A recent study reported that for young patients with relapsed/refractory (R/R) B-cell acute lymphoblastic leukemia (ALL), treatment with tisagenlecleucel was associated with improved quality of life (QOL). Results were reported in Lancet Oncology.
This analysis of QOL with tisagenlecleucel was a secondary end point of the global phase 2 ELIANA trial (ClinicalTrials.gov Identifier: NCT02435849). In this study, patients with R/R B-cell ALL were treated once with intravenous tisagenlecleucel treatment, at a dosage based on body weight. Included patients were aged 21 years or younger at first diagnosis of B-cell ALL.
Patient-reported QOL was measured by European Quality of Life-5 Dimensions (EQ-5D) and Pediatric Quality of Life Inventory (PedsQL) questionnaires at baseline and at multiple points following tisagenlecleucel therapy.
A total of 58 patients were evaluated, of whom 86% had a complete PedsQL report at baseline, and 83% had a complete EQ-5D visual analog scale (VAS) report at baseline.
At month 3, following tisagenlecleucel treatment, 30 of 37 patients (81%) reported attaining the PedsQL minimal clinically important difference (MCID), and the EQ-5D VAS MCID was attained in 24 of 36 patients (67%). At this time point, the overall EQ-5D VAS score showed a mean improvement of 16.8 points from baseline, and the total PedsQL score had improved by a mean of 13.3 points.
The number of patients remaining in the study and completing QOL reports became less over time, but improvements in QOL were durable at 12 months among those continuing with the study.
“The findings from this study suggest that rapid improvements in broad aspects of patient-reported quality of life occurred after one-time treatment with tisagenlecleucel,” stated the investigators in their report.
Laetsch TW, Myers GD, Baruchel A, et al. Patient-reported quality of life after tisagenlecleucel infusion in children and young adults with relapsed or refractory B-cell acute lymphoblastic leukaemia: a global, single-arm, phase 2 trial. Lancet Oncol. doi: 10.1016/S1470-2045(19)30493-0