Transplantation and cellular therapy · 2025
Patient-Reported Outcomes of CAR T-Cell Therapy in Non-Hodgkin Lymphoma Patients and Their Impact on Survival.
СтатьяМногоцентровое исследованиеНаблюдательное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Spanjaart Anne Mea, Coz Elsa, Rioufol Catherine, Maucort-Boulch Delphine, Roche Sylvain, Beijamini Vanessa, Vledder Amária, Ghesquieres Hervé, Kersten Marie José, da Silva Maria Gomes
Аннотация
BACKGROUND: Chimeric antigen receptor T-cell (CAR-T) therapy has significantly improved outcomes for patients with non-Hodgkin lymphoma (NHL), but not all patients achieve long-term remission, and serious side effects are common. Predicting prognosis after CAR-T remains challenging. Patient-reported outcomes (PRO), such as health-related quality of life (HRQoL), provide valuable insights into the impact of the disease and treatment on patients' wellbeing. However, real-world PRO data are limited and it is unknown whether PROs carry independent prognostic value that could enhance survival prediction models.
OBJECTIVES: To evaluate changes over time in different HRQoL domains among NHL patients treated with CAR-T in the real-world, and to assess the added predictive value of baseline HRQoL scores in prediction models for progression-free survival (PFS) and overall survival (OS).
STUDY DESIGN: QUALITOP (NCT05626764) is an international prospective cohort study monitoring multidimensional HRQoL aspects after cancer immunotherapy. HRQoL was prospectively collected by FACT-Lym, before CAR-T and at month 1, 3, 6, and 12 postinfusion. Cox proportional hazards models were applied to assess the predictive value of baseline FACT-Lym scores on PFS and OS. Additionally, time-dependent area under the receiver operating characteristic curves (AUC) were calculated at 3, 6, 12, and 18 months postinfusion to evaluate model performance over time.
RESULTS: Between May 2020 and May 2024, 115 NHL patients were treated with commercially available CAR-T products and included for analysis. A clinically meaningful improvement in HRQoL was observed at month 12. FACT-Lym total, lymphoma-specific, physical, and functional subscale-scores were significantly associated with both PFS and OS, independent of elevated C-reactive protein, elevated lactate dehydrogenase, and ECOG performance status. The models including baseline FACT-Lym scores predicted OS most accurately at month 3, with the highest AUC observed for the FACT-Lym total score (AUC = 84.8).
CONCLUSION: This study showed that, in real-world, HRQoL improves over time in NHL patients treated with CAR-T and that PRO scores add value to prognostic models, holding promise for future clinical decision-making.
OBJECTIVES: To evaluate changes over time in different HRQoL domains among NHL patients treated with CAR-T in the real-world, and to assess the added predictive value of baseline HRQoL scores in prediction models for progression-free survival (PFS) and overall survival (OS).
STUDY DESIGN: QUALITOP (NCT05626764) is an international prospective cohort study monitoring multidimensional HRQoL aspects after cancer immunotherapy. HRQoL was prospectively collected by FACT-Lym, before CAR-T and at month 1, 3, 6, and 12 postinfusion. Cox proportional hazards models were applied to assess the predictive value of baseline FACT-Lym scores on PFS and OS. Additionally, time-dependent area under the receiver operating characteristic curves (AUC) were calculated at 3, 6, 12, and 18 months postinfusion to evaluate model performance over time.
RESULTS: Between May 2020 and May 2024, 115 NHL patients were treated with commercially available CAR-T products and included for analysis. A clinically meaningful improvement in HRQoL was observed at month 12. FACT-Lym total, lymphoma-specific, physical, and functional subscale-scores were significantly associated with both PFS and OS, independent of elevated C-reactive protein, elevated lactate dehydrogenase, and ECOG performance status. The models including baseline FACT-Lym scores predicted OS most accurately at month 3, with the highest AUC observed for the FACT-Lym total score (AUC = 84.8).
CONCLUSION: This study showed that, in real-world, HRQoL improves over time in NHL patients treated with CAR-T and that PRO scores add value to prognostic models, holding promise for future clinical decision-making.