Prospective longitudinal study on quality of life in relapsed/refractory multiple myeloma patients receiving second- or third-line lenalidomide or bortezomib treatment

Abstract

Treatment advances for multiple myeloma (MM) that have prolonged survival emphasise the importance of measuring patients' health-related quality of life (HRQoL) in clinical studies. HRQoL/functioning and symptoms of patients with relapsed/refractory MM (RRMM) receiving second- or third-line lenalidomide or bortezomib treatment were measured in a prospective European multicentre, observational study at different time points. At baseline, patients in the lenalidomide cohort were frailer than in the bortezomib cohort with more rapid disease progression at study entry (more patients with Eastern Cooperative Oncology Group performance status >2, shorter time from diagnosis, more chronic heart failure, higher serum creatinine levels, more patients with dialysis required). About 40% of the patients receiving lenalidomide discontinued the study in <6 months while 55% in the bortezomib cohort discontinued. No substantial HRQoL deterioration was observed for the first 6 months in patients with RRMM receiving one or the other treatment. For patients still on treatment at study completion (month 6), only the European Organization for Research and Treatment of Cancer Quality-of-Life Core domains of Diarrhoea and Global Health Status/QoL had worsened in the lenalidomide and bortezomib cohorts, respectively. A clinically meaningful deterioration in HRQoL was more often observed for patients who discontinued the study prior to 6 months in the bortezomib cohort than in the lenalidomide cohort.

Figure 1

Patients' disposition and study completion by treatment group. Reasons for discontinuation are as reported by the physician. *Other reasons include death, loss to follow-up, withdrawn consent, other and missing (include two patients in the bortezomib cohort who never received treatment: one discontinued for consent withdrawal and the other for other reasons).

Figure 2

Description of changes in domains scores for the three EORTC questionnaires over time in the lenalidomide and bortezomib cohorts. Bort: bortezomib, with N=59–62 at month 3, 40–42 at month 6 and 27–29 at discontinuation; Len: lenalidomide, with N=113–120 at month 3, 90–93 at month 6 and 23–27 at discontinuation; MID corresponding to a meaningful worsening (straight line), and a meaningful improvement (dashed line), MID defined as standard error of measurement for multi-item domains and as 0.5 × SD at baseline for single-item domains.