In patients with relapsed or refractory multiple myeloma, the efficacy benefits seen when elotuzumab was added to lenalidomide/dexamethasone (Ld) were achieved without negatively affecting health-related quality of life (HRQoL).
This comes from a final analysis of patient- reported outcomes (PROs) from the phase 3 ELOQUENT-2 trial reported at the 2019 ASH Annual Meeting by David Cella, PhD, from Northwestern University in Chicago. Consistent with the initial analysis, the investigators observed nominal differences in HRQoL with the addition of elotuzumab to lenalidomide and dexamethasone (ELd) when compared with standard therapy with Ld alone.
“These findings complement results from the final overall survival analysis of ELOQUENT-2, which demonstrate a statistically significant and clinically meaningful improvement in overall survival with ELd versus Ld alone,” said Dr Cella.
As recent progress and novel therapies have led to improved survival and durable responses in patients with multiple myeloma, HRQoL assessments have become increasingly important, particularly in heavily pretreated patients. In other words, it’s no longer enough that patients are living longer; they should actually be able to enjoy that time.
In the trial, 646 patients who had received between 1 and 3 prior lines of treatment were randomly assigned to either ELd (n = 321) or Ld (n = 325). A total of 319 and 311 patients, respectively, completed 1 or more postbaseline assessments and were included in the PRO analysis. Three different questionnaires were administered at baseline, on day 1 of each treatment cycle, and at the end of treatment or study withdrawal: the Brief Pain Inventory– Short Form (BPI-SF), the European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life 30 questionnaire (QLQ-C30), and the myeloma-specific module (QLQ-MY20).
After a median follow-up of almost 25 months, treatment with ELd led to a 30% reduction in the risk of progression or death versus Ld. After 3 years of follow-up, PRO results confirmed that this improvement in efficacy was achieved without any detriment to HRQoL.
At the final overall survival analysis, after a minimum follow-up of 71 months, median overall survival was 48.3 months in the elotuzumab arm compared with 39.6 months in the Ld arm, representing an 18% reduction in the risk of death with the addition of elotuzumab.
Between treatment arms and across all domains of interest, the investigators observed no clinically meaningful changes in BPI-SF, EORTC QLQ-C30, or QLQ-MY20 mean scores from baseline, meaning that the addition of elotuzumab did not significantly increase or decrease quality of life. Given the efficacy improvements seen with the 3-drug combination, this is a positive result.
But the addition of elotuzumab actually did improve some domains of HRQoL for certain patients. Elotuzumab- treated patients who started with moderate or severe pain (score of ≥5) had significantly lower mean pain severity scores in treatment cycles 1 through 5, and similar results were observed for pain interference and worst pain domains.
Additionally, a higher proportion of patients deemed to be clinical responders (based on complete or partial responses according to the European Society for Blood and Marrow Transplantation criteria) had prolonged reductions in pain scores across all BPI-SF domains when compared with nonresponders, including pain severity (18% vs 6%), pain interference (15% vs 6%), and worst pain (30% vs 13%). However, time to sustained score reduction was not significantly different between clinical responders and nonresponders.
