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. 2023 Mar;19(3):e407-e416.
doi: 10.1200/OP.22.00501. Epub 2022 Dec 12.

Development of a Core Set of Patient- and Caregiver-Reported Signs and Symptoms to Facilitate Early Recognition of Acute Chimeric Antigen Receptor T-Cell Therapy Toxicities

Anne M Spanjaart  1   2   3 , Elise R A Pennings  1   2   3   4 , Milan Kos  5 , Pim G N J Mutsaers  6 , Pieternella J Lugtenburg  6 , Tom van Meerten  7 , Jaap A van Doesum  7 , Monique C Minnema  8 , Margot Jak  8 , Suzanne van Dorp  9 , Joost S P Vermaat  10 , Marjolein W M van der Poel  11 , Martijn G H van Oijen  5 , Maria T Kuipers  1   2   3 , Inger S Nijhof  1   2   3   12 , Marie José Kersten  1   2   3
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Development of a Core Set of Patient- and Caregiver-Reported Signs and Symptoms to Facilitate Early Recognition of Acute Chimeric Antigen Receptor T-Cell Therapy Toxicities

Anne M Spanjaart et al. JCO Oncol Pract. 2023 Mar.

Abstract

Purpose: Prompt recognition of acute chimeric antigen receptor T (CAR T)-cell-mediated toxicities is crucial because adequate and timely management can prevent or reverse potential life-threatening complications. In the outpatient setting, patients and informal caregivers have to recognize and report signs and symptoms marking these acute toxicities. This study provides a core set of patient- and caregiver-reported signs and symptoms (outcomes, P/CROs) and definitions of red flags warranting immediate action to include in a daily checklist for support at home, with the goal to make outpatient post-CAR T-cell care safer, optimize patient and caregiver support, and thereby facilitating an early discharge/hospital visit reduction strategy.

Methods: We performed a systematic review of phase II/III trials of US Food and Drug Administration-approved CAR T-cell products and selected all common and severe adverse events that could be translated into a P/CRO for inclusion in a two-round modified Delphi procedure. Eleven CAR T-cell-dedicated hematologists from the Dutch CAR T-cell tumorboard representing all treating centers selected P/CROs for inclusion in the core set and defined red flags. The final core set was evaluated with patients and caregivers.

Results: From nine clinical trials, 457 adverse events were identified of which 42 could be used as P/CRO. The final core set contains 28 items, including five signs for measurement via wearables and two signs for caregiver-performed assessments.

Conclusion: This study provides a core set of P/CROs that can serve as a framework for (eHealth) tools that aim to enable patients and caregivers to more effectively recognize and report signs and symptoms of acute toxicities after CAR T-cell therapy, which will enhance safe outpatient treatment monitoring.

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Conflict of interest statement

Development of a Core Set of Patient- and Caregiver-Reported Signs and Symptoms to Facilitate Early Recognition of Acute Chimeric Antigen Receptor T-Cell Therapy Toxicities

The following represents disclosure information provided by authors of this manuscript. All relationships are considered compensated unless otherwise noted. Relationships are self-held unless noted. I = Immediate Family Member, Inst = My Institution. Relationships may not relate to the subject matter of this manuscript. For more information about ASCO's conflict of interest policy, please refer to www.asco.org/rwc or ascopubs.org/op/authors/author-center.

Open Payments is a public database containing information reported by companies about payments made to US-licensed physicians (Open Payments).

Figures

FIG 1.
FIG 1.
Development of the core set of P/CROs that mark acute toxicities after CAR T-cell therapy. AVPU, alert, responsive to voice, responsive to pain, unresponsive level of consciousness; CAR T, chimeric antigen receptor T; ICE, immune effector cell-associated encephalopathy; P/CROs, patient- and caregiver-reported signs and symptoms.
See this image and copyright information in PMC

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