Background: While there is increasing real-world (RW) evidence on the tafasitamab-lenalidomide (TL) combination in patients (pts) with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL), data regarding its impact on health-related quality of life (HRQoL) are still lacking. HRQoL is a crucial pt-reported outcome for evaluating the effects of a specific treatment in a RW setting, along with clinical effectiveness. We present HRQoL data from an interim analysis of the PRO-MIND study (NCT06299553) of TL in pts with R/R DLBCL in Italy.

Methods: PRO-MIND is a noninterventional, multicenter, prospective observational cohort study conducted at 30 sites. It is enrolling adult pts with R/R DLBCL ineligible for autologous stem cell transplant (ASCT) who are receiving TL as a second, third, or fourth line of treatment, following standard clinical practices in Italy. HRQoL was measured with the EORTC QLQ-C30 and the high-grade lymphoma-specific EORTC QLQ-NHL-HG29. Questionnaires were administered during preplanned sequential study visits. Comparison of PRO-MIND HRQoL scores with an age-matched normative Italian population was conducted with Welch's t-test. Questionnaires were analyzed using mixed-model for repeated measures for longitudinal changes and by Cox regression analysis to verify the association between baseline scores and progression-free survival (PFS) and overall survival (OS).

Results: At the cut-off date of January 31, 2025, 52 pts (27 males, 25 females) with a median age of 78 years (range: 73.0-82.0) and a median follow-up (FU) of 3.5 months (range: 2.9-12.6) were enrolled. Primary refractory disease (defined as no response to, or progression during or within 6 months of, frontline therapy) was recorded for 52% of pts; 81% had advanced disease (Ann Arbor stage III/IV) and 86% had ECOG 0-1. DLBCL-not otherwise specified accounted for 81% of cases; 64%, 26%, and 10% of pts had received 1, 2, and 3 prior lines of therapy, respectively. The EORTC QLQ-C30 was completed by 84.6% (44/52) of pts, and the EORTC QLQ-NHL-HG29 by 78.8% (41/52). Median number of TL cycles was 3.0 (range: 2.9-4.0).

Comparison of EORTC QLQ-C30 scores from the PRO-MIND cohort (n=44) with age-matched normative values from the general healthy Italian population (n=1036) revealed a significant reduction in social functioning (–17), role functioning (–10), and cognitive (–9) domains. Symptom scores indicated increased insomnia (+11) and moderately increased loss of appetite (+8) in the PRO-MIND cohort vs normative data. Mean scores were overlapping in 7 of the 8 domains in the comparison of the EORTC QLQ-NHL-HG29 results between the PRO-MIND cohort (n=41) and the reference group (n=165). The exception was a significant decrease in “Fertility concerns”, consistent with the advanced age of the study population. During the observation period, there were no significant changes in EORTC QLQ-C30 scores from baseline. The only difference was a nonsignificant increase in Global Health Status (+17.6 points) and Physical Functioning (+11.7 points) at visit 5, but this was based on data from only 2 pts. Other symptom domains remained stable, with modest fluctuations (<±10 points). At baseline, the Summary Score of the EORTC QLQ-C30 questionnaire was significantly associated with a reduction in the risk of progression or death (PFS: hazard ratio [HR] = 0.886, 95% CI: 0.801, 0.979, P=0.0178) and showed a positive trend for OS (HR = 0.920, 95% CI: 0.829, 1.022, P= 0.1200). With the EORTC QLQ-NHL-HG29 instrument, the “Health and Functioning Concerns” score dropped by 10.4 points at visit 2 (P=< 0.0001), reflecting an initial improvement that proved transient, as scores returned to baseline at subsequent visits. Neuropathy showed a peak of +18.0 points at visit 4 (95% CI 1.3, 34.6); however, due to the limited number of questionnaires available, no definitive conclusions could be drawn. The other domains remained unchanged, with minimal nonsignificant oscillations.

Conclusions: The interim analysis of the PRO-MIND study suggests that treatment with TL does not significantly impair the initially favorable HRQoL and the low pretherapy symptom burden in elderly pts with R/R DLBCL ineligible for ASCT. Better perceived health status at baseline is linked to longer PFS, emphasizing treatment tolerability also from a pt-centered perspective. Findings require confirmation with longer FU and a larger pt cohort.

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2025
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