Background: We recently reported the results of the phase III randomized HOVON87/NMSG18 study showing comparable efficacy of treatment with melphalan, prednisolone and thalidomide following by thalidomide maintenance (MPT-T) versus melphalan, prednisolone and lenalidomide followed by lenalidomide maintenance (MPR-R) (Zweegman S et al. Blood 2016;127(9):1109- 1116). As not only efficacy but also potential toxicity affecting quality of life (QoL) guides the choice of treatment, health-related (HR) QoL is important. Aims: To evaluate the HRQoL results of the HOVON87/NMSG18 study. Methods: Two validated HRQoL instruments (EORTC QLQ-C30 and MY20) were obtained at baseline, after 3 and 9 induction cycles (3ID and 9ID) and after 6 and 12 months of maintenance therapy (6MT and 12MT). The subscales global QoL, physical functioning, pain, fatigue, constipation, diarrhea, nausea/vomiting, insomnia, disease symptoms, side effects of treatment and neuropathy were analysed. Change in HRQoL score over time between treatment arms was assessed by linear mixed models. Independent sample t-tests were used to determine changes from baseline. Minimal important difference (MID) within arms was defined as a difference in score of >=1 standard error of measurement (SEM) or, if a subscale consisted of one parameter only, MIDlevels described in previous literature were used. To determine clinically relevant superiority of one arm, a difference in score of >=5 was used and in addition significance level was calculated. Results: From 553 (90.2%) of the 613 patients who participated in the HRQoL part of the study a baseline questionnaire was available. Forty (15%) of patients randomized to MPT-T versus 68 (24%) of patients randomized to MPR-R completed therapy until 12 months of maintenance therapy. Change in HRQoL between arms over time: in MPT-T improvement of HRQoL over time as compared to MPR-R was found for the subscales diarrhea and insomnia. In contrast, MPR-R showed improvement over time for the subscales pain, constipation, side effects of treatment and neuropathy, as compared to MPT-T. Change in HRQoL per arm: In MPT-T MID was reached for the following subscales; global QoL increased after 9ID until 12MT (MID range 7-13), pain decreased at every time point (MID range -21 to -23), disease symptoms deceased after 9ID (MID -12), fatigue decreased during MT (MID 12) and insomnia decreased at each time point (MID range -11 to -21). In MPR-R the MID was reached for the following subscales; global QoL increased after 9ID until 12MT (MID range 8-14), physical functioning increased at 12MT (MID 13), pain decreased at every time point (MID range -14 to -26) and insomnia decreased at 6MT (MID -10). Difference between MPT-T and MPR-R: In the MPT-T arm significantly (p=5 points) less pain and disease symptoms at 3ID, less fatigue at 3ID and 9ID, less diarrhea and less insomnia at all time points were observed. In contrast, patients on MPRR reported better global QoL, better physical functioning and less pain at 12MT, in general less side effects of treatment, and less constipation and neuropathy separately, at all time points than patients treated with MPT-T. (Table Presented) Summary/Conclusions: Both treatment with MPT-T and MPR-R controlled pain and resulted in an improvement in global QoL as compared to baseline after 9ID and during maintenance. Treatment with thalidomide initially resulted in less pain and disease symptoms. At all treatment stages thalidomide caused less diarrhea, fatigue and insomnia as compared to treatment with lenalidomide. In contrast, therapy with lenalidomide resulted in less side effects of treatment, less constipation and less neuropathy as compared to thalidomide at all stages of treatment. In addition, long term maintenance therapy with lenalidomide resulted in better global QoL, better physical functioning and less pain.
|Number of pages||1|
|Publication status||Published - 2017|