Health-related quality of life in non-transplant eligible newly diagnosed multiple myeloma patients treated with melphalan/prednisolone plus either thalidomide or lenalidomide; results of the HOVON87/NMSG18 study

Abstract

Aims: The aim is to evaluate the health-related quality of life (HRQoL) results of HOVON87/NMSG18 study (Zweegman et al., Blood 2016;127(9):1109-1116). Non-transplant eligible, newly diagnosed multiple myeloma patients were randomized between melphalan/prednisolone plus either thalidomide or lenalidomide for nine induction cycles, followed by thalidomide or lenalidomide maintenance (MPT-T or MRP-R). The study showed comparable efficacy of treatment. Methods: The validated instruments, EORTC QLQ-C30 and EORTC QLQ-MY20, were used for HRQoL measurement and were optional in the study. The patients answered the questionnaires at baseline, after 3 and 9 induction cycles and after 6 and 12 months of maintenance. Changes in HRQoL score over time during treatment and between groups were evaluated according to previously published levels of minimal important difference. Results: 613 of the total of 637 randomized patients chose to participate in the HRQoL reporting, and the baseline questionnaire was available from 553 patients (90.2%). Patient drop-out during follow-up was due to progressive disease, toxicity, death and other, and reduced the number of patients completing the therapy to 42 (15%) patients in the MPT-T and 93 (33%) in the MPR-R group. Both groups reported clinically meaningful improvement in global quality of life (QoL), physical functioning, pain, disease symptoms and insomnia. In the evaluation of difference between groups, the patients receiving MPR-R reported increasing diarrhea, better controlled pain at induction phase and increased global QoL and physical functioning during maintenance phase compared to MPT-T. The patients receiving MPT-T reported increasing constipation, better controlled pain during maintenance phase, better controlled fatigue during induction treatment and decreased insomnia compared to MPR-R. Conclusions: HRQoL during treatment is important to myeloma patients, especially when treatment efficacy of the treatment regimens is comparable. MPR-R and MPT-T both demonstrated improvements in global QoL, physical functioning and pain. Fatigue and insomnia were better controlled in the MPT-T group, which can be attributed to the thalidomide side effect of sleepiness. For interpretation of the HRQoL results patient drop-out rate must be taken in account, and we will recommend a HRQoL study design with high focus on data completeness and registration of reasons for missing data. (Figure Presented).