Axicabtagene Ciloleucel CAR-T Treatment Improved Quality of Life Over Standard of Care in R/R LBCL

Axicabtagene ciloleucel, an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell treatment, improved quality of life (QOL) compared to standard of care (SOC) in second-line treatment of patients with relapsed/refractory large B-cell lymphoma (LBCL), according to a recent study.

The study was a comparative analysis of patient-reported outcomes (PROs) in the randomized, phase III ZUMA-7 clinical trial, which compared axicabtagene ciloleucel treatment to SOC with high-dose chemotherapy and autologous hematopoietic stem cell transplantation in patients with relapsed/refractory large B-cell lymphoma. The analysis, led by Mahmoud Elsawy, MB BCh, MSc, of the Queen Elizabeth II Health Sciences Centre, was published in Blood.

PROs were assessed at baseline and on days 50, 100, and 150, as well as at month nine and every three months from randomization until 24 months or an event-free survival event. The assessments used to measure PROs were the European Organization for Research and Treatment of Cancer’s Quality of Life Questionnaire-Core 30 (QLQ-30) physical functioning scale, global health status/QOL, and the 5-level EQ-5D visual analogue scale (EQ-5D-5L VAS). Clinically meaningful changes were defined as 10 points for QLQ-C30 and seven points for EQ-5D-5L VAS.

The QOL analysis included patients with a baseline PRO and completion of at least one follow-up PRO. A total of 296 patients in the ZUMA-7 trial met inclusion criteria for QOL analysis.

Statistically significant differences in the mean change of scores from baseline were observed at day 100 between patients treated with axicabtagene ciloleucel (n=165) and patients who received SOC (n=131). Axicabtagene ciloleucel was significantly favored in QLQ-C30 global health status/QOL (estimated difference, 18.1; 95% CI, 12.3-23.9; P<.0001), physical functioning (estimated difference, 13.1; 95% CI, 8.0-18.2; P<.0001), and EQ-5D-5L VAS (estimated difference, 13.7; 95% CI, 8.5-18.8; P<.0001).

Scores at day 150 significantly favored axicabtagene ciloleucel over SOC for QLQ-C30 global health status/QOL (estimated difference, 9.8; 95% CI, 2.6-17.0; P=.0124) and EQ-5D-5L VAS (estimated difference, 11.3; 95% CI, 5.4-17.1; P=.0004).

“Superior clinical outcomes and favorable patient experience with [axicabtagene ciloleucel] should help inform treatment choices in second-line [treatment of relapsed/refractory large B-cell lymphoma],” the authors concluded.

Elsawy M, Chavez JC, Avivi I, et al. Patient-reported outcomes in ZUMA-7, a phase 3 study of axicabtagene ciloleucel in second-line large B-cell lymphoma. Blood. 2022. doi:10.1182/blood.2022015478