Initial safety run-in results of the phase III POLARGO trial: Polatuzumab vedotin plus rituximab, gemcitabine, and oxaliplatin in patients (pts) with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL).
Notice bibliographique
Résumé
7551 Background: Transplant-ineligible pts with R/R DLBCL have a poor prognosis (Gisselbrecht C, et al. Br J Haematol 2018). Several treatment options are available including platinum-based chemotherapies such as oxaliplatin plus rituximab and gemcitabine (R-GemOx). Adding polatuzumab vedotin to R-GemOx (Pola-R-GemOx) may improve outcomes for pts with a continued unmet medical need. The safety of polatuzumab vedotin and platinum-based therapy combinations must be considered as both are associated with neuropathy. POLARGO (NCT04182204; MO40598) is a Phase III, multicenter, open-label, randomized trial evaluating the safety and efficacy of Pola-R-GemOx vs R-GemOx in pts with R/R DLBCL. Methods: Results from the safety run-in stage of POLARGO are presented. The primary endpoint is the safety and tolerability of polatuzumab vedotin (1.8 mg/kg) + R-GemOx (R, 375 mg/m 2 ; Gem, 1000 mg/m 2 ; Ox, 100 mg/m 2 ) given every 21 days for up to 8 cycles. Safety was assessed by the incidence, nature, and severity of adverse events (AEs; NCI CTCAE v5.0), with a focus on peripheral neuropathy (PN). Dose interruptions and reductions were used to assess tolerability. Granulocyte-colony stimulating factor was given as primary prophylaxis with each cycle (C) of therapy; anti-infective prophylaxis for pneumocystis and herpes virus was mandatory. Results: As of October 26, 2021, 15 pts were enrolled and 11 (73%) pts received ≥4 cycles of Pola-R-GemOx. Median age was 76 (range 47–87) years, 10 (67%) pts had an IPI score of 3–5, 7 (47%) had ≥2 prior therapy lines, and 8 (53%) were refractory to last treatment. Grade (Gr) 3–4 AEs were reported in 5 (33%) pts: thrombocytopenia (20%) and neutropenia (13%) were the most common. Two (13%) pts had serious AEs (Gr 3 febrile neutropenia and Gr 3 infection [n = 1 each]). There were no Gr 5 AEs or AEs leading to drug discontinuation. Eight (53%) pts had Gr 1 or 2 PN; there were no cases of Gr >3 PN. Three (20%) pts had drug interruptions due to PN. Two (13%) pts had a dose reduction of polatuzumab vedotin and oxaliplatin due to PN at C5 and C8, respectively; one pt (7%) had a dose reduction of polatuzumab vedotin due to Gr 4 thrombocytopenia at C2. End-of-treatment (EOT) objective response rate was 40% (95% CI: 16–68) and complete response rate was 27% (95% CI: 8–55); 7 (47%) pts had progressive disease at EOT. Ten (67%) pts received subsequent therapies following Pola-R-GemOx, including CAR-T cell therapy (n = 3) and stem-cell transplant (n = 1). Conclusions: In the safety run-in stage, Pola-R-GemOx was safe and tolerable. PN was manageable with dose interruptions and reductions; no cases of Gr ≥3 PN were observed. The toxicity of this combination did not compromise delivery of subsequent treatments. POLARGO is currently enrolling pts to receive Pola-R-GemOx vs R-GemOx; results will be presented at a future meeting. Clinical trial information: NCT04182204.
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 | 0,006 | 0,007 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,002 | 0,000 |
| Bibliométrie | 0,000 | 0,001 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,001 |
| Intégrité de la recherche | 0,000 | 0,002 |
| 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 ».