PS1391 ASSESSMENT OF THE BURDEN OF DISEASE IN TERMS OF HEALTH‐RELATED QUALITY OF LIFE IN PATIENTS WITH MULTIPLE MYELOMA NOT ELIGIBLE FOR ASCT IN SPAIN: INTERIM ANALYSIS OF QOLMMBUS STUDY
Authors: de la Rubia J. , Domingo A. , Delgado O. , García A. , López A. , Sureda A. , Sampol A. , Herráez S. , Caballero G. , Garzón S. , Montllo C. , Pérez‐Persona E. , Martí J. , de la Puerta E. , López A. , Abella E. , Álvarez M.Á. , Lostaunau G. , Vilanova D. , Mateos M.V. 
Published: June 2019

Background:Multiple myeloma (MM) is an incurable disease that is associated with severe symptoms affecting Health‐Related Quality of Life (HRQoL). Patients (pts) over 70 years of age may benefit less from new treatments (Tx) due to their heterogeneity and added comorbidity.Aims:Here, we report on the impact of new Tx on disease burden in terms of HRQoL and direct health costs as well as defined cut‐off points for GAH (Geriatric Assessment in Hematology) assessment.Methods:QoLMMBuS (NCT02946333) is an ongoing multicenter, prospective, observational study conducted at 53 Spanish sites in pts with MM who are not eligible for ASCT. Primary end points were HRQoL (baseline and 5 months), reported by: EQ‐5D (EuroQol) and QLQ C30/QLQ‐MY20 (EORTC) and direct health costs (inpatient hospitalization and diagnostic techniques). Secondary endpoints included demographic and baseline clinical characteristics, together with the classification of pts by the GAH scale performed at baseline (cut‐off point 42). Interim analysis with data cut‐off date: Nov 2018.Results:161 evaluable pts were enrolled between Nov 2016 and Oct 2018: median age (range) 77.6 (73.9–82.6) years, 44.7% male, ECOG 0/I 57.8%, stage II (R‐ISS) 41.6%, disease isotypes IgG, IgA 66.2% and 33.1%, respectively. High‐risk cytogenetics were detected in 18% of the pts: alterations in chromosome 1 (11.8%), del(17)(p13) (5%) and t(14;16)(q32;q23) (3.1%) were the most common. Renal failure was reported in 17.4% pts and cardiovascular and endocrine diseases were the most frequent comorbidities, 72.7% and 41.0%, respectively. Regarding GAH scale, the median score was 61.0 (31–84). Data for all domains were obtained from 74 pts; of these, 68.9% pts showed high probability of developing toxicity to the Tx (>42 points). A total of 156 pts received lenalidomide (32.0%) or bortezomib (68.0%) as a first line therapy. With a median follow‐up of 5.0 (3.5–11.1) months, the response rates were: CR 17.9%, PR 67.2%, SD 1.9% and PD 1.5%. 61.5% of pts remain on first line therapy. The median OS has not been reached. The analysis of changes from baseline through 5 months with EQ‐5D and QLQ C30 showed that pts had an increase in HRQoL‐mean values for the key domains of global health status/QoL, physical, role and emotional functioning over the course of Tx, although pts experienced a significant worsening in dyspnea domain (p = 0.003). The mean QLQ‐MY20 values showed a significant improvement for domains of disease symptoms (p = 0.037) and future perspective (p = 0.010) and a worsening in side effects of Txs and body image (Figure). Of the 156 pts, 56.4% experienced at least 1 adverse event. Of these, six (3.7%) pts reported at least one grade 3–4 toxicity. The most common reason for discontinuation was death in 24 pts. At the time of this analysis, 103 inpatient hospitalizations were reported with a mean time of 5 days/pt. Average costs/pt were 3,804.67 € (€2,653.98 Hematology unit + €1,150.69 other units). Mean direct costs of diagnosis per patient was €1,205.39.Figure. Changes from baseline for EQ‐5D, EORTC QLQ‐C30 and QLQ‐MY20Summary/Conclusion:Lenalidomide and bortezomib were the two main drugs used in first line Tx of MM pts not eligible for ASCT. These preliminary analyses indicate that pts experienced a significant improvement in disease symptoms and future perspective and a significant worsening in dyspnea domains within the first months which have a lower impact on direct health costs over time. The efficacy and safety profile remained favorable at the time of analysis.image