Longitudinal patient-reported outcomes and quality-of-life trajectories over 2 years in CAR-T therapy recipients

Health-related quality of life (HRQoL) measured by patient-reported outcomes (PROs) is understudied in patients who receive chimeric antigen receptor T-cell (CAR-T) therapies. We hypothesized that CAR-T therapies generate long-term HRQoL benefits, and that PRO trajectories in the immediate postinfusion period may serve as prognostic indicators for treatment response. We measured longitudinal HRQoL among patients with hematologic malignancies receiving CAR-T therapy using the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health-10 and PROMIS-29 Profile instruments at 13 time points over a 2-year period after CAR-T therapy. PROs were analyzed by linear mixed-effect modeling. We enrolled 83 patients, mostly with aggressive lymphomas (49%) and myeloma (43%). Long-term improvements in physical and social role functioning as well as sleep were observed in the entire study cohort at 2 years after CAR-T therapy, regardless of whether patients were aged ≤65 or >65 years. Women reported improvements in fatigue (P = .016) and global physical health (P = .041) at 2 years despite having worse pre-CAR-T HRQoL compared with men. Patients who later achieved a response to CAR-T therapy at 3 months had significantly worse fatigue at day 15 after CAR-T therapy compared with nonresponders, with no significant differences in other HRQoL domains. At day 30 after CAR-T therapy, fatigue was similar for responders and nonresponders. At 2 years after CAR-T therapy, responders had significant improvements in social role functioning (P = .041) compared with nonresponders. CAR-T therapy confers long-term HRQoL benefits in patients with hematologic malignancies. Patient-reported fatigue in the acute post-CAR-T therapy period may serve as a prognostic "PRO marker" for treatment response, which warrants further prospective study.