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Sidana, S.1; Dueck, A.2; Burtis, M.1; Griffin, J.3; Thanarajasingam, G.1; Warsame, R.1; Thompson, C.1; Cheville, A.3; Gertz, M.1; Yost, K.3; Dispenzieri, A.1; Bisneto, Villasboas J.1; Paludo, J.1; Ansell, S.1; Rajkumar, S.1; Bennani, N.1; Johnston, P.1; Siddiqui, M.1; Lin, Y.1; Kumar, S.1

doi: 10.1097/01.HS9.0000564264.01877.a2
Poster Session II: Quality of life, palliative & supportive care, ethics and health economics

1Hematology, Mayo Clinic, Rochester

2Biostatistics, Mayo Clinic, Arizona

3Health Sciences Research, Mayo Clinic, Rochester, United States

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CAR (chimeric antigen receptor)-T cell therapy has shown promise in hematologic malignancies, with some rapid and durable responses. It is now even being directly compared in clinical trials to established forms of cellular therapy like stem cell transplant (SCT) for some hematological cancers. However, CAR-T cell therapy is associated with significant adverse events, including unique toxicities like cytokine release syndrome and CAR-T cell related encephalopathy syndrome, which can occur in up to a third of patients. Impact of CAR-T cell therapy on short-term and long-term quality of life (QOL) of patients is not known. Given the significant short-term adverse effects of CAR-T cell therapy, it is important to evaluate its impact on QOL of patients, in addition to efficacy.

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The overall goal of our study is to evaluate quality of life and symptom burden over time in patients receiving CAR-T cell therapy and compare them to that of prospective cohorts of patients undergoing autologous and allogeneic SCT for hematologic malignancies.

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QOL was prospectively evaluated in adult patients with hematologic malignancies undergoing CAR-T therapy vs. those undergoing autologous SCT and allogeneic SCT. QOL was assessed using FACT-G questionnaire at baseline, 2 weeks and monthly thereafter for six months. Preliminary data regarding total FACT-G score (range 0-108) and subdomains of functional well-being (FWB; range: 0-28), physical WB (PWB; range: 0-28) emotional WB (EWB; range: 0-24) & social WB (SWB; range: 0-28) are described. Median scores are reported and groups were compared using Wilcoxon Rank Sum/Kruskal Wallis test.

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45 patients were recruited to the study (CAR-T: 10; Autologous SCT: 22; Allogeneic SCT: 13) from July 2018 to January 2019. Follow up data at 2 weeks and 1 month were available for 23 and 15 patients, respectively (Table). Median age was similar across three groups (61.4 to 62.5 years, p = 0.9). There was no statistically significant difference in baseline total FACT-G QOL scores, though scores were overall lower in the allogeneic SCT group (CAR-T: 85, autologous SCT: 84 and allogeneic SCT: 68, p = 0.13). The baseline scores in the subdomains of EWB and FWB were numerically higher in the CAR-T group, followed by autologous SCT group and were lowest in allogeneic SCT group. At 2 weeks vs. baseline, overall QOL decreased by only 2 points in CAR-T group vs. 22 & 18 points in autologous & allogeneic SCT groups (p = 0.09). At 2 weeks, change in PWB vs. baseline was less pronounced in the CAR-T group compared with others, with a median decrease of 1 point in CAR-T group vs. 9 points in autologous SCT group and 13 points in allogeneic SCT group, respectively. (p=0.03). At 1 month, overall QOL was 6 points lower than baseline in CAR-T group vs. 3 and 14 points lower in autologous and allogeneic SCT groups, respectively (p = 0.34). Importantly, PWB had at least returned to baseline in the CAR-T group with a median increase of 1 point from baseline in the CAR-T group compared with a decrease of 2 points in the autologous SCT group and of 4 points in the allogeneic SCT group, respectively (p = 0.73).



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Preliminary data show that patients undergoing CAR-T cell therapy do not experience a more significant dip in QOL compared with autologous and allogeneic SCT, with some indication of better PWB in the short-term. Accrual & follow-up are ongoing. Updated results, including 3-month follow up will be presented at the meeting.

Copyright © 2019 The Authors. Published by Wolters Kluwer Health Inc., on behalf of the European Hematology Association.