Relapsed/refractory patients

QoL study of RRMM patients treated with second- or third-line lenalidomide or bortezomib

A prospective observational study to measure health-related quality of life (HRQoL) in patients with relapsed/refractory multiple myeloma (RRMM), was conducted by Xavier Leleu and colleagues from Hopital de La Miletrie, Poitiers, France, and was published in Blood Cancer Journal in March 2017. Currently, there is no cure for RRMM, yet patients have prolonged survival due to improved treatments, and therefore ensuring a high quality of life throughout this treatment journey is paramount. This study was aimed at assessing the impact and burden of treatment on patient Health-related Quality of Life (HRQoL), in real-life context.

Key Highlights:
Study Design:
  • European multicentre, prospective, longitudinal study conducted in Belgium, France, Germany, Ireland, Italy and United Kingdom
  • Patients with RRMM who were receiving second/third line treatment with lenalidomide or bortezomib were included in the study (n=258) between December 2010 and February 2014
  • The study was conducted over 6 months (study completion)
  • 62 patients received lenalidomide: (39.5% discontinued by study completion)
  • 96 patients received bortezomib: (55.2% discontinued by study completion)
  • Patient age: lenalidomide cohort: 77-93 years; bortezomib cohort: 74-85 years
  • Time since diagnosis: lenalidomide cohort = 3.9+/-3.0 years; bortezomib cohort = 2.8+/- 2.5 years
  • Significant difference between age and time since diagnosis for both cohorts: P<0.05
  • Study participants were assessed using three questionnaires: The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life core (QLQ-C30), QLQ-Multiple Myeloma (QLQ-MY20), and QLQ-Chemotherapy-Induced Peripheral Neuropathy (QLQCIPN20), covering a range of Symptom and Functional domains
  • Questionnaires were completed at baseline, month 3 and month 6
 Results:
  • Descriptive statistics were applied to the change in EORTC questionnaire scores from baseline to month 6 (or discontinuation)
  • The minimal important difference (MID) was used to define the smallest change in a QoL score considered important to patients
  • No substantial HRQoL deterioration was observed for the first 6 months in patients with RRMM receiving either lenalidomide or bortezomib
  • At study completion (6 months), only EORTC QoL Core domains of Diarrhoea in the lenalidomide cohort and Global Health Status/QoL in the bortezomib cohort had reductions from baseline reaching MID, indicating a worsening of these measurements
  • A clinically meaningful deterioration in HRQoL was observed more frequently in patients who discontinued the study before 6 months in the bortezomib cohort, than in the lenalidomide cohort
Conclusions:

This study provided real-world data to show that HRQoL was not significantly affected in patients receiving second- or third- line treatment with either lenalidomide or bortezomib. This provides re-assurance for practitioners using these treatment regimens, as a high quality of life throughout the treatment journey is important. Since the study population was small, the authors noted that repeating this study in a larger population could produce more robust results and provide a better understanding of the overall treatment impact.

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.

References
  1. Leleu X. et al. Prospective longitudinal study on quality of life in relapsed/refractory multiple myeloma patients receiving second- or third-line lenalidomide or bortezomib treatment. Blood Cancer Journal. 2017 Mar 17;7(3):e543. DOI: 10.1038/bcj.2017.20.
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