Professor / Hematologist Division of Hematology 1, Clinical trial unit AOU città della salute e della scienza, University of Torino Torino, Piemonte, Italy
Introduction: Lenalidomide (LEN) is the standard of care for Multiple Myeloma (MM) patients (pts), often given until progression. Progressive disease negatively impacts quality of life (QoL), however real-world evidence in LEN refractory (Ref) pts is lacking.
Methods: Data were drawn from the Adelphi MM Disease Specific Programmeâ„¢, a cross-sectional survey with retrospective data completed by haematologists/haem-oncologists in Europe (France, Germany, Italy, Spain, and United Kingdom) from May-Nov 2021. Physicians completed patient record forms for their next 8 pts with a MM diagnosis, actively receiving treatment, and aligned to the following quota: 2x each of: first-line (1L) or second-line (2L), third-line (3L), fourth-line and beyond (4L+), and tri-exposed (exposed to a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 targeted drug). Eligible pts voluntarily completed a questionnaire which included the EuroQol Visual Analogue Scale (EQ-VAS) [range: 0-1; 1 = best health] and European Organisation for Research and Treatment of Cancer (EORTC) QoL questionnaires (EORTC-QLQ-C30 and EORT-QLQ-MY20) [range: 0-100; 100 = best functioning / worst symptomology]. Bivariate comparisons were made between LEN and non-LEN Ref pts at time of data collection. LEN Ref is defined by the International Myeloma Working Group as progressive disease during LEN treatment or within 60 days of discontinuation.
Results: 173 physicians provided data for 1,163 MM pts; 528 (45%) were LEN Ref, which had a higher mean [SD] age (71.9 [8.73] vs 70.4 [8.91] years; p=0.0058), were more likely to receive caregiver support (44% vs 36%, p=0.0082), experience bone lesions (70% vs 62%, p=0.0026) and more comorbidities vs non-LEN Ref pts (84% vs 78%, p=0.0248). Meaningful differences in employment status (p=0.0158) and Katz Activities of Daily Living (ADL) scores (p=0.008) were also observed, as 79% and 74% of LEN Ref and non-LEN Ref pts were retired, and 5% and 10% were in full/part-time work (respectively). 75% of LEN Ref pts and 82% of non-LEN Ref scored 5-6 (full independence) in the Katz ADL. Of pts that completed the questionnaire (n=248), 106 were LEN-Ref (46%) and had lower mean [SD] EQ-VAS scores (56.9 [17.86] vs 61.6 [16.83]; p=0.0326), reported more bone fractures (13% vs 2%, p=0.0017) and worse mean [SD] EORTC fatigue scores (49.6 [20.12] vs 43.5 [22.09], p=0.0280). The mean [SD] EORTC functioning score domains were 59.7 [23.40] vs 62.4 [22.25] (p=0.3501) for physical, 53.4 [26.01] vs 55.8 [27.67] (p=0.4928) for role, 69.8 [23.42] vs 72.9 [24.29] (p=0.3109) for cognitive, and 60.0 [25.5] vs 64.44 [27.45] (p=0.2028) for social, across LEN and non-LEN Ref pts respectively.
Conclusions: This data shows that LEN Ref pts experience more bone lesions and frequent fractures, have less independence and report numerically inferior QoL compared to non-LEN Ref pts. There is an unmet need for new and innovative treatments that can reduce burden and improve QoL in LEN Ref pts.