QUALITY OF LIFE IN RELAPSED/REFRACTORY MANTLE CELL LYMPHOMA PATIENTS TREATED WITH LENALIDOMIDE VS INVESTIGATOR’S CHOICE: MCL-002 (SPRINT) TRIAL

Background
Measurement of health-related quality of life (QoL) is especially important in patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL), as they generally receive multiple lines of therapy over the course of their disease. TheEuropean multicenter MCL-002 (SPRINT) phase II study was the first randomized study of lenalidomide vs investigator’s choice (IC) in R/R MCL patients with ≤3 relapses on prior therapy and who were ineligible for intensified treatment or stem cell transplantation.

Aims
Examine health-related QoL in R/R MCL patients receiving lenalidomide vs IC.

Methods
Patients were randomized 2:1 to receive lenalidomide (25 mg/day on days 1-21 of each 28-day cycle until progressive disease or intolerability vs single-agent IC (chlorambucil, cytarabine, fludarabine, gemcitabine, or rituximab). As a planned secondary study endpoint, QoL was measured using the EORTC QLQ-C30 at baseline, after cycles 2, 4, 6, and 8, and at treatment discontinuation. EORTC QLQ-C30 included 5 functional domains, 9 symptom scales, and 1 global health status/QoL scale. Changes from baseline QoL score at each visit for the primary (global health status/QoL) and secondary domains (physical function and fatigue) and their 95% confidence intervals were calculated. A mixed model was employed to analyze differences in mean domain/scale scores between the treatment arms to account for repeated measurements of QoL during follow-up visits. Patients with ≥10 percentage point change (clinically meaningful) for each domain/scale at one or more visits were compared between the two groups using the Chi-square test.  

Results
254 patients (lenalidomide n=170, IC n=84) were enrolled in the trial. QoL data completion declined from 93% at screening to 51% at treatment discontinuation during the course of the study, with higher non-compliance rates typically seen among IC than among lenalidomide patients. QoL was maintained (non-deterioration: no worsening >10 points) with lenalidomide from baseline through last treatment cycle for evaluated primary and secondary QoL domains. Patients treated with lenalidomide reported similar QoL vs IC single agents across all domain/scale scores and at each follow-up visit. A trend towards higher rates of clinically meaningful improvement in QoL was observed in lenalidomide treated patients across most function and symptom domains/scales at one or more follow-up visits. Statistically significant QoL differences (≥10%) comparing lenalidomide vs IC treatment arms were identified for physical function (24% vs 8%,P=0.003) and pain (29% vs 18%; P=0.047).

Summary
Patients with R/R MCL maintained their QoL while receiving lenalidomide despite a longer duration of treatment compared with single agent IC therapy. In addition, patients receiving lenalidomide experienced higher rates of clinically meaningful improvement in QoL for physical function and pain.

Keyword(s): Imids, Mantle cell lymphoma, Quality of life

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