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/m2; Gem, 1000 mg/m2; Ox, 100 mg/m2) 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 machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,003 | 0,002 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,001 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,001 |
| Communication savante | 0,001 | 0,001 |
| Science ouverte | 0,001 | 0,001 |
| Intégrité de la recherche | 0,001 | 0,003 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,004 | 0,001 |
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 source (Gemma direct ou Codex distillé), 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 ».