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. 2024 Aug 9;24(1):984.
doi: 10.1186/s12885-024-12574-2.

Feasibility of collecting longitudinal patient-reported outcomes in individuals with relapsed or refractory large B-cell lymphoma who received chimeric antigen receptor T-cell (CART) therapy

Amaris Balitsky  1   2   3 , G R Pond  4   5 , G A Davies  6   5 , G Fraser  6 , T Kouroukis  6   5 , M Levine  6   4   5 , R M Meyer  6   4   5 , R Foley  6   5
Affiliations

Feasibility of collecting longitudinal patient-reported outcomes in individuals with relapsed or refractory large B-cell lymphoma who received chimeric antigen receptor T-cell (CART) therapy

Amaris Balitsky et al. BMC Cancer. .

Abstract

Purpose: Chimeric antigen receptor T-cell (CART) therapy has shown clinical efficacy in refractory and relapsed large B-cell lymphomas, but is associated with serious acute and long-term toxicities. To understand the patient perspective, we measured a patient-reported outcome (PRO), specifically, health-related quality of life (HRQoL), at multiple time points over one year.

Methods: This was a prospective feasibility study of a cohort of patients who were eligible for standard of care CART therapy, tisagenlecleucel. Demographic data and disease characteristics were collected. HRQoL was measured using FACT-Lym at baseline, and months 1, 3, 6 and 12. FACT-Lym includes FACT-G (physical, social, emotional and functional well-being domains), plus a lymphoma subscale.

Results: Thirty-four of 35 patients approached, consented to participate. Two of them did not receive their infusion due to progressive disease. 50% were female and median age was 62 (23-77). Twenty-nine patients (91%) completed baseline FACT-Lym and 20 of 21 (95%) eligible patients completed 12-month FACT-Lym. 52% completed all 4 post-baseline FACT-Lym measures. Exploratory analyses for changes in FACT-Lym scores are reported.

Conclusion: It is feasible to measure longitudinal PROs in patients who receive CART therapy. This study will inform future studies in evaluating the patient perspective on CART therapy.

Keywords: Chimeric antigen receptor T-cell (CART) therapy; Health-related quality of life; Large B-cell lymphoma; Patient-reported outcomes.

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Conflict of interest statement

AB, honoraria from Novartis, BMS and Kite/Gilead; GP, honorarium from Takeda, consulting fees from Merck, Astra-Zeneca and Profound Medical, close family member who is an employee of Roche Canada and owns stock in Roche Ltd; GF none; GD Honoraria from Janssen and Roche; TK none; ML none; MR none; RF honoraria from Janssen, Novartis, BMS, Gilead, and consultancy from Novartis, Gilead.

Figures

Fig. 1
Fig. 1
Changes in HRQoL as change from baseline for (A) FACT-Lym total scores and (B) FACT-Lym domains. FACT-G, Functional Assessment of Cancer Therapy – General; TOI, Trial outcome index; FACT-L, Functional Assessment of Cancer Therapy – Lymphoma; PWB, physical well-being; SWB, social well-being; EWB, emotional well-being; FWB, functional well-being; FACT-Lym, lymphoma subscale
See this image and copyright information in PMC

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