Health-related quality of life after second-line axi-cel in transplant-ineligible patients with large B-cell lymphoma

The phase 2 ALYCANTE trial aimed to evaluate the investigator-assessed complete metabolic response at 3 months from the axicabtagene ciloleucel (axi-cel) infusion as a primary end point in patients with high-risk relapsed/refractory large B-cell lymphoma who are ineligible for autologous stem cell transplantation (ASCT). This study showed a significant improvement in complete metabolic response rate at 3 months based on historical controls. This study reports the health-related quality of life (HRQoL) results as a secondary end point. HRQoL was assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) cancer-specific questionnaire, the Quality of Life Questionnaire high-grade non-Hodgkin lymphoma 29 (QLQ-NHL-HG29) , and the EuroQol Quality of Life Scale-5 dimensions-5 levels of severity (EQ-5D-5L) generic questionnaire at baseline and 1, 3, 6, and 12 months after axi-cel infusion. Among the 62 patients included, 60 (97%) completed a baseline and at least 1 postbaseline HRQoL assessment. At 1 month infusion, adjusted mean change in HRQoL scores from baseline showed a clinically significant deterioration (greater than the clinical threshold) in physical, role, social functioning, and fatigue. However, all HRQoL dimensions recovered by 3 months after infusion and remained stable or continued to improve by 12 months. In an exploratory analysis, adjusted mean change in HRQoL score from baseline in ALYCANTE was similar to or better than in ASCT-eligible patients who received axi-cel in the phase 3 ZUMA-7 trial. Finally, the global health status and fatigue scores of the ALYCANTE population improved to levels comparable to the general French population of similar age by 3 months after infusion. These findings indicate that axi-cel improves HRQoL regardless of transplant eligibility, supporting its use across a broad patient population. This trial was registered at www.clinicaltrials.gov as #NCT04531046.

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Publication Details

Journal
Blood Advances
Published
2026-01-09
DOI
https://doi.org/10.1182/bloodadvances.2025018057
Primary Topic
Lymphoma Diagnosis and Treatment
Type
article
Field-Weighted Citation Impact
0.00

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article

Health-related quality of life after second-line axi-cel in transplant-ineligible patients with large B-cell lymphoma

R. Houot, G. Cartron, Amélie Anota, C Laurent et al.
Blood Advances
Lymphoma Diagnosis and Treatment
article

Health-related quality of life after second-line axi-cel in transplant-ineligible patients with large B-cell lymphoma

R. Houot, G. Cartron, Amélie Anota, C Laurent, Debus, Morgane Cheminant, Magalie Joris, E. Itti, Yassine Al Tabaa, Émilie Charton, Xavier Palard-Novello, S. Choquet, P. Feugier, Olivier Casasnovas, Thomas Gastinne, Paul Blanc‐Durand, Clement Bailly, Lucie Oberic, Remy Dulery, Francisco Llamas Gutierrez, Catherine Thieblemont, Emmannuel Bachy, Jacques-Olivier Bay, François Lemonnier, Fabrice Jardin, Gabriel Brisou, Cedric Portugues, Franck Morschhauser
article en

Abstract

The phase 2 ALYCANTE trial aimed to evaluate the investigator-assessed complete metabolic response at 3 months from the axicabtagene ciloleucel (axi-cel) infusion as a primary end point in patients with high-risk relapsed/refractory large B-cell lymphoma who are ineligible for autologous stem cell transplantation (ASCT). This study showed a significant improvement in complete metabolic response rate at 3 months based on historical controls. This study reports the health-related quality of life (HRQoL) results as a secondary end point. HRQoL was assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) cancer-specific questionnaire, the Quality of Life Questionnaire high-grade non-Hodgkin lymphoma 29 (QLQ-NHL-HG29) , and the EuroQol Quality of Life Scale-5 dimensions-5 levels of severity (EQ-5D-5L) generic questionnaire at baseline and 1, 3, 6, and 12 months after axi-cel infusion. Among the 62 patients included, 60 (97%) completed a baseline and at least 1 postbaseline HRQoL assessment. At 1 month infusion, adjusted mean change in HRQoL scores from baseline showed a clinically significant deterioration (greater than the clinical threshold) in physical, role, social functioning, and fatigue. However, all HRQoL dimensions recovered by 3 months after infusion and remained stable or continued to improve by 12 months. In an exploratory analysis, adjusted mean change in HRQoL score from baseline in ALYCANTE was similar to or better than in ASCT-eligible patients who received axi-cel in the phase 3 ZUMA-7 trial. Finally, the global health status and fatigue scores of the ALYCANTE population improved to levels comparable to the general French population of similar age by 3 months after infusion. These findings indicate that axi-cel improves HRQoL regardless of transplant eligibility, supporting its use across a broad patient population. This trial was registered at www.clinicaltrials.gov as #NCT04531046.

Blood AdvancesVol. 10(5)
Hôpital Necker-Enfants Malades (FR), Centre National de la Recherche Scientifique (FR), Université de Bordeaux (FR), Inserm (FR), Université Fédérale de Toulouse Midi-Pyrénées (FR), Lyon College (US), Université Paris-Est Créteil (FR), Université de Lille (FR), Centre Hospitalier Universitaire de Nantes (FR), Université Rennes 2 (FR), Sorbonne Université (FR), Institut Necker Enfants Malades (FR), Centre de Recherches en Cancérologie de Toulouse (FR), Centre de Recherche en Cancérologie et Immunologie Intégrée Nantes Angers (FR), Centre Hospitalier Universitaire de Montpellier (FR), Centre Hospitalier Universitaire Amiens-Picardie (FR), Assistance Publique – Hôpitaux de Paris (FR), Institut universitaire du cancer de Toulouse Oncopole (FR), University of Clermont Auvergne (FR), Centre Léon Bérard (FR), Bordeaux Population Health (FR), The Lymphoma Academic Research Organisation (FR), Laboratoire de Thermique et Energie de Nantes (FR), Centre Eugène Marquis (FR), Hôpital Lyon Sud (FR), Pitié-Salpêtrière Hospital (FR), Centre Hospitalier Universitaire de Clermont-Ferrand (FR), Hôpitaux Universitaires Henri-Mondor (FR), Centre de Recherche Saint-Antoine (FR), Laboratoire National Henri Becquerel (FR), Clinique Clémentville (FR), Maison des Sciences sociales et des Humanités de Dijon (FR), Hôpital Saint-Louis (FR), Lymphoma Study Association (FR), Institut Paoli-Calmettes (FR), Centre Hospitalier Universitaire de Rennes (FR), Institut Mondor de Recherche Biomédicale (FR), Université de Rennes (FR), Université de Lorraine (FR), Nantes Université (FR)
Amgen, Bristol-Myers Squibb, Pfizer, AstraZeneca, Sanofi, Gilead Sciences, Celgene, CSL Behring, Les Laboratories Pierre Fabre, Philippe Foundation, Atara Biotherapeutics, BeiGene, Incyte, Institut National de la Santé et de la Recherche Médicale, Fondation ARC pour la Recherche sur le Cancer, Ligue Contre le Cancer, Astellas Pharma, Institut National Du Cancer, Servier, Grifols, Centre Hospitalier Universitaire de Rennes, Cilag
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Lymphoma Diagnosis and Treatment
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