The Assessment of Health-Related Quality of Life in Relapsed or Refractory Myeloma Patients Receiving Lenalidomide and Low Dose Dexamethasone: A Result of Hola Study
Authors: Kim Seok Jin , Park Yong , Mun Yeung-Chul , Kim Jin Seok , Kim Kihyun , Min Chang-Ki 
Published: October 2019

Abstract
Introduction
Multiple myeloma is still considered an incurable disorder. Nevertheless, many patients now live beyond five years with improvements in treatment. As a result, the management of heath related quality of life (QoL) has emerged as an important issue in myeloma patients. Lenalidomide has been widely used for relapsed or refractory myeloma. As lenalidomide is an oral agent, lenalidomide-based treatment for multiple myeloma is mostly out-patient based. Thus, patients receiving lenalidomide should spend most of their time managing symptoms at home with unclear impact on their life quality. To date there are limited data about longitudinal QoL and psychosocial effects of patients receiving lenalidomide treatment.
Methods
The study population was relapsed or refractory myeloma patients who would be treated with lenalidomide and low-dose dexamethasone as a clinical practice. The length of a cycle was 28 days and the treatment consisted of lenalidomide 25mg per day (D1-21) and dexamethasone 40mg once a week (D1, 8, 15, and 22). The objective of the study was to assess serial changes of QoL and psychosocial problems in relapsed or refractory myeloma patients receiving lenalidomide. After obtaining informed consent, we assessed the baseline QoL using the EORTC QLQ C30 and myeloma-specific questionnaires. We also assessed distress, psychosocial problems, sleep, depression, pain and social support using distress scales, Pittsburgh sleep quality index, geriatric depression scales, and brief pain inventory. Distress was assessed every visit at outpatient clinic. The follow-up assessment of QoL and psychosocial problems was performed before the 4th and 12th cycle. When a patient progressed during treatment, the final assessment was done at the end of treatment.
Results
A total of 140 myeloma patients were enrolled between March 2013 and April 2017. The median age was 67 years (range: 45-81 years), and male was dominant (n = 92, 66%). The median time from diagnosis to enrollment was 2.8 years (range: 0.4 - 14.1 years), and the median number of previous treatments was three (range: 1 - 8). All patients were previously treated with bortezomib-containing treatment including bortezomib/dexamethasone, bortezomib/thalidomide/dexamethasone and bortezomib/melphalan/prednisone. Patients received lenalidomide and dexamethasone for their relapsed disease (n = 98, 70%) or refractory disease to previous treatments (n = 42, 30%). The baseline evaluation showed the presence of psychosocial problems including depression (n = 51, 36%), distress with problems (n = 42, 30%) and suffering from insufficient support (n = 29, 21%). During treatment, 58 patients withdrew from the study due to disease progression. The serial assessment of QoL showed the improvement of general health in tandem with the response to lenalidomide/dexamethasone treatment. The physical, role and emotional functioning were also improved compared to baseline values at the time of enrollment. As might be expected, the QoL items reflecting the general health and physical/role functioning showed higher values in patients responding to treatment than patients who failed to respond to lenalidomide/dexamethasone. However, some aspects of QoL, notably cognitive and social functioning, were not improved during treatment in responders and non-responders. The serial monitoring of distress level also showed no significant change regardless of response to lenalidomide. Although the difference was not statistically significant, patients reported their physical symptoms such as fatigue, constipation, dyspepsia and neuropathy were improved during treatment. However, the majority of patients experienced insomnia and financial difficulties.
Conclusions
The health-related QoL of myeloma patients such as global health and functioning improved as patients were treated with lenalidomide and low-dose dexamethasone. However, a substantial number of patients continued to suffer from sleep disturbance and physical symptoms such as neuropathy. Accordingly, distress level of patients was not changed even though patients achieved complete response to lenalidomide. The discordant results suggest that physicians should pay close attention to the various aspects of QoL and psychosocial problems, managing appropriately those facets that are not improved in association with response to treatment.

Disclosures
No relevant conflicts of interest to declare.