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Longitudinal Patient Reported Outcomes with CAR-T Cell Therapy vs Autologous and Allogeneic Stem Cell Transplant. Transplantation and cellular therapy Sidana, S., Dueck, A. C., Thanarajasingam, G., Griffin, J. M., Thompson, C., Durani, U., Burtis, M., Warsame, R., Paludo, J., Gertz, M. A., Dispenzieri, A., Ansell, S. M., Rajkumar, S. V., Yost, K., Bennani, N., Lin, Y., Kumar, S. 2022

Abstract

BACKGROUND: There is limited data on patient experience after chimeric antigen receptor (CAR) T cell therapy, especially in comparison to autologous and allogeneic transplant, which are more established forms of cellular therapy.OBJECTIVE: We prospectively evaluated longitudinal patient-reported quality of life (QoL), symptom burden and cognition after CAR-T cell therapy and compared it with prospective cohorts of patients undergoing autologous stem cell transplant (autoSCT) and allogeneic SCT (alloSCT).STUDY DESIGN: This was a single center study. The primary endpoint was change in QoL. Secondary endpoints were patient-reported adverse events (PRO-AEs) measured by PRO-CTCAE and cognitive function (NeuroQOLv2 questionnaire). Time profile of PRO-AEs was evaluated using longitudinal analysis Toxicity over Time (ToxT). Patients completed questionnaires at baseline, week 2 and monthly for 6 months.RESULTS: 104 patients were evaluable (CAR-T: 34, autoSCT: 33, alloSCT: 37). Baseline QoL was similar across groups. We observed a short-term decline in QoL in all groups that gradually returned to baseline. The nadir in QoL was at week 2 and coincided with peak in symptom burden. The decline in overall QoL, physical and functional well-being was significantly less with CAR-T vs. SCT groups and returned to baseline faster. Patients in the alloSCT group experienced the greatest symptom burden, greater decrease in performance status, largest short-term decline in QoL and slowest recovery.CONCLUSION: This study provides comprehensive data comparing QoL, PRO-AEs and cognition in CAR-T cell therapy vs. autoSCT and alloSCT, and the first application of ToxT to PRO-CTCAE data. Short-term QOL, including physical and functional domains was better in the CAR-T group vs. SCT groups, although all groups experienced an initial decline coinciding with peak symptoms. These data can serve as a guide for patient education, symptom management, and future studies in CAR-T cell therapy.

View details for DOI 10.1016/j.jtct.2022.05.004

View details for PubMedID 35550440