PATIENT-REPORTED OUTCOMES IN RELAPSED/REFRACTORY MULTIPLE MYELOMA (RRMM) IN THE OVERALL AND JAPANESE POPULATIONS FROM ELOQUENT-2
Author(s)
McKendrick J1, Zyczynski T2, Kudlac A1, Davis C2, Cella D3
1PRMA Consulting Ltd, Fleet, UK, 2Bristol-Myers Squibb, Princeton, NJ, USA, 3Northwestern University, Chicago, IL, USA
OBJECTIVES: RRMM is associated with significant burden of pain. In the ELOQUENT-2 study (NCT01239797), elotuzumab, an immunostimulatory monoclonal antibody, combined with lenalidomide and dexamethasone (ELd), reduced risk of progression/death by 30% versus lenalidomide plus dexamethasone (Ld) alone in patients with RRMM (Lonial et al. NEJM 2015;373:621–31). In this analysis, we compare patient-reported outcome (PRO) results between the overall and Japanese ELOQUENT-2 populations. METHODS: Patients were randomized to ELd or Ld and treated in 28-day cycles until disease progression/unacceptable toxicity. Change from baseline in Brief Pain Inventory–Short Form [BPI-SF] Pain Severity and Pain Interference domain scores were secondary endpoints; change in the Worst Pain domain was also analyzed (lower scores=less pain). RESULTS: Overall, 646 patients were randomized to ELd (n=321) or Ld (n=325); 319 and 311 had ≥1 post-baseline PRO assessment, respectively. The Japanese subpopulation with PRO data comprised 60 patients (ELd 31; Ld 29). Baseline BPI-SF scores were low in both the Japanese and overall populations (Pain Severity: ELd 2.4 and 2.6, Ld 2.1 and 2.9; Pain Interference: ELd 1.9 and 2.8, Ld 2.1 and 3.2; Worst Pain: ELd 3.1 and 3.6, Ld 2.8 and 3.8; all for Japanese and overall populations, respectively). Change from baseline for each BPI-SF domain was small in all groups, with greater reductions in the Japanese versus overall group for ELd-treated patients (Pain Severity: –0.27 vs –0.02; Pain Interference: –0.11 vs 0.28; Worst Pain: –0.56 vs –0.14). Similar results were seen for Ld. No significant difference between the ELd or Ld treatments in BPI-SF score change was seen in either study population. CONCLUSIONS: Baseline BPI-SF scores were low in the overall and Japanese populations, and remained low during the study period. The addition of elotuzumab to the Ld regimen did not compromise patient outcomes. Additional health-related quality of life analyses are underway.
Conference/Value in Health Info
2016-09, ISPOR Asia Pacific 2016, Singapore
Value in Health, Vol. 19, No. 7 (November 2016)
Code
PCN45
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Oncology