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.

Autor:	Spanjaart AM; Amsterdam UMC Location University of Amsterdam, Hematology, Amsterdam, the Netherlands.; Cancer Center Amsterdam, Amsterdam, the Netherlands.; LYMMCARE, Amsterdam, the Netherlands., Pennings ERA; Amsterdam UMC Location University of Amsterdam, Hematology, Amsterdam, the Netherlands.; Cancer Center Amsterdam, Amsterdam, the Netherlands.; LYMMCARE, Amsterdam, the Netherlands.; Erasmus School of Health Policy and Management, Erasmus University Rotterdam, Rotterdam, the Netherlands., Kos M; Amsterdam University Medical Centers, University of Amsterdam, Department of Oncology, Amsterdam, the Netherlands., Mutsaers PGNJ; Erasmus MC Cancer Institute, University Medical Center Rotterdam, Department of Hematology, Rotterdam, the Netherlands., Lugtenburg PJ; Erasmus MC Cancer Institute, University Medical Center Rotterdam, Department of Hematology, Rotterdam, the Netherlands., van Meerten T; University Medical Center Groningen, Department of Hematology, Groningen, the Netherlands., van Doesum JA; University Medical Center Groningen, Department of Hematology, Groningen, the Netherlands., Minnema MC; University Medical Center Utrecht, Department of Hematology, Utrecht, the Netherlands., Jak M; University Medical Center Utrecht, Department of Hematology, Utrecht, the Netherlands., van Dorp S; Radboud University Medical Center, Department of Hematology, Nijmegen, the Netherlands., Vermaat JSP; Leiden University Medical Center, Department of Hematology, Leiden, the Netherlands., van der Poel MWM; Department of Internal Medicine, Division of Hematology, GROW School for Oncology and Developmental Biology, Maastricht University Medical Center, Maastricht, the Netherlands., van Oijen MGH; Amsterdam University Medical Centers, University of Amsterdam, Department of Oncology, Amsterdam, the Netherlands., Kuipers MT; Amsterdam UMC Location University of Amsterdam, Hematology, Amsterdam, the Netherlands.; Cancer Center Amsterdam, Amsterdam, the Netherlands.; LYMMCARE, Amsterdam, the Netherlands., Nijhof IS; Amsterdam UMC Location University of Amsterdam, Hematology, Amsterdam, the Netherlands.; Cancer Center Amsterdam, Amsterdam, the Netherlands.; LYMMCARE, Amsterdam, the Netherlands.; St Antonius Ziekenhuis Nieuwegein, Hematology, Nieuwegein, the Netherlands., Kersten MJ; Amsterdam UMC Location University of Amsterdam, Hematology, Amsterdam, the Netherlands.; Cancer Center Amsterdam, Amsterdam, the Netherlands.; LYMMCARE, Amsterdam, the Netherlands.
Jazyk:	angličtina
Zdroj:	JCO oncology practice [JCO Oncol Pract] 2023 Mar; Vol. 19 (3), pp. e407-e416. Date of Electronic Publication: 2022 Dec 12.
DOI:	10.1200/OP.22.00501
Abstrakt:	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.
Databáze:	MEDLINE
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