TY - JOUR
T1 - Longitudinal Patient Reported Outcomes with CAR-T Cell Therapy Versus Autologous and Allogeneic Stem Cell Transplant
T2 - PROs with CAR-T therapy versus Stem Cell Transplant
AU - Sidana, Surbhi
AU - Dueck, Amylou C.
AU - Thanarajasingam, Gita
AU - Griffin, Joan M.
AU - Thompson, Carrie
AU - Durani, Urshila
AU - Burtis, Michelle
AU - Warsame, Rahma
AU - Paludo, Jonas
AU - Gertz, Morie A.
AU - Dispenzieri, Angela
AU - Ansell, Stephen M.
AU - Rajkumar, S. Vincent
AU - Yost, Kathleen
AU - Bennani, Nora
AU - Lin, Yi
AU - Kumar, Shaji
N1 - Publisher Copyright:
© 2022 The American Society for Transplantation and Cellular Therapy
PY - 2022/8
Y1 - 2022/8
N2 - There are limited data on patient experience after chimeric antigen receptor (CAR) T-cell therapy, especially in comparison to autologous and allogeneic transplantation, which are more established forms of cellular therapy. 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 transplantation (autoSCT) and allogeneic SCT (alloSCT). This was a single center study. The primary endpoint was change in QoL. Secondary endpoints were patient-reported adverse events (PRO-AEs) measured by Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (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. One hundred four 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 versus 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. This study provides comprehensive data comparing QoL, PRO-AEs and cognition following CAR-T cell therapy versus 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 versus 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.
AB - There are limited data on patient experience after chimeric antigen receptor (CAR) T-cell therapy, especially in comparison to autologous and allogeneic transplantation, which are more established forms of cellular therapy. 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 transplantation (autoSCT) and allogeneic SCT (alloSCT). This was a single center study. The primary endpoint was change in QoL. Secondary endpoints were patient-reported adverse events (PRO-AEs) measured by Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (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. One hundred four 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 versus 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. This study provides comprehensive data comparing QoL, PRO-AEs and cognition following CAR-T cell therapy versus 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 versus 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.
KW - Adverse events
KW - CAR-T therapy
KW - Chimeric antigen receptor
KW - Cognition
KW - Patient experience
KW - Patient-reported outcomes
KW - Quality of life
UR - http://www.scopus.com/inward/record.url?scp=85133302874&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85133302874&partnerID=8YFLogxK
U2 - 10.1016/j.jtct.2022.05.004
DO - 10.1016/j.jtct.2022.05.004
M3 - Article
C2 - 35550440
AN - SCOPUS:85133302874
SN - 2666-6367
VL - 28
SP - 473
EP - 482
JO - Transplantation and Cellular Therapy
JF - Transplantation and Cellular Therapy
IS - 8
ER -