Table 3 The importance of PRO data in relation to outcomes in MM.

From: Management of patients with multiple myeloma beyond the clinical-trial setting: understanding the balance between efficacy, safety and tolerability, and quality of life

Study

Regimen

Setting

N

PRO data and impact on outcomes

Ludwig et al.22

ITd-I

RRMM

90

Significantly longer PFS (median 10.2 vs 6.6 months) and OS (median not reached vs 22.9 months) in patients with higher vs lower (dichotomized around median) Global Health Status/QoL score on EORTC-QLQ-C30 at baseline

Significantly longer OS (median not reached vs 22.9 months) in patients with higher vs lower (dichotomized around median) physical functioning score at baseline

Strasser-Weippl et al.71

–

NDMM

 

Psychosocial QoL scores – role functioning, emotional functioning, social functioning, cognitive functioning – prognostic for OS

Viala et al.72

Bortezomib

RRMM

202

15 PRO parameters from the EORTC QLQ-C30, EORTC QLQ-MY24, FACIT-Fatigue, and FACT/GOG-NTx instruments were significant predictors for mortality on univariate analysis

Fatigue (OR 1.052) and physical functioning (OR 0.964) from EORTC QLQ-C30 were significant predictors for mortality on multivariate analysis

Predictive power for mortality of clinical variables was increased by addition of PRO variables

PROFILES registry68

–

MM

226

EORTC QLQ-C30 summary score associated (HR 0.89) with all-cause mortality in MM patients

Global Health Status/QoL scale (HR 0.90) and physical functioning scale (HR 0.90) also associated with all-cause mortality in MM patients

SEER-MHOS analysis70

–

Elderly NDMM

521

Self-reported health using the SEER-MHOS instrument dichotomized as ‘high’ or ‘low’

Risk of all-cause (HR 1.32) and MM-specific (HR 1.22) mortality elevated in patients with ‘low’ vs ‘high’ self-reported health

NMSG 4/90 analysis69

MP

NDMM

524

Global Health Status/QoL, physical functioning, role functioning, cognitive functioning, fatigue, and pain domain scores on EORTC QLQ-C30 were statistically significant predictors of survival on univariate analysis.

Poor physical functioning and cognitive functioning remained significant predictors of survival on multivariate analysis.

  1. EORTC QLQ-C30/MY20 European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core-30/Myeloma-specific module, FACT-BMT Functional Assessment of Cancer Therapy – Bone Marrow Transplant instrument, HR hazard ratio, IADL instrumental activities of daily living, ITd-I ixazomib-thalidomide-dexamethasone plus ixazomib maintenance, KPS Karnofsky performance status, MM multiple myeloma, MP melphalan-prednisone, NDMM newly diagnosed multiple myeloma, NMSG Nordic Myeloma Study Group, OS overall survival, PFS progression-free survival, PRO patient-reported outcome, QoL quality of life, RRMM relapsed/refractory multiple myeloma, SEER-MHOS Surveillance, Epidemiology, and End Results – Medicare Health Outcomes Survey; TTP time to progression.
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