SAKK 35/14 RANDOMIZED TRIAL OF RITUXIMAB WITH OR WITHOUT IBRUTINIB FOR UNTREATED PATIENTS WITH ADVANCED FOLLICULAR LYMPHOMA IN NEED OF THERAPY
Notice bibliographique
Résumé
The Swiss Group for Clinical Cancer Research (SAKK) and the Nordic Lymphoma Group (NLG) conducted the SAKK 35/14 randomized phase-2 trial (NCT02451111) to evaluate the safety and efficacy of frontline treatment with ibrutinib plus rituximab compared to rituximab plus placebo in adult patients (pts) with advanced follicular lymphoma in need of therapy. Ibrutinib was administered orally (560 mg once a day) for 24 months (104 weeks), while rituximab was given intravenously (375 mg/m2) on day 1 of weeks 1, 2, 3, and 4, and subsequently every 2 months for 12 maintenance administrations, given either intravenous (375 mg/m2) or subcutaneous (1400 mg flat dose) based on local policy. The primary endpoint was the complete remission (CR) rate at 24 months after randomization determined on PET/CT scans by an independent review panel. In total, 192 pts were randomized (98 in arm A rituximab + placebo; 94 in arm B rituximab + ibrutinib) with stratification by rituximab maintenance route, lymphoma grade, follicular lymphoma international prognostic index, and bulky (≥6 cm) disease. The CR rate at 24 months was 36% (95% CI, 26%–46%) in arm A and 40% (95% CI, 30%–51%) in arm B with an odds ratio (OR) of 0.80 (95% CI, 0.44–1.46; p = 0.233). At a median follow-up of 42 months, the 3-year progression-free survival (PFS) rate was 36% in arm A (95% CI, 19%–54%) and 45% (95% CI, 25%–64%) in arm B, with a hazard ratio (HR) of 1.63 (95% CI, 0.99–2.7; p = 0.056). At 3 years after randomization, 45% (95% CI, 36%–56%) of pts in arm A and 39% (95% CI, 30%–50%) in arm B had already required a new treatment, with a HR of 1.47 (95% CI, 0.93–2.32; p = 0.099). The 3-year overall survival rate (OS) approximated 96% in both arms (95% CI, ∼89%–99%) with a HR of 1.02 (95% CI, 0.29–3.55; p = 0.979). The percentage of pts experiencing at least one adverse event (AE) was similar in the two arms (100% and 99%). However, 29% of pts experienced at least one AE of grade ≥3 in arm A while this was the case for 49% of pts in arm B. The percentage of pts experiencing AEs related to trial treatment was also lower in arm A (67%) than in arm B (84%). A total of 93 SAEs were reported, 42 in arm A, affecting 26% of pts, and 51 in arm B, involving 39% of pts. A total of 7 SUSARS occurred, 1 in arm A and 6 in arm B. The most frequent AEs of grade ≥3 during treatment were neutropenia (8% in arm A and 14% in arm B), lymphocytosis (5% in arm A and 10% in arm B), hypertension (5% in each arm), and maculo-papular skin rash (not observed in arm A, 11% in arm B). The SAKK35/14 study was partly funded by Janssen Cilag AG, Roche Pharma (Schweiz) AG, and the Hubacher Fonds. Keywords: immunotherapy, indolent non-Hodgkin lymphoma, molecular Targeted Therapies Conflicts of interests pertinent to the abstract A. Stathis Consultant or advisory role: Janssen, Roche Research funding: Abbvie, ADC Therapeutics, Amgen, AstraZeneca, Bayer, Cellestia, Incyte, LoxoOncology, Merck, Novartis, Pfizer, Philogen, Roche Educational grants: AstraZeneca Other remuneration: Expert testimonies: Bayer, Eli/Lilly F. Hitz Consultant or advisory role: Takeda, Abbvie, Roche E. Zucca Consultant or advisory role: BeiGene, BMS/Celgene, Celltion Healthcare, Curis, Eli/Lilly, Incyte, Ipsen, Janssen, Kyte (a Gilead Company), Merck, Roche Research funding: AstraZeneca, BMS/Celgene, Incyte, Janssen, Merck, Roche Educational grants: Abbvie, BeiGene, Janssen, Roche.
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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 | 0,002 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,003 | 0,000 |
| Bibliométrie | 0,000 | 0,001 |
| Études des sciences et des technologies | 0,000 | 0,001 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 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 ».