Page 319 - Haematologica Vol. 109 - July 2024

LETTER TO THE EDITOR
Figure. 1. Mean scores at baseline through cycle 6 of treatment with melflufen plus dexamethasone or pomalidomide plus dexa- methasone. C: cycle; D: day; dex: dexamethasone; melflufen: melphalan flufenamide; QoL: quality of life; VAS: visual analog scale.
population (Online Supplementary Table S1). Mean baseline global health status/QoL scores were 65.3 in the target population and 61.9 in the non-target population, physi- cal functioning scores were 73.2 and 71.5, and emotional functioning scores were 83.3 and 78.0. Similarly, mean baseline scores for fatigue (30.7 and 40.7), pain (26.2 and 35.4), MM-specific disease symptoms (23.0 and 27.1), side effects of treatment (15.9 and 16.3), and EQ-5D-3L VAS scores (64.8 and 62.8) were similar between the target and non-target populations. Likewise, mean PRO scores remained generally consistent through cycle 6 of treat- ment with melflufen and dexamethasone between the target and non-target populations (Online Supplementary Figure S2).
These results are consistent with the preserved HRQoL seen with melflufen plus dexamethasone in the HORIZON study.7 Although progression in <36 months after prior ASCT is a negative prognostic factor for overall survival,5 PRO measures of the target and non-target populations within the melflufen group were similar at baseline and remained consistent through cycle 6 of therapy. In patients with RRMM, HRQoL tends to decrease with each subsequent
line of therapy.2 Currently available therapeutic options for RRMM mostly maintain HRQoL but do not achieve clinically meaningful improvements.13 Comparisons across trials, however, are limited by differences in reporting of clinically meaningful improvements, and differences in patient populations and trial design. In the phase III APOLLO study of pomalidomide plus dexamethasone with or without daratumumab, HRQoL measured using the EORTC QLQ-C30 and EORTC QLQ-MY20 questionnaires remained generally consistent with baseline in both arms, although between-group differences did not favor the pomalidomide-dexamethasone arm for most QoL scales.14 In the phase II DREAMM-2 study, HRQoL measured by the EORTC QLQ-MY20 scale was maintained with long-term follow-up with belantamab mafodotin, with only up to 38% of evaluable patients (n=45) experiencing improve- ments in pain in different locations at week 7.15
Results from our analysis are limited by the fact that PRO assessments were collected only from patients who were randomized after protocol amendment 4.1.
Subgroup analyses for the target and non-target populations within the melflufen group were further limited by small pa-
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