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. 2022 Dec;10(12):e006082.
doi: 10.1136/jitc-2022-006082.

Patient-reported outcomes in adoptive cell-therapy trials: mind the gap

Eleonora Ghisoni  1   2 , Matteo Morotti  1   2 , Sara Colomer-Lahiguera  3   4 , Manuela Eicher  3   4 , George Coukos  1   2 , Lionel Trueb  1 , Massimo Di Maio  5
Affiliations

Patient-reported outcomes in adoptive cell-therapy trials: mind the gap

Eleonora Ghisoni et al. J Immunother Cancer. 2022 Dec.

Abstract

Adoptive cell therapies (ACT) have demonstrated promise in the treatment of patients with cancer, leading to long-lasting responses and, in some cases, even cure. Technological advances have brought these individualized therapies closer to reality, establishing them as credible therapeutic option. However, to date, few efforts have been made to understand patients' experience during ACT trials. Patient-reported outcomes (PROs) and patient-reported outcome measures (PROMs), which are instruments used to report PROs, are increasingly being used in oncology to capture patients' perspective, provide real-world data on treatment safety, and support decision-making processes, such as health economic decisions. Due to the inherent complexity of ACT, the inclusion of PROMs in this field remains limited. In this commentary, we discuss the benefit of capturing PROs in ACT trials, the challenges of PROM administration and collection, and we propose simple and actionable recommendations to promote their adoption in ACT trials.

Keywords: Clinical Trials as Topic; Immunotherapy, Adoptive.

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Conflict of interest statement

Competing interests: GC reports grants from Celgene, grants from Boehringer-Ingelheim, personal fees from Genentech, grants from Roche, personal fees from Roche, grants from BMS, personal fees from BMS, personal fees from AstraZeneca, grants from Iovance Therapeutics, grants from Kite Pharma, personal fees from NextCure, personal fees from Geneos Tx, and personal fees from Sanofi/Aventis. MDM received grants or contracts to his institution from Tesaro and GSK, consulting fees from Novartis, Roche, AstraZeneca, Merck Serono, Pfizer, Merck Sharp & Dohme, Janssen, Eisai, Takeda, Boehringer Ingelheim, Servier; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Novartis, Roche, AstraZeneca, Pfizer, Merck Sharp & Dohme, Janssen, Astellas, Boehringer Ingelheim; participation on a Data Safety Monitoring Board or Advisory Board for Merck Sharp & Dohme, Janssen, Astellas and Amgen. ME reports grants or contracts to her institution from Kaiku Health, Novartis, Roche, Vifor, BMS and Payment or honoraria for lectures, presentations from Roche, BMS and Vifor. The other authors have no conflict of interest to declare.

Figures

Figure 1
Figure 1
Schematic representation of the patient journey during the adoptive cell-therapy process with key recommendations to capture patient-reported outcomes. Upper part: Patient journey through cell-therapy process. Middle part: Key recommendations for the clinical team to recognize and address the potential barriers early during the ACT process. Lower part: Key points that should be captured by patient-reported outcome measures longitudinally. ACT, adoptive cell therapies; CAR, chimeric antigen receptor; GP: general practitioner; HRQoL, health-related quality of life; PROs, patient-reported outcomes. Figure created with BioRender.com.
See this image and copyright information in PMC

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