DP044 | PRELIMINARY ANALYSIS OF CLL-ZANU2024, AN ITALIAN NON-INTERVENTIONAL STUDY ASSESSING THE REAL-WORLD USE OF ZANUBRUTINIB IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)
Notice bibliographique
Résumé
The CLL-ZANU2024 study is an Italian, observational, multicenter, longitudinal secondary data analysis evaluating the safety and efficacy of Zanubrutinib in real-world post-marketing setting. It retrospectively examines chronic lymphocytic leukemia (CLL) patients who initiated Zanubrutinib from October 2023, regardless of prior treatment. The study aimed to enroll patients (pts) across 56 Italian sites, providing the first Italian real-world data register on Zanubrutinib in CLL. The primary end-point was time to treatment discontinuation (TTD) and reasons for discontinuation; the secondary end-point was time to next treatment or death (TTNTD). As of May 2024, 393 pts were included. Median age was 76 years (range 44-94), and 63.2% were male. Zanubrutinib was first-line treatment in 237 pts (60.3%) (treatment-naïve, TN) and subsequent-line therapy in 156 pts (39.7%) (refractory/relapsed, RR). At treatment start, Binet stage was: A in 10.4%, B in 38.4%, C in 51.1%. Del(17p), TP53 mutation, and IGHV status were available in 91.1%, 90.8%, and 87.8% of pts, respectively. Del(17p) was detected in 16.5% (31 TN, 28 RR), TP53 mutations in 20.2% (36 TN, 36 RR), and IGHV was unmutated in 70.1% (154 TN, 88 RR). Among 348 pts with both del(17p) and TP53 data, concomitant abnormalities were observed in in 9.5%, del(17p) only in 6.9%, and TP53-mutation only in 10.6%. Bulky lymph nodes (>10 cm) were observed in 6.4%. Most pts (75.8%) received an initial zanabrutinib dose of 320 mg/day, as per Summary of Product Characteristics (SmPC). At a median follow-up of 8 months (range 1-32) median TTD was not reached in the entire cohort nor in TN and RR subgroups (Figure 1A). The 12-month discontinuation rate was 10.6% overall (9.3% TN, 12.8% RR). Overall, 7.6% (30/393) of patients (18 TN, 12 RR) discontinued treatment. Main reasons were toxicity (15 pts) and disease progression (10 pts). Patients with a Canadian Study of Health and Aging (CSHA) Clinical Frailty Scale (CFS) >3 had a significantly higher probability of discontinuating therapy (12-month discontinuation rate CFS < or =3 vs CFS>3: 6.2% vs 22.3%, P<0.0001) (Figure 1B), while IGHV status and TP53 disruption did not significantly impact on TTD. The 12-month TTNTD probability was 94.6% overall (95.8 % TN, and 92.5% RR). This preliminary report from the largest available real-world study on zanubrutinib in CLL confirms a favorable safety profile in both TN and RR settings, with a low rate of discontinuation.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,001 | 0,000 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,000 |
| Bibliométrie | 0,001 | 0,001 |
| Études des sciences et des technologies | 0,000 | 0,001 |
| Communication savante | 0,000 | 0,001 |
| Science ouverte | 0,002 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,005 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule tête enseignante, pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».