scholarly journals Health-related quality of life of carfilzomib- and daratumumab-based therapies in patients with relapsed/refractory multiple myeloma, based on German benefit assessment data

2019 ◽  
Vol 29 (1) ◽  
pp. 69-79 ◽  
Author(s):  
Katja Weisel ◽  
Heinz Ludwig ◽  
Achim Rieth ◽  
Andrea Lebioda ◽  
Hartmut Goldschmidt

Abstract Background Carfilzomib and daratumumab are licensed in relapsed/refractory multiple myeloma (RRMM), but no head-to-head trials have been conducted. Methods We used data from dossiers prepared for the German Federal Joint Committee based on two phase III randomized trials of carfilzomib-based therapies (ASPIRE, ENDEAVOR) and two of daratumumab-based therapies (POLLUX, CASTOR) to conduct a descriptive assessment of health-related quality of life (HRQoL). HRQoL was assessed using the European Organisation for Research and Treatment of Cancer 30-item HRQoL Questionnaire, with hazard ratios calculated for carfilzomib- and daratumumab-based therapy versus comparators for time to HRQoL deterioration of ≥ 10 points. Analyses were also conducted on data from the EORTC 20-item myeloma-specific questionnaire, the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity scale, and the visual analog scale of the EuroQoL 5-dimension, 5-level questionnaire, where results for these instruments were available. As the designs and patient population of the four trials were similar but not identical, the analysis included only indirect, descriptive comparisons. Results Compared with lenalidomide/dexamethasone, median time to deterioration in global health status/QoL was longer for carfilzomib-based therapy versus control, but similar for daratumumab-based therapy and control. Compared with bortezomib/dexamethasone, time to deterioration was significantly longer for carfilzomib-based therapy versus control for global health status/QoL and numerous functional and symptom subscales. HRQoL measurement is feasible in large RRMM populations. Conclusion Descriptive assessment of HRQoL data suggests potential benefits for carfilzomib-based over daratumumab-based therapy.

2020 ◽  
Vol 2020 ◽  
pp. 1-10 ◽  
Author(s):  
Maike Jörling ◽  
Sandra Rutzner ◽  
Markus Hecht ◽  
Rainer Fietkau ◽  
Luitpold V. Distel

Objectives. Baseline health-related quality of life (HRQoL) scores predict survival, which has already been demonstrated in various studies. However, we were interested in whether changes in baseline scores during treatment are also significant predictors of survival. Methods and Materials. We analysed the data of 400 consecutive cancer patients receiving radiochemotherapy. Leading diagnoses were head and neck cancer (34.5%), rectal cancer (24.5%), and lung cancer (13%). HRQoL was studied at baseline, six weeks after therapy and after each completed year after the start of therapy until drop out of the study using the EORTC QLQ-C30 questionnaire. The change score was calculated as the baseline score subtracted from the score after therapy. Statistics included Kaplan-Meier estimates and Cox regression. Results. High global health status (p=0.005) and low pain scores (p=0.040) at baseline were related to favourable overall survival. Change scores of role functioning (p=0.027), global health status (p<0.018), and pain (p<0.001) were predictive of overall survival. Pain was the superior predictor of survival (p=0.001) among all variables and QoL scores studied by multivariate analysis. A deterioration in pain was associated with a 2.8 times higher chance of survival (HR 0.36). Conclusions. Deterioration of HRQoL baseline pain score by cancer treatment is a favourable and superior prognostic factor for survival.


2009 ◽  
Vol 27 (1) ◽  
pp. 78-84 ◽  
Author(s):  
Berend J. Slotman ◽  
Murielle E. Mauer ◽  
Andrew Bottomley ◽  
Corinne Faivre-Finn ◽  
Gijs W.P.M. Kramer ◽  
...  

Purpose Prophylactic cranial irradiation (PCI) in patients with extensive-disease small-cell lung cancer (ED-SCLC) leads to significantly fewer symptomatic brain metastases and improved survival. Detailed effects of PCI on health-related quality of life (HRQOL) are reported here. Patients and Methods Patients (age, 18 to 75 years; WHO ≤ 2) with ED-SCLC, and any response to chemotherapy, were randomly assigned to either observation or PCI. Health-related quality of life (HRQOL) and patient-reported symptoms were secondary end points. The European Organisation for the Research and Treatment of Cancer core HRQOL tool (Quality of Life Questionnaire C30) and brain module (Quality of Life Questionnaire Brain Cancer Module) were used to collect self-reported patient data. Six HRQOL scales were selected as primary HRQOL end points: global health status; hair loss; fatigue; and role, cognitive and emotional functioning. Assessments were performed at random assignment, 6 weeks, 3 months, and then 3-monthly up to 1 year and 6-monthly thereafter. Results Compliance with the HRQOL assessment was 93.7% at baseline and dropped to 60% at 6 weeks. Short-term results up to 3 months showed that there was a negative impact of PCI on selected HRQOL scales. The largest mean difference between the two arms was observed for fatigue and hair loss. The impact of PCI on global health status as well as on functioning scores was more limited. For global health status, the observed mean difference was eight points on a scale 0 to 100 at 6 weeks (P = .018) and 3 months (P = .055). Conclusion PCI should be offered to all responding ED SCLC patients. Patients should be informed of the potential adverse effects from PCI. Clinicians should be alert to these; monitor their patients; and offer appropriate support, clinical, and psychosocial care.


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