P1680: health-related quality of life in transplant-ineligible real-life multiple myeloma patients treated with fixed-duration bortezomib-melphalan-prednisone vs. continuous lenalidomide-dexamethasone

Topic: 35. Quality of life and palliative care Background: Multiple myeloma (MM) is a chronic disease, and fixed-duration therapies to treat it are rare. The impact of continuous treatment on health-related quality of life (HRQoL) may be burdensome, especially in elderly patients (pts). Nine 42-day cycles (12 months [mo] of therapy) of bortezomib-melphalan-prednisone (VMP) and continuous treatment with lenalidomide-dexamethasone (Rd) represented the standard-of-care treatments for transplant-ineligible (NTE) newly diagnosed (ND)MM pts before the introduction of daratumumab upfront. No prospective data are available comparing HRQoL in pts receiving VMP vs Rd in a randomized fashion, especially after VMP completion. Aims: We conducted an analysis of patient-reported outcomes (PROs) in the context of the Real MM randomized multicenter phase IV trial (NCT03829371, funded by the Italian Medicines Agency AIFA, Independent Research), to compare HRQoL differences associated with VMP vs Rd treatment in an unselected real-life MM population. We previously demonstrated that a transient and reversible worse HRQoL was observed in the VMP vs Rd arm early in the treatment course (D’Agostino et al, EHA 2022). Here we report an updated analysis focusing on a comparison of VMP vs Rd after VMP treatment completion (time points: +18 mo and +24 mo). Methods: NTE NDMM pts were randomized to receive VMP vs Rd according to standard practice. All pts provided informed consent. PROs were collected and analyzed using the validated EORTC QLQ-C30 scales and the EQ-5D-5L visual analog scale (VAS) instruments. PROs were collected at baseline, every 3 mo during the first year and every 6 mo thereafter. The PRO analyses included pts who had at least a baseline and a follow-up questionnaire available. Data through month 24 are reported. Change in HRQoL from baseline in VMP vs Rd pts were analyzed in a linear mixed model adjusted for International Myeloma Working Group (IMWG) frailty score and cytogenetic risk. Results are presented as least squares (LS) mean changes from baseline. Results: 129 pts (64 in the VMP and 65 in the Rd arms) had available PROs and were eligible for the analysis. Overall, 47% of pts had >75 years and 44% were frail. No differences in terms of baseline characteristics and response rates were found in the VMP vs Rd arms. No significant differences in the mean baseline values of PROs were found in the two arms, and a deep impairment of baseline HRQoL reflected a NTE NDMM population. The median follow-up was 28 mo. The changes from baseline values of the different HRQoL scales were analyzed focusing on the time points after VMP treatment completion (+18 and +24 mo). Global Health Status (GHS) was significantly better with VMP vs Rd at 24 mo (+16.7 vs +4.6; P=0.013; Figure). The VMP arm was also associated with a lower fatigue (-10.5 vs +0.9; P=0.052), pain (-22.8 vs -2.7; P=0.003) and insomnia (-12.4 vs +5.3; P=0.013) at 24 mo. The EQ-5D-5L VAS scale behaved similarly, with a significantly higher score in the VMP vs Rd arm at 24 mo (+10.0 vs +1.5; P=0.041). Regardless of treatment, best response was not associated with changes in GHS or EQ-5D-5L VAS scale, while frail pts showed a long-lasting impairment in GHS and EQ-5D-5L VAS scale (as compared with fit and intermediate-fit pts) that was still present at +24 mo. Summary/Conclusion: After an initial impairment of HRQoL with VMP treatment vs Rd, the treatment-free interval after VMP was associated with a significant improvement of HRQoL as compared with continuous Rd. Frail pts showed poor HRQoL improvements over time, as compared with fit and intermediate-fit pts.Keywords: Multiple myeloma, Real world data, Quality of life, Bortezomib