Page 197 - Haematologica - Vol. 105 n. 6 - June 2020

HRQoL with thalidomide and lenalidomide
significant improvement was observed in global QoL (P=0.003, clinically relevant at T3), physical- (P<0.001) and role functioning (P<0.001, clinically relevant at T4), fatigue (P<0.001) and dyspnea (P=0.004). In contrast, no signifi- cant improvement occurred during thalidomide mainte- nance. There was even statistically significant worsening of peripheral neuropathy symptoms (P<0.001, clinically relevant at both T3 and T4) (Online Supplementary Table S3 and Online Supplementary Figure S4). Between arms, there were clinically meaningful differences in physical and role functioning (better with lenalidomide), in appetite loss
P=0.004
(worse with lenalidomide) and in neuropathy (worse with thalidomide) (Online Supplementary Table S4 and Online Supplementary Figure S4). All differences in QLQ-C30 scales were of small effect size (of note for neuropathy, no effect sizes are available).23
Analyses to account for missing data due to different discontinuation rates between arms
Because more patients in the thalidomide arm discon- tinued treatment compared to the lenalidomide arm17, HRQoL of patients on protocol in the thalidomide arm
P=0.004
P<0.001
P=0.003
P<0.001
Figure 3. Health-related quality of life change over time. Estimated change in health-related quality of life (HRQoL) score from baseline with corresponding 95% confidence intervals (CI) and P-values for the five scales with a statistically signifi- cant difference in change over time between treatment arms. Time points with clin- ically meaningful difference between arms (minimal important difference [MID] >5 points) are marked with *. The dotted horizontal line represents the calculated threshold for minimal important difference, the black for melphalan-prednisone- thalidomide induction and thalidomide maintenance therapy (MPT-T) and the blue for the melphalan-prednisone-lenalidomide induction and lenalidomide mainte- nance therapy (MPR-R) treatment. The green arrows indicate the direction of improvement in functional scales or reduction in symptom scales. The red arrows indicate the direction of deterioration in functional scales or worsening of symptom scales.
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