Health-Related Quality of Life and Symptom Burden in Patients with Diffuse Large B-Cell Lymphoma Before Treatment with Tafasitamab and Lenalidomide: An Ad Hoc Analysis of Italian Real-World Data from the PRO-MIND Study.

: Diffuse large B-cell lymphoma (DLBCL) exhibits substantial clinical heterogeneity and poor prognosis in relapsed/refractory (R/R) settings. PRO-MIND is a prospective, multicenter real-world study evaluating tafasitamab-lenalidomide followed by tafasitamab monotherapy in patients with transplant-ineligible R/R DLBCL in Italy. This ad hoc, cross-sectional, baseline analysis aimed to characterize health-related quality of life (HRQoL) and symptom burden before tafasitamab-lenalidomide initiation in the PRO-MIND cohort. : Thirty-eight patients across 30 centers completed the EORTC QLQ-C30 and QLQ-NHL-HG29 questionnaires at pretreatment baseline, prior to starting tafasitamab-lenalidomide. EORTC QLQ-C30 scores (0-100) were compared with age-specific normative values for the Italian general population using Welch's t-test. Differences of ≥5 points were considered clinically meaningful and ≥10 points clearly clinically important. Effect sizes (Cohen's d) were calculated to complement -values for between-group comparisons. : Compared with normative data, the PRO-MIND cohort had significantly lower EORTC QLQ-C30 functioning scores for physical (Δ 12.7, = 0.0135), role (Δ 16.1, = 0.0168), social (Δ 15.2, = 0.0019), and cognitive (Δ 8.5, = 0.0460) functioning. Symptom scales revealed worse fatigue (Δ 14.8, = 0.0097), insomnia (Δ 13.9, = 0.0291), appetite loss (Δ 9.4, = 0.0435), and pain (Δ 8.7, = 0.0430) in the PRO-MIND cohort versus normative data, with effect sizes in the small-to-moderate range. EORTC QLQ-NHL-HG29 scores indicated a high prevalence of concerns about future health (84.2%), disease recurrence (81.6%), and dependency (78.9%), as well as physical symptoms, including lack of energy (71.1%), sleep difficulties (63.2%), and pain or discomfort (60.5%). : This cross-sectional, baseline-only analysis of the PRO-MIND real-world cohort showed that patients with transplant-ineligible R/R DLBCL scheduled to receive tafasitamab-lenalidomide already had pronounced impairments in physical, role, social, and cognitive functioning, along with substantial fatigue, insomnia, pain, appetite loss, and psychological concerns. These baseline benchmarks underscore the importance of systematic HRQoL assessment and targeted supportive interventions focusing on these domains before and during treatment. Future longitudinal PRO-MIND analyses will complement these findings by describing how HRQoL evolves after tafasitamab-lenalidomide initiation.