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

Abstract

Background Carfilzomib and daratumumab are licensed in relapsed/refractory multiple myeloma (RRMM), but no headto-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 daratumumabbased therapy.

Real-World Evaluation of Health-Related Quality of Life in Patients With Multiple Myeloma From Germany

“…15 HRQoL data also play an important role in health technology and cost-effectiveness assessments of new treatments. [16][17][18][19][20] The management of patients with MM could therefore be improved by a better understanding of the extent to which the disease and its treatment impact HRQoL. 7 However, real-world data on HRQoL in patients with MM remain scarce.…”

Transarterial Radioembolization Versus Atezolizumab–Bevacizumab in Unresectable Hepatocellular Carcinoma: A Matching-Adjusted Indirect Comparison of Time to Deterioration in Quality of Life

“…Even though many clinical trials now include QOL as one of the key outcomes, its analysis is still not standardized, thereby hindering the comparability of results across trials and the literature [33,34]. Time to deterioration in QOL analyses rely, among other factors, on the threshold used to determine clinical relevance, with a change of 10 or more points on the GHS (in a single measurement) being one of the most common thresholds [33][34][35][36][37][38][39][40]. Although to a lesser extent, other thresholds have also been evaluated [41,42].…”

The impact of lenalidomide maintenance on second‐line chemotherapy in transplant eligible patients with multiple myeloma

“…Examining outcomes after prior lenalidomide exposure, the median PFS in CASTOR Daratumumab, bortezomib and dexamethasone arm (DVd) was 7.8 months (lenalidomide refractory) – 21.2 months (prior lenalidomide exposure and receiving DVd in 2nd line). Data specifically in patients getting DVd after relapse on LM is not reported 27‐32 . However, in all the trials listed above, data examining the regimens specifically in relapse after LM are lacking.…”