非霍奇金淋巴瘤患者 CAR-T 细胞治疗的患者报告结局及其对生存的影响

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.

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.

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).

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.