstract Background The impact of disease and treatment on the patient’s overall well-being and functioning is a topic of growing interest in clinical research and practice. The aim of this study is to obtain reference data on quality of life of Croatian general population. Further, we aim to assess the impact of the disease and its primary systemic treatment on their health related quality of life (HrQoL) in multiple myeloma (MM) patients. Patients and methods Participants for the first part of the study were randomly selected from adult Croatian population. In the clinical part of the study MM patients were included as prospectively diagnosed within two years in two major Croatian haematological centres. The EORTC QLQ-C30 in both trials and QLQ-MY20 in MM patients only were applied for HrQoL assessment. Results Gender, age and place of residence have great impact on quality of life scores in Croatian population. The MM patients at the time of diagnosis have lower QLQ-C30 scores for global quality of life, functional and symptom scale scores, as well as single items. The type of disease followed by the choice of therapy options are important HrQoL determinants. Conclusions The norm values available now for Croatian population will help to interpret HrQoL for clinicians and aid in planning cancer care interventions. This study identified treatment effect consistent with those from other observational studies and provided new data on HrQoL across two different treatment choices for MM patients.


2019 ◽  
Vol 18 (4) ◽  
pp. 269-279.e5
Author(s):  
Heinz-Josef Lenz ◽  
Guillem Argiles ◽  
Takayuki Yoshino ◽  
Sara Lonardi ◽  
Alfredo Falcone ◽  
...  

2020 ◽  
Vol 4 (1) ◽  
Author(s):  
Milenka Jean-Baptiste ◽  
Katharine S. Gries ◽  
William R. Lenderking ◽  
John Fastenau

Abstract Background Smoldering multiple myeloma (SMM) is an early form of multiple myeloma (MM). SMM is typically considered asymptomatic, and research on how it affects health-related quality of life (HRQoL) is limited. This study assessed the symptoms and HRQoL of patients with SMM and those who progressed from SMM to MM and evaluated the content validity of two patient-reported outcome instruments (EORTC QLQ-C30 and nine items from the EORTC QLQ-MY20) for use in SMM clinical trials. To address these objectives, concept elicitation and cognitive interviews were conducted with SMM patients and recently diagnosed MM patients. Results Fifteen adult SMM and six adult MM participants with a prior SMM diagnosis were interviewed. On average, SMM study participants were 61 years old (46.0–78.0), 11 (73%) were female, and diagnosed 2.6 (±2.0) years ago. Each participant had experienced at least one symptom, most commonly tiredness/fatigue, weakness, and pain. The most common HRQoL impacts were emotional and physical. SMM study participants demonstrated good understanding of both the EORTC QLQ-C30 and EORTC QLQ-MY20 subscales and found them relevant to their SMM health state. The average age of MM participants was 53 years old (39.0–62.0); 5 (83%) were female and diagnosed 1.9 years ago (±2.1). MM participants most commonly reported tiredness, weakness, constipation, shortness of breath, and dry mouth as occurring when they progressed from SMM to MM. Conclusions Although previously described as asymptomatic, these SMM participants reported experiencing symptoms that affected their lives. Additionally, the EORTC subscales measured symptoms SMM patients experienced. The participants with MM reported that the symptom burden and HRQoL impacts increased when diagnosed with MM. These findings suggest the need for increased surveillance of symptoms within the SMM population and further suggest that the EORTC subscales can be used to assess symptoms and impacts in both the SMM and MM populations.


2019 ◽  
Vol 17 (1) ◽  
Author(s):  
Diriba Alemayehu Gadisa ◽  
Esayas Tadesse Gebremariam ◽  
Getnet Yimer Ali

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.


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