Patient-Reported Outcomes and Health-Related Quality of Life from the OUTREACH Study

Lisocabtagene maraleucel (liso-cel) is a CD19-directed 4-1BB chimeric antigen receptor (CAR) T-cell therapy that has shown clinical efficacy in patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL). Patient-reported outcome (PRO) and health-related quality-of-life (HR-QoL) results from the phase 2 OUTREACH study (NCT03744676), which enrolled patients with R/R LBCL across outpatient (OP) and inpatient (IP) settings at community sites in the United States, were presented at the 64th Annual American Society of Hematology Congress and Exposition.

Adults with R/R LBCL after ≥2 lines of therapy and Eastern Cooperative Oncology Group performance status of ≤1 were enrolled at community sites. Patients with left ventricular ejection fraction ≥40%, creatinine clearance >30 mL/min, secondary central nervous system lymphoma, and prior autologous hematopoietic stem-cell transplantation were eligible. Following leukapheresis and lymphodepleting chemotherapy, patients received liso-cel at a target dose of 100 × 106 CAR T-cells. Patients completed the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 (EORTC QLQ-C30) as well as the EQ-5D-5L health utility index (HUI) and visual analog scale (EQ-VAS) before treatment (≤7 days before lymphodepletion), before infusion on the day of liso-cel administration (day 1), and on days 29, 60, 90, 180, 270, 365, 545, and 730/end of study; patients also completed the questionnaires at disease progression. The primary HR-QoL domains of interest were the EORTC QLQ-C30 global health (GH)/QoL, physical functioning, role functioning, cognitive functioning, fatigue, and pain domains, as well as the EQ-5D-5L HUI and EQ-VAS. A linear mixed model for repeated measures analysis was performed to assess the least squares (LS) mean change from baseline for visits with ≥10 patients.

Among 82 liso-cel‒treated patients, completion rates for the HR-QoL assessment at baseline were high (EORTC QLQ-C30, 89%; EQ-5D-5L HUI and EQ-VAS, 93%). At baseline, patients in OUTREACH had numerically slightly worse mean scores across most domains of the HR-QoL assessment compared with the general US population with similar age and gender distributions; these differences were not statistically significant. Mean changes from baseline were maintained or improved across visits for all EORTC QLQ-C30 primary domains of interest, as well as the EQ-5D-5L HUI and EQ-VAS. Overall LS mean changes from baseline through day 730 showed significant improvements in EORTC QLQ-C30 GH/QoL (P <.001), role functioning (P = .020), fatigue (P <.001), and pain (P <.001), as well as the EQ-VAS (P <.001). Clinically meaningful improvements in fatigue and pain were observed as early as 15 and 6 weeks, respectively. At the individual level, most patients experienced either meaningful improvement or no change in the primary domains of interest, and more than half experienced meaningful improvements in GH/QoL (23%-60%), fatigue (28%-65%), and pain (39%-90%), and at most time points, with the lowest percentages observed on days 1 or 29. No significant differences in HR-QoL among patients monitored in the OP setting versus IP setting were observed.

In OUTREACH, patients had slightly impaired HR-QoL at baseline compared with the general US population. HR-QoL was either improved or maintained from baseline in most patients with R/R LBCL who received liso-cel as third-line or later treatment in OUTREACH, with the greatest improvements observed in the GH/QoL, role functioning, fatigue, and pain domains. These findings demonstrate the importance of PRO/HR-QoL assessments as supportive measurements of treatment outcomes in patients with R/R LBCL, lending support to the utilization of liso-cel in such patients at community centers and monitoring in the OP setting.


Linhares Y, Liu FF, Freytes C, et al. Lisocabtagene maraleucel in patients with relapsed or refractory large B-cell lymphoma treated as outpatients or inpatients in the community/nonuniversity setting: patient-reported outcomes/health-related quality of life from the OUTREACH study. Presented at: 64th American Society of Hematology Annual Meeting and Exposition, December 10-13, 2022; New Orleans, LA. Poster presentation 4910.

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